Derived from healthy human blood， human albumin is widely applied for treating critically and seriously ill patients. However， inappropriate off-label and irrational use of human albumin has remained prevalent， resulting in significant wasting of valuable drug resources. Currently， there is an acute dearth of authoritative guidelines or consensus on clinical application management of human albumin in China. To address this wide gap， a multidisciplinary panel of experts， under the auspices of Committee of Hospital Pharmacy of Chinese Pharmaceutical Association， has collaborated on developing a comprehensive consensus for standardizing management measures and providing guidance for rational utilization of human albumin. This consensus focused upon eight major aspects of clinical application management， including supply management， formulating clinical application standards， management of off-label drug use， training in rational usage， management of prescription sessions， prescription review processes， informatization management and patient education regarding medication usage.

Osteoporosis has been the most prevalent bone disease. It is characterized clinically by systemic low bone mass and microstructural damage to bone tissue， resulting in heightened vulnerability to fractures due to greater bone fragility. With a rapid aging of society， the prevalence of osteoporosis has markedly spiked. However， its public awareness， diagnostic rate and treatment level remain low. Osteoporotic fractures carry severe consequences， particularly among elders， leading to disability and even death. Consequently， osteoporosis and associated fractures have emerged as critical public health issues in China. Anti-osteoporosis agents may be divided into anti-resorptives， anabolics of stimulating bone formation and dual-acting drugs. Based upon the latest clinical trials and drug application status for osteoporosis， a multidisciplinary panel of experts assembled by Hospital Pharmacy Committee of Chinese Pharmaceutical Association has collaborated to develop this consensus for standardizing rational drug dosing for improved patient outcomes and satisfactions.

Small interfering RNA （siRNA） lipid-lowering drugs are a new class of lipid-lowering agents. At present， there is little evidence-based evidence and practical experience for this class of drugs. In order to strengthen the awareness of medical workers and standardize the rational use of such drugs in clinical practice， led by the Beijing Hospital， the National Center for Geriatrics， Geriatric Pharmacy Professional Committee of Chinese Medical Education Association and Hospital Pharmacy Professional Committee of Chinese Pharmaceutical Association organized relevant clinical medicine， pharmacy and evidence-based experts. Based on the evidence-based evidence and clinical practice， Delphi method was used to collect expert opinions， and fully discussion was performed through three rounds of expert consultation. The consensus introduced the mechanism of siRNA lipid-lowering drugs， and taking the marketed drug inclisiran as an example， the clinical evidence and drug safety were described， in order to provide reference for the standardized clinical application of siRNA lipid-lowering drugs.

Glucokinase agonist dorzagliatin is a new oral antidiabetic drug independently developed in China， which provides a new drug option for type 2 diabetic patients newly diagnosed or poorly controlled with metformin. In order to standardize the clinical application of dorzagliatin and deepen the understanding of medical workers on the patient choice， usage and dosage， drug interactions， and adverse reactions， led by Beijing Hospital， the National Center for Gerontology， Geriatric Pharmacy Professional Committee of China Medical Education Association， and Hospital Pharmacy Professional Committee of Chinese Pharmaceutical Association organized relevant clinical medicine， pharmacy and evidence-based experts to develop the consensus after three rounds of expert opinion collection and thorough discussion by using the Delphi method based on evidence-based evidence and clinical practice. A total of 9 recommendations were formulated， which will provide reference for the rational use of dorzagliatin in clinical practice.

Therapeutic drug monitoring （TDM） is an important support position for achieving personalized drug administration， ensuring the safety， effectiveness and cost-effectiveness of medication. Its job responsibilities have special requirements for personnel's professional abilities. However， there is currently no competency framework or other standard document for the position of therapeutic drug testing at home and abroad to support talent cultivation and performance development in this position. In order to fill this vacancy， the Division of Therapeutic Drug Monitoring of the Chinese Pharmacological Society and the Professional Committee of Hospital Pharmacy of the Chinese Pharmaceutical Association jointly initiated the organization of experts and front-line professionals in this field， combined with relevant research progress at home and abroad and actual work needs， and adopted the improved Delphi method to develop the Competency Framework for Pharmacists in Therapeutic Drug Monitoring （2023）. This framework consists of three levels of indicators， among which the first level indicators include professional ethics and conduct， general abilities， TDM related professional theoretical knowledge and skills， TDM testing practice and management， new project evaluation and method development， TDM report interpretation and rational drug use management， totaling six categories. The third level indicators respectively set recommended standards for personnel competence in TDM testing positions and interpretation positions. The development of this framework will lay the foundation for the establishment of competency in domestic TDM positions.

The use of hemostatic drugs during peri-operative period is an important measure to reduce blood loss and promote postoperative rehabilitation. Meanwhile， the improper use of hemostatic drugs may increase the risk of thromboembolic disease and disseminated intravascular coagulation. This consensus is aim to regulate the rational use of hemostatic drugs during peri-operative period. Based on the latest evidence of evidence-based medicine and suggestions from pharmaceutical and clinical experts， this consensus states the mechanism， clinical application suggestions and pharmaceutical care of commonly used non-blood hemostatic drugs during peri-operative period， which doesn’t contain blood products. The purpose of this work is to provide reference for clinicians and surgical pharmacists to rationally use hemostatic drugs during peri-operative period.

OBJECTIVE To systematically summarize the current practice status and implementation effects of pharmacist-managed clinics （PMC） in healthcare institutions in China and provide reference for further improvement of PMC norms， processes and evaluation systems. METHODS Major databases were systematically searched to collect the standards and norms of PMC in China， national multicenter cross-sectional studies， and controlled studies assessing the implementation effects of PMC from inception to February 2023. Qualitative analysis of the criteria， availability， service model and implementation effectiveness of pharmacy clinics in China was conducted. RESULTS Forty-six studies were finally included. Totally 8 studies addressed the standards of comprehensive or specialist PMC， proposed the basic requirements for opening PMC， and standardized and recommended all major aspects of PMC services. Totally 7 multicenter cross-sectional studies suggested that the opening rate of PMC in China was generally low， with a wide range of specialties and a variety of attendance patterns， while the fees varied widely across regions. Thirty-one studies explored the implementation effects of PMC in different specialties， and the interventions basically followed the basic process of therapeutic drug management. The outcome indicators mainly involved medication adherence， consultation satisfaction， and incidence of adverse drug reactions， etc.. All included studies suggested that PMC could improve patients’ medication adherence and clinical outcomes. CONCLUSION China has initially constructed standards and specifications for PMC， and overall satisfied implementation results have been achieved. However， the service model， content and evaluation system of specialized PMC need to be further improved.

In recent years， with a rapid development of subcutaneous drug delivery techniques， more and more antineoplastic monoclonal antibodies of existing intravenous agents have been approved for subcutaneous dosing. Pharmaceutical manufacturing， pharmacokinetic characteristics， clinical efficacy and safety， clinical rational use and pharmaceutical management of innovative subcutaneous antineoplastic drugs have attracted growing attention. However， there is still a global lack of normative guidance for innovative subcutaneous antineoplastic drugs. Therefore， Hospital Pharmacy Specialty Committee of Chinese Pharmaceutical Association organized domestic experts to propose the definition of innovative subcutaneous preparations of antineoplastic drugs based upon existing resources of evidence-based medicine and clinical drug dosing experiences. Recommendations were offered on unique characteristics， clinical rational use， pharmaceutical management and care of innovative subcutaneous antineoplastic drugs.

OBJECTIVE To evaluate the advantages and hazards of denosumab vs. zoledronic acid （ZA） in bone protection for breast cancer and provide evidence-based proof for clinical decision-making. METHODS Health technology assessment （HTA） related websites， including PubMed， WanFang， Cochrane Library and CNKI， were systematically searched. The systematic review/Meta-analysis and pharmacoeconomic evaluation on denosumab and ZA for modified bone therapy in breast cancer were included. According to the inclusion and exclusion criteria， two reviewers independently identified the literature， extracted the data and assessed the quality of the included studies， and then performed qualitative description and comparison of the results. RESULTS Six systematic review/Meta and five pharmacoeconomic evaluation were included. Compared with ZA， denosumab was more effective in delaying the time of first occurrence and recurrence of skeletal-related events （SREs）， reducing the incidence of SREs， and preventing pain in breast cancer with bone metastases. Denosumab reduced the fracture rates in postmenopausal breast cancer treated with aromatase inhibitors， while ZA did not show the effect. Compared with ZA， the adverse effects of denosumab were less severe inedema， pyrexia， renal failure and bone pain. However， denosumab may promote the occurrence of osteonecrosis of jaw. Denosumab may have more cost-effectiveness advantages than ZA in domestic and international medical settings. CONCLUSION Compared with ZA， denosumab is safer， more effective and more economical in bone care of breast cancer.

Duchenne muscular dystrophy （DMD） is an X-linked recessive genetic disease caused by mutations in the DMD gene. This gene is the largest known gene in humans， consisting of 79 exons that encode a dystrophin protein containing 3685 amino acids. The size of the DMD gene contributes to the complexity and heterogeneity of mutation types， presenting challenges for the development of therapeutic drugs. Significant progress has been made in recent years toward the treatment of this disease， with several novel drugs approved for clinical development in various regions of the world as research advances. However， there is currently no cure for this disease. This review summarizes the new research progress of DMD gene therapy， and focuses on introducing the most widely available codon reading and exon skipping therapies and their therapeutic mechanisms. In addition， the issues of clinical endpoint selection and accessibility of drug information in DMD new drug research were discussed， as well as the challenges and challenges currently faced by gene therapy， providing new insights for DMD new drug development.

As a polymer material with a three-dimensional network structure， hydrogel has excellent properties of hydrophilicity， flexibility and swelling. Also it has decent biocompatibility and degradability. Therefore hydrogels have great potential applications in such biomedical fields as drug delivery and tissue scaffolds. Summarizing the latest domestic and foreign literatures， this review introduced different types of hydrogels responsive to temperature， pH， redox， enzyme， electricity and multiple factors. The applications of hydrogels in biomedicine included tissue engineering， drug carrier， dressing， sensor and 3D cell culture.

Multidrug-resistant Pseudomonas aeruginosa has become one of the common pathogens of nosocomial infections. It can simultaneously develop resistance to common antibiotics through multiple resistance mechanisms. Increasing treatment difficulties and patient mortality significantly， it has become a global public health challenge. This review focused upon the epidemiological features and risk factors of Pseudomonas aeruginosa infection， the resistance characteristics to commonly used antibiotics and analyzes the sensitivity criteria and clinical applications of new antibiotics against multidrug-resistant Pseudomonas aeruginosa including ceftolozane/tazobactam， ceftazidime/avibactam， imipenem-cilastatin/relebactam and cefiderocol. It may provide references for clinical applications.

OBJECTIVE To evaluate the comprehensive clinical value of domestic and imported montelukast sodium （MS） in the treatment of children with asthma. METHODS Six dimensions of safety， effectiveness， economy， suitability， accessibility and innovation， expert consultation and literature survey were employed for determining the clinical comprehensive evaluation index system. Delphi method and analytic hierarchy process were utilized for screening the index system and determine the weights of all indices. Evidence collection proceeded through literature researches， real world researches and questionnaire surveying. Experts were invited to score MS according to evidence sets. Total score of clinical comprehensive evaluation of two drugs was calculated by the weights of indices. RESULTS A comprehensive clinical evaluation index system of MS was established， including 6 primary indices （safety， effectiveness， suitability， accessibility， economy & innovation）， 14 secondary indices and 32 tertiary indices. Total score of MS centrally purchased domestically was 8.12 points and total score of imported original drug was 8.03 points. The scores of safety， effectiveness and innovation of imported original research drugs were slightly higher than those of pooled drugs. And the scores of economy， accessibility and suitability of pooled drugs were slightly higher than those of imported original research drugs. CONCLUSION The comprehensive clinical value of MS centrally purchased domestically for treating pediatric asthma is superior to that of imported original drugs.

OBJECTIVE To investigate the protective effect of Qinggan Yipi Capsules (QgYp) on carbon tetrachloride-induced hepatic fibrosis (HF) in rats and explored the potential mechanism of QgYp in improving HF through regulating intestinal microbiota. METHODS A total of 36 Sprague-Dawley rats were randomly divided into the following groups:normal group, model group, low-dose QgYp group, medium-dose QgYp group, high-dose QgYp group, and colchicine group. Hepatic fibrosis was induced by intraperitoneal injection of carbon tetrachloride oil solution. After 4 weeks, drug intervention was initiated and continued until the 8th week. Pathological changes were observed under a light microscope using HE and Masson staining. The levels of serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were determined using an automated biochemical analyzer. The serum levels of hyaluronic acid (HA), laminin (LN), procollagen type Ⅲ (PCⅢ), and collagen type Ⅳ (Ⅳ-C) were measured using ELISA. Additionally, another 24 Sprague-Dawley rats were randomly assigned to the normal group, model group, and medium-dose QgYp group. The same methods of modeling and drug administration as mentioned above were used, and after 8 weeks, cecal contents were collected for analysis of gut microbiota using 16S rRNA sequencing technology. RESULTS Compared to the model group, the rats in the various QgYp groups exhibited a significant increase in body weight (P＜0.05). Additionally, the liver weight and liver coefficient significantly decreased (P＜0.05). The histopathological examination revealed a significant improvement in liver tissue fibrosis and collagen fiber deposition (P＜0.05). In the QgYp moderate-dose group and QgYp high-dose group, the levels of ALT, AST, HA, LN、PCⅢ, and Ⅳ-C were significantly reduced (P＜0.05), and there was no significant difference between the two groups. The analysis of gut microbiota demonstrated that QgYp increased the richness and diversity of the gut microbiota in HF rats and altered the composition of the gut microbiota (P＜0.01). QgYp supplementation led to an increased abundance of beneficial bacteria, such as g__norank_f__norank_o__Clostridia_UCG-014 and Akkermansia, while decreasing the abundance of harmful bacteria, such as Romboutsia, Blautia, and Clostridium sensu stricto 1. CONCLUSION QgYp exhibits the potential to ameliorate carbon tetrachloride-induced hepatic fibrosis in rats, and its mechanism is associated with the modulation of gut microbiota diversity and abundance.

OBJECTIVE To analyze the factors that affect the peak to valley concentration of vancomycin blood in patients after orthopedic surgery, and to explore a population pharmacokinetic software that can predict the peak to valley concentration of vancomycin blood in patients after orthopedic surgery.METHODS Direct chemiluminescence technology was used to determine vancomycin peak and trough blood concentrations in postoperative orthopedic patients in The Sixth Affiliated Hospital of Xinjiang Medical University. Basic information of patients and routine blood and biochemical indexes before drug administration were collected, and the influencing factors of vancomycin blood peak and trough concentrations were analyzed by binary logistics regression. four population pharmacokinetics software, SmartDose, Vancomycin dose recommendation and blood concentration prediction tool, Vancomycin Calculator and Vancomycin Calculator+JPKD, were used to predict vancomycin blood peak and trough concentrations in postoperative orthopedic patients, and absolute weight deviation was used to determine the software applicable to predict vancomycin blood peak and trough concentrations in postoperative orthopedic patients. RESULTS Eighty-two patients were included in this study and creatinine clearance and cystatin C were found to differ between the groups for peak and trough concentrations, respectively (P＜0.05). Binary logistics regression analysis revealed that cystatin C was an independent protective factor for vancomycin peak and trough concentrations (OR=28.482 and OR=62.691, both P＜0.05). The absolute weight deviation of Vancomycin Calculator+JPKD predicted vancomycin blood peak and trough concentrations in post-operative orthopedic patients were <30%. CONCLUSION Cystatin C levels may be an important parameter affecting vancomycin peak and trough concentrations in post-operative orthopedic patients, and Vancomycin Calculator+JPKD predicts vancomycin peak and trough concentrations better in post-operative orthopedic patients.

OBJECTIVE To control the quality of drugs and establish microbial limit test methods for four antibacterial liquid preparations including diphenhydramine hydrochloride， clobetasol propionate and lincomycin hydrochloride liniment， compound clobetasol propionate liniment， glacial acetic acid paint and concentrated compound benzoic acid paint. METHODS The bacteriostatic effect of the tested solution was eliminated by plate method and membrane filtration method， and the recovery tests of the total number of aerobic bacteria， fungi and yeast were carried out. The control bacteria were verified by medium dilution method and membrane filtration method. RESULTS The recoveries of the total aerobic microbial count and the total yeast and mold count for all kinds of testing strains were 0.5–2.0. In the method validations， Pseudomonas aeruginosa and Staphylococcus aureus were detected， and no control bacteria were detected out in the negative control group. CONCLUSION It is proved that the method is scientific and feasible， and the results are accurate and reliable. It is suitable for the quality control of the 4 liquid pharmaceutical preparations， which can objectively reflect the contamination status of microorganisms in drugs.

Objective To explore whether or not Changji’an Formula （CJAF） treats diarrhea-predominant irritable bowel syndrome （IBS-D） through interfering with tryptophan metabolism and its downstream NMDAR1/ERK/BDNF signaling pathway. Methods Twenty-four Sprague-Dawley （SD） male rats were randomized into 4 groups of normal， model， CJAF （16.74 g·kg^–1） and pinaverium bromide （18 mg·kg^–1） （n=6 each）. Three-factor method was employed for establishing a rat model of IBS-D. After successful modeling， CJAF was dosed by gavage once daily for 2 weeks. Finally the rats were sacrificed for tissue harvesting. The model was evaluated by drying method to determine the water content of feces， abdominal wall withdrawal reflex for assessing the visceral sensitivity， determination of sugar-water preference and hematoxylin-eosin （HE） stain. The plasma content of tryptophan metabolite was determined by LC-MS. Quantitative polymerase chain reaction （q-PCR） was utilized for detecting the mRNA expressions of NMDAR1， CREB1 and BDNF. Western blot was utilized for detecting the protein expressions of IDO1， NMDAR1， ERK1/2， pERK， CREB1 and BDNF. And immunofluorescence was employed for detecting the expression of IDO1. Enzyme-linked immunosorbent assay （ELISA） was used for determining the expression of IFN-γ. Results As compared with model group， CJAF and Pinaverium Bromide groups had lower fecal water content， lower AWR score and higher sugar-water preference value （P<0.05）. Plasma levels of TRP and KA spiked， the levels of Kyn and QA declined and the expression of IFN-γ was down-regulated （P<0.05）. And mRNA/protein expressions of IDO1， NMDAR1， pERK， CREB1 and BDNF dropped in colon （P<0.05）. Conclusion CJAF may improve the symptoms of pain and diarrhea in IBS-D model rats， Its mechanism is probably correlated with the regulation of tryptophan-kynurenine metabolism， an inhibition of IDO1 expression and the regulation of NMDAR1/ERK/BDNF signaling pathway.

OBJECTIVE To systematically review the short/long-term economic evaluations of Semaglutide Injection. METHODS The databases of PubMed， Embase， Web of Science， Cochrane Library， EBM Reviews-Health Technology Assessment， EBM Reviews-NHS Economic Evaluation Database， China National Knowledge Infrastructure （CNKI）， Wanfang， VIP and ISPOR were searched from inception until December 1， 2023. Two researchers independently screened reports， extracted raw data and evaluated qualities. RESULTS A total of 38 articles were included. From the perspective of research countries， Semaglutide Injection was economically advantageous compared to other GLP-1 receptor agonists （e.g. dulaglutide， exenatide ER & liraglutide） and insulin glargine. When compared with SGLT-2 inhibitors （empagliflozin & canagliflozin）， Semaglutide Injection demonstrated superior long-term economic benefits. CONCLUSION Further economic studies based upon real-world data of Chinese populations are required for providing decision-making references for stakeholders.

OBJECTIVE To compare the consistency of transdermal effect of 5% minoxidil solution test product versus reference product. METHODS Bama miniature pig skin was utilized as a material for transdermal penetration and vertical modified Franz diffusion cell for determining the penetration of minoxidil solution. Liquid chromatography/tandem mass spectrometry （LC-MS/MS） was employed for determining the relationship between total amount of drug permeation in receiving solution and retention of drug in skin with time. RESULTS Test and reference products in skin for 24 h cumulative permeation were （49 721±29 707） and （45 372±23 755） ng·cm^–2； Average permeation rates were （2 352±1 309） and （2 182±1 080） ng·cm^–2·h^–1； 24 h skin retention （218 276±137 675） and （188 040±49 523） ng·g^–1；Average permeation rates of test and reference products at a cumulative permeation of about half total permeation （12 h） were （2 172±1 330） and （1 947±1 037） ng·cm^–2·h^–1. CONCLUSION Degree and rate of transdermal penetration of 5% minoxidil solution test/reference formulation fulfill the consistency requirements for topical formulations. And drug retention characteristics of minoxidil solution are similar in Bama miniature pig skin.

OBJECTIVE To investigate the influencing factors of meropenem-related thrombocytopenia in patients with pulmonary infection and their predictive value. METHODS In a retrospective case-control study， the clinical data of patients treated with meropenem for pulmonary infection in a Grade-A tertiary hospital from January 2018 to December 2021 were searched and screened by the Chinese Hospital Pharmacovigilance System （CHPS）. Unifactorial and multivariate logistic regression were used to analyze the influencing factors of meropenem-related thrombocytopenia. RESULTS Totally 625 patients were selected in the study， including 73 with meropenem-related thrombocytopenia. Unifactorial analysis showed that age， hypertension， coronary heart disease， baseline platelet value， serum creatinine value and respectively combined with quinolones， cephalosporins， penicillins and linezolid were significantly correlated with thrombocytopenia （P<0.05）. Multivariate logistic regression analysis showed that hypertension （OR=1.811， 95%CI： 1.029–3.188）， baseline platelet value （OR=0.988， 95%CI： 0.983–0.993）， and combined use of cephalosporins （OR=2.998， 95%CI： 1.573–5.711） or penicillin （OR=2.703， 95%CI： 1.317–5.548） were independent risk factors for the development of meropenem-related thrombocytopenia in patients with pulmonary infection. CONCLUSION Hypertension， baseline platelet value， and combined use of cephalosporins or penicillins are important factors affecting meropenem-related thrombocytopenia in patients with pulmonary infection. Combined multivariate analysis can effectively evaluate and predict the risk of meropenem-related thrombocytopenia in patients with pulmonary infection.

With the highest global disease burden， atopic dermatitis （AD） is a chronic inflammatory skin disease requiring positive treatment and long-term management. In the past， topical corticosteroids （TCS）， topical calcineurin inhibitors （TCI） and systemic immunosuppressants acted as major treatments for AD. Due to patient concerns of adverse reactions of TCS and traditional immunosuppressants， as well as uneven medical levels among different regions， clinical therapy of AD， especially systemic therapy of moderate-to-severe AD， often faces the problems of delayed initiation and poor patient compliance. Recently targeted drugs such as biologics and Janus kinase （JAK） inhibitors have been successively approved and systemic therapy for AD has gradually improved. However， due to relatively limited clinical application experiences of these drugs， drug selection， drug timing， tapering and withdrawing， adverse reaction management and other issues have brought new challenges to clinical therapy. With the introduction of the concept of “treat-to-target”， AD therapy has emphasizes primary patient needs， guidance of therapy goal and individualized management. Therefore therapeutic drug dosing and patient compliance management have become important factors affecting the “treat-to-target”. And pharmaceutical care plays a growingly prominent role in the management of AD therapeutic drugs. This consensus was intended to standardize drug use in AD management， summarize key points of pharmaceutical care， ensure drug safety and improve patient medication compliance， thereby improving the therapy outcomes and promoting the quality of AD therapy management in China.

OBJECTIVE To analyze the therapeutic drug monitoring （TDM） results of six second-generation antipsychotics， and to provide reference for individualized and rationalized schizophrenia treatment. METHODS Retrospective analyses of the TDM results of six second-generation antipsychotics were obtained from the outpatient and inpatient cases in Xi’an Mental Health Center from January 2020 to December 2020. A Med Calc 5.2 statistical software was used to analyze the subsequent data. RESULTS The results showed that the proportion of one TDM in outpatients was significantly higher than that in inpatients （P<0.01）. Conversely， the proportion of monitoring frequency more than 2 times was higher in inpatients than that in outpatients （P<0.01）. A higher plasma concentration was observed in female patients than in male patients （P<0.05） through the nonparametric Mann-Whitney U test， including olanzapine， amisulpride， and risperidone+paliperidone， but the plasma concentration of quetiapine+desethylquetiapine was found to be lower in female patients compared to male patients （P<0.01）. Furthermore， a higher plasma concentration exposure （including amisulpride， quetiapine+norethylquetiapine， and aripiprazole+dehydroaripiprazole） was identified in patients over or equal to 60 years of age compared to those under 60 years of age （P<0.05）， whereas， the olanzapine， risperidone+paliperidone， and clozapine+norclozapine concentrations had no statistically significant differences between the two different age groups （P>0.05）. Among all the monitored samples， the blood concentration of olanzapine had the highest proportion in the therapeutic window by 74.98%， and that of clozapine showed the lowest proportion （20.53%）. Moreover， the blood concentrations of amisulpride， aripiprazole and aripiprazole+dehydroaripiprazole were dramatically higher than the reference ranges recommended by the consensus， while those of clozapine and norethylquetiapine were significantly lower than the recommended reference ranges. CONCLUSION In clinical practice， it is essential to monitor drug concentrations for both outpatients and inpatients， so as to enhance the implementation of individualized drug administration， and ensure the safety and effectiveness of clinical medication.

OBJECTIVE To explore the safety differences of baloxavir marboxil and oseltamivir to provide references for post-marketing research and clinical rational drug use. METHODS The adverse events of baloxavir marboxil and oseltamivir reported in FDA Adverse Event Reporting System （FAERS） from quarter Ⅰ of 2019 to quarter Ⅲ of 2022 were retrieved with reporting odd ratio （ROR） and Bayesian confidence propagation neural network （BCPNN）. Results ADE signals of baloxavir marboxil and oseltamivir involved multiple systems. Different from the signals of congenital familial genetic disorder， reproductive system and breast diseases unique to oseltamivir， baloxavir marboxil as a primary suspect drug has unique signals of kidney and urinary system diseases. In system organ class （SOC） with signals for both drugs， obvious differences existed in AED signal intensity in psychiatric diseases， pregnancy/puerperium/perinatal conditions， ocular organ diseases and various nervous system diseases. Baloxavir marboxil reported the most number of no adverse event signals while oseltamivir yielded the most number of vomiting signals. Conclusion ADE signals obtained in this study are consistent with the existing common ADRs in package insert. However， significant differences exist in system organs and signal intensity of pregnancy/postpartum/perinatal conditions， congenital familial genetic diseases， ocular organ diseases， kidney and urinary system diseases. For population at a high risk of ADE as mentioned above， this study provides references for individualized drug selections and ensuring clinical safety and rational drug use.

Objective To elucidate the mechanism of Guizhi Shaoyao Zhimu Decoction （GSZD） on autophagy in a rat model of rheumatoid arthritis （RA） through regulating the signaling axis of PI3K/AKT/mTOR. Methods Sixty rats were randomized into six groups of normal， model， GSZD low/medium/high-dose and rapamycin. Except for normal group， the other groups were subcutaneously injected with bovine type Ⅱ collagen protein for establishing a RA model. The corresponding drugs were dosed for 4 weeks. Footpad thickness was measured and arthritis index （AI） scored regularly. Four weeks later， synovial tissues of rat knee joint were harvested. The pathological changes of synovial tissues were observed after hematoxylin-eosin （HE） stain. Ultrastructural changes of synovial cell were observed by transmission electron microscopy. The expressions of Beclin1， LC3， p62， PI3K， AKT and mTOR mRNAs and proteins were detected by quantitative real-time polymerase chain reaction （qRT-PCR） and Western blot. Results GSZD could effectively alleviate footpad thickness and AI score in RA rats. The results of transmission electron microscopy indicated that synoviocytes had lower autophagy while the number of autolysosomes and autophagosomes jumped after GSZD dosing. The results of qRT-PCR and Western blot indicated that， as compared with normal group， the expressions of Beclin1 mRNA and protein， LC3 mRNA and LC3II/LC3I were down-regulated in synovial tissues （P<0.01） while the expressions of p62， PI3K， AKT， mTOR mRNAs and proteins rose sharply in model group （P<0.01）. As compared with model group， the expressions of Beclin1mRNA and protein， LC3mRNA and LC3II/LC3I spiked markedly in synovial tissues （P<0.01， P<0.05） while the expressions of p62， PI3K， AKT， mTOR mRNAs and proteins dropped in GSZD high-dose and rapamycin groups （P<0.05， P<0.01）. Conclusion GSZD could attenuate footpad thickness and pathomorphism of RA rats. And its therapeutic mechanism may be correlated with a down-regulation of PI3K/AKT/mTOR pathway and an acceleration of autophagy.

Lung cancer is characterized by high mortality， poor prognosis and low 5-year survival rate. At present， the comprehensive treatment based on chemotherapy is the main treatment for non-small cell lung cancer （NSCLC）. According to the stage and the type of lung cancer， patients received comprehensive treatment including surgery， radiotherapy， chemotherapy and targeted therapy. However， the not significance of early symptom， the huge difference of individuals， the resistance of radiotherapy and chemotherapy limited the diagnosis and treatment， which caused harmful effects to patients. Metabolomics plays an increasingly important role in exploring tumor biomarkers， evaluating overall metabolic changes， and studying pathogenesis. This paper mainly reviewed the research progress of biomarkers for the prognosis effect evaluation of lung cancer treatment based on metabolomics technology， so as to provide an important theoretical basis for the individualized precision treatment of lung cancer and help clinical patients to maximize the treatment benefits.

OBJECTIVE To explore the research focused on the awarded pharmacy administration grants from the department of management science of National Natural Science Foundation of China (NSFC), and to provide reference source for hospital pharmacists to apply for the grants from department management science of NSFC.METHODS A total of 60 grants of pharmacy administration were selected from the department of management science of NSFC from 2015 to 2020. The key words such as research content, theory/model and types of the grants were extracted and analyzed.RESULTS From 2015 to 2020, the hotspots topics of the awarded pharmacy administration grants from the department of management science funded by NSFC were mainly patient and medication safety, pharmacist intervention/service and pharmaceutical related policies (30.00%, 25.00% and 21.67%). The research related to the department of management science was highly correlated with the daily work of hospital pharmacy, while the number of the awarded individuals working in universities was higher than that of medical institutions.CONCLUSION NSFC management science department pharmaceutical management grants research focused on antibacterial drug management, adverse drug reactions, essential drugs and so on, and concentrated on model construction and strategy research. Therefore, it is recommended that hospital pharmacists improve the combination of daily work and scientific research, and strengthen the study of management methods in order to improve the winning rate of such funding grant applications.

Gene therapy has demonstrated great therapeutic potentials for such major refractory diseases as malignant tumors， infectious， autoimmune and rare disease， etc. Gene delivery vectors are essential for a successful implementation of gene therapy. Polythylenimine （PEI） is a widely studied cationic gene delivery vector， showing stable and efficient gene transfection in numerous cell lines and transfection conditions. PEI25k is regarded as a "gold standard" for gene transfection. Although PEI has broad application prospects in the field of gene delivery， there are still urgent problems to be tackled， including low transfection efficiency in vivo， high cytotoxicity， low targeting capability and lysosomal degradation of loaded gene. This review summarized the latest advances of designing novel polyethylenimine-based nanosystems for gene therapy， including high molecular weight linear PEI， PEI modified with polysaccharides， hydrophilic polymers or dextran， crosslinked low molecular weight branched PEI， PEI-based inorganic nanoparticles and co-delivery vectors of drug/gene based upon PEI. It was intended to provide theoretical rationales for further constructing gene delivery carriers with high efficiency and low toxicity.

OBJECTIVE To optimize the maintenance dosing regimen of amisulpride in schizophrenics using Monte Carlo simulations （MCs）. METHODS Based upon the published population pharmacokinetic （PPK） data of amisulpride in schizophrenics， using MCs to predict its steady-state plasma concentration （C_ss） and its recommended blood concentration reference range of 100-600 ng·mL^–1 under different dosage regimens. Probability of target attainment （PTA） was applied along with monitoring clinical blood drug concentrations for verification. RESULTS When amisulpride was 350-400 mg qd， 150-300 mg bid and 100-200 mg tid， PTA value of C_ss was >90% in the range of 100-600 ng·mL^–1. At a daily dose ≥1 050 mg， C_ss was likely to surpass 600 ng·mL^–1 （simulation probability ≥75.61%）. Blood concentration of amisulpride at a conventional dose in 24 samples was 48.10-1 032.03 ng·mL^–1 with an average value of （466.64±284.10） ng·mL^–1. CONCLUSION MCs may predict C_ss of amisulpride in Chinese schizophrenics. According to clinical treatment， it is reasonable to set the reference concentration range of amisulpride at 100-600 ng·mL^–1 under a conventional dose.

OBJECTIVE To investigate the effect and molecular mechanism of quercetin (Que) on skin melanin deposition in guinea pigs with ultraviolet B (UVB) -induced melasma. METHODS High, medium, and low doses of quercetin ointment and 0.25% arbutin ointment were prepared. Thirty-five female guinea pigs were randomly divided into control group (Normal), Model group, Matrix group, and Que low, middle, high dose groups and Arbutin positive control group. The Normal group was not treated, and the other groups were irradiated with 6 500 mJ·cm^-2 UVB to establish chloasma model in guinea pigs (10 min·d^-1, once every other day). After 36 days of continuous treatment, the skin color changes of guinea pigs were observed by photographing. HE and Masson-Fontana staining were used to observe skin melanin deposition. ELISA was used to detect the expression of SOD, CAT, GSH-Px in skin tissue. Immunohistochemical method was used to detect the expression of melanin synthesis related regulatory factors (MITF, TYR, TYRP1) in skin tissue of each group. Western blot was used to detect the protein expressions of key proteins of p38MAPK-ERK signaling pathway (P38MAPK, p-P38MAPK, ERK, p-ERK) and MITF, TYR in skin tissue. RESULTS Quercetin increased the expression of SOD, CAT and GSH-Px in guinea pig skin tissue (P＜0.05). Low-dose quercetin reduced melanin deposition in guinea pig skin, down-regulated MITF, TYR, TYRP1 and p-p38MAPK expression (P＜0.05), and up-regulated p-ERK expression (P＜0.05). Quercetin at medium and high doses increased melanin deposition and the expression of MITF, TYR and TYRP1 in guinea pig skin (P＜0.05). At the same time, the expression of p-p38MAPK was up-regulated and p-ERK was down-regulated in high dose quercetin group (P＜0.05).CONCLUSION Low-dose quercetin can improve the melanin deposition in guinea pigs with UVB-induced melasma, while high-dose quercetin can aggravate the deposition of melanin, possibly by regulating the expression of key proteins in the P38MAPK-ERK signaling pathway and downstream melanin synthesis related factors.

OBJECTIVE To prepare dendritic cell （DC） vaccine assisted by Glycyrrhiza inflata polysaccharide and to study its immunotherapeutic effect in H22 hepatoma-bearing mice. METHODS Bone marrow-derived dendritic cells （BMDC） were isolated from mouse bone marrow and cultured， DC was sensitized with H22 hepatoma antigen， and then a certain concentration of Glycyrrhiza inflata polysaccharides adjuvant was added to prepare DC vaccine. The morphological changes of DC were observed under an inverted microscope， and the phenotype of DC vaccine was detected by flow cytometry. H22 hepatoma-bearing mice was established and randomly divided into model group， positive group， DC group， TNF-α group， GiP group and GiP-B1 group by digital table method. The tumor-bearing mice were immunized with DC vaccine assisted by Glycyrrhiza inflata polysaccharides. The mice were sacrificed on the fifth day after the last administration， and the organ index and tumor inhibition rate were detected. The contents of IL-12 （P70）， IFN-γ， IL-4 and IL-10 cytokines in serum were detected by enzyme linked immunosorbent assay （ELISA）. The pathomorphological changes of liver and tumor tissue were observed by HE staining， and the expression levels of Bax and Bcl-2 protein in tumor tissue were detected by immune-histochemistry. RESULTS Glycyrrhiza inflata polysaccharides as an adjuvant of DC vaccine could up-regulate the expression of DC surface markers（P<0.05）. The DC vaccine assisted by Glycyrrhiza inflata polysaccharides could slow down the tumor growth rate in tumor-bearing mice， increase the spleen index and thymus index of tumor-bearing mice （P<0.05）， increase the contents of IL-12 and IFN-γ in serum of tumor-bearing mice（P<0.05）， decrease the contents of IL-10 and IL-4（P<0.05）， and increase the ratio of Bax/Bcl-2 in tumor tissue （P<0.01）. CONCLUSION Glycyrrhiza inflata polysaccharide， as an adjuvant of DC vaccine， can induce DC maturation and activation in vitro， and has a certain immunotherapeutic effect in tumor-bearing mice. Its anti-tumor mechanism may be related to up-regulating the secretion of IL-12 and IFN-γ， mediating cellular immunity and promoting tumor cell apoptosis.

OBJECTIVE To construct a prediction model based on machine learning algorithm for predicting the prognosis of aneurysmal subarachnoid hemorrhage（aSAH）. METHODS A total of 326 patients with aSAH treated in Tianjin Huanhu Hospital from October 2020 to September 2021 were reviewed. According to the ratio of 7∶3， all the data were randomly divided into training set （to construct the prediction model） and test set （to evaluate the prediction model）. SMOTE was used to deal with the imbalance data. Least absolute shrinkage and selection operator （Lasso） analysis was used to select the optimal variables. Logistic regression （LR）， BP neural network， K near neighbor （KNN）， random forest （RF）， decision tree （DT）， support vector machine （SVM）， naive Bayes （NB） and XGBoost algorithm based on machine learning were used to construct the predictive model. RESULTS Eleven optimal features were obtained by Lasso regression. The accuracy of LR， BP neural network， KNN， RF， DT， SVM， NB and XGBoost model were 0.847， 0.847， 0.816， 0.867， 0.806， 0.827， 0.745 and 0.816， and AUC were 0.784， 0.794， 0.646， 0.821， 0.499， 0.765， 0.737 and 0.676， respectively. CONCLUSION Machine learning models are relatively more effective in predicting aSAH prognosis， and the RF model exhibits the best performance.

OBJECTIVE To investigate the efficacy and potential mechanism of urolithin A （UA） in the treatment of renal fibrosis induced by unilateral ureteral obstruction （UUO） based on network pharmacology， molecular docking and animal experiment. METHODS Network pharmacology techniques were used to analyze the mechanism of improving renal fibrosis action of UA. Auto Dock Tool software was used to perform molecular docking of UA with key targets to improve renal fibrosis. UUO was used to establish a rat renal fibrosis model. The regulatory effect of UA on renal fibrosis marker proteins was verified by immunohistochemical staining of fibronectin and collagen Ⅰ. The regulatory effects of UA on p-Akt1 and Akt1 were examined by immunofluorescence staining and Western blot. The effects of UA on the expression of PI3K and p-PI3K upstream， and GSK3β and p-GSK3β downstream of Akt1 were examined by Western blot. RESULTS A total of 21 core targets were obtained by screening through network pharmacology techniques. Through PPI network topology analysis， GO biological function annotation and KEGG pathway enrichment analysis， it was found that UA could play a role in the treatment of renal fibrosis through signal pathways such as PI3K-Akt， p53 and key core targets such as Akt1， CCND1， CDK4， EGFR， CDK2， ERBB2， CDK6， GSK3B， BCL2L1， PTK2， ESR1 and PTGS2. Akt1 was the key target with the highest node degree in the PPI network study. Molecular docking further verified the high docking affinity of UA and Akt1. Animal experiments showed that UA could significantly reduce the expression of fibronectin and collagen Ⅰ in UUO rats （P＜0.01）， and inhibit the expression of p-Akt1 （P＜0.01）， as well as inhibited the phosphorylation of PI3K upstream and GSK3β downstream of Akt1 （P＜0.01）. CONCLUSION UA can effectively alleviate renal fibrosis by inhibiting PI3K/Akt1/GSK3β signal pathway， and effectively reduce the expression of fibronectin and collagen Ⅰ in rat kidney， which provide scientific basis for further study of UA in the treatment of renal fibrosis.

OBJECTIVE To study the effect of hordenine on melanin synjournal process in B16 cells and its mechanism of action. METHODS Western blot was used to detect the expression of TYR， TRP1 and TRP2 in B16 cells after the treatment with hordenine （50，100，200 μmol·L^–1） to determine the impact on the melanin synjournal process. After PKA agonist treatment， the correlation between the effect of hordenine on melanin synjournal process in B16 cells and cAMP/PKA/CREB/MITF signaling pathways. RESULTS Hordenine （ 50，100，200 μmol·L^–1） could inhibit the protein expression of cAMP， PKA， p-CREB and MITF in melanoma B16 cells group， thus inhibiting TYR， TRP1 and TRP2 expression during melanin synjournal process. CONCLUSION Hordenine can inhibit melanin synjournal process in B16 cells， and the mechanism may be related to inhibiting cAMP/PKA/CREB/MITF signaling pathways.

Psoriasis （PsO） is an autoimmune skin disease with a global prevalence of 2%-3%. Numerous studies have confirmed that the activation of innate immune cells and pathogenic T cells is the key link leading to skin inflammation and keratinocyte proliferation. Therefore， regulating the homeostasis of the immune system in patients with psoriasis may become the focus of drug development for psoriasis. In recent years， related biological agents and small molecule drugs targeting “IL-23-Th17” have shown better therapeutic effects than traditional drugs for the treatment of psoriasis. This review described the dynamic changes of cells involved in the immune response during the occurrence and development of psoriasis and summarized the latest advances in psoriasis therapeutic’s so as to provide new idea for the clinical treatment and drug deiecopment of psoriasis.

OBJECTIVE To visualize the intelligent construction and development of PIVAS in China over the last two decades by CiteSpace software. METHODS The relevant articles on the development of PIVAS intelligence were retrieved from the databases of China National Knowledge Infrastructure （CNKI）， Wanfang and VIP. NoteExpress and CiteSpace software suites were utilized for visualizing the number of publications， authors， institutions and keywords. RESULTS A total of 121 articles were included and the largest number of articles appeared in 2021 （23 articles）. And 241 keywords were counted and 12 clusters were formed for keyword analysis. Top 5 keywords were pharmacy intravenous admixture service， information， automation， centralized intravenous drug dispensing center and intelligence. According to the statistics of the publishing institutions of PIVAS intelligent construction， Hebei General Hospital and First Affiliated Hospital of Soochow University submitted the largest number of publications （6 articles）. Among 350 authors， Pang Guoxun had the largest number of publications （7 articles）. Among 60 statistical journals， China Pharmacy and Straits Pharmacy predominated （12 articles）. According to the statistics of applying intelligent construction in PIVAS in China， use of intelligent equipment could significantly minimize deployment errors and improve work efficiency. And its application outcomes were excellent. CONCLUSION The intelligent development of PIVAS in China has been rapid. Employing information management and automation equipment for constructing an intelligent service platform， it can significantly boost work efficiency， optimize workflows and effectively promote the innovation of pharmaceutical services. It represents a future direction of the construction and development of PIVAS at modern medical institutions.

Objective To explore the therapeutic effects and mechanism of Pulsatilla Decoction on Vulvovaginal candidiasis （VVC） based upon network pharmacology and animal experiments. Methods The active ingredients and corresponding targets of Pulsatilla Decoction were collected through literature reviews and searching the database of TCMSP. Gene Cards was applied for obtaining the potential targets related to VVC and Cytoscape 3.6.0 for constructing the network of “drug active components-targets-pathways”. And the database of String was utilized for constructing a protein interaction network. Gene ontology （GO） enrichment analysis and Kyoto Encyclopedia of Genes and Genomes （KEGG） were performed by the platform of DAVID. Molecular docking was performed with AutoDock software. Specific pathogen free Kunming （SPF-KM） mice were randomized into six groups of normal， model， low/medium/high-dose Pulsatilla Decoction and fluconazole. VVC model was established through an inoculation of Candida albicans. All groups were continuously dosed for 14 days. Fungal quantities in vaginal lavage fluid were determined by Gram stain and plate counting. Hematoxylin-eosin （HE） stain was utilized for observing the morphology of vaginal tissue. Enzyme-linked immunosorbent assay （ELISA） was employed for detecting the serum contents of IL-17， IL-23 and IL-1β. The expressions of core regulatory factors， including TNF-α， STAT3， HSP90， ESR and key regulator ROR-γT protein in IL-23/IL-17 axis were measured by Western blot. Results Through network pharmacology screening， the core components identified for treating VVC included anemoside B4， dihydroniloticin， obacunone， β-sitosterol and berberine. Additionally， 18 key target proteins and 75 pathways were identified as crucial for therapeutic effects for VVC. As compared with model group， a treatment of Pulsatilla Decoction could significantly lower both fungal burden in vagina and serum levels of IL-17， IL-23 and IL-1β. Moreover， the protein expression levels of TNF-α， STAT3， HSP90， ESR and ROR-γT dropped in vaginal tissue （P<0.05）. Conclusion Pulsatilla Decoction exerts its therapeutic effects on VVC through modulating the targets of STAT3 and TNF-α and regulating the axis of IL-23/IL-17.

Honey-processed Astragali Radix（HAR） is a commonly used clinical decoction piece which could be obtained by stir-frying the honey soaked Astragali Radix（AR）. HAR is the only processed AR included in the Chinese Pharmacopoeia（2020 edition）. In recent years， the research on AR and HAR mainly included the identification of small molecular components， optimization of honey processing and comparison of pharmacological effects. This article summarized the historical evolution of honey processing， the process optimization， the influence of honey processing on the components， efficacy and clinical application of Astragalus membranaceus， and pointed out the shortcomings of research on the honey processing of AR， so as to provide basis for the subsequent research direction， and provide reference for the selection and application of the two drugs in clinical practice.

Objective To explore the treatment of oral vancomycin for skin adverse reaction caused by Clostridium difficile infection. Methods Domestic and foreign databases were searched from the inceptions until July 2023. The relevant literatures were retrieved and the related data extracted for descriptive statistical analysis. Results A total of 15 patients were recruited， including 9 males and 6 females. All of them had an indication of antibiotic use and vancomycin was prescribed for C. difficile infection. In terms of age， there were 2 children and 8 patients were 65 years and above. Five cases developed kidney injury. Oral dose of vancomycin was ≥500 mg·d^–1 （n=11）. Skin adverse reactions included red man syndrome， maculopapular rash and linear IgA bullous dermatosis. Blood concentration of vancomycin was （0.1–28.7） mg·mL^–1（n=5）. In terms of adverse reaction management， drug was discontinued （n=14） and antihistamines offered （n=12）. For 4 cases on anti-C. difficile regimen， fedamycin （n=1） and metronidazole （n=3） were prescribed. All of them had varying degrees of improvements and 2 cases died from underlying diseases. Conclusion During the treatment of C. difficile infection， oral vancomycin may be absorbed throughout body and leads to rash. Greater attention should be paid to high-risk groups.