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.

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.

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.

 

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.

OBJECTIVE To investigate the mechanism of Qinggan Yipi Capsules in alleviating anti-tuberculous drug-induced liver injury (ATB-DILI) by inhibiting hepatocyte iron death.METHODS Mouse model of ATB-DILI was established by intragastric administration of isoniazid and rifampicin. C57BL/6 mice were randomly divided into PBS control group (NC group), ATB-DILI group and Protectant group, and then given PBS, INH+RFP and INH+RFP+Qinggan Yipi capsules, respectively. The contents of ALT, AST and ALP were detected by serum enzymology. The levels of TMRE, ROS, lipid peroxidation and Fe²⁺ concentration were detected by flow cytometry. RNA sequencing was used to detect gene expression. The expression of glutathione peroxidase 4 (GPX4) and ester acyl-CoA synthetase long chain family member 4 (ACSL4) were detected by qPCR. The protein expression of GPX4 and ACSL4 were detected by Western blot. Body weight and survival status of mice were investigated and recorded. Finally, livers of mice were taken for pathological analysis after H&E staining.RESULTS Compared with ATB-DILI group, Protectant group prolonged the survival time and increased the survival rate (P=0.001 3). The contents of ALT, ALP and AST in serum of Protectant group were significantly lower than those of ATB-DILI group (P=0.020 5, P=0.001 6, P=0.034 5). Genes in lipid metabolism related pathways were down-regulated in the Protectant group, among which Fasn and Scd1 were significantly down-regulated (P=0.039 1, P=0.041 7). The variation of TMRE, ROS, lipid peroxidation and Fe²⁺ concentration in Protectant group were improved. Compared with ATB-DILI group, the expression of ACSL4 protein in Protectant group was significantly decreased (P=0.000 03).CONCLUSION Qinggan Yipi Capsules can down-regulate the expression of Fasn, Scd1, GPX4 and ACSL4 in lipid metabolism related pathways, reduce the expression of ALT, AST and ALP, and improve the ferroptosis and dyslipidemia in liver, and then alleviate ATB-DILI and significantly improve the survival rate of model mice.

OBJECTIVE To determine the causes and influencing factors of physicians'routine skin test for cephalosporin prescribing,so as to provide reference for standardizing the practice of skin test and improving the management of antibacterial drugs in Peking University Third Hospital. METHODS The mixed methods research of qualitative study and quantitative study were adopted.Based on the quantitative tool developed by previous qualitative study,we conducted a questionnaire survey among doctors at a tertiary hospital in Beijing by a quantitative method.Univariate analysis and logistic regression analysis were used to determine the factors affecting physicians'prescription behavior of cephalosporin skin test. RESULTS A total of 271 questionnaires were collected,with 261 valid questionnaires and an effective response rate of 96.3%.The proportion of physicians who conducted routine skin test was 78.2%(204/261).The results of logistic regression analysis showed that the main factors influencing the physicians'prescription behavior of cephalosporin skin test were the knowledge of documents related to in-hospital skin test,routine requirements of departments,nurse intervention and experience teaching of senior physicians.Other descriptive statistics showed that 83.3%(170/204) of physicians in the skin test group stated that they conducted cephalosporin routine skin test due to self-protection concerns. CONCLUSION Most physicians (78.2%) conducted cephalosporin routine skin test before administering medication to patients in Peking University Third Hospital.The results of single-factor analysis and multi-factor analysis should be combined to formulate targeted interventions to standardize the practice of skin test of such drugs.

OBJECTIVE To investigate the current status and influencing factors of outpatient medication education, and to provide reference for improving the quality of pharmacy services.METHODS This study was conducted by using questionnaires and on-site data collection. The questionnaire survey was performed to collect the medication education of 920 patients in the outpatient pharmacies of two large general tertiary hospitals in Dongguan from August 2021 to September 2022, and 1 040 prescriptions and 900 prescriptions dispensing time were collected on site for statistical analysis.RESULTS The results showed that the older the patients, the lower the drug awareness rate; patients with higher education and more thorough medication education were associated with higher drug awareness rate; 81.41% of patients wanted to receive medication education when taking medicine at the window. There was no difference in the needs of patients at different ages for medication education, but patients with higher education levels were more likely to obtain medication education through medicine window and the Internet; patients with low medication compliance preferred to get medication reminder services through mobile phone software. The average medication education time for patients was only 6.78 seconds, accounting for only 7.30% of the average prescription dispensing time.CONCLUSION Different medication education methods should be adopted for patients at different ages. The integrity of patient medication education should be improved in order to improve medication awareness; providing medication education at the dispensing window is the current mainstream medication education method; the current mode of dispensing needs to be changed and the time for medication education should be increased.

OBJECTIVE To explore the therapeutic effect of Bear Bile Powder on TNBS-induced experimental colitis in rats, and to predict the therapeutic substances, targets and potential pathways of bear bile powder in the treatment of inflammatory bowel disease by combining network pharmacology and molecular docking methods.METHODS The rats were randomly divided into normal group, model group, positive drug group, high, medium and low Bear Bile Powder groups. Experimental colitis was induced by TNBS enema in SD rats. Disease activity index(DAI) score, colon length and pathological changes were measured. Then the components of bear bile powder were obtained by UPLC-Q Exactive Orbitrap-MS/MS analysis, and the network pharmacology related database was used to predict the possible signaling pathways and the affinity between them.RESULTS Compared with the model group, the DAI scores of the Bear Bile Powder groups were significantly decreased (P＜0.01), and the colon length was increased to varying degrees, especially in the low-dose group (P＜0.05). The inflammatory cell infiltration in the colon tissue of the Bear Bile Powder groups was reduced, the colonic mucosal epithelium was basically intact, and the glands were arranged regularly. Compared with the model group, the content of TNF-α in the low-dose Bear Bile Powder group decreased significantly (P＜0.05), the content of IL-10 increased significantly(P＜0.001), and the content of IL-1β and IL-6 in each dose of bear bile powder groups also decreased significantly (P＜0.05). The results of network pharmacology and molecular docking indicated that bilirubin may be an important component in the treatment of IBD. PIK3CA, AKT1, MAPK1, MAPK14 and MAPK3 were important targets for the treatment of diseases. PI3K-Akt signaling pathway, FoxO signaling pathway, MAPK signaling pathway, EGFR tyrosine kinase inhibitor resistance, and HIF-1 signaling pathway were important signaling pathways for the treatment of diseases.CONCLUSION Bear Bile Powder can alleviate TNBS-induced experimental colitis in SD rats. Bilirubin may be the key component of Bear Bile Powder in the treatment of IBD, and its mechanism may be related to inhibiting inflammation, inducing intestinal mucosal autophagy and intestinal immunity.

OBJECTIVE To establish a method to quantitatively detect the changes of seven components in patients with drug-induced liver injury caused by tuberculosis before and after oral administration of Shaoyao Gancao Decoction granules in order to investigate the changes of each blood component after transfusion.METHODS Plasma samples were precipitated by methanol. The main components were separated by reverse gradient elution on a thermo scientific syncronis C₁₈ column. The chromatographic effluent was detected by electrospray ion source in positive and negative ion modes, and the main chromatographic peaks were assigned by mass spectrometry. Biphenyl diester was selected as internal standard to determine the concentration of each component.RESULTS The contents of seven principal components in Shaoyao Gancao Decoction granules in patients could be quantitatively detected, and the contents of paeoniflorin and albiflorin were much higher than that of glycyrrhizic acid, glycyrrhizin, isoglycyrrhizin, liquiritigenin and isoliquiritigenin. At 45 minutes after oral Shaoyao Gancao Decoction granules, only 4 of above components were detected. The average blood content of paeoniflorin was 2.79 μg·mL^-1, that of albiflorin was 1.14 μg·mL^-1, that of glycyrrhizic acid was 0.67 μg·mL^-1, and that of glycyrrhizin was 0.49 μg·mL^-1.CONCLUSION In this study, the composition of Shaoyao Gancao Decoction granules was rapidly analyzed by LC-MS/MS in population with antituberculous drug induced liver injury, which provides ideas and methodology reference for the research on the efficacy of traditional Chinese medicine compound in special population.

OBJECTIVE To analyze the characteristics of adverse drug reactions (ADRs) caused by trastuzumab emtansine (T-DM1) and provide reference for clinical medication. METHODS The case reports of ADRs caused by T-DM1 recorded in PubMed,Embase,SCI,CNKI,Wanfang and VIP databases were retrieved and analyzed. RESULTS There were 29 reports on ADR cases caused by T-DM1,including 36 cases in total,and all of them were female,most of them were aged from 40 to 69 years old (28 cases,accounting for 77.78%).The original disease was breast cancer except one case of lung adenocarcinoma.The occurrence time range was from 1 day to 30 months,mainly concentrating within 12 months of medication,and involving 8 systems and organs such as skin,liver and gallbladder,respiration and eyes,etc.Totally 31 patients of the 36 cases were with drug withdrawal or reduction and/or symptomatic treatment,and 27 patients were improved while 4 patients died.Among them,2 patients were with pigmentation,and one developed liver metastasis. CONCLUSION Clinicians and pharmacists should pay attention to ADRs caused by T-DM1,and do a good job of medication monitoring and follow-up after medication to ensure the safety of clinical medication.

By summarizing the advantages and disadvantages of the traditional intravenous drug dispensing work mode and centralized intravenous drug dispensing work mode,this paper explains the necessity of building and developing centralized intravenous drug dispensing and supply work mode in China.According to the Guidelines for the Establishment and Management of Pharmacy Intravenous Admixture Services,strengthen the review of medication orders and the implementation of quality control measures in pharmacy intravenous admixture service is the key to ensure the quality of finished infusion and ensure the safety of infusion.

临床药师通过分享2例肺癌患者使用替雷利珠单抗致免疫相关性肺炎的关联性评价、诊疗与药学监护等过程,并汇总与梳理免疫相关性肺炎的发病机制、诊疗方法、免疫检查点抑制剂的不良反应与疗效的关系以及长期使用糖皮质激素开展的药学监护,以期为医务工作者更充分了解免疫相关性肺炎的发病特点、临床表现、影像学特征及可能的预测因子提供参考,达到早期诊断与治疗的目的,旨在保障患者用药的安全性与有效性。

OBJECTIVE To perform a comprehensive clinical evaluation of atorvastatin, rosuvastatin, pivastatin, fluvastatin, simvastatin, pravastatin and lovastatin in five dimensions, including effectiveness, safety, pharmaceutical characteristics, economy and other attributes, so as to provide reference for drug selection and scientific, rational and safe drug use in medical institutions.METHODS Selection and Evaluation Form of Drug Use (Chemical Drugs) List in the Tertiary Public Medical Institutions in Hebei Province was used for the evaluation. The evaluation system included 5 level 1 indicators, 18 level 2 indicators and 74 level 3 indicators, which were used for the clinical comprehensive evaluation of 7 statins.RESULTS Totally seven varieties and twenty product specifications were evaluated. The scores were as follows: atorvastatin 77.9-82.1, rosuvastatin 77.8-80.8, simvastatin 78-78.1, pivastatin 71.1-76.5, fluvastatin 74-74.6, lovastatin 67.7-68.3 and pravastatin 65.7-69.1.CONCLUSION Statins are the first choice for the treatment of dyslipidemia, but different statins have various advantages in clinical treatment. The quantitative scoring of drugs can provide intuitive evidence for drug selection and scientific, rational and safe drug use in medical institutions.

OBJECTIVE To study the pharmacodynamic material basis and potential mechanism of Galega officinalis L. in anti-non-small cell lung cancer.METHODS The non-small cell lung cancer A549 cells were treated with the 90% ethanol extract and different polar extracts of Galega officinalis L.. The potential active sites were screened by comparing the proliferation inhibition rate of each site on A549 cells. The effect of the active part of Galega officinalis L. on cell migration activity was studied by cell scratch test and Transwell cell migration test. UPLC-Q-Exactive-MS/MS technology was used to analyze and identify the chemical components with the best proliferation inhibition effect. The core targets of anti-non-small cell lung cancer were screened by network pharmacology, GO and KEGG enrichment analyses were carried out in the DAVID database, and the visualization analysis was carried out using the bioinformatics platform. Component-key target-pathway network was established by using Cytoscape. Autodock vina was used for molecular docking, and Pymol software was used for the visualization processing to analyze the prediction mechanism.RESULTS The ethyl acetate fraction of Galega officinalis L. could effectively inhibit the proliferation and migration of A549 cells. The 15 components such as crocin, quercitrin and afzelin were the potential active components of Galega officinalis L. against non-small cell lung cancer. The results of network pharmacology and molecular docking showed that flavonoids matched well with the targets such as EGFR, HRAS and MAPK.CONCLUSION The resistance of Galega officinalis L. to non-small cell lung cancer may be through multiple components and targets. This study provides scientific basis for the development, application and quality evaluation of Galega officinalis L. with anti-lung cancer function.

OBJECTIVE To investigate the skin permeability of mouse monoclonal antibody against human interleukin-8 (MMA-8) cream and therapeutic effect on imiquimod-induced psoriatic mouse model. METHODS The skin permeability of MMA-8 cream was studied by in vitro diffusion cell method and skin tissue sections, and verified by fluorescence microscopy imaging. The efficacy of MMA-8 cream was evaluated by the imiquimod-induced psoriatic mouse model. RESULTS The in vitro percutaneous penetration test showed that the 24-h cumulative penetration (Q_{24 h}) of MMA-8 in mouse skin reached (110.88±24.93) ng·cm^-2, which was significantly higher than that of the rat group[(10.07±6.35) ng·cm^-2] and nude mice group[(9.18±4.70) ng·cm^-2](P<0.01). The Q_{24 h} of the human skin group applying cream by smearing was (11.69±3.18) ng·cm^-2 (intact skin) and (91.30±34.65) ng·cm^-2 (stripped skin). As for the human skin group applying cream by rubbing was (46.92±23.44) ng·cm^-2 (intact skin) and (82.46±5.39) ng·cm^-2 (stripped skin). The areas with the highest levels of MMA-8 in the skin were found to be 0~90 μm (mouse skin) and 0~600 μm (human skin) by skin tissue sections. The results of fluorescence microscopy showed that the drug was mainly retained in the stratum corneum in the intact skin, but could reach the dermis in the stripped skin. According to the pharmacodynamics experiment, compared with the model group, the psoriasis area severity index score, psoriasis pathology score and MIP-2 content in the skin in MMA-8 group were significantly decreased(P<0.01). CONCLUSION The penetration path of MMA-8 cream in the intact skin is mainly through the hair follicle, and the stratum corneum has an obvious hindering effect on the penetration. The highest retention areas of MMA-8 in the skin are the epidermis and the upper dermis. MMA-8 cream can reduce the content of MIP-2 in psoriasis-like skin lesions, improve the lesion status in mice, thus plays a role in the treatment of psoriasis.

Camrelizumab is an immunotherapy drug, and the incidence of reactive cutaneous capillary endothelial proliferation (RCCEP) is high in tumor patients during clinical use, which would affect the quality of life and appearance characteristics of patients, make patients panic and decrease their treatment enthusiasm. In this paper, the clinical manifestations, grading standards, pathogenesis and other aspects of RCCEP were expounded, and various schemes of prognosis treatment for RCCEP were summarized, so as to improve the compliance of patients with camrelizumab and provide reference for clinical treatment.

OBJECTIVE To explore the establishment of a quality management system based on "Hong Kong-Macao Medicines and Devices" policy, providing reference for improving real-world data(RWD) quality.METHODS According to the key points of RWD quality risk, combined with work practice and literature review, establishing RWD quality management system. The convenience sampling method was adopted to conduct quality control for RWD produced by The University of Hong Kong-Shenzhen Hospital from April 2021 to November 2022 using products of "Hong Kong-Macao Medicines and Devices" policy, with a random check ratio of 10%-20%. And frequency statistics and component ratio were used for statistical description, and SPSS 21.0 software was used for statistical analysis.RESULTS A set of general quality management system has been established covering the four dimensions of "Hong Kong-Macao Medicines and Devices" policy system, personnel, training and quality control. Through the implementation of quality control, the common problems in RWD collection of "Hong Kong-Macao Medicines and Devices" policy are summarized, among which the top three are: data recording problems (44.4%), research design problems (31.9%), and file management problems (15.3%).CONCLUSION This study establishes RWD management system based on the practice of "Hong Kong-Macao Medicines and Devices" policy, focusing on the integrity, accuracy and transparency of data. It will help to identify and intervene RWD quality risk, with certain maneuverability and reference value, and provide beneficial reference for exploring suitable strategies of RWD application in our country.

OBJECTIVE To investigate the protective effect of phlorizin (PZ) on trophoblast cells senescence induced by advanced oxidative protein products (AOPPs) and its corresponding mechanism.METHODS The trophoblast cell line HTR-8/SV neo cells were cotreated with PZ (20 μg·mL^-1) and AOPPs (200 μg·mL^-1) for 48 h. The levels of cell cycle, senescence-associated β-galactosidase (SA β-Gal), senescence-associated heterochromatin foci (SAHF) and mitochondrial membrane potential (ΔΨ_m) were measured to evaluate cellular senescence. The level of intracellular reactive oxygen species (ROS) was detected by flow cytometry, and the expression levels of proteins p53 and p21 were detected by Western blotting.RESULTS Co-treatment with AOPPs and PZ significantly deceased the percentages of cells in G0/G1 phase (P＜0.01), and the levels of SA β-Gal and SAHF (P＜0.01 for both comparison) as well, and increased the percentages of cells in G2 phase (P＜0.05) and ΔΨ_m (P＜0.01) compared with those in AOPPs group. The results of flow cytometry showed that co-treatment with AOPPs and PZ significantly decreased the level of ROS compared with that in AOPPs group (P＜0.01). Meanwhile, co-treatment with AOPPs and PZ significantly down-regulated the relative expression levels of p53 and p21 proteins compared with those in AOPPs group (P＜0.01 for both comparison).CONCLUSION PZ has antioxidant capacity and may reverse the pro-senescence effect of AOPPs on trophoblast cells.

OBJECTIVE To evaluate the effectiveness, safety and economy of vedolizumab in the treatment of ulcerative colitis, so as to provide evidence-based reference for clinical decision and rational drug use.METHODS PubMed, the Cochrane Library, CNKI, Sinomed, Wanfang and VIP databases were retrieved,and the related HTA websites were searched. HTA reports, systematic reviews/Meta-analysis and pharmacoeconomic research of vedolizumab in the treatment of ulcerative colitis were collected. The retrieval time ranged from the establishment of the database/station to August 2022. The results were analyzed by descriptive summary.RESULTS Totally 8 Meta-analysis and 9 pharmacoeconomic researches were included. The results showed vedolizumab could significantly improve the clinical response rate, clinical remission rate, endoscopic remission rate and steroid free remission rate of patients with ulcerative colitis when compared with those of placebo(all P＜0.05). Compared with adalimumab, golimumab and ustekinumab, vedolizumab had higher clinical response rate and clinical remission rate(all P＜0.05). Vedolizumab had the same therapeutic effect as infliximab and tofacitinib. Safety analysis showed that there was no significant difference between vidrizumab and placebo or other drugs for ulcerative colitis. The results of pharmacoeconomic researches showed that vedolizumab was more cost-effective than other drugs in China and many other countries.CONCLUSION Vedolizumab has promising effectiveness, safety and economic advantages in the treatment of ulcerative colitis.

OBJECTIVE To analyze the influence of exposure intensity of methotrexate (MTX) on the risk of adverse drug reactions (ADRs) during chemotherapy in children with Langerhans cell syndrome (LCH), and to promote safe individualized medication.METHODS MTX serum concentrations and related clinical data were collected from 65 children with LCH aged from 7.5 months to 11 years old. The data was introduced into the published population pharmacokinetic (PPK) model of children with acute lymphocyte leukemia (ALL). The extrapolation applicability of PPK model from ALL to LCH was investigated by goodness of fit (GOF), visual predictive test (VPC) and normalized predictive distribution error (NPDE). Bayesian maximum posterior probability method was used to estimate MTX pharmacokinetic parameters and exposure levels. The ADRs during chemotherapy were evaluated by CTCAE version 5.0. The relationship between exposures and risks of ADRs graded 2 and above was analyzed by using random forest method and conditional decision tree method.RESULTS The GOF, VPC and NPDE results proved that the PPK model of MTX was suitable for LCH patients, and the prediction results were accurate and reliable. The pharmacokinetic parameters were as follows: V₁ of (12.40±6.97) L,V₂ of (2.37±0.45) L,CL₁ of (3.02±0.44) L·h ^-1,CL₂ of (0.27±0.05) L·h^-1. The results of random forest method showed that the previous four predictors influencing the risk of ADRs graded 2 and above were AUC_0-∞, AUC_0-72h, AUC_0-48h and AUC_0-24h, and the influence of serum concentrations was mild. The area under the ROC curve was 0.89. The conditional decision tree method showed that the cut-off points of exposure for ADRs graded 2 and above were AUC_0-∞ ≥108.462 mg·h·L^-1, AUC_0-72h ≥106.642 mg·h·L^-1, AUC_0-48h ≥105.774 mg·h·L^-1 and AUC_0-24h ≥104.372 mg·h·L^-1.CONCLUSION The relationships between MTX exposure and the risk of ADRs in LCH patients was established through PPK model calculation and machine learning, which can provide reference for clinical prevention of ADRs.

OBJECTIVE To explore the differences in the saponin components of American ginseng (Panax quinquefolium) and enhance immunity in different parts (main root, whisker root, stem, leaf, flower, reed head), and clarify the pharmacodynamic substance basis and target of American ginseng to enhance immunity.METHODS High performance liquid chromatography was used to detect saponins in different parts of American ginseng. The number of neutrophils in the tail of zebrafish was detected to investigate the immune enhancement effect of American ginseng. Partial least squares correlation regression analysis was used to determine the pharmacodynamic substances. Based on network pharmacology, the core targets and pathways of American ginsenoside to enhance immune effects were explored.RESULTS The content of ginsenoside in different parts of American ginseng varied greatly, and the total saponin content was as follows: flowers＞leaves＞ taproot＞ whiskered root＞ reed head ＞ stem. Pharmacological experiments showed that extracts from different parts of American ginseng could increase the number of neutrophils, and all of them had significant immune enhancement (P＜0.01). Partial least square correlation analysis showed that ginsenoside Re, ginsenoside Rc and ginsenoside Rb₂ in American ginseng had strong correlation, and the VIP value was greater than 1. Network pharmacology analysis showed that the core targets of American ginseng to enhance immunity were VEGFA, JUN, FGF2, etc., and the common targets involved biological processes such as response to stimuli, biological regulation, and regulation of cellular processes, and played a role through PI3K-Akt, Rap1, MAPK and other signaling pathways.CONCLUSION American ginseng has an immune-enhancing effect, and the content of saponins in different parts is significantly different, and its immune-enhancing effect is positively correlated with the content of saponins. At the same time, this study uses the spectrum-effect and network pharmacology of Chinese medicines to preliminarily elucidate the pharmacodynamic substance basis and action target of American ginsenoside to enhance immunity.

Diabetes has become one of the chronic diseases that seriously threaten human life and health. Traditional hypoglycemic drugs often have problems such as unstable blood sugar control, easy to induce a variety of adverse reactions, and poor patient compliance with medication. Therefore, in recent years, the research and development and application of hypoglycemic drugs based on new targets have attracted more and more attention. As the world's first approved long-acting dipeptidyl peptidase 4 inhibitor (DPP-4 inhibitor), trelagliptin has attracted much attention for its favorable efficacy, less adverse reactions and excellent patient compliance. In this paper, the action mechanism, pharmacokinetics, pharmacodynamics, clinical study and safety evaluation of trelagliptin were systematically reviewed in order to provide the references for its rational clinical application.

OBJECTIVE Nucleoside compounds are the main effective components of Pinellia ternata. To compare the differences in the contents of nucleoside components in Pinellia ternata and its processed products, so as to provide reference for scientific evaluation and effective quality control.METHODS HPLC combined with multivariate statistical analysis was used to determine the contents of nucleoside components in Pinellia ternata and its processed products, and the differential components of Pinellia ternata before and after processing were screened.RESULTS The results showed that the content of each component in the raw samples was significantly higher than that in the processed products. The average contents of guanosine and adenosine were higher in Pinelliae Rhizoma Praeparatum than those of Pinelliae Rhizoma Praeparatum Cum Zingibere Et Alumine (P<0.05). The mean content of each component was not significantly different from that of Pinelliae Rhizoma Praeparatum cum Alumine. There was no obvious difference between Pinelliae Rhizoma Praeparatum Cum Zingibere Et Alumine and Pinelliae Rhizoma Praeparatum cum Alumine. The results of the principal component analysis (PCA) showed that Pinellia ternata and its processed products could be significantly distinguished. The results of orthogonal partial least squares-discriminant analysis (OPLS-DA) showed uridine and thymidine were the differential components between Pinellia ternata and Pinelliae Rhizoma Praeparatum. Uridine, guanosine, adenosine and thymidine were the differential components between Pinellia ternata and Pinelliae Rhizoma Praeparatum Cum Zingibere Et Alumine. Uracil, uridine, guanosine, adenosine and thymidine were the differential components between Pinellia ternata and Pinelliae Rhizoma Praeparatum cum Alumine. The differences among Pinelliae Rhizoma Praeparatum, Pinelliae Rhizoma Praeparatum Cum Zingibere Et Alumine and Pinelliae Rhizoma Praeparatum Cum Alumine were uracil, guanosine and adenosine. No clear distinction was observed between Pinelliae Rhizoma Praeparatum cum Zingibere Et Alumine and Pinelliae Rhizoma Praeparatum Cum Alumine. The results showed that the contents of nucleosides reflected the differences between Pinellia ternata and its processed products.CONCLUSION The content determination method established is scientific, accurate, stable and convenient to operate, which provides reference for the quality control of Pinellia ternata and its processed products.

Dihydromyricetin is the main medicinal substance of vine tea,which has many significant pharmacological activities,but its low bioavailability restricts its clinical application.In recent years,various preparation technologies have provided new ways to improve the solubility and bioavailability of dihydromyricetin,providing an effective solution for its drug formation.This paper reviewed the research progress of various preparation technologies and dosage forms of dihydromyricetin to improve its bioavailability,and analyzed the problems faced by new dosage forms in improving the development of druggability of dihydromyricetin,in order to provide reference for the development and application of dihydromyricetin.

OBJECTIVE To summarize the experiences of clinical pharmacists’ participation in the treatment with intracranial infection,so as to provide reference for the treatment.METHODS Census the clinical pharmacists’ participation in the consultations of the neurosurgery patients who have intracranial infection during January 2020 to December 2021 in People’s Hospital of Guangxi Zhuang Autonomous Region.RESULTS Linical pharmacists participated in 551 consultations on intracranial infection(314 patients),499(276) of whom were completely adopted,with a complete adoption rate of 90.6%,the overall effective rate was 89.1%.The purpose of consultation was mainly to apply for antibiotics for special use,and vancomycin was used most frequently.The detection rate of etiology was 11.8%.CONCLUSION The participation of clinical pharmacists in patients with intracranial infection treatment can promote the rationality of the use of anti-bacterial drugs in intracranial infection from the perspective of pharmacy,and improve the effectiveness of clinical anti-infective diagnosis and treatment.

OBJECTIVE To discuss the diagnosis and treatment of Mycobacterium marinum infection in order to provide clinical reference.METHODS Refer to the case data of patients diagnosed as Mycobacterium marinum infection in the clinical pharmacist consultation cases from January 2016 to December 2021, and investigate the patient's exposure history, injury site, diagnosis time, treatment plan and adverse drug reactions etc.RESULTS Five patients with Mycobacterium marinum infection had a history of exposure to seafood or seafood environment. The injured parts of all patients were hands, of which three were type Ⅱ infection and two were type Ⅲ infection. The diagnosis time was 29-368 days, and the course of treatment was 121-249 days. Four patients were treated with two drugs and one with three drugs. All five patients were cured, and none of the patients had serious adverse drug reactions.CONCLUSION The cooperation between clinical pharmacists and clinicians can shorten the time of diagnosis and promote safe and rational use of drugs.

OBJECTIVE To analyze the current status of clinical trials on infertility based on domestic and international clinical trial registration platforms, providing reference for clinical trials on infertility in China. METHODS Clinical trial information was collected from 19 clinical trial registration platforms recognized by the International Committee of Medical Journal Editors(ICMJE) and China drug clinical trial registration and information disclosure platform, The characteristics of clinical trials on infertility in China were statistically analyzed, based on the classification of "pre-marketing, post-marketing, and other clinical trials". RESULTS From 2005 to 2022, a total of 3 289 clinical trials on infertility had been registered on the platform. Clinical trials on infertility in China exhibit the following characteristics compared to European and American countries:(1)Lower proportions of pre-marketing and post-marketing trials, but higher proportions of other clinical trials (49.96% vs.71.99%); (2)Higher rates of incomplete subject recruitment in all categories in China; (3)Higher rates of randomized controlled trials (RCT)without blinded design in all categories in China; (4)Higher proportions of randomized methods such as stratified/clustered in pre-marketing (0.34% vs.5.56%) and other clinical trials (1.12% vs.7.22%) in China; (5)Higher proportions of centrally allocated trials in pre-marketing (0.34% vs.3.70%) and other clinical trials (1.50% vs.9.75%) in China. All these differences were statistically significant(P<0.05). CONCLUSION The number of registered clinical trials on infertility in China has been increasing over the years, but still remains relatively low compared to European and American countries. China faces challenges in terms of new drugs development, subject recruitment difficulties, and issues related to trial design. Further efforts are needed to improve the quality and quantity of clinical trials on infertility in China.

OBJECTIVE To perform the economical evaluation of polyethylene glycol loxenatide combined with metformin in the treatment of type 2 diabetes, so as to provide basis for clinical drug selection, rational drug use and medical insurance decision for patients with poor blood glucose control treated with metformin alone.METHODS Markov model for 0.1 mg polyethylene glycol loxenatide combined with metformin or metformin alone in the treatment of type 2 diabetes was established. Cohort simulation in Markov model was applied to obtaining long-term effect and cost of each regimen. With three times GDP in 2022 as the willingness payment, the incremental cost-utility ratio was analyzed. The single factor sensitivity analysis and probability sensitivity analysis were carried out to ensure the stability of the analysis results.RESULTS Compared with monotherapy, the cumulative utility of the combination therapy was improved by 0.48 QALYs, the probability of complications was reduced by 10.61% and the mortality rate was decreased by 6.62%; the ICER was 147 033.58 yuan/QALYs, which was less than WTP, with a cost-utility advantage and acceptable increased cost. The results of the sensitivity analysis showed that the study was well stable, with the probability of a cost-utility advantage of the combination regimen being 97.2%.CONCLUSION For T2DM patients with poor glucose control treated with metformin alone, the combination of 0.1 mg polyethylene glycol loxenatide with metformin is a predominant regimen.

Venlafaxine is an anilenediamine antidepressant with a wide antidepressant spectrum, fast drug onset, high bioavailability, high safety tolerance, and better absorption inhibition of 5-HT selection compared to other traditional antidepressants. It plays an important role in the treatment of severe depression, generalized anxiety disorder and depression comorbidity, but the pharmacokinetic process is greatly different, and its blood concentration is affected by various factors such as the patient itself, drug interaction and gene polymorphisms, resulting in unsatisfactory treatment effect or ineffective treatment. This paper aims to review the factors affecting blood concentration of vanafaxine by searching PubMed, Medline, Embase, CENTRAL, PsycNET, Chinese biomedical literature database, CNKI, VIP, Wanfang until December 2022 to provide a reference for the safe and effective use of the drug in clinical application.

OBJECTIVE To compare the pharmacodynamic effects of Sanfang Yizi Prescription with different kidney-tonifying prescriptions in the adenine-induced kidney-yang deficiency polyuria model in rats.METHODS Rats with kidney-yang deficiency polyuria were induced by adenine intragastric administration for 4 weeks, and 2 weeks after modeling, the rats were respectively given Sanfang Yizi Prescription, Suoquanwan, Erjingwan, and Shuilu Erxiandan liquid. After treatment, the daily behavior of each group was observed, the nocturnal and daily urine of each group was recorded, and the levels of urea nitrogen and creatinine in urine were detected. The levels of urea nitrogen, creatinine, aldosterone and antidiuretic hormone were measured. The liver, kidney, spleen and testis were weighed and the organ indices were calculated.RESULTS Compared with those in the blank group, the rats in the model group showed slow weight gain, bowed back and curling up, dull and sparse fur, and reduced voluntary activities, and the nocturnal urine volume, daily urine volume, organ index and biochemical indexes were significantly different (P＜0.05), indicating that the model of kidney-yang deficiency polyuria was successfully replicated. After 4 weeks of drug administration, compared with those in the model group, the nocturnal urine volume and daily urine volume in Sanfang Yizi Prescription group decreased significantly (P＜0.05), and the effects were significantly better than those in the other drug groups, while the nocturnal urine volume and daily urine volume in the other drug groups showed no significant difference (P＞0.05); the urinary level of urea nitrogen and creatinine in each drug group increased significantly (P＜0.05). Compared with the blank group, there was no significant difference (P＞0.05), among which the effects were most obvious in Sanfang Yizi Prescription group. The serum levels of urea nitrogen and creatinine decreased significantly and the levels of aldosterone and antidiuretic hormone increased significantly (P＜0.05) in each drug administration group, and only the serum indicators in Sanfang Yizi Prescription group showed no significant differences compared with those in the blank group (P＞0.05). The organ index, kidney appearance and kidney HE section results of rats in each drug administration group showed different degrees of improvement, among which the best improvement was observed in Sanfang Yizi Prescription group.CONCLUSION The pharmacodynamic effect of Sanfang Yizi Prescription in rats with kidney-yang deficiency polyuria is significant, which is superior to that of Suoquanwan, Erjingwan and Shuilu Erxiandan liquid.

OBJECTIVE To optimize the processing technology of Magnolia officinalis processed with ginger.METHODS Taking ginger juice dosage, moistening time, setting power and processing time as the investigation factors, and magnolol content, honokiol content and cell survival rate as the evaluation indexes, the entropy weight method was used for the comprehensive evaluation. On the basis of single factor experiment, response surface methodology was further selected to screen the best processing parameters of Magnolia officinalis processed with ginger. In addition, the back propagation (BP) neural network was used to find the best processing parameters, and the optimized processing parameters were verified.RESULTS To compare with the optimum processing technology of the entropy weight method, the actual comprehensive score of BP neural network optimization process was the highest (87.11), which was close to the predicted value of 88.27. The BP neural network optimization process was better than the response surface process, and the predicted result was stable and reliable. The best processing technology of processed Magnolia officinalis was as follows: every 100 g of Magnolia officinalis, the amount of ginger juice was 15 mL, the moistening time was 30 min, the power was set at 1 000 W, and the processing time was 7 min.CONCLUSION The established processing technology of Magnoliae officinalis processed with ginger is stable and feasible, and the processed products have good quality with good protective effect on gastric mucosa.

OBJECTIVE To explain the traditional Chinese medicine (TCM) processing synergism mechanism of Qixue Shuangbu Prescription (QSP) for treating chronic heart failure (CHF) from the point of view of "decoction phase state-nano assembly".METHODS The phase of decoction was separated by centrifugation and dialysis. Laser pointer, nano particle size analyzer and transmission electron microscope (TEM) were used to characterize the phase of decoction.RESULTS Three phases of true solution, nano colloid solution and suspended solution were successfully separated from the whole decocting solution before and after the processing of QSP. Compared with the crude QSP group, the Tyndall effect was stronger in processed QSP group, the particle size distribution of the separated nano colloid liquid was more uniform, the polydispersion index was smaller, the surface potential was larger, the conductivity was lower, and the system was more stable. At the same time, nano spherical aggregates were observed by TEM, which further speculated that TCM processing may promote the nano assembly of the active ingredients by changing the decoction system. It had a certain "meridian tropism effect" in the body, achieving targeted delivery to the lesion and playing a synergistic role in anti-CHF.CONCLUSION The study analyzed the TCM processing synergistic mechanism of QSP against CHF from the perspective of "decoction phase state and nano assembly", which provide a new strategy for innovative research on the processing mechanism of TCM for the first time.