Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C₀), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug‍-‍drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage* ; Drug Monitoring/methods* ; Humans ; Organ Transplantation ; Immunosuppressive Agents/administration & dosage* ; Delphi Technique

OBJECTIVE To provide standardized guidance for the clinical application and management of biosimilars， and promote their widespread and rational use in clinical treatment. METHODS The design， planning， and drafting process as well as the full report of Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China （2024 Edition） followed the WHO Handbook for Guideline Development （2nd edition）， which fully considered the best current evidence from evidence-based medicine， multidisciplinary expert experience， and patient preferences and values. Grading of Recommendations Assessment， Development， and Evaluation （GRADE） approach was adopted to evaluate the quality of evidence and determine the strength of recommendations. RESULTS & CONCLUSIONS Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China （2024 Edition） presented 10 recommendations including 7 strong recommendations and 3 weak recommendations. The recommendations covered the entire process of clinical application and management of biosimilars. Medical institutions and relevant health regulatory departments can refer to this guideline for the scientific management of the extrapolation of unapproved indications of biosimilars. Healthcare providers can refer to this guideline for pre-treatment assessments， patient education， pre-treatment regimen before administration， and dosage regimen adjustments. Multidisciplinary medical teams can refer to this guideline to provide pharmacovigilance and patient management throughout the treatment process.

Objective Our study aimed to provide a comprehensive overview of the current status and dynamic trends of the human immunodeficiency virus (HIV) prevalence in Sichuan,the second most heavily affected province in China,and to explore future interventions. Methods The epidemiological,behavioral,and population census data from multiple sources were analyzed to extract inputs for an acquired immunodeficiency syndrome (AIDS) epidemic model (AEM). Baseline curves,derived from historical trends in HIV prevalence,were used,and the AEM was employed to examine future intervention scenarios. Results In 2015,the modeled data suggested an adult HIV prevalence of 0.191％ in Sichuan,with an estimated 128,766 people living with HIV/AIDS and 16,983 individuals with newly diagnosed infections. Considering current high-risk behaviors,the model predicts an increase in the adult prevalence to 0.306％ by 2025,projecting an estimated 212,168 people living with HIV/AIDS and 16,555 individuals with newly diagnosed infections. Conclusion Heterosexual transmission will likely emerge as the primary mode of AIDS transmission in Sichuan. Furthermore,we anticipate a stabilization in the incidence of AIDS with a concurrent increase in prevalence. Implementing comprehensive intervention measures aimed at high-risk groups could effectively alleviate the spread of AIDS in Sichuan.

【Objective】 To analyze the influence of plasma donation on human total protein level and the impact of different blood collection tubes on total protein level detection. 【Methods】 A total of 1 373 plasma donors from 11 apheresis plasma stations in 6 provinces/autonomous regions from March to April, 2021 were selected. Whole blood was collected by ordinary blood collection tube without anticoagulant, heparin anticoagulant tube and sodium citrate anticoagulant tube, and then respectively divided into serum group, heparin anticoagulant group, and sodium citrate anticoagulant group. After separating serum and plasma, the samples were subjected to total protein detection using the biuret method. Kruskal-Wallis test was used to compare the total protein levels among different tubes. The plasma donors were divided into male group (n=597) and female group (n=776), and the total protein levels between different genders were compared by t test. The plasma donors were divided into Sichuan group, Hubei group and Gansu group according to the region, and the Games-Howell test was used for comparison. 【Results】 The median serum total protein level of 1 373 donors was 73.1g/L, which was consistent with the reference range of 65-85 g/L. The median total protein levels of the serum group, heparin anticoagulant group and sodium citrate anticoagulant group were 73.1g/L, 73.3g/L and 63.8g/L, respectively, with statistically significant difference (P<0.05). There was statistical significance in total protein level between sodium citrate anticoagulant group and serum group, sodium citrate anticoagulant group and heparin anticoagulant group(P<0.05), but no statistical significance was noticed between serum group and heparin anticoagulant group (P> 0.05). The serum total protein levels of male group and female group were (72.41±5.40)g/L and (73.67±4.95)g/L, reseectively, and the difference was statistically significant (P<0.05). The serum total protein level in Sichuan group, Hubei group and Gansu group was (73.91±4.29)g/L, (74.17±5.11)g/L and (67.09±3.65)g/L, respectively (P<0.05).The difference between Gansu group and Hubei group, Gansu group and Sichuan group was statistically significant (P<0.05), but no significant difference was noticed between Sichuan group and Hubei group (P>0.05). 【Conclusion】 Plasma donors who meet the donation criteria will not experience abnormal total protein levels due to regular plasma donation. There were differences in total protein levels among different blood collection tubes, different genders and different regions. The total protein level of females was higher than that of males. The total protein level was the highest in Hubei province, followed by Sichuan and Gansu.Heparin anticoagulant group was the highest, followed by serum group and sodium citrate anticoagulant group.

AIM:To systematically evaluate the clinical interchangeability of adalimumab biosimi-lars in terms of efficacy,safety,and immunogenici-ty,and to provide evidence-based reference for clinical interchangeability.METHODS:Randomized Controlled Trials(RCTs)on the interchangeability of adalimumab biosimilars were systematically searched in PubMed,Embase,Cochrane Library,CNKI,WANFANG and SinoMed from inceptions to October 2023.Data were extracted from the litera-ture that met the inclusion criteria,risk of bias was assessed using the Cochrane Handbook for System-atic Reviews of Interventions 5.0 bias risk assess-ment tool.Meta-analysis was performed using Rev-man 5.4 software.The certainty of evidence was graded using the GRADE tool recommended by the Cochrane Collaboration.This study was conducted according to the PRISMA guideline.RESULTS:Eigh-teen studies were included,with 7 focusing on pso-riasis and 11 on rheumatoid arthritis.Regarding ef-ficacy,for psoriasis,there were no statistical differ-ences in PASI 75 response rates and sPGA scores of ≤1 after 1-4 switches between biosimilars and the reference drug(P＞0.05,moderate-quality evi-dence).For rheumatoid arthritis,there were no sta-tistical differences in ACR 20/50/70 response rates after 1-3 switches(P＞0.05,moderate-quality evi-dence).Regarding safety,there were no statistical differences in the risk of adverse events after single or multiple switches for both diseases(P＞0.05,moderate-quality evidence).Regarding immunoge-nicity,there were no statistical differences in the rate of anti-drug antibody production after single or multiple switches(P＞0.05,moderate-quality evi-dence).High-quality evidence is still lacking for the interchangeability of adalimumab biosimilars in other indications.CONCLUSION:The switches be-tween adalimumab biosimilars and the reference drug have no significant impact on clinical efficacy,safety and immunogenicity for psoriasis and rheu-matoid arthritis patients.

AIM:To evaluate and analyze the post-marketing adverse drug reaction(ADR)signals of polatuzumab vedotin,so as to provide reference for clinical safety management.METHODS:Using the FDA adverse drug event reporting system(FAERS)database and OpenVigil data platform,the ADR reports of polatuzumab vedotin were collect-ed from June 10,2019(FDA approval for market-ing)to the March 31,2023.The ADR signals were detected by using the reporting odds ratio(ROR)and proportional reporting ratio(PRR)in the pro-portional imbalance method.To increase the threshold and obtain stronger and more frequently occurring ADRs,a second screening of signals was performed.RESULTS:A total of 2 408 ADR reports related to polatuzumab vedotin were collected,and 83 ADR signals were detected after secondary screening.26 ADR signals were not mentioned in the drug instructions such as abnormal spinal mag-netic resonance imaging,increased bone resorp-tion,osteolysis,decreased aspartate aminotransfer-ase,decreased alanine aminotransferase,hypofibri-nogenemia,and pulmonary embolism.The system organ classes with a high signal counts or cumula-tive number of cases included infections and inva-sive diseases(24 signals,632 cases),various exami-nations(17 signals,675 cases),blood and lymphat-ic system diseases(11 signals,734 cases),various nervous system diseases(7 signals,153 cases),im-mune system diseases(3 signals,95 cases),system-ic diseases and various reactions at the site of ad-ministration(2 signals,145 cases),and systemic dis-eases and various reactions at the site of adminis-tration(2 signals,87 cases),etc.CONCLUSION:In addition to the common ADRs suggested by the in-structions,this study identified new ADR risk sig-nals for polatuzumab vedotin.In the clinical appli-cation of polatuzumab vedotin,in addition to the ADR mentioned in the instructions such as infec-tions,myelosuppression,peripheral neuropathies,infusion-related reactions,and abnormal liver func-tion,attention should also be paid to the risk sig-nals not mentioned such as abnormal spinal mag-netic resonance imaging,and increased bone re-sorption.

Objective    To investigate the clinical safety and feasibility of thoracic sympathectomy in the treatment of palmar hyperhidrosis based on ambulatory surgery. Methods    A retrospective analysis of 74 patients who underwent thoracoscopic sympathectomy in the Department of Thoracic Surgery of the First People's Hospital of Yunnan Province from January 2017 to April 2021 was performed, including 35 males and 39 females aged 12-38 (21.32±4.13) years. Patients were divided into two groups according to different treatments. There were 34 patients in a control group (adopting traditional surgery), and 40 patients in an observation group (adopting ambulatory surgery). The clinical effects of the two groups were compared. Results    No massive bleeding, conversion to thoracotomy, postoperative pneumo-thorax or severe pneumonia occured in all patients. Univariate analysis of intraoperative indexes showed that the two groups had no statistical difference in total hospitalization cost, operation time, anesthesia time or postoperative waiting time (P>0.05). The amount of intraoperative blood loss in the observation group was less than that in the control group (P<0.05). The time of postoperative out of bed and recovery of walking capacity and the incidence of electrolyte disturbance in the observation group were shorter or lower than those in the control group (P<0.05). There was no statistical difference in white blood count, neutrophils count or postoperative 24 h pulse oxygen saturation fluctuation peak between the two groups (P>0.05). Conclusion    Based on the optimized diagnosis and treatment model, thoraco-scopic sympathectomy with laryngeal mask airway which is performed during ambulatory surgery, is feasible and worth popularizing in thoracic surgery.

OBJECTIVE To build a standardized simulation teaching system for resident pharmacists and evaluate its effects， and to provide reference for improving the competency of resident pharmacists. METHODS The established simulation teaching system for pharmacy residents’ standardized training in the study included revising the simulation teaching syllabus， setting up simulation teaching courses， implementing the teaching method through “six types of simulations”， applying objective structured clinical examination （OSCE） for assessment， building a simulation teaching team and strengthening the simulation teaching management. The effect evaluation was perfermed with mixed research method， and qualitative and quantitative research methods were used to collect and analyze data and information. RESULTS ＆＆CONCLUSIONS Compared with the traditional teaching system， the passing rate of graduation examination （71.4% vs. 100%） and the score of after-department examination （[ 76.2±7.8） vs. （90.4±4.9）] under the simulation teaching mode were higher； through questionnaire surveys and qualitative interviews， we found that resident pharmacists who went through simulation teaching gave positive feedback on the role and impact of this system. The simulation teaching system can be used with good generalizability for the standardized training of resident pharmacists， and can provide strong basis and support for the high-quality development of hospital pharmacy.

OBJECTIVE To develop an individualized medication list for elderly patients by evidence-based pharmacy method， and to support clinical decisions on rational use of METHODS　Firstly， drugs with risk genetic information were screened out by systematically reviewing evidence-based pharmacy information. Secondly， researchers investigated the included drugs in lists from different data E- sources. Drugs included in three or more data sources and drugs proposed by the expert committee were then included in the medication list. Thirdly， for the drugs included in two data sources， researchers designed questionnaires to investigate the necessity of drug-related gene testing. According to the scoring results of the expert questionnaire， drugs with higher scores were included in the list. Data sources included real-world data （list of high frequency medication in hospitals， high frequency medication for elderly outpatients and inpatients in National Health Care Claims Data， drugs related to frequent medication errors and so on） and evidence-based pharmacy evidence （the websites of Clinical Pharmacogenomics Implementation Consortium， Dutch Pharmacogenetics Working Group， Food and Drug Administration and so on）. RESULTS　The study obtain 68 drugs with risk genetic information which were included in three data sources. Combined with 23 drugs proposed by the expert committee， a list containing 74 drugs was preliminarily formed after de-duplication. A total of 37 drugs included in two databases with risk genetic information were scored through the questionnaire survey to form a supplementary list of 26 drugs. This is the final composition of the list of 100 drugs developed in this study. Among them， there are 43 drugs for the central nervous system， 15 drugs for the cardiovascular system， 12 anti-tumor drugs and so on. Twelve drugs were included in six or more data sources， which mainly consisted of drugs for digestive system， all proton pump inhibitors. CONCLUSION　In this study， a list of 100 commonly used drugs which require individualized medication for the elderly was developed by evidence-based pharmacy method. The drug list will be updated in time as available evidence changes， and can provide guidance for rational use of medicines for elderly patients.

Objective:To evaluate the effects of intensive intervention on negative spouses in sero-discordant couples.Methods:From December 2019 to December 2020, all HIV sero-discordant couples in seven townships in Butuo County of Liangshan were enrolled and divided into intensive intervention group and routine intervention group. Both intensive intervention and routine intervention were conducted for one year. Baseline survey and follow-up were conducted respectively with a questionnaire survey and a serological testing in HIV sero-discordant couples in the two groups at 6 th month before and after the interventions. Multivariable Cox proportional hazards model and difference-in-difference model were used to evaluate the effect of the intensive intervention. Results:A total of 899 sero-discordant couples were enrolled (393 of intensive intervention group and 506 of routine intervention group), in whom 806 completed the follow up survey (349 of intensive intervention group and 457 of routine intervention group). Compared with routine intervention, intensive intervention had no effect to improve the correct answer rate of an AIDS related question in negative spouses ( P>0.05), but could improve their awareness of AIDS related knowledge ( β=1.40, P=0.008). Compared with routine intervention, intensive intervention could reduce the frequency of sex between HIV sero-discordant couples ( β=-0.73, P=0.021), and increase the frequency of condom use ( β=0.19, P=0.007), but had no effect to decrease the positive conversion rate in negative spouses ( β=-0.61, OR=0.55,95% CI:0.18-1.66, P=0.294). Conclusions:The intensive interventions could improve the awareness of AIDS related knowledge in negative spouses in sero-disordant couples and promote their safe sexual behavior, but had no effect to decrease the positive conversion in negative spouses. It is necessary to continue the intensive intervention and follow up to evaluate the effects of the intervention.