OBJECTIVE To assess the scientific rigor， clarity and feasibility of the recommendations of the Guidelines for Evidence-based Use of Biological Agents for the Clinical Treatment of Osteoporosis （hereinafter referred to as the Guideline） through external review， in order to further revise and improve the Guideline recommendations. METHODS This study employed a cross-sectional survey research design， a convenience sampling method was adopted to select frontline medical workers in the field of osteoporosis （including clinical doctors， clinical pharmacists， and nurses） as well as patients or their family members. External review was conducted through a combination of closed-ended and open-ended electronic questionnaires to get feedback from them on the appreciation，clarity and feasibility of the 32 preliminary recommendations in the Guideline. RESULTS A total of 90 external review subjects from 15 hospitals were collected， including 45 clinical doctors， 15 clinical pharmacists， 15 nurses and 15 patients or their family members. The overall appreciation degree of recommendations was 99.38%， the overall clarity degree of recommendations was 98.92%， and the overall feasibility degree of recommendations was 99.65%. At the same time， 111 subjective suggestions were collected， which provided an important reference for the further improvement of the Guideline recommendations. Based on the above feedback， the Guideline steering committee and core expert group revised the wording of 12 draft recommendations without deletion， and finally determined 32 recommendations. CONCLUSIONS The external review provides an important basis for the final formation of the Guideline， further improves the scientific rigor， clarity and feasibility of the recommendations， and ensures the standardization， practicality and implementability of the Guideline.

Objective:To systematically evaluate the current status and methodological quality of guideline and consensus in ovarian stimulation for in vitro fertilization (IVF), and to provide reference for the development of future guidelines and research. Methods:A systematic search was conducted in databases including PubMed, Embase, CNKI, Wanfang, Sinomed and relevant guideline websites from inceptions to October 2024. Data were extracted from the literature that met the inclusion criteria, and methodological quality was assessed using the Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ) tool. Descriptive analysis was performed with results presented in visual data charts.Results:A total of 23 studies were included, with 8 guidelines and 15 consensus. Totally 21 (91.3%) studies focused on the selection of ovarian stimulation protocols, with the majority concentrating on protocols for patients undergoing IVF treatment for the first cycle, and 12 (52.2%) studies focused on the selection of gonadotropin starting dosage. In terms of methodology, the average standardized scores in the 6 assessment domains of the AGREE Ⅱ tool were as follows: scope and purpose (85.1%), stakeholder involvement (66.6%), rigour of development (36.5%), clarity of presentation (70.1%), applicability (36.4%), and editorial independence (46.2%).Conclusion:Current recommendations in ovarian stimulation for IVF exhibit inconsistencies, and the methodological quality varies, which partially hinders the translation of evidence into clinical practice. Future research should further focus on the selection of ovarian stimulation protocols and gonadotropin starting dosage, promoting the update and refinement of guidelines and consensus to guide the precise treatment of ovarian stimulation.

Bruton's tyrosine kinase inhibitors (BTKi) are a class of novel small-molecule targeted antitumor drugs used to treat B-cell malignancies. However, safety issues associated with BTKi may lead to treatment interruption, compromising their efficacy. To promote the standardized management of safety in BTKi treatment, Evidence-Based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Hospital Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society, Expert Committee on Lymphoma of Chinese Society of Clinical Oncology, Expert Committee on Leukemia of Chinese Society of Clinical Oncology, Integrated Cancer Cardiology Branch of China Anti-Cancer Association, Hematology Branch of the Chinese Medical Association, and Hospital Pharmacy Professional Committee of the Cross-Straits Medicine Exchange Association formulated the Evidence-based Expert Consensus on the Clinical Management of Safety of Bruton′s Tyrosine Kinase Inhibitors (2024), which was published in the Chinese Journal of Cancer Research in June 2024. It covered 9 clinical issues in the following 3 domains: (1) the management of common adverse reactions of BTKi such as bleeding, cardiovascular events, hematological toxicity, infections, rashes, diarrhea, and arthralgia; (2) the management of drug-drug interactions; (3) management guidance for special populations. This consensus provides evidence-based recommendations for the safety management of BTKi medication in clinical practice. This article provides an interpretation and evidence summary of the consensus in Chinese, aiming to facilitate its implementation in China, enhance the safety management of BTKi treatment, and improve patient outcomes.

Objective:To systematically evaluate the current status and methodological quality of guideline and consensus in ovarian stimulation for in vitro fertilization (IVF), and to provide reference for the development of future guidelines and research. Methods:A systematic search was conducted in databases including PubMed, Embase, CNKI, Wanfang, Sinomed and relevant guideline websites from inceptions to October 2024. Data were extracted from the literature that met the inclusion criteria, and methodological quality was assessed using the Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ) tool. Descriptive analysis was performed with results presented in visual data charts.Results:A total of 23 studies were included, with 8 guidelines and 15 consensus. Totally 21 (91.3%) studies focused on the selection of ovarian stimulation protocols, with the majority concentrating on protocols for patients undergoing IVF treatment for the first cycle, and 12 (52.2%) studies focused on the selection of gonadotropin starting dosage. In terms of methodology, the average standardized scores in the 6 assessment domains of the AGREE Ⅱ tool were as follows: scope and purpose (85.1%), stakeholder involvement (66.6%), rigour of development (36.5%), clarity of presentation (70.1%), applicability (36.4%), and editorial independence (46.2%).Conclusion:Current recommendations in ovarian stimulation for IVF exhibit inconsistencies, and the methodological quality varies, which partially hinders the translation of evidence into clinical practice. Future research should further focus on the selection of ovarian stimulation protocols and gonadotropin starting dosage, promoting the update and refinement of guidelines and consensus to guide the precise treatment of ovarian stimulation.

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

Bruton's tyrosine kinase inhibitors (BTKi) are a class of novel small-molecule targeted antitumor drugs used to treat B-cell malignancies. However, safety issues associated with BTKi may lead to treatment interruption, compromising their efficacy. To promote the standardized management of safety in BTKi treatment, Evidence-Based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Hospital Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society, Expert Committee on Lymphoma of Chinese Society of Clinical Oncology, Expert Committee on Leukemia of Chinese Society of Clinical Oncology, Integrated Cancer Cardiology Branch of China Anti-Cancer Association, Hematology Branch of the Chinese Medical Association, and Hospital Pharmacy Professional Committee of the Cross-Straits Medicine Exchange Association formulated the Evidence-based Expert Consensus on the Clinical Management of Safety of Bruton′s Tyrosine Kinase Inhibitors (2024), which was published in the Chinese Journal of Cancer Research in June 2024. It covered 9 clinical issues in the following 3 domains: (1) the management of common adverse reactions of BTKi such as bleeding, cardiovascular events, hematological toxicity, infections, rashes, diarrhea, and arthralgia; (2) the management of drug-drug interactions; (3) management guidance for special populations. This consensus provides evidence-based recommendations for the safety management of BTKi medication in clinical practice. This article provides an interpretation and evidence summary of the consensus in Chinese, aiming to facilitate its implementation in China, enhance the safety management of BTKi treatment, and improve patient outcomes.

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.

Generative artificial intelligence (GAI) refers to AI technology capable of generating new content such as text, images, or audio from training data. GAI tools not only demonstrate rapid and efficient potential in literature screening, data extraction, and literature appraisal in systematic reviews, but can also be used for guideline evaluation and dissemination, enhancing the readability and promotion efficiency of guidelines. However, the accuracy of content generated by GAI tools, the rationality of cited evidence, the level of evidence, and the reliability of data still need verification. Additionally, data privacy protection and ethical issues are challenges that need to be addressed. This article aims to overview the current status of GAI tools in the formulation, evaluation, dissemination, and implementation of guidelines, explore the feasibility and new models of GAI tools in the field of guidelines, and improve the efficiency and quality of guideline formulation to better serve guideline developers and users.

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.