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 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 standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs， and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization （WHO）， strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States， and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions； research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center， and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions， including topic selection， evaluation implementation， evidence evaluation， and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs， which can effectively guide the high-quality and high-efficient development of this work， enhance the standardized output and transformation application value of evaluation evidence， and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.

OBJECTIVE To investigate the clinical characteristics of drug-induced liver injury （DILI） induced by glucagon- like peptide-1 receptor agonists （GLP-1RAs）， and to provide a reference for safe clinical medication. METHODS Using search terms such as “GLP-1”“GLP-1RAs”“semaglutide” “drug-induced liver injury”， relevant studies from PubMed， Embase， the Cochrane Library， CNKI， Wanfang Data and VIP were retrieved. Descriptive analysis was performed on cases of DILI induced by GLP-1RAs. RESULTS A total of 11 studies， comprising 11 patients， were included. Among them， 4 were male （36.4%） and 7 were female （63.6%）. Patient ages ranged from 17 to 64 years； 5 patients （45.5%） were between 50 and 65 years old. Six patients were treated for diabetes， and five for weight loss. Ten patients had underlying diseases. The shortest time to the onset of DILI was 5 days after medication， while the longest was approximately 180 days. The DILIs induced by GLP-1RAs were mainly hepatocellular injury type （6 cases）； severity levels included severe （3 cases）， moderate （6 cases）， and mild （2 cases）. Gastrointestinal symptoms and jaundice were the most common clinical manifestations. The association between DILI and GLP- 1RAs was assessed as “probable” in 10 cases and “possible” in 1 case. All 11 patients improved after drug discontinuation and （or） corresponding treatment. CONCLUSIONS DILI induced by GLP-1RAs is relatively concentrated in patients aged 50-65， with a higher incidence in females. The risk may be further increased in patients with underlying diseases. Clinical use of these agents should enhance pharmaceutical care， including identification of high-risk populations and patient education （especially symptom recognition）. When relevant symptoms appear， the drug should be discontinued immediately， with liver-protective therapy initiated when necessary， to ensure patient safety of drug use.

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:To compare the effects of enhanced heat preservation strategies and conventional heat preservation strategies in the operation room on body temperature, coagulation function, and myocardial injury in patients with cervical spinal cord injuries.Methods:A retrospective cohort study was conducted to analyze the clinical data of 160 patients with cervical spinal cord injuries admitted to Second Affiliated Hospital of Xi′an Jiaotong University and Affiliated Honghui Hospital of Xi′an Jiaotong University from February to October 2022, including 82 males and 78 females, aged 38-64 years [(50.6±8.7)years]. Injured segments included C 3 in 19 patients, C 4 in 33, C 5 in 39, C 6 in 38, and C 7 in 31. According to American Spinal Injury Association (ASIA) classification, 10 patients were classified into grade A, 83 grade B, 39 grade C, and 28 grade D. All the patients underwent cervical laminoplasty, decompression and bone graft fusion surgery. According to different heat preservation strategies intraoperatively, the patients were divided into conventional heat preservation group ( n=80) and enhanced heat preservation group ( n=80). The body temperature changes before surgery, at 2 hours during surgery, immediately after surgery, at 2 and 24 hours after surgery were compared between the two groups. The changes of coagulation function before surgery and at 4 hours after surgery were compared between the two groups, including the prothrombin time (PT), thrombin time (TT), and activated partial thromboplastin time (APTT). The incidence of myocardial injury and the number of patients with myocardial injury measured by the indicators of cardiac troponin I (cTnI) and high-sensitivity cardiac troponin T (hs-cTnT) at 48 hours after surgery. Before surgery and at 14 days after surgery, ASIA classification was used to evaluate the neurological functions, including sensory and motor functions between the two groups. The incidence of cardiovascular events at 12 months after surgery were compared between the two groups. Results:A total of 145 patients were followed up for 12-18 months [(15.7±1.6)months]. At 12 months after operation, there were 7 patients in the enhanced heat preservation group were lost to follow-up, compared to 8 patients in the conventional heat preserration group. There was no statistically significant difference in body temperature between the two groups before surgery or at 24 hours after surgery ( P>0.05). At 2 hours during surgery, immediately after surgery and at 2 hours after surgery, the body temperature was (36.90±0.12)℃, (37.00±0.06)℃, and (37.16±0.06)℃ in the enhanced heat preservation group, which were significantly higher than those in the conventional heat preservation group [(36.56±0.03)℃, (36.74±0.08)℃, and (36.84±0.08)℃] ( P<0.01). The serum levels of PT, TT and APTT were not significantly different between the two groups before surgery ( P>0.05), while they were (13.1±1.2)seconds, (19.2±1.1)seconds, and (36.2±3.3)seconds in the enhanced heat preservation group at 4 hours after surgery, which were significantly lower than those in the conventional heat preservation group [(14.3±1.0)seconds, (20.2±1.1)seconds, and (38.7±3.4)seconds] ( P<0.01). The incidence of myocardial injury in the enhanced heat preservation group was 5.0% (4/80) at 48 hours after surgery, which was lower than 12.5% (12/80) in the conventional heat preservation group ( P<0.05). With cTnI as the indicator of myocardial injury, there were 2 patients [2.6%(2/76)] with myocardial injury in the enhanced heat preservation group, which was much lower than 8 patients [11.8%(8/68)] in the conventional heat preservation group ( P<0.05). With hs-cTnT as the indicator of myocardial injury, 8 patients [10.5%(8/76)] in the enhanced heat preservation group experienced myocardial injury, similar with 10 patients [14.7%(10/68)] in the conventional heat preservation group ( P>0.05). There were no statistically significant differences in the ASIA scores of the sensory and motor functions between the two groups before surgery and at 14 days after surgery ( P>0.05). The incidence of cardiovascular events at 12 months after surgery in the conventional heat preservation group was 27.8% (20/72), which was significantly higher than 9.6% (7/73) in the enhanced heat preservation group ( P<0.01). Conclusion:For patients with cervical spinal cord injuries, compared with conventional heat preservation strategies, the enhanced heat preservation strategies in the operating room can improve the patients′ core body temperature and coagulation function, and significantly reduce the incidence of myocardial injury and cardiovascular events.