OBJECTIVE To provide standardized guidance for the rational clinical use of antibody-based drugs for the treatment of myasthenia gravis， and to enhance the evidence-based system of guidelines and consensus in this field. METHODS The consensus expert team consisted of 71 multidisciplinary experts from 28 provinces/autonomous regions/municipalities directly under the Central Government. Evidence was systematically retrieved through multiple databases， drug package inserts， and official websites of international and national health administrative authorities， drug regulatory agencies， healthcare security departments， and related industry associations， up to April 30， 2025. Evidence was graded according to the 2014 version of JBI pre-grading system for evidence from intervention studies. Based on full consideration of the current best evidence and multidisciplinary expert experience， the expert consensus recommendations were formulated using a modified Delphi method. RESULTS The Evidence-based expert consensus on the clinical application and pharmaceutical management of antibody-based drugs for the treatment of myasthenia gravis standardized the key points of whole-process pharmaceutical management for four antibody-based drugs approved for marketing in the mainland of China for the treatment of myasthenia gravis （efgartigimod alfa， efgartigimod alfa/hyaluronidase， eculizumab， and rozanolixizumab）. It formulated 37 expert consensus recommendations covering nine pharmaceutical management aspects： drug suitability selection， medication in special populations， administration methods， drug storage， therapeutic drug monitoring and pharmacogenetic testing， immunization management， drug interactions， pharmaceutical care， and off-label drug use. CONCLUSIONS Based on the current best evidence and multidisciplinary expert experience， this consensus establishes a whole-process management framework for antibody-based drugs for the treatment of myasthenia gravis， from clinical application to pharmaceutical management. It provides a scientific basis for the rational and precise use of these drugs in clinical practice， effectively promotes the enhancement of pharmaceutical management efficiency， and helps improve the overall therapeutic benefits for patients.

OBJECTIVE To construct a research question system of the Guideline for the Management of Therapeutic Drug Monitoring （hereinafter referred to as the Guideline ）， so as to provide the basis for the formulation of the Guideline . METHODS Based on literature research and expert interviews， the questionnaire about research questions of the Guideline was initially constructed. Through the modified Delphi method， the online questionnaire survey and expert consensus meeting were conducted among the Guideline development experts to determine the research question system of the Guideline . RESULTS A total of 59 questionnaires were distributed， and 52 valid questionnaires were collected. The positive coefficient of experts was 88.14%. The experts came from 21 provinces/autonomous regions/municipalities directly under the central government， covering multidisciplinary experts related to therapeutic drug monitoring， all of whom held senior professional titles. After one round of survey， a consensus was reached on the research questions， and a research question framework encompassing four research parts was constructed， including： indications for conducting therapeutic drug monitoring （4 first-level research questions，10 second-level research questions， 31 third-level research questions）； therapeutic drug monitoring technical process （3 first-level research questions， 9 second-level research questions， 13 third-level research questions）； result interpretation and clinical application （3 first-level research questions and 3 second-level research questions）； quality control （8 first-level research questions and 12 second-level research questions）. The importance scores for the four parts ranged from 4.71 to 4.88， with full-score rates all no less than 73.08%. The expert authori ty coefficients were all no less than 0.90， the coefficients of variation of importance scores were all no higher than 0.11， and Kendall’s W ranged from 0.464 to 0.626 （all P ＜0.05）. CONCLUSIONS The constructed research question system has high authority， scientificity， and reliability， laying a foundation for the standardized formulation of the Guideline .

OBJECTIVE To further standardize the technical operations and management processes throughout therapeutic drug monitoring （TDM）， clarify the clinical value of TDM implementation， improve the scientific validity and reliability of monitoring results， and provide a solid reference basis for the formulation and optimization of clinical individualized precision dosing regimens. METHODS The Guidelines for the Management of Therapeutic Drug Monitoring were formulated in accordance with the latest definition of guidelines by the Institute of Medicine of the National Academies and the standard guideline development methodology of the World Health Organization， and in compliance with the requirements of the appraisal of guidelines for research and evaluation. A modified Delphi method was adopted to establish the research question system； evidence-based medicine research methods were applied to systematically search multiple databases to screen the latest and most comprehensive evidence. Evidence was graded and evaluated based on the evidence grading system of the Chinese Evidence-Based Medicine Center， and the grading criteria for recommendation strength from the Oxford Centre for Evidence-Based Medicine were used to determine the recommendation strength. The recommendation opinions were formed through multidisciplinary expert consensus. RESULTS The Guidelines for the Management of Therapeutic Drug Monitoring cover four core modules， including TDM application indications， technical procedures， result interpretation and clinical application， and quality control， involving 18 primary research questions， 34 secondary research questions， and yield 82 recommendations. CONCLUSIONS The guidelines systematically standardize the key technical links and management requirements of the whole TDM process， provide scientific and operable standardized tools， help improve the standardization level of TDM work， promote the translation of monitoring results into clinical decision-making， and provide strong support for precision personalized medicine and ensuring the safety and rationality of medication use.

OBJECTIVE To investigate the effects and mechanisms of oliceridine fumarate （TRV130） in improving postoperative cognitive dysfunction （POCD） in elderly rats based on the Toll-like receptor 4 （TLR4）/nuclear factor-κB （NF-κB） pathway. METHODS Rats were randomly divided into the control group （normal saline）， the model group （normal saline）， the TRV130 group （2.8 mg/kg）， the TLR4/NF-κB pathway inhibitor （TAK-242） group （3 mg/kg）， the β -arrestin inhibitor （Barbadin） group （3 mg/kg）， and the traditional opioid drug （morphine） group （2.8 mg/kg）， with 15 rats in each group. Except for the control group， POCD models were established in all other groups. From the first day after surgery， drugs/normal saline were administered via caudal vein injection once daily for 3 consecutive days. After the last administration， the pathological damage of hippocampal tissue was observed； the cognitive function， serum inflammatory factor levels， hippocampal neurons apoptosis rate， and the expression of ionized calcium-binding adapter molecule 1 （Iba-1）， glial fibrillary acidic protein （GFAP）， and TLR4/NF-κB pathway-related mRNA and protein in hippocampal tissue were detected. RESULTS In the model group， the neurons in the CA1 region of the hippocampus were disordered and sparse， with decreased number， pyknotic and fragmented nuclei accompanied by inflammatory cell infiltration. Compared with the control group， the escape latency， serum levels of tumor necrosis factor α （TNF-α）， interleukin-6 （IL-6）， and IL-1β， hippocampal neurons apoptosis rate， average fluorescence intensities of Iba-1 and GFAP， mRNA expression levels of TLR4 and NF-κB p65， and their protein expression/phosphorylation levels in hippocampal tissue were significantly increased/elevated in the model group （ P ＜0.05）； the time spent in the target quadrant and the number of platform crossings were significantly shortened/decreased （ P ＜0.05）. Compared with the model group， the cognitive function， pathological， inflammatory， and apoptosis-related indicators were significantly improved in the TRV130 group， TAK-242 group， and Barbadin group （ P ＜0.05）； the mRNA expression levels of TLR4 and NF-κB p65 and their protein expression/phosphorylation levels were significantly decreased in the TRV130 group and TAK-242 group （ P ＜0.05）. CONCLUSIONS TRV130 may improve POCD in elderly rats by inhibiting the TLR4/NF-κB pathway and alleviating postoperative central nervous system inflammatory responses.

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 understand the situation of plague host vectors, indicator animals and residents infected with plague bacteria in Cangyuan County, Yunnan Province, China-Myanmar border region, and to explore the risk of plague epidemic, so as to provide reference basis for supplementary plague data and prevention and control in this area. Methods　A plague survey was carried out in three townships in Cangyuan County in 2023. The collected host animals organs and body surface parasitic fleas were bacterial cultured. Serum collected from border residents, indicator animals, and host animals was tested for plague F1 antibodies using indirect hemagglutination assay (IHA). The positive samples were rejudged by IHA, immune colloidal gold assay(GICA) and up-converting phosphor technology(UPT). Results　Totally 294 serum samples were collected from border residents, with an average age of (48.48±14.27) years old, with more females than males. Three were positive for F1 antibody against Yersinia pestis, with a positive rate of 1.02%. And 65 samples of indicator animal serum and 31 samples of Rattus tanezumi serum were collected, and the detection of plague F1 antibody was negative. And 198 rodents belonging to 3 orders, 5 families, 11 genus and 14 species were captured, with a total capture rate of 7.93%, with Rattus tanezumi (46.97%) and Rattus andamanensis (19.19%) as the dominant species. The capture rate in residential indoor areas was 3.72%, and Rattus tanezumi was the absolutely dominant species (100.00%). The capture rate in farming areas was 10.26%, the dominant species were Rattus tanezumi (36.36%), Rattus andamanensis (23.03%), Mus pahari (10.30%) and Hylomys suillus (10.30%). And 60 fleas belonging to 3 families, 5 genera and 6 species were seized, the average infection rate of fleas was 11.62%, and the total flea index was 0.30. The dominant species were Xenopsylla cheopis (28.34%), Palaeopsylla remota (23.33%), Ctenophthalmus quadratus (18.33%), Stivalius aporus (15.00%) and Palaeopsylla incurua (11.67%). A total of 198 murine organ samples were isolated and cultured, and 24 groups of flea samples were obtained, no Yersinia pestis was isolated. Conclusion　The investigation has not found any recent infection with Yersinia pestis in rodents, body surface parasitic fleas and indicator animals; however, it is found that there is still a certain proportion of positive population of plague F1 antibody in the serum of residents. Rattus tanezumi and Xenopsylla cheopis are the first dominant species of host and vector in the county, the indoor density of Rattus flavipectus exceeds 3%, reaching the animal pestis IV early warning, and there is a risk of recurrence in the plague foci.

OBJECTIVE To analyze the medication needs of parents of pediatric children in our hospital regarding drug instructions， and explore improvement strategies， thereby providing a basis for clinically guiding the rational use of drugs in pediatric patients. METHODS A self-designed questionnaire was used to randomly select the parents of pediatric patients in the pediatric outpatient and emergency departments of our hospital from July 1st to September 30th， 2024. A randomized face-to-face survey was conducted regarding their willingness to read drug instructions， their current understanding status， and their needs. The survey results were then statistically analyzed. RESULTS A total of 300 questionnaires were distributed in this survey， and 299 valid questionnaires were recovered， with an effective recovery rate of 99.7%. Before medication， the parents who “always” and “often” read the drug instructions in detail accounted for 39.1% （117 respondents） and 35.1% （105 respondents）， respectively. Statistically significant differences were observed in the willingness to read drug instructions among respondents with varying educational levels and occupations （P＜0.05）. Among the 299 respondents， only 48 people （16.1%）“ fully understood” the drug instructions， and the average understanding score of all the respondents was （3.77±0.83） points. The stronger the respondents’ willingness to read drug instructions， the higher their understanding scores of drug instructions （P＜0.05）. A total of 256 respondents thought that drug instructions were of great help to themselves， and the average helpfulness rating score of all the respondents was （4.28±0.78） points. Under the conditions of varying ages， educational levels， occupations， and willingness to read drug instructions， statistically significant differences were observed in the scores representing the degree of helpfulness of drug instructions to the respondents （P＜0.05）. Respondents paid the most attention to content in drug instructions such as “dosage and administration method”，“ adverse reactions”， and “indications and therapeutic categories”. The most difficult sections for them to understand included “chemical structure and properties”， “pharmacological and toxicological effects” ， and “pharmacokinetics”， etc. The demographic characteristics of the respondents were not significantly associated with the content areas of drug instructions they most desired to see improved （P＞0.05）. Most respondents （86.0%） hoped to improve the instructions mainly by “simplifying professional terms to make them more accessible”. Others included “highlighting key information” （60.5%） and “providing more detailed medication guidance” （49.2%）， etc. CONCLUSIONS Parents of pediatric patients in our hospital have a high demand for drug instructions but low comprehension. The pharmacy department should make targeted improvements to drug instructions based on parents’ actual needs， helping them accurately obtain medication knowledge and reduce potential medication safety risks.

OBJECTIVE To construct the research questions and topic selection evaluation index system of the Guideline for Topic Selection for Comprehensive Clinical Evaluation of Drugs （hereinafter referred to as the Guideline）， so as to provide the basis for the formulation of the Guideline. METHODS Through literature research， an expert questionnaire on the research questions and evaluation index system of the Guideline was initially constructed. Experts were selected according to relevant requirements of the guideline formulation and Delphi method； the research questions and evaluation indicators of the Guideline were screened by electronic questionnaire communication， and the weights of evaluation index system of topic selection were assigned by the analytic hierarchy process. RESULTS Five research questions of the Guideline were constructed， including the organization and management of theme selection， evaluation process， evaluation methods， evaluation index system， and index weight assignment. And a theme selection and evaluation index system， including 5 primary indexes， 9 secondary indexes and 17 tertiary indexes， was constructed. Kendall coefficients of the research questions and all indexes were ＞0.4， and the P values of χ2 test were＜0.05， which meant the evaluation results were consistent. The weights of all levels of the evaluation index system were assigned by analytic hierarchy process with consistency ratio of 0.007 6 （＜0.1）， and the model matrix passed the consistency test. CONCLUSIONS The research questions and topic selection evaluation index system of the Guideline established in this study are highly authoritative， scientific and reliable， which lay a foundation for the standardization of the Guideline.

In order to standardize the workflow for the clinical comprehensive evaluation of drugs， enhance the assessment of research evidence， and improve the application value of research outcomes in translational practice， the Chinese Pharmaceutical Association issued the Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs （T/CLPA 5-2025） in June 2025. The core points include clarifying the concept of clinical comprehensive evaluation of drugs and standardizing the main work processes and technical essentials. This article provides a detailed interpretation of the technical methods for standard formulation， the operational logic of the four core processes （theme selection， evaluation implementation， evidence evaluation， result application transformation）， and the key points of core technologies. The aim is to assist medical institution technicians， policymakers and researchers in accurately grasping the connotation of the standards， resolving practical concerns such as process connection and technology application， and enhancing the quality and homogenization of evaluation work. It provides support for the scientific decision-making of healthcare and health， and the rational clinical medication.

To analyze potential adverse drug events(ADEs) associated with ustekinumab and upadacitinib in the treatment of inflammatory bowel disease(IBD) based on an international authoritative database, thereby providing evidence for clinical medication safety.