1.Guidelines for standardized implementation of pharmacist-managed clinics (2026 edition)
Pengxiang ZHOU ; Maobai LIU ; Xiaoli DU ; Xiaoyang LU ; Mei DONG ; Rong DUAN ; Ruigang HOU ; Xiaoyu LI ; Qi CHEN ; Yanxiao XIANG ; Weiyi FENG ; Rong CHEN ; Deshi DONG ; Yong YANG ; Li LI ; Xiaocong ZUO ; Jinfang HU ; Hongliang ZHANG ; Qingchun ZHAO ; Qi LIN ; Yang HU ; Jiaying WU ; Rongsheng ZHAO
China Pharmacy 2026;37(9):1105-1112
OBJECTIVE To formulate Guidelines for the standardized implementation of pharmacist-managed clinics ( 2026 edition ) in response to the challenges faced by such clinics in China, including uneven development, large discrepancies in service specifications, insufficient patient awareness, and limited medical insurance coverage. METHODS Led by the Pharmaceutical Affairs Professional Committee of the Chinese Hospital Association, the Evidence-based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, and the Hospital Pharmacy Professional Committee of the Cross-strait Medical and Health Exchange Association, a total of 19 domestic hospital pharmacy experts were organized. Through a systematic review of national policies and literature research, current practical experience was summarized. Consensus on the contents of the guidelines was reached after in-depth discussions. RESULTS &CONCLUSIONS The guidelines covered five sections: definition and connotation of pharmacist-managed clinics, establishment requirements, implementation and management, post competency, and practical research. Firstly, the definition and connotation included three operational forms of pharmacist-managed clinics (independent mode, physician-pharmacist joint mode, and online pharmacist-managed clinic mode) and classified service modes (specialty-specific, drug-specific, and disease-specific pharmacist-managed clinics). The establishment requirements were further refined, covering system construction (pharmaceutical service management system, quality control and assessment mechanism), personnel qualifications (professional credentials, continuing education and professional training, etc), service recipients, as well as service venues and facilities. Subsequently, the implementation and management of pharmacist-managed clinics were proposed, involving service procedures, intervention measures, documentation and records, patient education and follow-up, humanistic care, as well as risk management and quality control. Finally, post competency encompassed the competency requirements for pharmacists providing services in pharmacist-managed clinics, as well as the suggestions on teaching methods; practical research encouraged the conduct of high-quality pharmaceutical practice in the setting of pharmacist-managed clinics. The guidelines provide valuable guidance for the standardized implementation of pharmacist-managed clinics in China in terms of establishment, management, teaching, and research, fill the guideline gap in this field, and can promote the high-quality development of pharmacist-managed clinics.
2.Evidence-based expert consensus on the clinical application and pharmaceutical management of antibody-based drugs for the treatment of myasthenia gravis
Rong DUAN ; Zhengxiang LI ; Xiaocong ZUO ; Rongsheng ZHAO ; Ruigang HOU ; Chunsheng YANG ; Guoyan QI
China Pharmacy 2026;37(9):1113-1121
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.
3.Construction of the research question system of the Guideline for the Management of Therapeutic Drug Monitoring based on modified Delphi method
Rong DUAN ; Liyan MIAO ; Zhengxiang LI
China Pharmacy 2026;37(10):1241-1245
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 .
4.Guidelines for the management of therapeutic drug monitoring
Zhengxiang LI ; Liyan MIAO ; Rong DUAN ; Xiaocong ZUO ; Xianglin ZHANG ; Zhuo WANG ; Miao YAN ; Lingli ZHANG ; Rongsheng ZHAO ; Suodi ZHAI ; Guobiao GAO ; Jinhui TIAN
China Pharmacy 2026;37(11):1381-1392
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.
5.Analysis of toxic material basis of Dryopteris crassirhizoma by UPLC-ESI-MS/MS
Rong-hui ZHENG ; Cui-jie WEI ; Fei-fei XIE ; Xin-ya WAN ; Xiao-jie LIANG ; Zhi-wen DUAN ; Dong-mei SUN ; Xiang-dong CEHN
Chinese Traditional Patent Medicine 2025;47(10):3305-3314
AIM To establish a UPLC-ESI-MS/MS method for analyzing the toxic material basis of 95%ethanol cold soaked ultrasonic extract(EC),95%ethanol heated reflux extract(EH)and water decoction extract(WD)from Dryopteris crassirhizoma Nakai.METHODS The analysis was performed on a 25 ℃ thermostatic agilent ZORBAX RRHD StableBond C18 column(2.1 mm×150 mm,1.8 μm),with the mobile phase comprising of methanol-0.2%formic acid flowing at 0.30 mL/min,and heated electrospray ion source was adopted in positive and negative ion scanning.Compounds were identified by Compound Discover 3.3 software combined with the database and related literature,and the main differential components were screened by Heatmap cluster analysis and partial least squares discriminant analysis.RESULTS 72 compounds were identified(22 phloroglucinols,19 flavonoids,8 phenylpropanoids,6 terpenoids and 17 other components).The main toxic differential components were phloroglucinols such as flavaspidic acid AB,didemethylpseudoaspidin AA and filixic acid PBP,flavonoids such as(-)-epicatechin,(-)-epigallocatechin,cianidanol,and other compounds such as indole-3-carboxaldehyde.CONCLUSION This method can rapidly,effectively and comprehensively characterize the main chemical composition of D.crassirhizoma,and provide a reference for the study of its pharmacological mechanism.
6.Discussion on the Treatment of Tumor-related Insomnia from"Heat Toxicity"
Chongyang QU ; Yinghua LI ; Shuzhen DUAN ; Rong MA ; Chunfang TIAN ; Min LIU ; Yuanyuan GUO ; Hongzhen YIN ; Shaobo HU ; Jie LI
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(7):172-175
Tumor-related insomnia is one of the common complications of tumor patients,which is secondary to tumor disease and related to tumor disease itself or tumor treatment.Combined with the unique pathogenesis of"heat-toxicity internal stagnation"of tumor-related insomnia,the important treatment methods are to clear away heat,attack toxicity,regulate qi and supplement healthy qi.This article explained the research status,etiology and pathogenesis,treatment principles of the disease,in order to provide new ideas and methods for the differentiation and treatment of tumor-related insomnia in TCM.
7.Characteristics of pain-anxiety-depression-fatigue symptom clusters in adolescents with acute lymphoblastic leukemia during early chemotherapy
Lei CHENG ; Yan-qing WANG ; Hai-ying HUANG ; Ling YU ; Ming-xia DUAN ; Xiao-rong MAO
Fudan University Journal of Medical Sciences 2025;52(6):803-810
Objective To investigate the characteristics of changes in pain-anxiety-depression-fatigue symptom clusters and their possible associated factors in adolescents with acute lymphoblastic leukemia(ALL)during early chemotherapy.Methods A prospective longitudinal study was conducted from Nov 2019 to Oct 2021,enrolling newly diagnosed adolescent ALL patients from 5 tertiary or pediatric specialty hospitals in Shanghai,Zhejiang Province,Sichuan Province,Anhui Province and Guangdong Province.Patient-reported pain,anxiety,depression,and fatigue were collected at five time points within the first nine weeks of chemotherapy using the PROMIS Pediatric-25 instrument.Latent profile analysis(LPA)and latent transition analysis(LTA)were applied to explore the latent classes of symptom clusters,their transition probabilities over time,and possible risk or protective factors associated with class membership.Results A total of 134 ALL cases were enrolled,and symptom clusters at all the 5 time points(T1-T5)were consistently classified into three groups of mild,moderate and severe symptoms.The severe symptoms group accounted for the largest proportion at each time point(54.5%,59.7%,66.4%,49.3%,and 47.0%,respectively),while the mild and moderate symptoms groups showed an initial decline followed by an increase.Among participants,40.2%maintained the same symptom status,and 77.4%experienced at least one episode of severe symptom status during the trajectory.Religious affiliation(T5)and family monthly income>5 000 Yuan(T2,T4 and T5)served as protective factors against severe symptoms.Higher baseline fatigue(T1)was associated with membership in the severe symptoms group at subsequent time points.Conclusion Pain-anxiety-depression-fatigue symptoms in adolescents with ALL during early chemotherapy can be categorized into mild,moderate and severe symptoms with dynamic transitions over time.Higher baseline fatigue was associated with increased risk of severe symptoms,whereas higher family income and religious affiliation appeared protective effects.
8.Effect of preoperative exercise intervention on lung cancer patients:a re-evaluation of systematic review
Xin JING ; Rong WANG ; Tianpei GU ; Liangwen GONG ; Xiaona DUAN ; Xinyi GU
Modern Clinical Nursing 2025;24(10):83-91
Objective To re-evaluate the systematic evaluation of effectiveness of preoperative exercise intervention in patients with lung cancer.Methods Literature in systematic reviews and meta-analyses of the effectiveness of preoperative exercise intervention among patients with lung cancer was retrieved from databases of PubMed,EMbase,Cochrane Library,Web of Science,CINAHL,Joanna Briggs Institute of Australia's Centre for Evidence-based Health Care Database(JBI),China National Knowledge Infrastructure(CNKI),Wanfang Data,VIP,and SinoMed from the inception to January 10,2024.Two reviewers independently screened the retrieved literature,extracted data,evaluated methodological quality,and summarised and graded the evidence.Results Eight systematic reviews were included.Methodological quality was rated moderate for one review,low for four,and very low for three.Preferred reporting items for systematic reviews and Meta-analyses was found comprehensive in three reviews,incomplete in four and seriously deficient in one.Seven outcome categories comprising 56 indicators were summarised and graded:nine indicators were of moderate certainty,29 of low certainty,and 18 of very low certainty.Pooled evidence from re-meta-analysis showed that preoperative exercises improved preoperative cardiopulmonary function,reduced the risk of post-operative pulmonary complications(PPCs),and shortened a hospital stay.Conclusion Preoperative exercise can improve patient outcomes after surgery.However,current studies often face methodological limitations,inadequate reporting standards and low-quality evidence.Future research should employ more rigorous designs and higher-quality evidence,including comparisons of different exercise modalities and durations,and provide a basis for developing efficient and optimally timed pre-operative exercise protocols.
9.Construction of the research questions and topic selection evaluation index system of Guideline for Topic Selection for Comprehensive Clinical Evaluation of Drugs based on Delphi method and analytic hierarchy process
China Pharmacy 2025;36(7):789-793
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.
10.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
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.

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