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.Construction of a frailty index for cervical kyphosis and analysis of its clinical value
Baining ZHANG ; Shuo DUAN ; Bingxuan WU ; Duo ZHANG ; Tianhua RONG ; Baoge LIU
Chinese Journal of Surgery 2025;63(5):429-435
Objectives:To develop a cervical kyphosis frailty index (CK-FI) and explore its clinical value in identifying high-risk patients undergoing cervical kyphosis correction surgery.Methods:In this retrospective case series, clinical data from 53 patients who underwent cervical kyphosis correction at the Department of Orthopedics, Beijing Tiantan Hospital, Capital Medical University, between January 2019 and December 2023 were analyzed. All patients had a minimum follow-up of 12 months. There were 27 males and 26 females, with an age of (53.4±14.5) years (range: 15 to 83 years). Demographic data, comorbidities, laboratory results, radiographic parameters, and functional assessments were collected. Fifteen key indicators related to physiological reserve and stress tolerance in cervical kyphosis patients were identified via Pearson correlation analysis to establish the CK-FI. Differences in demographic characteristics, clinical outcomes, postoperative complications, and length of hospital stay among CK-FI subgroups were analyzed using independent sample t-tests, one-way ANOVA,Wilcoxon signed-rank tests, Mann-Whitney U tests, Kruskal-Wallis tests, and chi-square or Fisher′s exact tests. Binary logistic regression was employed to determine independent risk factors for postoperative complications. Receiver operating characteristic (ROC) curve analysis was used to assess the predictive performance of CK-FI for postoperative complications. Results:Based on CK-FI scores, patients were classified into non-frail (CK-FI<0.3), frail (0.3≤CK-FI≤0.5), and severely frail (CK-FI>0.5) groups. The 30-day postoperative complication rate was 26.4% (14/53). Both univariate and multivariate analyses indicated that frailty ( OR=6.892, 95% CI: 1.239 to 38.353, P=0.028) and severe frailty ( OR=10.313, 95% CI: 1.877 to 56.659, P=0.007) were independent risk factors for postoperative complications. ROC analysis revealed that CK-FI had an area under the curve of 0.777 (95% CI: 0.637 to 0.917, P=0.001), with a specificity of 70.3% and a sensitivity of 81.3% in predicting postoperative complications. Conclusions:The CK-FI serves as a valuable tool for early detection of high-risk patients with cervical kyphosis, aiding in individualized perioperative management, optimizing preoperative preparation, reducing postoperative complications, and ultimately improving patient outcomes.
6.Challenges and critical issues in the management of cervical spine deformities
Shuo DUAN ; Tianhua RONG ; Baoge LIU
Chinese Journal of Surgery 2025;63(5):442-447
Cervical spine deformity (CSD) represent some of the most formidable challenges in spinal surgery, characterized by complex etiologies, high disability rates, and significant surgical risks. Recent advancements in the understanding of the pathophysiology and management strategies for CSD have facilitated a paradigm shift from traditional, experience-based approaches to precision medicine guided by multidimensional imaging data and comprehensive sagittal alignment assessment. Imaging-based classification systems have optimized the evaluation and classification of deformities by incorporating dynamic imaging and global sagittal balance parameters, thereby providing a reliable foundation for individualized treatment plans. Furthermore, the importance of comprehensive functional assessment has gained prominence, particularly with the use of the frailty index, which offers new insights for risk prediction and optimizing surgical decision-making. In terms of surgical strategies, the use of high-grade osteotomies has improved correction outcomes for complex deformities, yet also demands more stringent management of associated complications. The management of CSD is evolving towards greater precision and individualization, aiming to enhance outcomes by integrating multimodal imaging, functional assessments, and advanced surgical techniques-ultimately leading to better clinical prognosis and quality of life for patients.
7.In vitro and intracellular antibacterial activities of OPC-167832 against Mycobacterium fortuitum
Zhen-yan QI ; Xia YU ; Hai-rong HUANG ; Hong-fei DUAN
Chinese Journal of Zoonoses 2025;41(4):392-397
This study evaluated the potential of OPC-167832 as a new method for the treatment of Mycobacterium fortuitum infec-tion.Drug sensitivity tests were conducted with the broth microdilution method to determine the minimum inhibitory concentration(MIC)of OPC-167832 against standard strains of M.fortuitum and 44 clinical isolates of M.fortuitum.A DprE1 overexpression strain was constructed,and the effect in the MIC of OPC-167832 against M.fortuitum were explored.Intracellular germicidal tests and checkerboard tests were conducted to verify the ability of OPC-167832 to kill intracellular M.fortuitum,and its interaction with five drugs:amikacin,clarithromycin,imipenem,moxifloxacin,and clofazimine.The MIC50 and MIC90 against 44 clinical isolates of M.fortuitum were 0.031 25 μg/mL and 0.062 5μg/mL,respectively.The epidemiological cut-off value(ECOFF)was 0.062 5 μg/mL.Overexpression of DprE1 led to resistance to OPC-167832 in M.fortuitum.After 24 hours of incubation,the intracellular bacterial in-hibition rate of OPC-167832 at a 1 μg/mL concentration was 81.37%,exceeding the 74.05%inhibition rate of amikacin at a 1 μg/mL concentration.OPC-167832 showed strong inhibitory activity against M.fortuitum in vitro and in macrophages,and might provide a promising treatment for M.fortuitum infection.
8.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.
9.Characteristics of cognitive function and related influencing factors in Parkinson′s disease patients with or without olfactory anosognosia
Mengyuan TU ; Yanqiu WEI ; Yimeng CHEN ; Hongyao DUAN ; Jingfang RONG ; Zhanming MA ; Jiangbing LIU
Chinese Journal of Neurology 2025;58(5):506-512
Objective:To investigate the cognitive characteristics and related influencing factors in Parkinson′s disease (PD) patients with or without olfactory anosognosia (OA).Methods:A total of 113 PD patients who were treated at the Affiliated Hospital of Yangzhou University between March 2023 and April 2024 were selected. The PD Olfactory Dysfunction Auxiliary Diagnostic Card was used to assess olfactory function. Based on the olfactory identification scores and subjective awareness of olfactory dysfunction, patients were divided into the normosmic group, olfactory dysfunction group, and the later was further divided into olfactory dysfunction without OA (OA-) group, and olfactory dysfunction with OA (OA+) group. The results of the Unified Parkinson′s Disease Rating Scale-Ⅲ (UPDRS-Ⅲ) and Hoehn-Yahr (H-Y) staging assessments of the patients were collected. Non-motor symptoms such as cognitive function, anxiety, depression, sleep disturbances, and constipation were evaluated using relevant scales. Logistic regression analysis was used to explore the related factors affecting OA in PD patients with olfactory decline.Results:The Montreal Cognitive Assessment (MoCA) scores of the olfactory dysfunction group were lower than those of the normosmic group (20.30±4.47 vs 22.64±2.50, t=2.907, P=0.007). The Self-Rating Anxiety Scale scores (39.00±8.60 vs 43.86±10.63, t=2.444, P=0.016), visuospatial and executive function scores (2.35±1.32 vs 2.98±1.42, t=2.263, P=0.026), and orientation scores (4.88±1.14 vs 5.34±1.07, t=2.046, P=0.043) of the OA+ group were lower than those of the OA- group. Logistic regression analysis revealed that lower MoCA scores were an independent risk factor for PD combined with OA ( OR=0.853, 95% CI 0.743-0.980, P=0.024). Conclusions:PD patients with olfactory dysfunction exhibit more severe cognitive impairment. Among them, patients with OA show more significant impairments in visuospatial, executive function and orientation. Cognitive impairment may be an independent risk factor for PD combined with OA.
10.Research progress on the strategy and mechanism of sonodynamic immunotherapy
Zesheng LI ; Beibei ZHANG ; Shaobo DUAN ; Ruiqing LIU ; Yaqiong LI ; Yuzhou WANG ; Rong HUANG ; Lianzhong ZHANG
Chinese Journal of Ultrasonography 2025;34(4):357-363
Sonodynamic therapy(SDT)has garnered significant attention in cancer treatment modalities due to its superior tissue penetration capabilities,non-invasive approach,and controllability. SDT operates by utilizing sonosensitizers and ultrasound-responsive devices to induce the production of reactive oxygen species(ROS)under ultrasound stimulation,thereby eliciting immunogenic cell death(ICD)in tumor cells and the release of damage-associated molecular patterns,which in turn trigger an immune response against the tumor.However,the tumor microenvironment often results in a relatively weak immune response post-cancer treatment. To address this issue,extensive research is being conducted on combining SDT with immunotherapy,particularly focusing on immune checkpoint blockade(ICB)therapies. This review synthesizes the mechanisms of SDT,its integration with immunotherapy,especially ICB therapies,and the current state of research,with the objective of providing strategic guidance for the advancement of sonodynamic immunotherapy.

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