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  • Professional Committee on Lean Medication Research and Transformation of Jiangsu Society of Research Hospitals
    Herald of Medicine. 2026, 45(3): 357-367. https://doi.org/10.3870/j.issn.1004-0781.2026.03.001

    Type 2 diabetes mellitus is a chronic metabolic disease characterized by a high prevalence rate,a significant disease burden,and the need for long-term standardized management.The latest national epidemiological data reveal that in Jiangsu Province in 2023,the age-standardized prevalence of diabetes has reached 16.35%,ranking among the highest among provincial-level administrative regions in China and highlighting the severe challenges of diabetes prevention and control in Jiangsu Province.Effective pharmacological treatment is crucial for controlling blood glucose levels,delaying complications,and improving patients' quality of life.Based on the latest domestic and international authoritative guidelines for the diagnosis and treatment of adult type 2 diabetes,this consensus focuses on the selection of pharmacological treatment strategies at different stages of disease progression.It refines the medication regimens recommended in the guidelines in the form of a structured pathway,clarifies the therapeutic positioning,target populations,dosage ranges,and administration regimens of various classes of hypoglycemic drugs,while emphasizing the standardization and timeliness of pharmacological treatment.The aim is to establish a standardized pharmacological treatment pathway,bridge the gap between clinical guidelines and practice,provide clinicians with pathway-based treatment strategies,and offer solutions for rational drug use in clinical settings.

  • ZHAO Zhigang, DONG Zhanjun, LIU Jianping
    Herald of Medicine. 2026, 45(1): 1-9. https://doi.org/10.3870/j.issn.1004-0781.2026.01.001

    With the continuous development of China's medical and health sector,the demands for scientific rigor and regulatory compliance in drug evaluation and selection within medical institutions have markedly increased. Building upon recent advancements in the pharmaceutical field and evolving national drug policies,the Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (the Third Edition),hereinafter referred to as the “Guide”,revises and refines the drug evaluation indicators based on its first and second editions. On one hand,it employs a quantitative scoring system to enhance the differentiation of drug priorities within medical institutions,ensuring that evaluation criteria are closely aligned with national policy directions. On the other hand,it further details the scoring criteria,thereby improving operational feasibility and reducing implementation complexity in clinical practice. The Guide facilitates a quantitative scoring of drugs across five dimensions:effectiveness (28 points),safety (27 points),pharmaceutical characteristics (27 points),economy (10 points),and other attributes (8 points). This approach shifts the focus of drug evaluation back to clinical value,assisting medical institutions in conducting objective drug selection and evaluation.

  • RAN Jingyan, WAN Qing, FANG Jianguo, WANG Wenqing, XIONG Wei
    Herald of Medicine. 2026, 45(2): 204-211. https://doi.org/10.3870/j.issn.1004-0781.2026.02.006

    Modern medical treatments for obesity primarily focus on symptomatic approaches like pharmacotherapy and surgery, which often cause adverse reactions, side effects, and a high recurrence rate. Traditional Chinese Medicine (TCM) interventions, guided by the principles of holism and syndrome differentiation, deliver personalized treatments based on clinical patterns. Through multi-component and multi-target regulation, TCM offers proven efficacy with minimal side effects, demonstrating unique advantages. TCM treatment protocols for obesity have been established in the Obesity Diagnosis and Treatment Guidelines (2024 Edition),expert Consensus on TCM Diagnosis and Treatment of Obesity, and Multidisciplinary Diagnosis and Treatment Consensus for Obesity Based on Clinical Practice (2021 Edition). These guidelines recommend herbal formulas such as Shenling Baizhu San, Xiaoyao San, Peilian Mahuang Tang, and Maren Wan for obesity management. From the perspective of TCM pattern differentiation involving the spleen, stomach, liver, and kidney. This review summarizes clinical applications of the recommended formulas based on Chinese literature published between 2003 and 2025, aiming to provide references for clinical formula selection and medication.

  • SUN Jie, YAO Ying
    Herald of Medicine. 2025, 44(12): 1894-1899. https://doi.org/10.3870/j.issn.1004-0781.2025.12.003

    The rising prevalence of obesity poses a major challenge to global public health. Obesity not only contributes to various metabolic disorders including hypertension, diabetes, cardiovascular and cerebrovascular diseases,but is also closely linked to an elevated risk of malignancies, multi-organ damage, and reduced life expectancy, placing a substantial burden on both individuals and society. Lifestyle management remains the cornerstone of obesity treatment, with dietary intervention emerging as a central strategy for chronic disease prevention and control. This article categorized different weight-loss dietary patterns into “energy-restricted”, “nutritionally structured” and “diet-quality optimized” types, reviewing their underlying mechanisms and practical effectiveness. Furthermore, it examined their effects on key metabolic markers such as blood glucose, insulin resistance, and lipid profiles, thereby providing valuable insights for addressing the ongoing obesity epidemic.

  • Chinese Hospital Association Pharmaceutical Specialized Committee, National Institute of Hospital Administration Pharmaceutical Information Expert Committee, Chinese Association for Artificial Intelligence Bioinformatics and Artificial Life Specialized Committee
    Herald of Medicine. 2026, 45(4): 549-566. https://doi.org/10.3870/j.issn.1004-0781.2026.04.001

    Generative Artificial Intelligence (GenAI) is rapidly permeating various fields of hospital pharmacy, bringing transformative opportunities to prescription review, clinical medication decision-making, patient education, and pharmacy administration. However, challenges remain in ensuring the professional accuracy of generated content, maintaining output stability, and achieving adequate controllability of model outputs. As the primary interface for human-AI interaction in healthcare, prompt design critically determines the professionalism, safety, and regulatory compliance of AI outputs. Yet, standardized prompt frameworks tailored to the complex practice scenarios of hospital pharmacy remain unavailable. Therefore, the Chinese Hospital Association Pharmaceutical Specialized Committee, the National Institute of Hospital Administration Pharmaceutical Information Expert Committee and the Chinese Association for Artificial Intelligence Bioinformatics and Artificial Life Specialized Committee led a multidisciplinary collaboration to develop the consensus. This consensus formulated 14 recommendations, proposing general principles for GenAI application in hospital pharmacy and methodologies for prompt design. It clarified the application boundaries and differentiated prompt design essentials for five core scenarios-pharmaceutical care, pharmacy education, pharmaceutical research, pharmacy administration, and popular science in pharmacy. Also, it highlighted the current limitations of GenAI applications. As the first expert consensus in the field of hospital pharmacy focusing on GenAI application and prompt engineering, it aims to provide systematic theoretical guidance and practical tools for pharmacy professionals, standardize the rational application of GenAI, enhance the quality of intelligent pharmaceutical services, and ultimately promote high-quality development of hospital pharmacy.

  • ZHAO Wei, ZHAO Zhigang, WU Mingfen
    Herald of Medicine. 2025, 44(12): 1948-1955. https://doi.org/10.3870/j.issn.1004-0781.2025.12.011

    Objective To assess home medication adherence among elderly patients with chronic diseases in China, analyze influencing factors, and propose targeted intervention strategies. Methods A cross-sectional survey was conducted from October 2024 to March 2025, covering elderly patients (≥60 years) with chronic diseases across 31 provinces in China. Data were collected through face-to-face interviews by pharmacists, and binary logistic regression analysis was used to examine influencing factors and their interaction effects. Results A total of 6 692 valid questionnaires were collected (response rate: 98.47%). The rate of optimal medication adherence was 36.86% (2 467 cases). Facilitators included: female sex (OR=0.869, P=0.040), higher education (junior high school: OR=0.690, P=0.001; senior high/vocational school: OR=0.782, P=0.014), regular disease monitoring (OR=1.443, P=0.033), awareness of medication indications (OR=0.662, P=0.025), ability to describe adverse drug reactions (OR=1.548, P<0.01), reviewing drug instructions before use (OR=1.384, P=0.015), and higher medication literacy (OR=0.980, P<0.01). Barriers included: larger household size (OR=1.058, P=0.001), employment status (OR=0.731, P=0.001), medical insurance coverage (OR=0.791, P=0.002), and drug-related problems (OR=1.899, P<0.01). Educational level plays a pivotal moderating role in the interaction effects. Conclusions Medication adherence among Chinese elderly chronic disease patients remains suboptimal and is influenced by multidimensional factors. Tailored, stratified interventions integrating medical, psychosocial, and pharmaceutical management strategies are warranted to achieve precision care.

  • ZHU Shengjin, ZHU Xiaodeng, LI Kaiyang, YANG Mei, WU Xian, CHANG Bingcheng, ZENG Xiaoyan, LI Xiaoying
    Herald of Medicine. 2026, 45(5): 813-819. https://doi.org/10.3870/j.issn.1004-0781.2026.05.012

    Objective To explore the research status and future trend of mesenchymal stem cells (MSCs) related clinical trials in China,and to provide a reference for MSCs drug research and development. Methods To retrieve the clinical trials related to MSCs in China from the establishment of the registration and information publicity platform of drug clinical trials of the national medical products administration to September 25,2025,and to extract relevant data and information for inductive analysis. Results A total of 65 MSCS-related clinical trials were retrieved,of which 43 items (66.15%) were multi-center studies,recruiting a total of 3 112 participants.The sponsoring institutions and implementation team leaders were concentrated in Shanghai,Beijing,Guangdong,Zhejiang,and other provinces and cities with developed economic and abundant medical resources.There were 34 (52.31%) parallel-group designs and 31 (47.69%) single-arm trials.One of the parallel group designs did not randomize,and 6 of the 33 randomized trials did not use blinding.The trial stages were mainly phase I or phase II clinical trials,with 60 trials (92.21%).The main cell type studied was human umbilical cord mesenchymal stem cells (UC-MSCs),41 items(63.08%).The main indications were knee osteoarthritis (11 items,16.92%),graft-versus-host disease (7 items,10.77%),and ischemic stroke (7 items,10.77%).At present,only one MSCs therapy (Amimestrocel Injection) has been approved in China. Conclusions The clinical trials of MSCs in China are mainly concentrated in areas with well-developed economic and medical resources,and the study designs are not standardized.The experimental cell type was mainly UC-MSCs,with a focus on the treatment of knee osteoarthritis.At present,most studies are still in phase I-II clinical trials,and there is a lack of definitive clinical safety and efficacy data;it will take time for them to be approved for marketing.The future development of MSCs clinical trials in China should focus on precision and enhanced therapies,and strive to advance the maturity of the entire industry chain and the synergy of interna-tional cooperation and regulation.

  • Hubei Provincial Clinical Pharmacy Quality Control Center,Pharmaceutical Management Professional Committee, Hubei Provincial Hospital Association of Wuhan Pharmaceutical Society
    Herald of Medicine. 2026, 45(3): 367-377. https://doi.org/10.3870/j.issn.1004-0781.2026.03.002

    Influenza viruses are currently experiencing seasonal high activity in Hubei Province,posing a major public health threat to the population.High-risk groups,such as the elderly,children,pregnant women,patients with chronic diseases,and individuals with compromised immune systems,are more susceptible to severe complications,including respiratory failure,multi-organ dysfunction,and even death. To further standardize the clinical use of anti-influenza antiviral agents,promote their rational application medical institutions at all levels within Hubei Province,reduce the risk of antiviral resistance,and ensure the safety,effectiveness,cost-effectiveness,and appropriateness of pharmacotherapy,the Hubei Provincial Clinical Pharmacy Quality Control Center convened a multidisciplinary expert panel in influenza diagnosis and treatment and clinical pharmacy to develop the Guideline for the Rational Use of Anti-Influenza Antiviral Agents (hereinafter referred to as “the Guideline”).This Guideline was formulated based on a systematic review of the latest evidence-based medical literature,drug prescribing information,and clinical practice experience.,incorporating the epidemiological characteristics and healthcare context of Hubei Province. The Guideline applies to healthcare professionals involved in clinical diagnosis and treatment,pharmaceutical services,infection control,and related management activities across all levels and types of medical institutions in Hubei Province.It focuses on key aspects including precise indication assessment,optimal timing of administration,individualized drug selection,dosage adjustment,treatment-course management,and medication use in special populations,aiming to provide scientific,practical,and implementable guidance for clinical practice.

  • DU Zhijuan, LIU Zhefeng
    Herald of Medicine. 2026, 45(3): 460-465. https://doi.org/10.3870/j.issn.1004-0781.2026.03.015

    Chimeric antigen receptor natural killer (CAR-NK) cell therapy has emerged as a promising immunotherapeutic strategy for solid tumors,demonstrating distinct advantages over chimeric antigen receptor T (CAR-T) cell therapy.Compared to CAR-T cells,CAR-NK cells exhibit innate antitumor activity,multiple cytotoxic mechanisms,superior safety profiles,and diverse cell sources.Currently,more than 30 clinical trials worldwide are investigating CAR-NK applications in solid tumors,with preliminary successes observed in multi-target approaches against NKG2D,ROBO1,and other targets.However,significant challenges remain,including the immunosuppressive tumor microenvironment (TME),inadequate NK cell infiltration,and limited persistence.Combination strategies,particularly synergistic approaches with radiotherapy,have shown potential to enhance therapeutic efficacy.Future research should focus on optimizing CAR designs and developing novel combination regimens to overcome current limitations in solid tumor treatments and provide more effective treatment options for patients with solid tumors.

  • WANG Yuan, HAN Congfan, GAO Rong
    Herald of Medicine. 2026, 45(4): 731-734. https://doi.org/10.3870/j.issn.1004-0781.2026.04.025

    As the responsible entity for drug clinical trials, the sponsor's quality management system is directly related to the protection of subjects' rights, the reliability of trial data and the scientific validity of trial outcomes. This paper, based on the current Good Clinical Practice regulations in China and combined with the analysis of inspection practices, systematically analyzed the key points in current clinical trial inspection regarding the sponsor's quality management. Accordingly, this paper discussed the challenges and issues faced by sponsors in quality management,integrating the latest concepts of ICH E6(R3) to outline the development direction of sponsor quality management, with the aim of continuously enhancing the overall quality level of drug clinical trials in China.

  • LIU Haiyun, SONG Yuepeng, XU Ziwei, ZHAN Shimeng, LI Bingtao, JIANG Li, ZHANG Qiyun, ZENG Zhijun, WANG Xiaomin, XU Guoliang
    Herald of Medicine. 2026, 45(2): 186-196. https://doi.org/10.3870/j.issn.1004-0781.2026.02.004

    Objective To investigate the mechanism of pancreatic lipid metabolism of Gegen Qinlian Decoction (GQD) on insulin resistance (IR) and hypoxia in obese type 2 diabetes mellitus (T2DM) rats. Methods A total of 54 SD rats were randomly divided into normal control group and high fat group. The normal control group and the high-fat group were fed the normal diet for 13 weeks, and the serum IR index and HIF-2α content of rats were detected to establish the IR with hypoxia model. The model rats were randomly divided into model control group, positive drug group (rosiglitazone 5 mg·kg-1) and GQD high and low dose group (14.86, 1.65 g·kg-1). The model rats continued to be fed high-fat diet, while the normal control group was fed ordinary diet, and were given continuous gavage for 16 weeks. After administration, fasting insulin levels (FINS) were detected by radioimmunoassay, HIF-2α was detected by enzyme-linked immunosorbent assay (ELISA), fasting blood glucose (FBG) was detected by automatic biochemical analyzer. Hematoxylin-eosin (HE) staining was used to observe the pathological changes of pancreas. UPLC-Q-TOF-MS was used to collect pancreatic lipid metabolism data, and principal component analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA) were used to analyze the lipid metabolism of rat pancreatic tissue samples, and the markers of pancreatic metabolic difference were identified. Metabolic pathway analysis of potential biomarkers was performed using the Metabo Analyst 5.0 online website.The protein expressions of iPLA2 and CerS6 in pancreatic tissue were detected by Western blotting.Results ① Compared with model control group, FPG, IR index and HIF-2α of GQD high-dose and low-dose groups were significantly decreased,and the protein expressions of iPLA2 and CerS6 were also decreased (P<0.05, P<0.01), and irregular morphology of pancreatic islets of positive group and Gegen Qinlian decoction high-dose and low-dose groups were improved. ② The results of pancreatic metabolomics showed that there were 24 potential biomarkers in the model group, of which 3 biomarkers significantly increased and 21 biomarkers significantly decreased. GQD intervention could make the above biomarkers reverse. The 24 potential biomarkers of pancreatic lipids mainly regulate 7 metabolic pathways, including glycerophospholipid metabolism, sphingolipid metabolism, glycosyl phosphatidylinositol anchored biosynthesis, linoleic acid metabolism, unsaturated fatty acid biosynthesis, steroid hormone biosynthesis and α-linolenic acid metabolism. Conclusion The intervention of GQD on IR with anoxia in obese type 2 diabetes may improve the lipid metabolism disorders by regulating the contents of phospholipids, unsaturated fatty acids and steroid hormones in pancreas and their metabolic pathways.

  • ZHANG Jiaqi, SHI Yanting, ZHANG Tiantian, ZHOU He, LIANG Jie
    Herald of Medicine. 2026, 45(1): 31-40. https://doi.org/10.3870/j.issn.1004-0781.2026.01.004

    Inflammatory bowel disease (IBD),encompassing ulcerative colitis (UC) and Crohn's disease (CD),is a chronic relapsing inflammatory disorder that poses severe health and economic burdens due to its chronic and relapsing nature.The review examines traditional therapy,biologics,and small-molecule targeted drugs,highlighting their mechanisms and clinical advancements.Special attention is given to emerging therapeutic strategies,including novel drug development targeting TNF-like ligand 1A (TL1A),interleukin-6(IL-6),interleukin-22 ( IL-22),as well as innovative modalities such as chimeric antigen receptor T-Cell immunotherapy(CAR-Tregs),mesenchymal stem cell therapy,artificial intelligence(AI)-assisted treatment,and advanced combination therapies.Major challenges in IBD treatment,including difficulties in predicting therapeutic targets,primary or secondary non-response to biologics,mucosal healing efficacy limits,drug resistance mechanisms,and long-term risks of infection,cancer,and thrombosis,are also analyzed.The future of IBD management lies in precision medicine,non-invasive monitoring,and innovative drug development using AI and omics technologies.

  • ZHOU Wenjing, WU Minjiang, LIU Shaoxuan, LOU Xiaohuan, CAILIN Bowen, YU Man, MO Enpan, ZHANG Xun
    Herald of Medicine. 2026, 45(1): 161-166. https://doi.org/10.3870/j.issn.1004-0781.2026.01.023

    Objective To analyze the status of decentralized clinical trial (DCT) technology in non-rare diseases,and to discuss the concerns and countermeasures in the implementation process. Methods By convenient sampling,drug clinical trial projects carried out by four large public Grade III hospitals in Guangdong Province from 2021 to 2024 were selected as research objects and descriptive statistical analysis was carried out using SPSS 29.0 software.The technical application of DCT elements was analyzed in six aspects:electronic informed consent,direct to patient,remote visits,direct delivery of samples,remote monitoring of safety data,and digital medical technology. Results A total of 422 drug clinical trials were included,of which 165 (39.1%) involved remote visit technology,14.5% remote monitoring of safety data,10.4% direct mail of samples,6.4% digital medical technology,3.6% direct access to clinical trial drugs,and 0.9% involved electronic informed consent.In addition,the proportion of DCT elements used in international multi-center clinical trials was higher than that in domestic multi-center clinical trials in five aspects:remote visits,safety data monitoring,direct delivery of samples,digital medical technology,and direct access to experimental drugs.Regarding remote visits,direct to patient,direct delivery of samples,and digital medical technology,the proportion of cardiovascular system diseases and circulatory system diseases using the above DCT elements is relatively high,65.2%,17.4%,17.4%,4.3%,respectively. Conclusions There are great differences in applying different DCT elements in clinical trials of non-rare diseases.At present,remote visits and remote safety data monitoring are widely used.Overall,the application rate of DCT elements is relatively low and needs continuous promotion and popularization.Based on the concept of "patient-centered",the promotion and application of DCT in clinical trials in China should be promoted with the goal of quality assurance and efficiency improvement of clinical trials.

  • ZHOU Weijie, WANG Dandan, SHEN Aizong
    Herald of Medicine. 2026, 45(1): 142-148. https://doi.org/10.3870/j.issn.1004-0781.2026.01.020

    Objective To explore the construction pathway and application efficacy of smart pharmacies in outpatient services.The initiative aims to enhance pharmacy operational efficiency,optimize medication management,reduce hospital operational costs,and improve medication safety and healthcare experiences through technology-enabled solutions. Methods This study details how the outpatient pharmacy at the First Affiliated Hospital of USTC (Anhui Provincial Hospital) leverages automated equipment,intelligent systems,and smart management,this study establishes a comprehensive smart system covering the entire medication workflow: inventory monitoring,storage environment surveillance,prescription review,prescription task distribution,prescription dispensing,unit-dose packaging,prescription verification,medication guidance,and medication traceability. Results Through deep integration of automated equipment,intelligent systems,and smart management,approximately 40% of the outpatient pharmacy's dispensing volume and 37% of drug varieties were automated.With the intelligent prescription review system,prescription review coverage reached 100%,with a 98% success rate in intervening against irrational prescriptions.Compared to traditional manual dispensing,the average prescription processing time was reduced from 2 min to 32 s per patient,and the average patient waiting time decreased from 40 min to 6.9 min.Medication guidance coverage reached 100%,with patient satisfaction exceeding 95%.Furthermore,the smart pharmacy implementation achieved an inventory turnover rate of ≤8 days for over 85% of medications,significantly outperforming the national evaluation standards for tertiary public hospitals.With 9 routine dispensing windows,daily prescription processing capacity exceeded 8 000 prescriptions,serving over 5 000 patients per day,while maintaining a dispensing error rate ≤0.001%.These advancements significantly improved service efficiency and capacity without compromising. Conclusion By integrating advanced technologies and reengineering workflows,smart pharmacies achieve highly efficient,precise,and safe outpatient pharmaceutical services.

  • MA Hongyan, ZHOU Xiao, ZHANG Biyao, SHEN Chongde
    Herald of Medicine. 2025, 44(12): 2057-2061. https://doi.org/10.3870/j.issn.1004-0781.2025.12.026

    Objective To explore the application of the DeepSeek large languagemodel in assessing prescription rationality and evaluating its implementation effectiveness. Methods A random sample of 5 099 outpatient and emergency prescription records from our hospital in a specific month of 2024 was collected. The DeepSeeK large language model employs vector database technology for prescription review. An evaluation metrics analysis was conducted between the DeepSeeK’s reviews and pharmacist evaluations. Performance metrics including accuracy, precision, recall, specificity, and F1 were systematically calculated. Error pattern analysis encompassed false positive rate, false negative rate, and categorical comparison of discrepant prescriptions. Statistical deviation assessments were performed using x2 and Kappa coefficient to quantify inter-rater consistency. Results This study contains a total of 5 099 data, pharmacist group’s review results are reasonable for 4 879 cases and unreasonable for 220 cases. In contrast, The Deepseek model's review results in the AI group are reasonable for 4904 cases and unreasonable for 195 cases. The evaluation accuracy rate of the DeepSeeK model is approximately 93.82%, the precision rate is approximately 25.64%, the recall rate is approximately 22.73%, the specificity is approximately 97.03%, and the F1 value of the model is approximately 24.13%. Conclusion With rapid advancements in artificial intelligence, large language models like DeepSeek, leveraging their superior language comprehension and knowledge reasoning capabilities, can effectively assist pharmacists in prescription review, offering new technical support for clinical medication safety.

  • YIN Zhao, JIA Xuedong, SUN Zhiyong, ZHANG Wan, SUN Mingyang, LU Hao, GAO Wen, PAN Jie, ZHANG Hongliang, MIAO Yudong, HU Youhong
    Herald of Medicine. 2026, 45(3): 474-480. https://doi.org/10.3870/j.issn.1004-0781.2026.03.017

    In recent years,with the evolution of pharmaceutical service models,the value of pharmaceutical practice research in optimizing clinical medication decisions and improving the quality of pharmaceutical services has become increasingly evident.Currently,the three main research methods commonly used in this field are quantitative study,qualitative study,and mixed-methods study,reflecting a trend toward methodological diversity.However,in practice,there are still issues such as insufficient depth of interpretation in qualitative research and a lack of a systematic integration framework in mixed-methods research.This paper systematically reviews the core characteristics and applicable scenarios of the aforementioned three methods,focusing on analyzing the application logic of grounded theory and explanatory sequential design in pharmaceutical practice scenarios,such as medication adherence mechanism analysis and interprofessional collaboration intervention effectiveness evaluation.It combines typical cases to clarify the applicable boundaries and integration strategies for method selection.The study found that qualitative research can deeply reveal the cultural and social structural drivers behind patients' medication behaviors,while mixed-method research has unique advantages in constructing a "quantitative-qualitative validation--mechanism explanation" research loop.There is an urgent need to strengthen standardized construction in data integration and methodological collaboration.This paper helps guide researchers in achieving systematic thinking from problem definition to method selection,thereby enhancing the scientific rigor,applicability,and translational value of pharmaceutical practice research.

  • YIN Jiaxin, ZHANG Bicheng
    Herald of Medicine. 2026, 45(3): 453-459. https://doi.org/10.3870/j.issn.1004-0781.2026.03.014

    Bispecific antibodies (BsAbs) theoretically offer enhanced specificity,superior efficacy,and reduced off-target effects by simultaneously targeting two distinct antigens or two epitopes of the same antigen.Through mechanisms including immune cell recruitment/activation,dual-target signal blockade,and tumor microenvironment modulation,BsAbs have demonstrated significant anti-tumor potential in both solid tumors and hematologic malignancies,holding promise for advancing tumor treatment toward greater precision and personalization.This review summarizes the classification,mechanisms,and clinical trials of BsAbs in solid tumors,and discusses current challenges in the field,aiming to provide a theoretical foundation and practical reference for the clinical application of BsAbs in solid tumor therapy.

  • JIN Jing, ZHAI Xuejia, GUO Xin, ZHANG Qing, SUN Yu
    Herald of Medicine. 2026, 45(6): 1039-1044. https://doi.org/10.3870/j.issn1004-0781.2026.06.014

    Objective To summarize the major issues identified during inspections of clinical trial sites, conduct an in-depth analysis of associated risk factors, and explore strategies for improving clinical trial quality and regulatory effectiveness. Methods A retrospective analysis was conducted on on-site inspection data from the Provincial Drug Regulatory Authorities from 2024 to 2025. The analysis focused on the statistical evaluation of non-compliance categories, specific manifestations, and annual trends. Results A total of 488 non-compliance items were identified from 2024 to 2025, revealing a notable shift in defect distribution. Issues related to documentation systems surged to 36.93%, while those concerning qualification requirements rose to 29.05%. Key problems identified included: a disconnect between documented systems and actual practices; lack of operational feasibility in standard operating procedures (SOPs); inadequate hardware facilities and insufficient temperature/humidity monitoring; weak regulatory awareness among research personnel; excessive reliance on clinical research coordinators (CRCs) during trial implementation; and some principal investigators (PIs) undertaking excessive concurrent projects, thereby compromising trial quality. Additionally, varying degrees of non-compliance were observed in investigational drug management, documentation archiving, ethics review procedures, and protection of subject privacy. Conclusions Regulatory authorities should strengthen scrutiny of the operational feasibility, controlled management, and implementation consistency of institutional documentation systems. Enhanced dynamic oversight is required regarding PI eligibility, training, and concurrent project workloads. Institutions must upgrade hardware facilities and information management systems, while prioritizing standardized CRC management and supervision. Through closed-loop corrective action tracking, improved risk assessment, and categorized regulatory interventions, this approach can facilitate a systematic shift from formal compliance to substantive compliance in drug clinical trials.

  • GAO Yifan, YE Jianzhen, CHEN Huangli, GAO Feng
    Herald of Medicine. 2025, 44(12): 1914-1921. https://doi.org/10.3870/j.issn.1004-0781.2025.12.006

    Obesity is a non-communicable chronic disease whose increasing prevalence has contributed to a higher incidence of various obesity-related comorbidities, including type 2 diabetes, cardiovascular and cerebrovascular diseases, hyperlipidemia, hypertension, hyperuricemia, fatty liver disease, infertility and certain types of cancer. Nutritional intervention serves as the first-line and continuous approach in obesity management. However, its effectiveness heavily depends on patient compliance, which poses a challenge for some individuals and may lead to suboptimal weight loss outcomes. Pharmacotherapy has emerged as an important strategy for weight reduction due to its efficacy and convenience. Nonetheless, weight-loss medications are associated with limitations such as specific indications, adverse effects, and loss of muscle mass, highlighting the essential role of appropriate nutritional support as a foundation for drug therapy. This article reviewed the mechanisms of action, efficacy and common adverse reactions of the six weight-loss drugs approved in China, with a focus on the impact of combined nutritional interventions on enhancing treatment outcomes and mitigating adverse effects. The aim is to provide insights and evidence for optimizing clinical management strategies for obesity.

  • LI Xiaofen, SUN Bo, ZHANG Min, LI Ming
    Herald of Medicine. 2026, 45(6): 1027-1034. https://doi.org/10.3870/j.issn1004-0781.2026.06.012

    To further improve the quality and regulatory effectiveness of drug clinical trials, this paper systematically reviews the landscape of China's drug registration clinical trial supervision, provides an in-depth analysis of the core regulatory philosophyof the United States and the European Union in drug clinical trial regulation, anddraws on their practical experience, and fromthe new perspective of regional coordinative development proposes feasible recommendations across four dimensions—regulatory mechanisms, scope, inspectors, and tools, to establish a novel collaborative regulatory model. This will provide forward-looking theoretical references for refining China's regulatory model for drug clinical trials.