1.Expert Consensus on Clinical Application of Yifei Zhike Capsules
Xin CUI ; Hongchun ZHANG ; Weiwei GUO ; Chengjun BAN ; Zhifei WANG ; Yuanyuan LI ; Yingjie ZHI ; Xuefeng YU ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):218-224
As an exclusive Miao medicine of Honwing Pharma (Guizhou) Co. Ltd., Yifei Zhike capsules are both a prescription drug and an over-the-counter (OTC) drug. Its main ingredients include Ranunculus ternatus and Panax notoginseng. With the effects of nourishing Yin and moistening the lungs, as well as relieving cough and reducing phlegm, Yifei Zhike capsules are often used in the treatment of acute and chronic bronchitis, pulmonary tuberculosis, and other diseases. However, there is insufficient understanding of their efficacy, suitable syndromes, and safety in clinical practice, with a lack of relevant expert consensus on clinical application. To standardize their clinical application, 30 experts from the fields of respiratory medicine, pharmacy, and evidence-based medicine were invited to develop an Expert Consensus on the Clinical Application of Yifei Zhike Capsules (Consensus for short) through evidence-based medicine methods. The Consensus clarified the syndrome characteristics, disease stages, dosages, treatment courses, combined medication, and other norms in the treatment of acute/chronic bronchitis and pulmonary tuberculosis and could be applicable to clinical physicians and pharmacists in medical and health institutions at all levels. In disease diagnosis, it provided diagnostic criteria for traditional Chinese medicine and Western medicine and clarified that the suitable traditional Chinese medicine syndrome was the syndrome of Qi-Yin deficiency with intermingled phlegm-blood stasis. Clinical studies have confirmed that Yifei Zhike capsules combined with standard anti-tuberculosis therapy can effectively improve the symptoms of pulmonary tuberculosis patients, increase the sputum smear conversion rate, and promote the absorption of lesions. When treating acute cough caused by respiratory tract infections, Yifei Zhike capsules can increase the markedly effective rate and the seven-day disappearance rate of cough symptoms. Meanwhile, recommendations for specific usage, dosages, and treatment courses were given for different diseases, and it was pointed out that long-term medication required key monitoring of adverse reactions. In safety, the adverse reactions of Yifei Zhike capsules involved multiple aspects such as the digestive system and allergic reactions, and pregnant women and women during menstruation were prohibited from using it. In addition, modern research has shown that Yifei Zhike capsules have an adjuvant therapeutic effect on tuberculous pleurisy and may be effective for inflammatory and benign pulmonary nodules. However, further research should be conducted on the toxicological safety of long-term medication. The formulation of the Consensus provides a scientific basis for the rational clinical application of Yifei Zhike capsules, which helps to improve clinical efficacy and reduce medication risks.
2.Expert Consensus on Clinical Application of Yifei Zhike Capsules
Xin CUI ; Hongchun ZHANG ; Weiwei GUO ; Chengjun BAN ; Zhifei WANG ; Yuanyuan LI ; Yingjie ZHI ; Xuefeng YU ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):218-224
As an exclusive Miao medicine of Honwing Pharma (Guizhou) Co. Ltd., Yifei Zhike capsules are both a prescription drug and an over-the-counter (OTC) drug. Its main ingredients include Ranunculus ternatus and Panax notoginseng. With the effects of nourishing Yin and moistening the lungs, as well as relieving cough and reducing phlegm, Yifei Zhike capsules are often used in the treatment of acute and chronic bronchitis, pulmonary tuberculosis, and other diseases. However, there is insufficient understanding of their efficacy, suitable syndromes, and safety in clinical practice, with a lack of relevant expert consensus on clinical application. To standardize their clinical application, 30 experts from the fields of respiratory medicine, pharmacy, and evidence-based medicine were invited to develop an Expert Consensus on the Clinical Application of Yifei Zhike Capsules (Consensus for short) through evidence-based medicine methods. The Consensus clarified the syndrome characteristics, disease stages, dosages, treatment courses, combined medication, and other norms in the treatment of acute/chronic bronchitis and pulmonary tuberculosis and could be applicable to clinical physicians and pharmacists in medical and health institutions at all levels. In disease diagnosis, it provided diagnostic criteria for traditional Chinese medicine and Western medicine and clarified that the suitable traditional Chinese medicine syndrome was the syndrome of Qi-Yin deficiency with intermingled phlegm-blood stasis. Clinical studies have confirmed that Yifei Zhike capsules combined with standard anti-tuberculosis therapy can effectively improve the symptoms of pulmonary tuberculosis patients, increase the sputum smear conversion rate, and promote the absorption of lesions. When treating acute cough caused by respiratory tract infections, Yifei Zhike capsules can increase the markedly effective rate and the seven-day disappearance rate of cough symptoms. Meanwhile, recommendations for specific usage, dosages, and treatment courses were given for different diseases, and it was pointed out that long-term medication required key monitoring of adverse reactions. In safety, the adverse reactions of Yifei Zhike capsules involved multiple aspects such as the digestive system and allergic reactions, and pregnant women and women during menstruation were prohibited from using it. In addition, modern research has shown that Yifei Zhike capsules have an adjuvant therapeutic effect on tuberculous pleurisy and may be effective for inflammatory and benign pulmonary nodules. However, further research should be conducted on the toxicological safety of long-term medication. The formulation of the Consensus provides a scientific basis for the rational clinical application of Yifei Zhike capsules, which helps to improve clinical efficacy and reduce medication risks.
3.Compilation Instructions for Expert Consensus on Clinical Application of Yifei Zhike Capsules
Xin LI ; Hongchun ZHANG ; Xuefeng YU ; Weiwei GUO ; Chengjun BAN ; Zhifei WANG ; Yuanyuan LI ; Yingjie ZHI ; Xin CUI ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):143-148
The compilation instructions for the Expert Consensus on Clinical Application of Yifei Zhike Capsules systematically expound the development background, methodological framework, and core achievements of this consensus. In view of the problems existing in the clinical application of Yifei Zhike Capsules, such as insufficient efficacy evidence and lack of standardized syndrome differentiation, the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences took the lead and collaborated with 21 tertiary grade-A hospitals and research institutions across China to form a multidisciplinary expert group (comprising 30 experts in clinical medicine, pharmacy, and methodology). The compilation work was carried out in strict accordance with the World Health Organization (WHO) guidelines, the GB/T 1.1-2020 standard, and the writing specifications for the explanatory notes of expert consensus on clinical application of Chinese patent medicines. Through systematic literature retrieval (including 32 studies, with 24 clinical studies), Grading of Recommendations Assessment, Development and Evaluations (GRADE)-based evidence grading, and multiple rounds of discussions using the nominal group method (25 experts voted to determine 17 clinical questions), 5 evidence-based recommendations and 11 expert consensus suggestions were formed. It is clarified that this medicine (Yifei Zhike Capsules) is applicable to the treatment of expectoration/hemoptysis in acute and chronic bronchitis and the adjuvant treatment of pulmonary tuberculosis. It is recommended that it can be used alone or in combination with anti-tuberculosis drugs. The safety evaluation shows that this medicine mainly induces the following adverse reactions: mild gastrointestinal reactions (such as nausea and abdominal pain) and rashes. The contraindicated populations include pregnant women and women during menstruation. The compilation process of the consensus underwent three rounds of expert letter reviews, two rounds of peer reviews, and quality control assessments to ensure methodological rigor and clinical applicability. In addition, through policy alignment, academic promotion, and a dynamic revision mechanism, the standardization of clinical application was promoted, providing a demonstration for the evidence-based transformation of characteristic therapies of Miao medicine.
4.Disrupting atherosclerotic plaque formation via the "qi meridian-blood channel": mechanism of Jiangzhi Huaban Decoction for regulating hepatic reverse cholesterol transport to improve atherosclerosis.
Hongyang WANG ; Wenyi ZHU ; Xushen CHEN ; Tong ZHANG ; Zhiwei CAO ; Jin WANG ; Bo XIE ; Qiang LIU ; Xuefeng REN
Journal of Southern Medical University 2025;45(9):1818-1829
OBJECTIVES:
To explore the molecular mechanism of Jiangzhi Huaban Decoction (JZHBD) for improving atherosclerosis through the "qi meridian-blood channels" pathway.
METHODS:
ApoE-/- mouse models of atherosclerosis were established by high-fat diet feeding for 8 weeks, with C57BL/6 mice on a normal diet as the controls. Forty ApoE-/- mouse models were randomized into model group, low-, medium-, and high-dose JZHBD treatment groups, and atorvastatin treatment group (n=8) for their respective treatments for 8 weeks. The changes in body weight and overall condition of the mice were monitored weekly. After the treatments, serum levels of TC, TG, HDL-C, LDL-C, TBA, ALT, and AST of the mice were measured, pathological changes in the liver and aortic root plaques were examined with HE staining, and lipid accumulation in the liver and aortic wall was assessed using Oil Red O staining. The core molecular mechanism was studied through transcriptomics, and the expressions of the key pathway proteins were confirmed using Western blotting and immunohistochemistry.
RESULTS:
Treatment with JZHBD significantly reduced blood lipid and total bile acid levels, improved liver function and hepatic steatosis, and decreased aortic lipid deposition and plaque area in the mouse models of atherosclerosis. Transcriptomic analysis suggested that the therapeutic mechanism of JZHBD involved reverse cholesterol transport, PPAR signaling, and the inflammatory pathways. In atherosclerotic mice, JZHBD treatment obviously up-regulated hepatic expressions of PPARγ, LXRα, ABCA1, ABCG1, and CYP7A1, down-regulated hepatic expressions of p-p65/p65, IL-6, IL1β in the liver, increased ABCG5 and ABCG8 expressions in the intestines, and decreased ICAM-1 and VCAM-1 expressions in the aortic plaques.
CONCLUSIONS
JZHBD improves atherosclerotic vascular damage and plaque formation possibly by regulating hepatic reverse cholesterol transport and inflammation via modulating the hepatic PPARγ/LXRα/NF-κB signaling pathway.
Animals
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Drugs, Chinese Herbal/therapeutic use*
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Mice, Inbred C57BL
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Plaque, Atherosclerotic/metabolism*
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Liver/metabolism*
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Mice
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Atherosclerosis/metabolism*
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Cholesterol/metabolism*
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PPAR gamma/metabolism*
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Male
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Diet, High-Fat
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Biological Transport
6.Evaluation of pharmacokinetics and metabolism of three marine-derived piericidins for guiding drug lead selection.
Weimin LIANG ; Jindi LU ; Ping YU ; Meiqun CAI ; Danni XIE ; Xini CHEN ; Xi ZHANG ; Lingmin TIAN ; Liyan YAN ; Wenxun LAN ; Zhongqiu LIU ; Xuefeng ZHOU ; Lan TANG
Chinese Journal of Natural Medicines (English Ed.) 2025;23(5):614-629
This study investigates the pharmacokinetics and metabolic characteristics of three marine-derived piericidins as potential drug leads for kidney disease: piericidin A (PA) and its two glycosides (GPAs), glucopiericidin A (GPA) and 13-hydroxyglucopiericidin A (13-OH-GPA). The research aims to facilitate lead selection and optimization for developing a viable preclinical candidate. Rapid absorption of PA and GPAs in mice was observed, characterized by short half-lives and low bioavailability. Glycosides and hydroxyl groups significantly enhanced the absorption rate (13-OH-GPA > GPA > PA). PA and GPAs exhibited metabolic instability in liver microsomes due to Cytochrome P450 enzymes (CYPs) and uridine diphosphoglucuronosyl transferases (UGTs). Glucuronidation emerged as the primary metabolic pathway, with UGT1A7, UGT1A8, UGT1A9, and UGT1A10 demonstrating high elimination rates (30%-70%) for PA and GPAs. This rapid glucuronidation may contribute to the low bioavailability of GPAs. Despite its low bioavailability (2.69%), 13-OH-GPA showed higher kidney distribution (19.8%) compared to PA (10.0%) and GPA (7.3%), suggesting enhanced biological efficacy in kidney diseases. Modifying the C-13 hydroxyl group appears to be a promising approach to improve bioavailability. In conclusion, this study provides valuable metabolic insights for the development and optimization of marine-derived piericidins as potential drug leads for kidney disease.
Animals
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Male
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Mice
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Aquatic Organisms/chemistry*
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Biological Availability
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Cytochrome P-450 Enzyme System/metabolism*
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Glucuronosyltransferase/metabolism*
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Microsomes, Liver/metabolism*
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Molecular Structure
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Biological Products/pharmacokinetics*
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Pyridines/pharmacokinetics*
7.Association between hypertension and the risk of gallstone disease
Wenqian YU ; Linjun XIE ; Shiyi LI ; Yanmei LOU ; Guoheng JIANG ; Hongyu LI ; Zitong YAN ; Xuan BAI ; Jing LUO ; Chi ZHANG ; Guangcan LI ; Xuefeng SHAN ; Xin WANG
Journal of Clinical Hepatology 2024;40(6):1215-1225
Objective This article aims to investigate the association between hypertension and the risk of GSD by conducting a national multicenter study,a systematic review,and a meta-analysis.Methods The study was conducted in three stages.In the first stage,subjects were recruited for health examination in four hospitals in Chengdu,Tianjin,Beijing,and Chongqing,China,from 2015 to 2020,and the multivariate logistic regression analysis was used to investigate the association between hypertension and the risk of GSD in each center.In the second stage,Embase,PubMed,Wanfang Data,VIP,and CNKI databases were searched for related studies published up to May 2021,and a meta-analysis was conducted to further verify such association.In the third stage,the random effects model was used for pooled analysis of the results of the multicenter cross-sectional study and the findings of previous literature.Results A total of 633 948 participants were enrolled in the cross-sectional study,and the prevalence rate of GSD was 7.844%.The multivariate logistic regression analysis showed that hypertension was positively associated with the risk of GSD(P<0.05).Subgroup analysis showed that there was no significant difference in the association between hypertension and GSD between individuals with different sexes,ages,and subtypes of GSD.A total of 80 articles were included in the systematic review and the meta-analysis,and the results showed that the risk of GSD was increased by 1.022 times for every 10 mmHg increase in diastolic pressure and 1.014 times for every 10 mmHg increase in systolic pressure.Conclusion Hypertension significantly increases the risk of GSD,and the findings of this study will provide a basis for the etiology of GSD and the identification of high-risk groups.
8.Progress in multiomics research on high altitude polycythemia
Guiping ZHENG ; Wei NIAN ; Xuefeng SHI ; Youbang XIE
Chinese Journal of Hematology 2024;45(8):795-800
Chronic mountain sickness (CMS) or Monge syndrome is a disease that is prevalent at altitude above 2 500 meters. High altitude polycythemia (HAPC) is one subtype of CMS. EPAS1 and EGNL1 are the most critical high-altitude adaptation genes in the genome of the Tibetan population. The HIF-PHD-VHL system plays an important role in the pathogenesis of HAPC. The protease encoded by the SENP1 gene regulates hypoxia related transcription factors such as HIF and GATA to affect the expression of EPO or EPOR involved in red blood cell generation. With the development of genetic testing and omics technology, new progress in the fields of metabolomics, proteomics and metabolomics has been made in the pathogenesis of HAPC. The above new research results provide a preliminary basis for bone marrow hematoecology and hematopoietic regulation of HAPC. The diagnostic criteria for CMS have certain limitations, especially in patients with excessive erythrocytosis who should undergo genetic testing recommended for congenital and polycythemia vera. This article provides a review of the latest research on HAPC in various omics techniques, hematopoietic regulation and diagnostic processes which is more conducive to understand the pathogenesis. The clinical diagnosis of excessive erythrocytosis emphasizes the importance of genetic testing.
9.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
10. Quality management and indicator system for clinical trials of medical devices
Jiahui DAI ; Sijia SUN ; Xuefeng XIE ; Xuefeng XIE ; Jiahui DAI ; Sijia SUN ; Xuefeng XIE
Chinese Journal of Clinical Pharmacology and Therapeutics 2023;28(1):51-58
AIM: Exploring medical device clinical trial quality management indicator system to continuously improve medical device clinical trial quality system construction. METHODS: Through literature research and Delphi method, we summarized the risks of medical device clinical trials in various aspects such as quality management, clinical trial data, and clinical trial research personnel construction, analyzed the risks and proposed a clinical trial quality management index system, as well as corresponding quality improvement measures. RESULTS: To establish an appropriate medical device clinical trial quality evaluation management tool for quality risk monitoring and management, and to support and help the construction of a medical device clinical trial quality management system. CONCLUSION: To identify risks in various aspects of clinical trials and establish a preliminary assessment index system to provide a reference for the evaluation of the effectiveness of clinical trial quality management.

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