中国药物警戒 ›› 2024, Vol. 21 ›› Issue (6): 660-665.
DOI: 10.19803/j.1672-8629.20240050

• 安全与合理用药 • 上一篇    下一篇

3010例芪蛭通络胶囊的真实世界安全性研究

潘知玉1, 朱健1, 于亚南1, 刘骏1, 姜燕华1, 钱真真1, 吴广2, 王忠1, 武红莉1#, 荆志伟1,*   

  1. 1中国中医科学院中医临床基础医学研究所,北京 100700;
    2河南中医药大学第一临床医学院,河南 郑州 450046
  • 收稿日期:2024-01-19 出版日期:2024-06-15 发布日期:2024-06-18
  • 通讯作者: *荆志伟,男,研究员·博导,中医临床药理学。E-mail:drjzw@163.com; #为共同通信作者。
  • 作者简介:潘知玉,女,博士,中医临床药理学。
  • 基金资助:
    国家自然科学基金资助项目（82074584）; 中国中医科学院科技创新工程项目（CI2021A04702）

A real-world safety study of 3 010 cases of Qizhitongluo capsule

PAN Zhiyu1, ZHU Jian1, YU Yanan1, LIU Jun1, JIANG Yanhua1, QIAN Zhenzhen1, WU Guang2, WANG Zhong1, WU Hongli1#, JING Zhiwei1,*   

  1. 1Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
    2The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou Henan 450046, China
  • Received:2024-01-19 Online:2024-06-15 Published:2024-06-18

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摘要： 目的 探索芪蛭通络胶囊上市后在真实世界中的临床安全性。方法 通过药物源性前瞻性集中监测及巢式病例对照研究方法,对6个省份的19家机构2020年11月24日至2022年11月25日内所有使用芪蛭通络胶囊患者进行安全性评价。结果 共纳入3 010例患者,其中不良反应发生21例,包括胃肠系统疾病15例,各类神经系统疾病2例、精神病类2例、各种肌肉骨骼和结缔组织疾病2例,主要表现为腹部不适、腹泻、口腔溃疡、头痛及失眠等,无严重不良反应发生。多因素分析结果显示不良反应发生与芪蛭通络胶囊的服药频率有关,超出说明书建议的服药频率用药会增加不良反应发生率。结论 芪蛭通络胶囊不良反应发生率为0.70%,多集中于胃肠系统疾病。

关键词: 芪蛭通络胶囊, 中成药, 巢式病例对照, 服药频率, 安全性, 真实世界, 药品不良反应

Abstract: Objective To explore the clinical safety of Qizhitongluo capsule in the real world after its launch. Methods The safety of Qizhitongluo capsule was evaluated in all patients using the capsules from November 24, 2020 to November 25, 2022 at 19 institutions in 6 provinces (Henan, Shanxi, Guangxi, Liaoning, Shandong, and Heilongjiang) by means of drug-derived prospective centralised surveillance and nested case-control methods. Results A total of 3010 patients were included, and 21 cases of adverse reactions occurred, accounting for 0.7%, including 15 cases of gastrointestinal diseases, 2 cases of various neurological disorders, 2 cases of psychiatric disorders, and 2 cases of various musculoskeletal and connective tissue disorders, which were mainly manifested as abdominal discomfort, diarrhoea, oral ulcers, headache, and insomnia, etc., and no serious adverse reactions occurred. The results of multifactorial analysis showed that the occurrence of adverse reactions was related to the dosage frequency of Qizhitongluo capsules, and the frequency of dosage exceeding the dosage frequency recommended by the instruction manual would increase the incidence of adverse reactions. Conclusion The incidence of adverse reactions of Qizhitongluo capsules was 0.70%, mostly in gastrointestinal diseases, and also in psychiatric diseases and musculoskeletal and connective tissue disease.

Key words: Qizhitongluo capsules, proprietary Chinese medicines, nested case-control, frequency of dosage, safety, real world, adverse drug reaction

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