中国药物警戒 ›› 2021, Vol. 18 ›› Issue (9): 864-868.
DOI: 10.19803/j.1672-8629.2021.09.14

• 安全与合理用药 • 上一篇    下一篇

连花清瘟胶囊/颗粒不良反应的系统评价与Meta分析

刘博1,2, 王雪3, 关绍晨4, 安默然2, 穆雅杰1, 于海霞1, 李永林5, 张亚同2,*   

  1. 1北京小汤山医院药剂科,北京 102211;
    2北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究所,药物临床风险与个体化应用评价北京市重点实验室,北京 100730;
    3首都医科大学宣武医院图书馆,北京 100015;
    4首都医科大学宣武医院循证医学中心,北京 100015;
    5北京小汤山医院药学部,北京 102211
  • 收稿日期:2020-08-15 出版日期:2021-09-15 发布日期:2021-09-18
  • 通讯作者: *张亚同,男,副主任药师,临床药学。E-mail：zyt2002888@foxmail.com
  • 作者简介:刘博,女,硕士,药师,临床药学。
  • 基金资助:
    国家重点研发计划（2020YFC2009001）

Adverse Reactions of Lianhua Qingwen Capsules/Granules: A Systematic Review and Meta-analysis

LIU Bo1,2, WANG Xue3, GUAN Shaochen4, AN Moran2, MU Yajie1, YU Haixia1, LI Yonglin5, ZHANG Yatong2,*   

  1. 1Department of Pharmacy, Beijing Xiaotangshan Hospital, Beijing 102211, China;
    2Department of Pharmaceutical Science, Beijing Hospital; National Center of Gerontology; Institute of Geriatric Medicine, Chinese Academy of Medical Science; Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, Beijing 100730, China;
    3Xuanwu Hospital Library, Capital Medical University, Beijing 100015, China;
    4Center for Evidence-Based Medicine, Xuanwu Hospital, Capital Medical University, Beijing 100015, China;
    5Department of Pharmacy, Beijing Xiaotangshan Hospital, Beijing 102211, China
  • Received:2020-08-15 Online:2021-09-15 Published:2021-09-18

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摘要： 目的 系统评价连花清瘟胶囊/颗粒临床应用中的药品不良反应（adverse drug reaction, ADR）报告率及特征。方法 检索收集中国知网、万方数据、维普网、SinoMed数据库和PubMed、Embase 从建库至2020年7月7日中有关连花清瘟胶囊/颗粒ADR研究,并对ClinicalTrials.gov及中国临床试验注册中心相关注册研究进行了筛查,对符合纳入标准的文献用Cochrane ADR方法组评估伤害证据质量要素的推荐意见评价文献质量,并用STATA软件进行单组率Meta分析。结果 共纳入180项试验,12 039例患者,报告ADR 531例,总ADR报告率为2.37%（95%CI: 1.64%~3.21%）。ADR报告率随发表时间逐渐升高,尤其是随机对照试验（RCT）研究。ADR主要症状为胃肠系统损害（361例/67.98%）、神经系统损害（36例/6.78%）和皮肤及其附件损害（29例/5.46%）。联合用药（2.79%）较单用连花清瘟（1.92%）ADR报告率高。结论 应加强连花清瘟在临床使用过程中的用药监测,以减少ADR发生。

关键词: 连花清瘟胶囊, 连花清瘟颗粒, 药品不良反应, 系统评价, Meta分析

Abstract: Objective To systematically assess the reporting rate and characteristics of adverse drug reactions (ADR) during clinical use of Lianhua Qingwen capsules/granules. Methods The CNKI, Wanfang platform, CQVIP, SinoMed and PubMed, Embase and the Cochrane library were searched systematically for related literature that had been published by July 7, 2020. The quality of literature was evaluated using the recommendations of Cochrane ADR method group in order to assess the quality elements of injury evidence. Meta-analysis was carried out with STATA software. Results A total of 12 039 patients were included in this study, and 531 cases of ADR were reported, so the total reporting rate of ADR was 2.37% (95%CI: 1.64%~3.21%). The reporting rate of ADR increased with time, especially in the RCT study. The main manifestations of ADR were gastrointestinal system damage (361 cases/67.98%), nervous system damage (36 cases/6.78%) and skin and its appendages damage (29 cases/5.46%). Combined medications (2.79%) had a higher reporting rate of ADR than the single use (1.92%). Conclusion To reduce the cases of ADR, the monitoring of clinical use of Lianhua Qingwen should be strengthened.

Key words: Lianhua Qingwen capsules, Lianhua Qingwen granules, adverse drug reaction, systematic review, meta-analysis

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