中国药物警戒 ›› 2023, Vol. 20 ›› Issue (5): 536-543.
DOI: 10.19803/j.1672-8629.20211052

• 安全与合理用药 • 上一篇    下一篇

复方丹参喷雾剂/气雾剂治疗冠心病心绞痛有效性与安全性的Meta分析

成冯镜茗1, 吕健2, 谢雁鸣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中国中医科学院西苑医院药物临床试验管理规范中心,北京 100091
  • 收稿日期:2021-12-06 出版日期:2023-05-15 发布日期:2023-05-16
  • 通讯作者: *谢雁鸣,女,首席研究员·博导,中医临床评价。E-mail: ktzu2018@163.com
  • 作者简介:成冯镜茗,女,硕士,中成药上市后循证评价。
  • 基金资助:
    国家重点研发计划（2018YFC1707400）

Efficacy and safety of compound salvia miltiorrhiza spray/aerosol for angina pectoris due to coronary artery disease: a Meta analysis

CHENG Fengjingming1, LYU Jian2, XIE Yanming1,*   

  1. 1Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
    2Center for Standardization of Drug Clinical Trial Management of Xiyuan Hospital of China Academy of Chinese Medical Science, Beijing 100091, China
  • Received:2021-12-06 Online:2023-05-15 Published:2023-05-16

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摘要： 目的 对复方丹参喷雾剂/气雾剂治疗冠心病心绞痛的有效性和安全性进行系统评价。方法 系统检索中国知网、万方数据、维普网、中国生物医学文献数据库、Cochrane Library、PubMed、Embase、Web of Science,自建库至2021年5月5日的数据。筛选出复方丹参喷雾剂/气雾剂治疗冠心病心绞痛的随机对照试验进行Meta分析,使用TSA软件对冠心病心绞痛显效率结局指标的样本量进行预测,运用推荐分级评估、发展和评价（GRADE）证据评价方法对纳入的结局指标进行质量评价。结果 共纳入9项研究,总样本量为1 113例,试验组702例,对照组411例。Meta分析结果显示,复方丹参喷雾剂/气雾剂单用的治疗效果优于复方丹参片;联合硝酸酯类药物治疗冠心病心绞痛在提高冠心病心绞痛显效率、心电图显效率以及药品不良反应发生率与单用硝酸酯类药物无显著差异,但在稳定斑块（降低低密度脂蛋白、血清总胆固醇、血小板黏附率变化）方面优于单用硝酸酯类药物。不良反应主要为鼻咽部不适,可自行缓解,未发生严重不良反应。结论 复方丹参喷雾剂/气雾剂治疗冠心病心绞痛有良好的临床疗效和安全性。

关键词: 复方丹参喷雾剂/气雾剂, 冠心病心绞痛, 随机对照试验, 硝酸酯类, 系统评价, Meta分析, GRADE评价, 药品不良反应

Abstract: Objective To evaluate the efficacy and safety of compound salvia spray/aerosol in the treatment of angina pectoris due to coronary artery disease. Methods Eight databases including CNKI, Wanfang Data, VIP, SinoMed, Cochrane Library, PubMed, Embase, and Web of Science were searched for related data that was published from inception to May 5, 2021. Randomized controlled trials of compound salvia spray/aerosol in the treatment of angina pectoris due to coronary artery disease were screened for meta-analysis. TSA software was used to predict the sample size of the outcome indicators. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to evaluate the quality of the included outcome indicators. Results A total of 9 studies were included, with a total sample size of 1 113 cases, 702 of which were in the trial group and 411 in the control group. The results of Meta-analysis showed that the therapeutic effect of compound salvia spray/aerosol alone was better than that of compound salvia tablets. Compared with nitrate drugs alone, the combination of nitrate drugs was not significantly different in terms of therapeutic effect against angina pectoris due to coronary artery disease, the effective rate of ECG or the incidence of adverse drug reactions. However, it was superior to nitrate drugs alone in the stabilization of plaques. The main adverse reaction was nasopharyngeal discomfort, which could resolve itself, and no serious adverse reactions occurred. Conclusion Compound salvia spray/aerosol is highly effective and safe in the treatment of angina pectoris due to coronary artery disease.

Key words: compound salvia miltiorrhiza spray/aerosol, angina pectoris, randomized controlled trial, nitrate drugs, systematic review, Meta-analysis, GRADE assessment, adverse drug reaction

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