[关键词]
[摘要]
目的 基于网状 Meta 分析方法对不同中成药改善痰瘀互结型冠心病患者血脂及微循环状态的有效性和 安全性进行评估。方法 检索中国知网(CNKI)、万方数据库(Wanfang)、维普中文期刊(VIP)、中国生物医学 文献数据库(SinoMed)、PubMed、EMbase、Cochrane Library、Web of Science 等数据库自建库至 2023 年 4 月 3 日 有关中成药治疗痰瘀互结型冠心病患者血脂及微循环状态的随机对照试验(RCTs),采用 Review Manager 5.4 和 Stata 15.1 软件进行文献质量评价及网状 Meta 分析。结果 最终纳入 37 项 RCTs,总样本量 4 064 例,包括 15 种中成药。网状 Meta 分析综合结果提示中成药联合西医常规治疗冠心病的疗效优于单纯西医常规治疗,且 未见严重不良反应。临床总疗效累积概率排前 3 位的中成药为冠脉再通膏、瓜蒌皮注射液、祛瘀消斑胶囊;在 改善甘油三酯(TG)及低密度脂蛋白(LDL-C)方面,排前 3 位的中成药为瓜蒌皮注射液、护心康片、冠心舒通 胶囊;在改善血浆黏度及纤维蛋白原方面,排前 3 位的中成药为银杏达莫注射液、瓜蒌皮注射液、冠心舒通胶 囊;在改善内皮功能[一氧化氮(NO)及内皮素 1(ET-1)]方面,排前 3 位的中成药为银杏达莫注射液、丹蒌片、 通脉愈心丸;在降低炎症超敏 C 反应蛋白(hs-CRP)方面,排前 3 位的中成药为银杏达莫注射液、护心康片、 冠心舒通胶囊。结论 当前证据表明,痰瘀同治类中成药联合西医常规治疗冠心病在提高临床疗效、改善血脂 及微循环状态方面具有较明显的优势,尤其是能兼顾治疗痰与瘀的中成药优势更明显,如冠脉再通膏、瓜蒌皮 注射液,可作为中西医临床指导用药方案之一。但因纳入文献的数量少、质量不高,研究结果仍需要更多高质 量、多中心、双盲随机试验加以验证,以提供更可靠的循证医学参考。
[Key word]
[Abstract]
Objective To evaluate the effectiveness and safety of different Chinese patent medicine in improving blood lipid and microcirculation in coronary heart disease patients with phlegm-blood stasis syndrome based on network meta-analysis. Methods The randomized controlled trials (RCTs) of different Chinese patent medicine in the treatment of blood lipid and microcirculation in coronary heart disease patients with phlegm-blood stasis syndrome were collected by searching CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of science databases from the establishment of the database to April 3,2023. Literature quality evaluation and network meta-analysis were conducted using Review Manager 5.4 and Stata15.1 software. Results Thirty-seven RCTs were included,with a total sample size of 4 064 cases,involving 15 different Chinese patent medicines. The network meta-analysis showed that the efficacy of Chinese patent medicine combined with conventional Western medicine is often better than that of conventional Western medicine alone. There are no serious adverse reactions. The top three Chinese patent medicines with cumulative probability of total clinical efficacy were Guanmai Zaitong soft extract,Gualoupi Injection and Quyu Xiaoban Capsule. In terms of improving triglyceride (TG)and low-density lipoprotein (LDL-C), the top three Chinese patent medicines were Gualoupi Injection, Huxinkang Tablet and Guanxin Shutong Capsule. In terms of improving plasma viscosity and fibrinogen, the top three Chinese patent medicines were Ginkgo Damo Injection, Gualoupi Injection and Guanxin Shutong Capsule. In terms of improving endothelial function [nitric oxide (NO) and endothelin-1 (ET-1)],the top three Chinese patent medicines were Ginkgo Damo Injection,Danlou Tablet and Tongmai Yuxin Pill. In terms of reducing inflammation hypersensitivity C-reactive protein (hs-CRP), the top three Chinese patent medicines were Ginkgo Damo Injection, Huxinkang Tablet and Guanxin Shutong Capsule. Conclusion The current evidence shows that the combination of TCM,which is used for the treatment of phlegm-blood stasis syndrome,with conventional Western medicine in the treatment of coronary heart disease has advantages in improving clinical efficacy, blood lipids and microcirculation. TCM especially for the treatment of phlegm-blood stasis syndrome shows more obvious advantage, such as Guanmai Zaitong soft extract and Gualoupi injection,which can be taken into consideration as part of the clinical guidelines. However,due to the limited number and quality of the included literatures,the research results still need to be verified by more high-quality, multi-center, double-blind randomized trials. The purpose is to provide more reliable evidence-based medical reference.
[中图分类号]
R285.6
[基金项目]
国家自然科学基金面上项目(82074060);中国中医科学院科技创新工程项目(CI2021A04602);中国中医科学院西苑医院提升中医药 临床循证证据级别研究专项(XYZX0304-02)。