评价指南中11种中成药防治冠心病PCI术后支架内再狭窄的疗效

To Evaluate the Efficacy of 11 Kinds of Chinese Patent Medicines in Guide in the Treatment of In-Stent Restenosis after PCI for Coronary Heart Disease

摘要: 目的：基于网状Meta分析，评价《中成药治疗冠心病临床应用指南》中11种中成药对经皮冠状动脉介入(percutaneous coronary intervention, PCI)治疗术后防治支架内再狭窄(in-stent restenosis, ISR)的临床疗效及安全性。方法：本指南中涉及的中成药共11种，分别是通心络胶囊、丹蒌片、麝香保心丸、复方丹参滴丸、芪参益气滴丸、血府逐瘀胶囊、参松养心胶囊、芪苈强心胶囊、稳心颗粒、脑心通胶囊、速效救心丸，通过八大中英文数据库(中国知网、万方数据知识服务平台、VIP、中国生物医学文献数据库、PubMed、Web of Science、Cochrane Library、EMbase)，分别检索这11种中成药联合常规西药治疗对比单独使用常规西药治疗用于冠心病PCI术后防治ISR的随机对照试验研究，对照组予常规西药治疗，试验组在对照组基础上分别加用以上中成药。进行文献质量评价及Meta分析运用RevMan5.4软件。结果：纳入RCTs共有28项，涉及中成药6种，包含3114例患者。Meta分析结果显示：与对照组相比，试验组可以使冠心病患者PCI术后支架内再狭窄率明显降低，RR = 0.42，95% CI = [0.35, 0.51]，且具有统计学意义，Z = 8.98 (P < 0.00001)；同时，试验组与对照组相比，还可以减少心血管不良事件的发生，RR = 0.42，95% CI = [0.35, 0.49]，且具有统计学意义，Z = 10.16 (P < 0.00001)。结论：稳心颗粒、通心络胶囊、复方丹参滴丸、芪参益气滴丸、芪苈强心胶囊、麝香保心丸联合常规西药治疗对于预防冠心病PCI术后支架内再狭窄、降低心血管不良事件发生率具有显著优势，不过，以上结论还需要大量高质量的RCT试验来进一步验证。

Abstract: Objective: Based on mesh meta-analysis, evaluate the clinical efficacy and safety of 11 kinds of tra-ditional Chinese patent medicines in the Guidelines for Prevention and treatment of in stent reste-nosis after percutaneous coronary intervention. Methods: Select the guide involved in “Tongxinluo Capsule”, “Danlou Tablet”, “Shexiang Baoxin Pill”, “Compound Danshen dropping Pill”, “Qishen Yiqi dropping Pill”, “Xuefu Zhuyu Capsule”, “Shensong Yangxin Capsule”, “Qili Qiangxin Capsule”, “Wen-xin Granule”, “Naoxintong Capsule”, “Suxiao Jiuxin Pill”. Through eight major Chinese and English databases (CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science), randomized controlled trials (RCTs) studies on the treatment of 11 kinds of proprietary Chinese medicines combined with conventional western medicine compared with the treatment of conven-tional Western medicine alone for the prevention and treatment of ISR after PCI were respectively searched. The control group was treated with conventional western medicine, and the experimental group was treated with the above proprietary Chinese medicine on the basis of the control group. Literature quality evaluation and meta-analysis were performed using RevMan5.4 software. Re-sults: A total of 28 RCTs involving 6 proprietary Chinese medicines were included, including 3114 patients. The results of meta-analysis showed that compared with the control group, the experi-mental group could reduce the rate of in-stent restenosis in patients with coronary heart disease after PCI, RR = 0.42, 95% CI = [0.35, 0.51], with statistical significance, Z = 8.98 (P < 0.00001). Meanwhile, compared with the control group, the experimental group could also reduce the inci-dence of cardiovascular adverse events, RR = 0.42, 95% CI = [0.35, 0.49], with statistical signifi-cance, Z = 10.16 (P < 0.00001). Conclusion: Wenxin Granule, Tongxinluo capsule, compound Dans-hen dropping pill, Qishenyiqi dropping pill, Qiliqiangxin capsule and Shexiangbaoxin Pill combined with conventional Western medicine have significant advantages in preventing in-stent restenosis after PCI and reducing the incidence of cardiovascular adverse events. However, the above conclu-sions still need to be further verified by a large number of RCT tests.