摘要：目的：系统评价蒙药赞丹-3治疗冠心病心绞痛的临床疗效及其安全性，为临床用药提供可参考的循证依据。方法: 从建库至2020年9月30日为检索期限，检索数据库为：中国期刊全文数据库、中文科技期刊全文数据库、万方数据库、维普、PubMed、the Cochrane Library及 Web of Science 等数据库，搜集蒙药赞丹-3治疗冠心病心绞痛的临床随机对照试验研究，按照不同的治疗方法分为试验组（仅用赞丹-3治疗）和对照组（常规基础治疗、中药复方剂治疗、安慰剂治疗等），以临床总有效率、心绞痛及心电图改善率、胸闷、气短、心悸等主要症状的改善率、血脂、血液流变学指标的变化、不良反应情况等为结局指标，对纳入文献采用Cochrane偏倚风险评估工具进行评价，对文献的结局指标采用 StataSE-64 软件进行 Meta分析及其安全性评价。结果:共纳入的18篇随机对照试验研究文献里共涉及1558例患者，纳入研究的总体方法学质量一般。Meta分析结果显示，与对照组相比，试验组明显提高患者的临床总有效率（RR=1.166，95%CI =1.114 -1.221，P＜0.0017），差异有统计学意义；明显改善心绞痛发作频率[WMD=-3.849，95 %CI =(-5.570-2.127)，Z=4.38(P=0)]、缩短心绞痛发作的持续时间[WMD=-2.961，95%CI=(-3.566- -2.366)，Z=9.75(P=0)]，差异均有统计学意义，试验组均优于对照组；提高心电图改善率(RR=1.073，95%CI=0.99 -1.163，P=0.086) ,但无统计学差异；试验组降低不良反应发生率( RR=1.049，95%CI =0.518-2.124，P=0.895) ,但无统计学差异，报告的不良反应均以胃肠道反应为主，无严重不良事件，且未见脱离报告。结论: 赞丹-3用于冠心病心绞痛的治疗，能提高临床总有效率，缓解心绞痛症状。提高临床疗效，可能通过降低炎症反应、改善血脂代谢异常来达到治疗心绞痛的治疗目的，且安全性较高。 关键词：蒙药赞丹-3; 冠心病心绞痛; 随机对照试验;系统评价；mate分析

Abstract: Objective:To systematically review the clinical efficacy and safety of Mongolian medicine Zaandan-3 in the treatment of coronary heart disease angina pectoris, and to provide evidence-based evidence for clinical medication. Methods: The retrieval period was from the establishment of the database to September 30, 2020. The retrieval databases were: Chinese Journals Full-text Database, Chinese Science and Technology Journals Full-text Database, Wanfang Database, VIP, PubMed, the Cochrane Library and Web of Science and other databases. The clinical randomized controlled trial study of Mongolian medicine Zandan-3 in the treatment of coronary heart disease angina pectoris. According to different treatment methods, it is divided into a treatment group (only using Zandan-3 treatment) and a control group (conventional basic treatment, traditional Chinese medicine compound treatment, placebo treatment) etc.), the clinical total effective rate, the improvement rate of angina pectoris and electrocardiogram, the improvement rate of chest tightness, shortness of breath, palpitations and other main symptoms, blood lipids, changes in hemorheology indexes, and adverse reactions were used as outcome indicators. Cochrane risk of bias assessment tool was used for evaluation, and StataSE-64 software was used to perform meta-analysis and safety evaluation of the outcome indicators in the literature.Results: A total of 1558 patients were involved in 18 randomized controlled trials, and the overall methodological quality of the included studies was average. Meta-analysis results showed that compared with the control group, the treatment group significantly improved the total clinical effective rate (RR=1.166, 95%CI =1.114 -1.221, P<0.0017), and the difference was statistically significant; the frequency of angina pectoris was significantly improved. [WMD=-3.849, 95%CI=(-5.570_2.127), Z=4.38(P=0)], shorten the duration of angina attacks [WMD=-2.961, 95%CI=(-3.566 - -2.366 ), Z=9.75(P=0)], the difference was statistically significant, the treatment group was better than the control group; improved ECG improvement rate (RR=1.073, 95%CI=0.990-1.163, P=0.086), but There was no statistical difference; the treatment group reduced the incidence of adverse reactions ( RR=1.049, 95%CI =0.518-2.124, P=0.895), but there was no statistical difference. The reported adverse reactions were mainly gastrointestinal reactions, and no adverse reactions were reported. Serious adverse events, and no disengagement reports. Conclusion: Zandan-3 for the treatment of coronary heart disease angina pectoris can improve the total clinical effective rate and relieve the symptoms of angina pectoris. To improve the clinical efficacy, the therapeutic purpose of treating angina pectoris may be achieved by reducing the inflammatory response and improving the abnormal blood lipid metabolism, and the safety is high. Keywords: Mongolian medicine zandan-3; Coronary heart disease, angina pectoris; Randomized controlled trial; Systematic review; Mate analysis

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内蒙古自然科学基金项目