丹红注射液对比丹参类注射剂治疗冠心病心绞痛的系统评价

发布时间：2017-12-28 13:04

本文关键词：丹红注射液对比丹参类注射剂治疗冠心病心绞痛的系统评价　出处：《山西中医学院》2016年硕士论文　论文类型：学位论文

【摘要】：目的:系统评价丹红注射液对比丹参类注射液治疗冠心病心绞痛的临床疗效。方法:计算机检索Cochrane图书馆、EMbase、Pubmed、CBM、CNKI、维普、万方数据库;检索丹红注射液对比丹参类注射剂治疗冠心病心绞痛临床随机对照试验。检索年限均从建库时间到2014年12月。由3位研究人员按照已制定的纳入、排除标准进行文献筛选,对所纳入文献参照Cochrane偏倚风险评估工具评价研究质量,提取资料并采用RevMan5.3软件进行系统评价。结果:(1)所纳入研究方法学设计不够严谨,文献质量均不高。(2)Meta分析结果显示:丹红注射液对比丹参类注射液治疗冠心病心绞痛在临床疗效总有效率[RR=1.31,95%CI(1.26,1.36),P0.00001]、心电图疗效有效率[RR=1.32,95%CI(1.25,1.39),P0.00001]、心绞痛改善有效率[RR=1.27,95%CI(1.21,1.33),P0.00001]、血浆黏度[SMD=-0.89,95%CI(-1.43,-0.35),P=0.001]方面,丹红注射液疗效优于对照组;但对于全血黏度低切值[SMD=-0.38,95%CI(-1.21,0.46),P=0.38]、全血黏度高切值[SMD=-1.29,95%CI(-2.56,-0.02),P=0.05]、甘油三酯(TG)[RR=-0.21,95%CI(-1.48,1.05),P=0.74]、总胆固醇(TC)[RR=-0.61,95%CI(-1.32,0.10),P=0.09]、心绞痛发作次数[SMD=-4.84,95%CI(-10.97,1.29),P=0.12]各项指标改善方面,丹红注射液与丹参类注射液疗效无显著差异。(3)亚组分析提示,在改善临床总疗效方面,不同剂量丹红注射液疗效均优于丹参类注射液,但40ml剂量疗效最差;对于改善心电图疗效,20ml和30ml丹红注射液疗效均优于丹参类注射液,但40ml疗效不显著;改善心绞痛疗效方面,不同剂量丹红注射液疗效均优于丹参类注射液,但趋向于20ml剂量疗效最佳;不同疗程丹红注射液疗效均优于丹参类注射液,但14~15天疗程疗效最佳;可以考虑规定20ml和15天为丹红注射液临床使用剂量和疗程。(4)不良反应的Meta-分析:丹红注射液组与丹参类注射液组不良反应组间差异不显著[RR=0.62,95%CI(0.36,1.07)],但趋势有利于治疗组,趋于治疗组不良反应低于对照组。结论:本研究基于38个随机对照试验,包括样本3928例的Meta分析,结果显示丹红注射液可以改善冠心病心绞痛患者临床疗效总有效率、心电图改善有效率和心绞痛疗效有效率,但对于全血黏度低切值、全血黏度高切、甘油三酯(TG)、总胆固醇(TC)、心绞痛发作次数各项指标改善,两类注射液差异不显著。丹红注射液疗效及安全性优于丹参类注射液,但由于受到纳入文献质量与数量的限制,本研究结果临床证据强度较低,仍需大量多中心大样本的随机对照试验加以验证。
[Abstract]:Objective: to systematically evaluate the clinical efficacy of Danhong injection compared with Salvia miltiorrhiza injection in the treatment of angina pectoris. Methods: We searched the Cochrane library, EMbase, Pubmed, CBM, CNKI, VIP, Wanfang database retrieval; Danhong injection contrast of Radix Salviae Miltiorrhizae Injection in treatment of angina pectoris of coronary heart disease clinical randomized controlled trial. The years of retrieval are from the time of construction to December 2014. 3 researchers were screened according to the established inclusion and exclusion criteria. The quality of the study was evaluated by referring to the Cochrane bias risk assessment tool, and the data were extracted and evaluated by RevMan5.3 software. Results: (1) the design of the research methodology was not strict, and the quality of the literature was not high. (2) the results of Meta analysis showed that Danhong injection and Danshen injection in comparison the clinical therapeutic effect of [RR=1.31,95%CI in treatment of angina pectoris of coronary heart disease (1.26,1.36), the efficiency of [RR=1.32,95%CI (1.25,1.39) P0.00001], P0.00001], ECG, angina, improve the effective rate of [RR=1.27,95%CI (1.21,1.33), P0.00001], plasma viscosity [SMD=-0.89,95%CI (-1.43, -0.35). P=0.001], Danhong injection is better than the control group; but the whole blood viscosity at low shear rate ([SMD=-0.38,95%CI -1.21,0.46), P=0.38], [SMD= and -1.29,95%CI value of whole blood viscosity at high shear rate (-2.56, -0.02), P=0.05], triglyceride (TG), P=0.74] [RR=-0.21,95%CI (-1.48,1.05), total cholesterol (TC), P=0.09] [RR=-0.61,95%CI (-1.32,0.10), angina pectoris episodes of [SMD=-4.84,95%CI (-10.97,1.29), the indexes of P=0.12] improvement, Danhong injection and Danshen injection treatment had no significant difference Iso. (3) subgroup analysis suggested that, to improve the clinical curative effect of different doses of Danhong injection treatment was better than Danshen injection, but 40ml dose effect is the worst; to improve the ECG curative effect, 20ml and 30ml were better than the effect of Danhong injection and Danshen injection, but the 40ml effect is not significant; the improvement of angina pectoris different doses of Danhong injection, the curative effect was better than Danshen injection, but tend to 20ml the best effect of different treatment doses; Danhong injection treatment was better than Danshen injection, but 14~15 days of treatment can be prescribed 20ml best; and 15 days of dosage and treatment for clinical consideration of Danhong injection. (4) Meta- analysis of adverse reactions: there was no significant difference between Danhong injection group and Salvia miltiorrhiza injection group in the adverse reaction group [RR=0.62,95%CI (0.36,1.07)], but the trend was beneficial to the treatment group, and the adverse reaction in the treatment group was lower than that in the control group. Conclusion: This study is based on 38 randomized controlled trials, including the analysis of 3928 samples of Meta, results showed that Danhong injection can improve the clinical efficacy in patients with coronary heart disease, the total efficiency of ECG improvement rate and angina pectoris efficiency, but for the whole blood viscosity at low shear rate, high shear whole blood viscosity, triglyceride (TG), total cholesterol (TC), angina improve indexes of two kinds of injection times, the difference was not significant. The efficacy and safety of Danhong injection is better than that of Danshen injection. However, due to the limitation of the quality and quantity of the included literatures, the clinical evidence intensity of this study is relatively low, which still needs a large number of multicenter large sample randomized controlled trials to verify it.
【学位授予单位】：山西中医学院
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R259

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