OBJECTIVE: To systematically review the clinical efficacy and safety of salvianolate injection in treatment of angina pectoris of coronary heart disease .METHODS:Randomized controlled trials between conventional therapy combined with salvianolate injection ( observation group ) and simple conventional therapy or conventional therapy combined with Danshen injection ( control group ) in respective treatment of angina pectoris of coronary heart disease were retrieved from CNKI ,VIP, Wanfang database and PubMed .Quality evaluation was conducted on involved literatures according to Cochrane systematic review , and RevMan 5.1 was adopted to carry out Meta analysis . RESULTS:A total of 13 studies were involved , including 1262 subjects .Results of Meta analysis indicated the total effective rates of angina pectoris improvement ( OR =3.72, 95％CI =2.68-5.16, P <0.00001 ) and ECG improvement rate(OR=2.55, 95％CI=1.66-3.92, P<0.0001) of observation group were significantly higher than those of the control group, with statistically significance differences(P<0.05).There was no statistical significance in the difference of incidences of adverse drug reactions between two groups ( RD=-0.03, 95％CI=-0.12-0.06, P=0.49 ) , without any severe adverse drug reactions reports .CONCLUSIONS: Present clinical evidence suggests the combination of conventional therapy and salvianolate injection works better in angina pectoris and ECG improvement than simple conventional therapy or conventional therapy combined with Danshen injection .However , due to the small amount and low quality of involved literatures , this conclusion needs more RCTs with larger sample , multi-center and long-term follow up for further verification .%目的:系统评价中药制剂注射用丹参多酚酸盐治疗冠心病心绞痛的临床疗效和安全性.方法:计算机检索中国期刊全文数据库、中文科技期刊全文数据库、万方数据库和PubMed等数据库,收集在常规治疗基础上联合应用注射用丹参多酚酸盐(观察组)与单纯常规治疗或在常规治疗基础上联合应用丹参注射液(对照组)分别治疗冠心病心绞痛的随机对照试验.根据Cochrane系统评价方法对纳入文献进行质量评价,采用RevMan 5.1软件进行文献荟萃(Meta)分析.结果:纳入13篇文献,共1262例患者.Meta分析结果显示,观察组患者的心绞痛症状改善总有效率(OR=3.72,95％CI=2.68～5.16,P<0.00001)、心电图改善总有效率(OR=2.55,95％CI=1.66～3.92,P<0.0001)均明显优于对照组,差异均有统计学意义.两组患者不良反应发生率的差异无统计学意义(RD=-0.03,95％CI=-0.12～0.06,P=0.49),且无严重不良反应报告.结论:目前的临床证据支持在常规治疗基础上加用注射用丹参多酚酸盐对心绞痛症状和心电图的改善效果优于单纯常规治疗或在常规治疗基础上加用丹参注射液.由于纳入研究的数量少、质量不高,上述结论有待更多大样本、多中心且随访时间长的随机对照试验进一步验证.
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