参附注射液辅助治疗冠心病心绞痛疗效的Meta分析

Meta-analysis on effect of Shenfu injection in treating angina pectoris

系统评价参附注射液治疗冠心病心绞痛的有效性及安全性。检索Embase,Pubmed,Cochrane图书馆,Clinical Trials.gov,中国期刊全文数据库（CNKI）,中国生物医学文献数据库（CBM）,维普中文科技期刊数据库（VIP）以及万方数字化期刊全文数据库等（检索年限从建库至2015年9月）,筛选并纳入采用参附注射液辅助治疗冠心病心绞痛的随机或半随机对照试验,依据Cochrane协作网工具评价纳入文献的方法学质量,并应用STATA 12.0软件进行统计学处理。最终17项研究入选,包括随机对照试验（RCT）16项和临床对照试验（CCT）1项,总计1 309例患者,其中659例患者接受参附注射液治疗。Meta分析结果显示,与常规治疗相比,联用参附注射液能显著改善冠心病患者心绞痛症状（OR=3.38,95%CI：2.47-4.64,P=0.000）及心电图缺血性ST-T改变（OR=3.30,95%CI：2.22-4.90,P=0.000）。Meta回归显示患者平均年龄与临床疗效OR（β=0.17）及心电图疗效OR（β=1.15）均存在正相关性。参附注射液相关并发症发生率为3.4%,无严重不良反应。现有临床证据表明参附注射液能显著改善冠心病心绞痛患者临床症状及心电图缺血表现,并具有良好的安全性。

To systematically evaluate the efficiency and safety of Shenfu injection in treating patients with angina pectoris. Retrievals were made in Embase,Pubmed,Cochrane Library,Clinical Trials. gov,CNKI,CBM,VIP and Wanfang（ before September 2015） for randomized or semi-randomized controlled trials reporting data of Shenfu injection in the adjuvant treatment of angina pectoris. The quality of included trials was evaluated according to tool evaluation at cochrane. org. STATA version 12. 0was applied for Meta analysis after quality assessment of included studies. Finally,a total of 17 studies,including 16 randomized controlled trials（ RCTs） and 1 controlled clinical trial（ CCT） involving 1 309 patients,met the inclusion criteria,of which 659 patients received Shenfu injection treatment. Meta-analysis results showed that Shenfu injection treatment group significantly improved angina pectoris symptoms（ OR = 3. 38,95 % CI： 2. 47-4. 64,P = 0. 000） and ischemic ST-T changes in electrocardiogram（ OR = 3. 30,95 % CI： 2. 22-4. 90,P = 0. 000）,compared with control group. In the Meta-regression analysis,the average age of patients was positively correlated with the improved clinical（ β = 0. 17） and electrocardiogram（ β = 1. 15） efficacies.Major complication rate of Shenfu injection was 3. 4 %,and no serious adverse events were reported. Current clinical evidence in this study proved that Shenfu injection could significantly improve clinical symptoms and ECG ischemic changes for angina pectoris patients,with a good safety.