摘要
目的:评价参麦注射液治疗冠心病的疗效及安全性。方法:计算机检索CNKI(1979年—2011年12月)、维普期刊(1989年—2011年12月)、万方数据(1987年—2011年12月)等数据库,全面搜集有关参麦注射液治疗冠心病的随机对照试验(RCT)的文献,运用Jadad评分法进行质量评价,数据分析采用RevMan5.0及Stata12软件。结果:共纳入18项研究,Meta分析结果显示:参麦注射液联合常规疗法相对于单纯常规疗法治疗冠心病,可使临床症状疗效的总有效率提高22%[RD=0.22,95%CI(0.17,0.26),P<0.000 01],相对危险度[RR=1.31,95%CI(1.20,1.43),P<0.000 1];可使心电图疗效的总有效率提高25%[RD=0.25,95%CI(0.19,0.31),P<0.000 01],相对危险度[RR=1.46,95%CI(1.32,1.62),P<0.000 1];可使心功能NYHA分级的改善率提高33%[RD=0.33,95%CI(0.16,0.49),P<0.000 01],相对危险度[RR=1.79,95%CI(1.28,2.51),P=0.000 6];增加左室射血分数[WMD=7.55,95%CI(2.28,12.83),P=0.005];此外分别各有1项研究显示参麦注射液有使冠心病患者提高左室每搏输出量,减小左室收缩末期内径,改善血液流变学指标,降低血NT-pro-BNP,ADMA,细胞因子,TNF-α,IL-6及血清酶,改善梗塞相关血管IRA再通指标,缩短症状改善时间及心电图恢复时间等作用。有3项研究报告了不良反应,主要为头昏、心悸、轻度腹胀、恶心、精神兴奋及面色潮红,无严重不良反应事件报道。结论:现有临床证据表明,参麦注射液治疗冠心病有一定效果,可提高治疗的总有效率。该文虽存在一些不足之处,但对临床仍具有一定的参考价值。有待于开展更多设计合理、执行严格、多中心大样本且随访时间足够的随机对照试验以进一步验证其疗效和安全性。
Objective： To evaluate the efficacy and safety of Shenmai injection in the treatment of coronary heart disease （CHD）. Method： CNKI （ 1979 to December 2011 ）, VIP （ 1989 to December 2011 ）, and Wanfang Data （ 1987 to December 2011 ） were retrieved for literatures concerning randomized controlled trials of Shenmai injection in the treatment of coronary heart disease. Their quality was assessed by the Jadad scale. Review Manager 5.0 and Stata 12 software were adopted for data analysis. Result： Alto- gether 18 randomized clinical trials were included in the Meta-analysis. According to the findings, compared with routine therapy alone, the combination of Shenmai injection and routine therapy increased the overall effective rate by clinical symptoms by 22% [ RD = 0. 22, 95% CI （0. 17, 0. 26）, P 〈0. 000 01 ], with the relative risk ratio of [ RR = 1.31,95% CI （1.20, 1.43）, P 〈0. 000 1 ] and the efficacy by electrocardiogram by 25% [ RD =0. 25, 95% CI （0. 19, 0. 31 ）, P 〈 0. 000 01 ], with the relative risk ratio of [ RR = 1.46, 95%CI （1.32, 1.62）,P 〈 0. 000 1]. It also improved New York heart association classification （NYHA） by 33% [RD =0. 33, 95%CI （0. 16, 0.49）, P〈0. 000 01], with the relative risk ratio of [RR =1.79, 95%CI （1.28, 2.51）, P =0.000 6] and left ventricular ejection fraction [WMD 7.55,95% CI （2.28,12. 83 ） ]. Additionally, studies reported that Shenmai injection could increase left ventricular stroke volume, decrease left ventricular end systolic diameter, improved hemodynamic indexes, reduced NT-pro-BNP, DMA, cytokines, TNF-α, IL-6 and serum enzyme, mitigated infarction-related revascularization IRA indexes and shortened the symptom improvement time and electrocardiogram recovery time. Three studies had reported adverse events, mainly dizziness, palpitation, mild abdominal distension, nausea, metal excitement and flushed face, with no serious adverse effect. Conclusion ： Clinical evidences prove that Shenmai injection has certain effect in treating CHD and remains to be improved in the overall effective rate. The essay, despite of some shortcomings, provides certain reference for clinical application. It is suggested holding more multicenter randomized controlled trials with rational design, strict implementation, large sample size and sufficient following-up time to further verify its efficacy and safety.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2012年第23期3651-3658,共8页
China Journal of Chinese Materia Medica
关键词
参麦注射液
冠心病
疗效与安全性
META分析
Shenmai injection
coronary heart disease
efficacy and safety
Meta-analysis
