红景天注射液治疗心绞痛的系统评价

Rhadiola injection for angina pectoris:A systematic review

目的系统评价红景天注射液治疗心绞痛的疗效及安全性。方法计算机检索Pub Med、Embase、Cochrane Library、CNKI、万方及VIP数据库中所有红景天注射液治疗心绞痛的疗效及安全性的随机对照研究,按照纳入和排除标准筛选文献、提取资料,并依据Cochrane Handbook 5.0.1的质量评价标准评价纳入研究的方法学质量。主要结果包括疾病疗效、心绞痛疗效、心电图疗效、中医证候总积分及不良反应。根据异质性检验结果选择固定效应模型或随机效应模型进行Meta分析。结果共纳入12个随机对照试验,合计1 442例患者。Meta分析主要结果显示:1红景天注射液+西医常规治疗组与西医常规治疗组比较,疾病疗效(RR=1.27,95%CI(1.09,1.48))、心绞痛疗效(RR=1.25,95%CI(1.14,1.38))及心电图疗效(RR=1.21,95%CI(1.10,1.34))差异均有统计学意义。2红景天注射液组与复方丹参注射液组比较,疾病疗效(RR=1.25,95%CI(1.04,1.50))、心电图疗效(RR=1.28,95%CI(1.09,1.50))及中医证候疗效(RR=1.09,95%CI(1.00,1.18))差异均有统计学意义,然而心绞痛疗效差异无统计学意义(RR=1.10,95%CI(0.92,1.32));与血塞通注射液组比较,心绞痛疗效(RR=1.08,95%CI(0.84,1.39))及心电图疗效(RR=1.13,95%CI(0.87,1.47))差异均无统计学意义。3红景天注射液组与单硝酸异山梨酯组比较,心绞痛疗效(RR=1.06,95%CI(0.96,1.16))及心电图疗效(RR=1.04,95%CI(0.97,1.11))差异均无统计学意义。治疗期间未发现严重不良反应。结论现有证据表明,红景天注射液治疗心绞痛有一定疗效且相对安全。但受纳入研究的质量影响解释结果应谨慎,尚需严格、高质量的临床试验进一步证实。

Objective It is to systematically assess the clinical effectiveness and safety of rhadiola injection for angina pec-toris.Methods The databases such as PubMed,Embase,Cochrane Library,CNKI,WanFang and VIP were searched to collect all randomized control trials（RCTs）about the clinical effectiveness and safety of rhadiola injection for angina pectoris.Litera-tures were screened according to the inclusive and exclusive criteria,the data were extracted,the methodological quality of the included studies was assessed in line with Cochrane Handbook 5.0.1.The primary outcome measure including therapeutic effect, angina treatment effect, electrocardiogram （ ECG） curative effect, general integral of traditional Chinese medicine （TCM） symptoms and adverse drug reaction.The meta-analysis was performed with the fixed -effect model or random-effect model according to heterogeneity.Results Twelve RCTs with 1442 patients were included.The outcomes of meta-analyses showed that, ①rhadiola injection plus western drugs vs.western drugs alone： compared with western drugs alone, significant differences were found in the therapeutic effect （RR =1.27, 95%CI（1.09,1.48））, angina treatment effect （RR =1.25, 95%CI（1.14,1.38））, and ECG measurements（RR =1.21, 95%CI（1.10,1.34））.②rhadiola injection vs.other TCM：compared with ompound Salvia militorrhiza （danshen） injection, significant differences were found in the therapeutic effect （RR =1.25, 95%CI（1.04,1.50））, ECG measurements （RR =1.28, 95%CI（1.09,1.50））, and general integral of TCM symptoms（RR =1.09, 95%CI（1.00,1.18））.while, angina treatment effect was not significantly different（RR =1.10, 95%CI（0.92,1.32））;compared with Xuesaitong injection, no significant differences was found in the angina treatment effect （RR =1.25, 95%CI（1.04,1.50））, ECG measurements（RR =1.13, 95%CI（0.87,1.47））.③ rhadiola injection vs. isosorbide mononitrate： there was no significant difference both for ECG improvement（RR =1.08, 95%CI（0.84,1.39））and for angina treatment effect （RR =1.06, 95%CI（0.96,1.16））.No severe adverse events were found in all included studies. Conclusion As the current evidence shows, rhadiola injection has some effects and is relatively safe to treat angina pectoris. 〈br〉 However,the results should be interpreted with caution because of the low quality of the induded studies.more rigorous trials with high quality are needed to give high level of evidence.