复方丹参注射液佐治新生儿缺氧缺血性脑病疗效的Meta分析

系统评价复方丹参注射液佐治新生儿缺氧缺血性脑病(hypoxic-ischemic encephalopathy,HIE)的临床疗效以及安全性。利用计算机检索PubMed,Embase,Cochrane Library、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、维普中文科技期刊数据库(VIP)和万方数字化期刊全文数据库等(各数据库检索时间均从建库起到2014年5月),同时检索相关文献的参考文献,并辅以手工检索相关杂志和会议论文等。收集有关复方丹参注射液治疗新生儿HIE的随机或半随机对照试验,并且依据Coehrane Handbook推荐的文献质量评价办法对符合纳入标准的文献进行质量评价,应用RevMan5.3软件进行统计学处理。最终纳入13个随机对照试验(randomised controlled trial,RCT),总计1 211例患儿,包括复方丹参注射液治疗组639例,常规治疗对照组572例。Meta分析结果显示,在常规治疗基础上加用复方丹参注射液可提高新生儿HIE的治疗有效率[RR=1.28; 95%CI(1.21~1.36)]、降低病死率[RR=0.42; 95%CI(0.23~0.75)]和减小远期神经系统后遗症的发生率[RR=0.48; 95%CI(0.35~0.65)],差异均有统计学意义。所纳入研究均未观察到不良反应的发生。目前有限的证据表明应用复方丹参注射液佐治新生儿HIE可以提高临床疗效,但由于所纳入研究质量不高,尚需更多设计良好、规模较大的多中心随机对照试验研究进一步加以验证。

Meta-analysis on effect of compound Danshen injection in treating neonatal hypoxic-ischemic encephalopathy

To systematically evaluate the clinical efficacy and safety of compound Danshen injection in treating hypoxic-ischemic encephalopathy (HIE) of newborns. Computer retrievals were made in PubMed, Embase, Cochrane Library, CBM, CNKI, VIP and Chinainfo (before May 2014) and relevant literature references, and manual retrievals were made for journals and conference papers, in order to collect randomized or semi-randomized controlled trials concerning compound Danshen injection in the treatment of neonatal HIE. The quality of included references was evaluated according to literatures recommended by Cochrane Handbook. RevMan 5.3 software was applied in the statistical treatment. Finally, a total of 13 randomized controlled trials were included, covering 1 211 patients (including 639 patients in the compound Danshen injection-treated group and 572 patients in the control group). Meta-analysis results showed that the routine treatment combined with compound Danshen injection can improve the treatment efficiency of neonatal HIE [RR=1.28; 95% CI(1.21-1.36)], reduce the mortality rate [RR=0.42; 95% CI (0.23-0.75)] and the incidence of long-term neurological sequelae [RR=0.48; 95% CI (0.35-0.65)], with statistical differences. No fatal side effect was observed in all of included trials. So far, limited evidences in this study proved that the application of compound Danshen injection in the treatment of neonatal HIE can enhance the clinical efficiency. However, because of the low quality of the included trials, more well-designed and large-scale multi-center randomized controlled trials shall be made in the future.