复方丹参注射液联合维生素E治疗新生儿硬肿症的系统评价

目的:系统评价复方丹参注射液联合维生素E治疗新生儿硬肿症的临床疗效。方法:计算机检索中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、维普(VIP)和万方数据库,PubMed和Cochrane图书馆,纳入复方丹参注射液联合维生素E治疗新生儿硬肿症的随机对照试验(RCT),对纳入研究进行Jadad质量评分,对同质性结果进行合并分析。结果:共纳入12项RCT,合计969例患者。所有文献Jadad评分均为3分。Meta分析结果显示,复方丹参注射液联合维生素E治疗新生儿硬肿症的显效率RR=1.72,95%C(I1.38,2.15),P<0.00001]、硬肿好转时间MD=-1.81,95%C(I-1.92,-1.70),P<0.00001]、硬肿消退时间MD=-1.58,95%C(I-1.82,-1.33),P<0.00001]、体温恢复时间MD=-2.40,95%C(I-3.34,-1.46),P<0.00001]及住院时间MD=-2.95,95%CI(-3.55,-2.36),P<0.00001]与对照组比较,差异均有统计学意义。结论:在常规治疗基础上联合复方丹参注射液和维生素E治疗新生儿硬肿症疗效优于单纯常规治疗,且安全性较好。但由于本研究纳入文献质量较低,有待临床开展大样本的RCT继续研究。

A Systematic Review of Compound Danshen Injection Combined with Vitamin E in the Treatment of Neonatal Scleredema

OBJECTIVE:To evaluate the clinical efficacy of Compound danshen injection combined with vitamin E in the treatment of neonatal scleredema.METHODS:According to evidence based medicine methods,randomized controlled trials(RCTs)were retrieved databases of CBM,CNKI,VIP,Wanfang,PubMed and the Cochrane Library.RCTs of Compound danshen injection combined with vitamin E in the treatment of neonatal scleredema were included,including studies’quality was evaluated by Jadad method,and Meta-analysis of homogeneity study results was performed.RESULTS:A total of 12 studies involving 969 patients were gathered,all of which Jadad score was 3.Meta-analysis results indicated the difference of excellence rateRR=1.72,95%CI(1.38,2.15),P<0.000 01],scleredema improving timeMD=-1.81,95%CI(-1.92,-1.70),P<0.000 01],scleredema regression timeMD=-1.58,95%CI(-1.82,-1.33),P<0.000 01],body temperature regression timeMD=-2.40,95%CI(-3.34,-1.46),P<0.000 01] and hospitalization timeMD=-2.95,95%CI(-3.55,-2.36),P<0.000 01] were significant between trial group and control group.CONCLUSION:Based on evidence recently,Compound danshen injection combined with vitamin E on the basis of conventional therapy is better than conventional therapy alone for neonatal scleredema.But as a result of this research inctuded studies of lower quality,to be further clinical sample RCT to continue to study.