摘要
目的:系统评价参麦注射液联合常规用药治疗小儿病毒性心肌炎患者的有效性及安全性。方法:计算机检索中英文相关文献数据库,纳入与有关参麦注射液治疗小儿病毒性心肌炎的随机对照试验(RCT),根据Cochrane手册"对RCT偏倚风险的评估工具"对纳入的研究进行方法学质量评价,用Rev Man软件进行统计分析。结果:纳入12个RCT共640名受试者,均为低质量研究。Meta分析结果显示,参麦注射液联合常规用药在治疗小儿病毒性心肌炎患者的临床疗效及降低乳酸脱氢酶等方面优于常规治疗组,治疗期间联合用药组未见严重不良反应/事件发生。结论:现有临床证据表明参麦注射液联合常规用药可以提高治疗小儿病毒性心肌炎的疗效,然而鉴于本研究纳入的文献质量较低,从而增加了结论产生偏倚的风险,因此参麦注射液治疗小儿病毒性心肌炎疗效和安全性仍需要高质量的临床试验加以证实。
Objective：To assess the efficacy and safety of Shenmai injection for Children with viral myocarditis. Methods： All clinical studies of Shenmai injection for Children with viral myocarditis were searched from, Medline, web of science, CBM, CNKI, VIP and Wanfang . Quality assessment and information extraction were done and screened by two independent reviewers. The quality of the included studies was evaluated according to the Coehrane Collaborationg tool for assessing risk of bias and allocation concealment. Revman 5.2.4 software was used for data analysis. Results ： A total of 12 randomized controlled trials with patients were included in this systematic review, all of them were low quality. Meta- analysis showed that group of Shenmai injection adding conventional treatment was better than the conventional treatment group in the therapeutic effect rate and reduce LDH, etc . The ADR/AE information of Shenmai injection in all included studies showed that the symptoms of serious ADR/AE were mild. Conclusions： Conclusions from this review may have a high risk of bias because of low quality of the researchers; hence it was adequate to draw any reliable conclusions about the efficacy of Shenmai injection in the treatment of Children with viral myocarditis. More trials with high quality are required in the following researches.
出处
《中国中医基础医学杂志》
CAS
CSCD
北大核心
2014年第11期1534-1539,共6页
JOURNAL OF BASIC CHINESE MEDICINE
基金
科技部"重大新药创制"科技重大专项"中药上市后再评价关键技术研究"(2009ZX09502-030)
