摘要
目的:系统评价丹参注射液超说明书治疗胎儿生长受限的有效性和安全性,为临床合理用药提供参考。方法:计算机检索Pubmed、CENTRAL、EMbase、中国生物医学文献数据库、中国学术期刊网络出版总库、维普数据库、万方数据库等,搜集丹参注射液治疗胎儿生长受限的相关随机对照试验,检索时限均从建库至2016年3月。由2位研究者独立筛选文献、提取资料和评价纳入研究的偏倚风险,进行文献荟萃(Meta)分析或描述性分析。结果:共纳入6个研究,共432例受试者。在胎儿生长受限的常规治疗基础上使用丹参注射液可改善新生儿出生体质量,促进妊娠期妇女宫高、腹围增长,促进胎儿双顶径、股骨长增长。但6篇原始研究均未报告丹参注射液治疗胎儿生长受限的死胎、新生儿死亡等不良结局及安全性结局。结论:丹参注射液可改善胎儿生长受限患者的新生儿出生体质量及妊娠期妇女、胎儿的重要指标,但仍需大样本、高质量、规范的随机对照试验进一步关注丹参注射液治疗胎儿生长受限的新生儿相关结局及安全性结局,以确定丹参注射液治疗胎儿生长受限的有效性与安全性。
OBJECTIVE： Systematically review the efficacy and safety of Danshen injections in treatment of fetal growth restriction,so as to provide reference for the rational drug use. METHODS： Pubmed,CENTRAL,EMbase,CBM,CNKI,VIP,Wanfang database were retrieved by computers to collect the randomized controlled trials（ RCTs） involving Danshen injections from inception to Mar. 2016. Included literatures were extracted and bias risks were evaluated independently by two reviewers,meta-analysis or descriptive analysis were conducted based on literature situations. RESULTS： A total of 6 RCTs were involved,including 432 participants. Danshen injections based on conventional therapy for fetal growth restriction can improve the neonate birth weight,fundal height and abdominal perimeter of mother,biparietal diameter and femur length of fetus. However,adverse and safety outcomes as stillbirth and neonatal death were not reported in all6 studies. CONCLUSIONS： Danshen injections can improve the neonate birth weight and important indicators for fetus and mother,yet high quality,regular,large-sample RCTs concerning neonatal relating and safety outcomes of Danshen injections in fetal growth restriction treatment are needed to determine its clinical efficacy and safety.
出处
《中国医院用药评价与分析》
2016年第10期1370-1373,共4页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
国家自然科学基金(No.81373381)
关键词
丹参注射液
胎儿生长受限
超说明书
系统评价
Danshen injections
Fetal growth restriction
Off-label use
Systematic review
