摘要
目的探讨阿托西班(atosiban)与利托君(ritodrine)治疗早产的临床疗效及安全性。方法根据系统评价原则,计算机全面检索相关文献数据库,收集国内外有关阿托西班和利托君治疗早产的随机对照试验(RCT),对符合本研究纳入标准的临床研究采用RevMan 5.1软件进行Meta分析。结果通过文献检索,共计4篇RCT文献符合本研究纳入标准,共计纳入420例患者。①3篇英文文献的方法学质量高,研究对象一致,均为早产患者,进行Meta分析的结果显示,阿托西班组与利托君组在治疗早产的有效率、延长分娩时间、增加新生儿出生体质量、降低新生儿窒息率及围生儿死亡率等方面比较,差异无统计学意义(P>0.05);但孕妇心动过速发生率与因母体不良反应中断治疗率,阿托西班组较利托君组显著降低,且差异均有统计学意义[RR=0.02,95%CI(0.01~0.08),P<0.01;RR=0.03,95%CI(0.01~0.15),P<0.01]。②1篇中文文献的方法学质量较差,且研究对象为先兆早产患者,独立进行描述性分析结果显示,阿托西班与利托君治疗先兆早产在显效时间、延长妊娠时间、保胎成功率、足月分娩率、增加新生儿出生体质量与降低不良反应发生率方面比较,差异均无统计学意义(P>0.05)。结论阿托西班治疗早产的临床疗效与利托君相当,国内外研究中比较二者不良反应发生率的结果有所不同,尚不能断定阿托西班治疗早产的安全性明显优于利托君。尚需更多国内外高质量、大样本的RCT结合成本-效益分析,以更全面、客观、正确地评价阿托西班在治疗早产中的确切临床价值。
Objective To explore the clinical efficacy and safety between atosiban and ritodrine in treatment of preterm labour.Methods The relevant data base were searched according to the principles of systematic review to collect all the randomized controlled trials(RCT)involving treatment of preterm labour using atosiban and ritodrine.According to treatment strategies,the subj ects were divided into atosiban group and ritodrine group.Meta-analysis of including studies was performed by Rev Man 5.1 software. Results A total of 4 pieces RCT were included with 420 subjects.① Three of them were English literature,RCT with high quality included patients of preterm labour.The Meta-analysis showed there were no statistic differences in tocolytic efficacy,gestational age at delivery,birth weight of neonatal,rates of neonatal asphyxia or perinatal death between two groups(P〉0.05).The incidence of maternal tachycardia and early drug termination due to adverse events in atosiban group were substantially lower than those in ritodrine group [RR=0.02,95%CI(0.01-0.08),P〈0.01;RR=0.03,95%CI(0.01-0.15),P〈0.01], respectively.②One Chinese study with relatively lower quality included patients of threatened preterm labour.A descriptive analysis conducted independently showed that there were no significant differences between two groups in time-to-effect,prolonged pregnancy duration,tocolysis rate,full-term delivery rate, birth weight or adverse events rate(P〉0.05).Conclusions Atosiban treatment of preterm labour was better than that of ritodrine.There had difference between domestic and abroad studies in term of incidence of adverse events.It is quite necessary to perform more high-quality and large-scale RCT in combination with cost-effectiveness evaluation to assess the exact clinic value of atosiban in treatment of preterm labour more reliably.
出处
《中华妇幼临床医学杂志(电子版)》
CAS
2014年第2期42-46,共5页
Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition)
基金
湖北省人口和计划生育委员会科研项目(JS-2012011)~~
关键词
评价研究
早产
阿托西班
利托君
系统评价
Evaluation studies
Premature birth
Atosiban
Ritodrine
Systematic review