产前应用糖皮质激素预防足月择期剖宫产儿呼吸窘迫综合征系统评价和Meta分析

Antenatal glucocorticoids for reducing neonatal respiratory distress syndrome after full-term elective cesarean section : a systematic review and meta-analysis

目的系统评价产前应用糖皮质激素(GC)预防足月择期剖宫产新生儿呼吸窘迫综合征(RDS)的有效性和安全性。方法计算机检索Pub Med、Embase、Cochrane图书馆、Clinical Trials.gov、中国生物医学文献服务系统(CBM)、万方数据库、中国知网(CNKI)和维普期刊数据库(VIP),纳入足月妊娠择期剖宫产的孕妇产前给予GC预防新生儿RDS的RCT,试验组产前给予GC治疗(药物种类、剂量、给药途径、疗程不作限制),对照组给予安慰剂或为空白对照。采用主题词与自由词相结合的方式进行检索,检索时间均为建库至2018年4月19日。主要结局指标为新生儿RDS发生率和新生儿病死率,次要指标为新生儿暂时性呼吸增快(TTN)发生率、新生儿呼吸困难发生率、因呼吸困难入住NICU率、新生儿败血症发生率、产妇感染率及不良反应发生率。按照Cochrane手册推荐的RCT的偏倚风险评估工具评价纳入文献的偏倚风险。采用Rev Man5.3软件进行Meta分析。结果共纳入4篇RCT文献3 893例单胎新生儿。4篇文献质量中等。Meta分析显示,试验组和对照组新生儿RDS发生率差异有统计学意义(OR=0.45,95%CI:0.24~0.83),新生儿病死率差异无统计学意义;试验组和对照组TTN发生率(OR=0.41,95%CI:0.29~0.59)、新生儿因呼吸困难入住NICU率(OR=0.42,95%CI:0.29~0.63)和新生儿呼吸困难发生率(OR=0.34,95%CI:0.22~0.53)差异均有统计学意义。1篇文献报告了新生儿败血症发生率和产妇感染率,两组差异均无统计学意义。产前应用GC,并未引起母亲严重的不良反应率。结论基于现有临床证据,产前使用1疗程的GC可以降低足月单胎择期剖宫产儿RDS风险。

Objective To assess the efficacy and safety of antenatal glucocorticoids for reducing neonatal respiratory distress syndrome after full-term（ more than 37 weeks） elective caesarean section. Methods Databases including Pub Med,Embase,The Cochrane Library,Clinical Trials. gov,CBM,Wan Fang Data,CNKI and VIP were searched to collect randomized controlled trials（ RCTs） about prenatal glucocorticoids for preventing neonatal respiratory distress syndrome（ RDS） after full-term elective cesarean section.Before delivery,experimental groups were treated with glucocorticoids（ the type,dose,route of administration and course of treatment of drugs were not limited）,and control groups were given a placebo or a blank control. We used the combination of subject headings and text words to search,all databases were searched from inception to April 19,2018. The primary outcomes were the incidence of neonatal RDS and neonatal mortality,the second outcomes were the incidence of transient tachypnea of newborn（ TTN）,neonatal respiratory distress,admitted to NICU with respiratory distress,neonatal sepsis,maternal infection and adverse reactions.The RCT bias risk assessment tool recommended by the Cochrane Handbook was used to evaluate the bias risk of the included literatures. Then meta-analysis was conducted by Rev Man 5. 3 software. Results A total of 4 RCTs papers,involving3 893 singleton neonates were included. The overall quality of the 4 literatures was moderate. Meta-analysis showed that the incidence of RDS between the experimental group and control group was statistically significant difference（ OR = 0. 45,95% CI：0.24-0.83）,no significant difference between the two groups were shown on neonatal mortality. There were significant differences in the incidence of TTN（ OR = 0. 41,95% CI： 0. 29-0. 59）,admitted to NICU with respiratory distress（ OR = 0. 42,95% CI： 0. 29-0.63）,neonatal respiratory distress（ OR = 0. 34,95% CI： 0. 22-0. 53）. One article reported the incidence of neonatal sepsis and maternal infection between the two groups,and there was no significant differences. Mothers of the treatment groups had a low adverse reaction rate. Conclusion Based on current clinical evidence,a course of antenatal glucocorticoids could be given to decrease the risk of neonatal RDS after term singleton elective cesarean section.