目的 系统评价布地奈德联合肺表面活性物质(PS)治疗新生儿胎粪吸入综合征(MAS)的有效性与安全性.方法 计算机检索PubMed、Cochrane Central Register of Controlled Trials(Central)、Embase、Web of Science、SinoMed、VIP、WanFang Data和CNKI数据库,搜集关于布地奈德联合PS治疗新生儿MAS的随机对照试验(RCT),检索时限均从建库至2023年9月2日.由2位研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan5.4软件进行Meta分析.结果 共纳入6个RCT,包括544例患儿.Meta分析结果显示,与单用PS相比,布地奈德联合PS治疗患儿的总有效率较高[RR=1.29,95％CI(1.17,1.41),P＜0.001]、住院时间较短[MD=-6.35,95％CI(-9.25,-3.46),P＜0.001]、吸氧时间较短[MD=-1.61,95％CI(-2.23,-0.98),P＜0.001]、呼吸机使用时间较短[MD=-26.46,95％CI(-35.98,-16.95),P＜0.001],治疗后各时段患儿的血气分析指标均改善(P＜0.05);布地奈德联合PS组患儿总并发症及不良反应发生率明显低于单用PS组[RR=0.35,95％CI(0.25,0.47),P＜0.001].亚组分析显示,布地奈德联合PS组患儿的持续肺动脉高压(PPHN)发生率[RR=0.38,95％CI(0.19,0.74),P=0.004]、肺出血发生率[RR=0.26,95％CI(0.10,0.69),P=0.007]均低于单用PS组;两组心力衰竭、败血症发生率差异均无统计学意义(P＞0.05).结论 当前证据显示,布地奈德联合PS治疗新生儿MAS可改善患儿的症状、体征、血气分析指标,加快病情康复,缩短病程,有助于降低并发症、PPHN、肺出血的发生风险,而不会增加心力衰竭、败血症的发生风险.但受纳入研究数量的限制,上述结论尚需更多高质量、大样本的RCT予以验证.
Efficacy and safety of budesonide combined with pulmonary surfactant in the treatment of neonatal meconium aspiration syndrome:a systematic review
Objective To evaluate the efficacy and safety of budesonide combined with pulmonary surfactant(PS)in the treatment of meconium aspiration syndrome(MAS)in neonates.Methods PubMed,Cochrane Central Register of Controlled Trials(Central),Embase,Web of Science,SinoMed,VIP,WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials(RCTs)of budesonide combined with PS in the treatment of neonatal MAS from inception to September 2,2023.Two researchers independently screened literature,extracted data and assessed the risk of bias of the included studies,meta-analyses were performed by using the RevMan 5.4 software.Results A total of 6 RCTs involving 544 patients were included.The results of meta-analysis showed that compared with PS group,budesonide combined with PS group had higher overall effective rate(RR=1.29,95％CI 1.17 to 1.41,P＜0.001),shorter hospital stay(MD=-6.35,95％CI-9.25 to-3.46,P＜0.001)and shorter time of oxygen inhalation(MD=-1.61,95％CI-2.23 to-0.98,P＜0.001),shorter the duration of ventilator use(MD=-26.46,95％CI-35.98 to-16.95,P＜0.001),improved the blood gas analysis indexes at each time after treatment(P＜0.05);In terms of safety,the incidence of total complications and adverse reactions in budesonide combined with PS group was significantly lower(RR=0.35,95％CI 0.25 to 0.47,P＜0.001).Subgroup analysis showed that the incidence of persistent pulmonary hypertension of the newborn(PPHN)in the budesonide combined with PS group was decreased(RR=0.38,95％CI 0.19 to 0.74,P=0.004),and the incidence of pneumorrhagia was decreased(RR=0.26,95％CI 0.10 to 0.69,P=0.007),and the difference was statistically significant;the incidence of heart failure and sepsis was not statistically significant compared with the PS group(P＞0.05).Conclusion Current evidence shows that budesonide combined with PS in the treatment of neonatal meconium aspiration syndrome can improve the symptoms and signs of MAS children,improve the blood gas analysis index,accelerate disease rehabilitation,shorten the course of the disease,can help reduce the risk of complications and PPHN,pneumorrhagia,and doesn't increase the incidence of heart failure,sepsis.Due to the limited quantity of the included studies,more high-quality and large-sample RCTs are needed to further validate the above conclusions.
万方数据
维普
