国产和进口枸橼酸咖啡因治疗早产儿呼吸暂停疗效的比较:前瞻性随机双盲对照研究

Comparison of the efficacy of domestic and imported caffeine citrate in the treatment of apnea in preterm infants:a prospective randomized double-blind controlled trial

目的比较国产和进口枸橼酸咖啡因治疗早产儿呼吸暂停的临床疗效。方法选取2018年4月至2019年12月胎龄28~33+6周的98例早产儿为研究对象,根据应用枸橼酸咖啡因种类不同随机分为国产组(n=48)和进口组(n=50),两组患儿均在生后6 h内使用枸橼酸咖啡因。比较两组患儿的治疗疗效、并发症、不良反应及临床结局。结果两组患儿生后7 d内呼吸暂停发生率、每天呼吸暂停发作次数、呼吸暂停消失时间、气管插管-注入肺表面活性物质-拔管技术失败率、无创辅助通气时间、氧疗时间、用药时间、住院天数、血气分析指标、肝肾功能指标比较,差异无统计学意义(P>0.05)。两组患儿并发症及病死率比较,差异均无统计学意义(P>0.05)。两组患儿不良反应发生率比较,差异均无统计学意义(P>0.05)。结论国产枸橼酸咖啡因治疗早产儿呼吸暂停安全有效,与进口枸橼酸咖啡因比较无显著差异。

Objective To compare the efficacy of domestic and imported caffeine citrate in the treatment of apnea in preterm infants.Methods A total of 98 preterm infants with a gestational age of 28-<34 weeks between April 2018 and December 2019 were enrolled.They were randomly administered with domestic(n=48)or imported caffeine citrate(n=50)within 6 hours after birth.The therapeutic effects,complications,adverse effects and clinical outcomes were compared between the two groups.Results There were no significant differences in the incidence of apnea within 7 days after birth,daily frequency of apnea,the time of apnea disappearance,the failure rate of intubation-surfactant-extubation strategy,the time of non-invasive assisted ventilation,the duration of oxygen therapy,the duration of caffeine citrate therapy,the length of hospital stay,blood gas analysis results,liver and kidney function testing results between the two groups(P>0.05).There were no significant differences in the incidence of complications and the mortality rate between the two groups(P>0.05).There was no significant difference in the incidence of adverse effects between the two groups(P>0.05).Conclusions The efficacy and safety of domestic caffeine citrate in the treatment of apnea are similar to those of imported caffeine citrate in preterm infants.