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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
贺婷, 廖正嫦, 丁颖, 王铭杰, 李文, 甘继敏, 岳少杰
中国当代儿科杂志 ›› 2020, Vol. 22 ›› Issue (7) : 684-689.
PDF(543 KB)
PDF(543 KB)
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.
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