不同维持剂量枸橼酸咖啡因治疗极低出生体重早产儿呼吸暂停的前瞻性随机对照研究

Clinical effect and safety of different maintenance doses of caffeine citrate in treatment of apnea in very low birth weight preterm infants: a prospective randomized controlled trial

摘要:

目的分析不同维持剂量枸橼酸咖啡因治疗极低出生体重早产儿呼吸暂停的疗效及安全性。方法将2016年1月至2018年1月收治的诊断为原发性呼吸暂停的极低出生体重早产儿78例随机分为高剂量咖啡因组（n=38）及低剂量咖啡因组（n=40）。两组均采取相同的枸橼酸咖啡因负荷量20 mg/kg治疗，24 h后分别给予每日10 mg/kg及5 mg/kg的维持剂量，观察比较两组患儿治疗的有效率及不良反应的发生率。结果高剂量咖啡因组治疗有效率（71%）高于低剂量咖啡因组（48%）（P < 0.05）；呼吸暂停持续时间、咖啡因治疗时间均较低剂量咖啡因组明显缩短（P < 0.05）。两组住院时间、心动过速及喂养不耐受发生率，以及支气管肺发育不良、坏死性小肠结肠炎及颅内出血的发生率比较差异无统计学意义（P > 0.05）。两组间病死率比较差异无统计学意义（P > 0.05）。结论高维持剂量枸橼酸咖啡因治疗极低出生体重早产儿呼吸暂停的效果优于低维持剂量咖啡因，而且未增加相关药物不良反应和早产儿严重并发症的发生率。

Abstract:

Objective To study the clinical effect and safety of different maintenance doses of caffeine citrate in the treatment of apnea in very low birth weight preterm infants. Methods A total of 78 very low birth weight preterm infants with primary apnea were enrolled who were admitted from January 2016 to January 2018. They were randomly divided into high-dose caffeine group with 38 children and low-dose caffeine group with 40 children. Both groups received a loading dose of 20 mg/kg caffeine citrate, and 24 hours later, the children in the high-dose caffeine group were given a maintenance dose of 10 mg/kg, and those in the low-dose caffeine group were given a maintenance dose of 5 mg/kg. The two groups were compared in terms of response rate and incidence rate of adverse events. Results The high-dose caffeine group had a significantly higher response rate than the low-dose caffeine group (71% vs 48%; P < 0.05). Compared with the low-dose caffeine group, the high-dose caffeine group had significantly shorter duration of apnea and time of caffeine treatment (P < 0.05). There were no significant differences between the two groups in length of hospital stay and incidence rates of tachycardia, feeding intolerance, bronchopulmonary dysplasia, necrotizing enterocolitis, and intracranial hemorrhage (P > 0.05). There was no significant difference in the mortality rate between the two groups (P > 0.05). Conclusions Higher maintenance dose of caffeine citrate has a better clinical effect than lower maintenance dose of caffeine citrate in the treatment of apnea in very low birth weight preterm infants, without increasing the incidence rates of adverse drug reactions and serious complications in preterm infants.