Caffeine versus aminophylline for the prevention of apnoea of prematurity in a teaching hospital in South Africa
Caffeine versus aminophylline for the prevention of apnoea of prematurity in a teaching hospital in South Africa
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DOI：
10.1080/20786190.2014.983310
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发表时间：
2015-01-01
影响因子：
1
通讯作者：
Mawela, Patience B.
中科院分区：
文献类型：
--
作者：
Schellack, Natalie;Gous, Andries G. S.;Mawela, Patience B.
研究目的：使用治疗药物水平和临床效果作为测定指标，确定新生儿人群中使用口服无水咖啡因和静脉注射氨茶碱的安全性和有效性。设计：前瞻性随机研究。患者：31例新生儿入院（氨茶碱n = 16，咖啡因n = 15），用于预防早产儿呼吸暂停（AOP）。结果：口服无水咖啡因或静脉注射氨茶碱使用规定的研究方案。在给药第4天维持剂量给药后2小时，采集两种药物的一个峰值水平。使用心血管、呼吸、胃肠道和中枢神经系统参数每4小时对两种方案进行临床监测。两组在胎龄（p = 0.782）、出生体重（p = 1）、性别（p = 0.722）和5分钟时确定的Apgar评分（p = 0.068）方面没有显着差异。两个研究组的血清浓度均在范围内（5-20 μ g/ml）。平均脉搏率（每分钟心跳次数）持续两天;第7天：160与148（p = 0.019）;第9天：168 vs. 147（p = 0.020）和中位呼吸率（每分钟呼吸次数）持续5天;第3天：68 vs. 61（p = 0.039）;第4天：67 vs. 57（p = 0.014）;第5天：64 vs. 58（p = 0.045）;第7天：65 vs. 50（p = 0.021）;第8天：66 vs. 56 p = 0.014）在氨茶碱研究组中显著更高。研究结果表明，咖啡因是一种有效的替代静脉注射氨茶碱预防AOP。口服咖啡因在资源贫乏的环境中也可能具有优势。
Study objectives: To determine the safety and efficacy of the use of oral anhydrous caffeine and intravenous aminophylline in the neonatal population using therapeutic drug levels and clinical effects as markers for determination.Design: Prospective randomised study.Patients: Thirty-one neonates admitted (aminophylline n = 16, caffeine n = 15) with a gestational age of less than or equal to 34 weeks for prevention of apnoea of prematurity (AOP) were enrolled.Results: Oral anhydrous caffeine or intravenous aminophylline were administered using prescribed study regimens. One peak level was taken for the two drugs on day 4 of treatment 2 hours after the maintenance dose was administered. The two regimens were clinically monitored using cardiovascular, respiratory, gastro-intestinal and central nervous system parameters four hourly. The two groups did not differ significantly for gestational age (p = 0.782), birth weight (p = 1), gender (p = 0.722), and Apgar scores determined at 5 minutes (p = 0.068). Serum concentrations were within range (5-20 mu g/ml) for both study groups. The median pulse rate (beats per minute) for two days; day 7: 160 vs. 148 (p = 0.019); day 9: 168 vs. 147 (p = 0.020) and median respiratory rate (breaths per minute) for five days; day 3: 68 vs. 61 (p = 0.039); day 4: 67 vs. 57 (p = 0.014); day 5: 64 vs. 58 (p = 0.045); day 7: 65 vs. 50 (p = 0.021); day 8: 66 vs. 56 p = 0.014) were significantly higher in the aminophylline study arm.Conclusion: The findings of the study indicated that caffeine is an effective alternative for intravenous aminophylline in prevention of AOP. The oral administration of caffeine may also have an advantage in a resource-poor setting.