摘要：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 μg/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.
关键词：aminophylline ; apnoea of prematurity (AOP) ; caffeine ; neonates
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