多中心平行对照比较布洛芬与安乃近的疗效和安全性

Multicenter parallel comparison of the efficacy and tolerability of ibuprofen vs metamizole

目的 :比较布洛芬与安乃近的疗效和安全性。方法 :本试验为双盲双模拟 ,单剂量 ,多中心 ,随机 ,平行对照试验设计 ,2 10例 6月到 12周岁发热儿童被随机分入布洛芬治疗组和安乃近治疗组 ,观察其退热镇痛疗效和不良反应。结果 :与安乃近组相比 ,布洛芬组的总体疗效好 ( 99.3 % ) ,退热起效时间早 ,退热持续时间长 ,P值均小于 0 .0 5。试验过程中没有发现不良反应。结论 :布洛芬混悬剂用于儿童发热安全高效 ,应为儿科急诊临床应用的较好选择。

OBJECTIVE To compare the efficacy and tolerability of ibuprofen suspension liquid or suspension drops vs metamizole sodium injectable used as antipyretics in febrile children.METHODS This was a double blind,single dose,multicenter,parallel,randomized study.All eligible subjects were randomized to metamizole sodium or ibuprofen group to observed on antipyretic and analgesic effect,as well as safety during the 8 h period.All statistical tests were two sided at significance level of 0.05 .RESULTS The demographic data of the two groups are comparable.As comparing the efficacy data,the overall antipyretic effect of ibuprofen group was superior to that of metamizole sodium group ( P < 0.05 ).The result shows that time at onset of antipyretic effect is earlier in ibuprofen group than in metamizole sodium group ( P < 0.05 ).In ibuprofen group,duration of antipyretic effect was longer than that in metamizole sodium group( P < 0.05 ).Both the two groups had good effect on pain relief.No adverse events occurred.CONCLUSIONS Ibuprofen suspension was highly effective and safe for children's fever,therefore,it should become the better choice in the clinical practice in pediatric emergency unit.