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多中心平行对照比较布洛芬与安乃近的疗效和安全性
引用本文:施文,王永铭,徐键,朱逞,朱建辛,严建江,许峰,于毅. 多中心平行对照比较布洛芬与安乃近的疗效和安全性[J]. 中国医院药学杂志, 2003, 23(7): 393-395
作者姓名:施文  王永铭  徐键  朱逞  朱建辛  严建江  许峰  于毅
作者单位:1. 复旦大学药学院,上海,200032
2. 上海强生制药有限公司,上海,200052
3. 北京儿童医院,北京,100045
4. 上海第二医科大学附属新华医院,上海,200092
5. 广州市儿童医院,广东,广州,510120
6. 重庆医科大学附属儿童医院,重庆,400010
7. 南京市儿童医院,江苏,南京,210008
摘    要: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,210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0.05。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。

关 键 词:布洛芬 安乃近 退热 镇痛
文章编号:1001-5213(2003)07-0393-03
修稿时间:2002-08-07

Multicenter parallel comparison of the efficacy and tolerability of ibuprofen vs metamizole
SHI Wen,WANG Yong Ming,XU Jian,et al. Multicenter parallel comparison of the efficacy and tolerability of ibuprofen vs metamizole[J]. Chinese Journal of Hospital Pharmacy, 2003, 23(7): 393-395
Authors:SHI Wen  WANG Yong Ming  XU Jian  et al
Abstract: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.
Keywords:ibuprofen  metamizole sodium  antipyretic  pain relief
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