McIntyre J, Hull D
Department of Child Health, University Hospital, Nottingham.
Arch Dis Child. 1996 Feb;74(2):164-7. doi: 10.1136/adc.74.2.164.
The purpose of this study was to compare antipyretic activity and evaluate tolerability of ibuprofen and paracetamol suspension in the treatment of febrile children. It was designed as a double blind, parallel group, multiple dose study comparing ibuprofen (20 mg/kg/24 hours) with paracetamol (50 mg/kg/24 hours) given at six hourly intervals for a maximum of 12 doses. Children on paediatric wards between the ages of 0.2 and 12 years, with fever as defined by an axillary temperature > or = 37.5 degrees C, were included. The main outcome measures were: change in axillary temperature; palatability of medication; changes in irritability and clinical condition; overall efficacy at the end of treatment; and number and nature of adverse events. The mean temperature change from baseline at four hours was -1.8 degrees C and -1.6 degrees C in ibuprofen and paracetamol groups respectively. In both groups: median palatability score was 'no reaction'; median irritability score at end point was 'not irritable'; median score for change in clinical condition was 'improved'; and median score for overall efficacy was 'good effect'. The proportion of patients experiencing adverse events was similar in both groups, the majority of events having doubtful or no relationship to therapy and being mild in severity. In conclusion, ibuprofen suspension was as effective and well tolerated as paracetamol in treatment of fever in young children.
本研究的目的是比较布洛芬和对乙酰氨基酚混悬液在治疗发热儿童时的退热活性并评估其耐受性。该研究设计为双盲、平行组、多剂量研究，将布洛芬（20毫克/千克/24小时）与对乙酰氨基酚（50毫克/千克/24小时）每6小时给药一次，最多给药12次进行比较。纳入了年龄在0.2至12岁之间、腋窝温度≥37.5摄氏度定义为发热的儿科病房儿童。主要观察指标为：腋窝温度变化；药物口感；烦躁程度和临床状况变化；治疗结束时的总体疗效；以及不良事件的数量和性质。布洛芬组和对乙酰氨基酚组在4小时时自基线起的平均温度变化分别为-1.8摄氏度和-1.6摄氏度。两组情况均为：口感中位数评分为“无反应”；终点时烦躁程度中位数评分为“不烦躁”；临床状况变化中位数评分为“改善”；总体疗效中位数评分为“效果良好”。两组中发生不良事件的患者比例相似，大多数事件与治疗的关系可疑或无关，且严重程度为轻度。总之，在治疗幼儿发热方面，布洛芬混悬液与对乙酰氨基酚同样有效且耐受性良好。
