Walson P D, Galletta G, Chomilo F, Braden N J, Sawyer L A, Scheinbaum M L
Department of Pediatrics, Ohio State University.
Am J Dis Child. 1992 May;146(5):626-32. doi: 10.1001/archpedi.1992.02160170106025.
To determine whether febrile children receiving 2.5-, 5-, or 10-mg/kg ibuprofen therapy via a liquid or 15-mg/kg acetaminophen therapy via an elixir every 6 hours for 24 to 48 hours show equivalent fever reduction or suffer adverse effects of the drug administered.
Randomized, double-blind, multidose, parallel-group, variable-duration (24 to 48 hours) clinical trial.
The academically affiliated Children's Hospital in Columbus, Ohio.
64 febrile (defined as oral or rectal temperature of 39 degrees C to 40.5 degrees C) but otherwise healthy children aged 6 months to 11 years 7 months randomly assigned to one of the four drug regimens.
Treatment with either ibuprofen or acetaminophen as described above. Administration of antibiotics or intravenous fluids was allowed only after at least 24 hours of treatment with the assigned drug.
MEASUREMENTS/MAIN RESULTS: In 61 of the 64 evaluable patients, treatments were effective and well tolerated during the entire study. While the rates of temperature reduction and maximal reduction of fever after administration of the initial dose were equal for patients receiving 10-mg/kg ibuprofen therapy and 15-mg/kg acetaminophen therapy, and both regimens were more effective than smaller doses of ibuprofen in reducing fever, after the second dose (and continuing to the end of the study) there were no statistically significant differences in temperature response among the treatment groups. Six children were withdrawn from the study, two because of dosing errors, three because of hypothermia (temperature of less than 35.6 degrees C; all three patients were in the acetaminophen group), and one because of gastrointestinal distress (this child was in the group receiving 2.5-mg/kg ibuprofen therapy). No other significant symptoms or adverse laboratory or physical findings were noted. While further confirmatory studies are needed, ibuprofen liquid (10 mg/kg) and acetaminophen elixir (15 mg/kg) administered every 6 hours for 24 to 48 hours appeared to be most effective in reducing fever. These two regimens were equally effective and equally tolerated in febrile children. Lower ibuprofen doses (2.5 and 5 mg/kg) were less effective than acetaminophen and 10-mg/kg ibuprofen therapy after the initial dose but were at least equally effective as these two higher-dose regimens thereafter.
确定发热儿童每6小时接受2.5毫克/千克、5毫克/千克或10毫克/千克布洛芬液体制剂治疗，或每6小时接受15毫克/千克对乙酰氨基酚酏剂治疗，持续24至48小时，是否能同等程度地降低体温或出现所给药的不良反应。
随机、双盲、多剂量、平行组、可变持续时间（24至48小时）的临床试验。
俄亥俄州哥伦布市一所大学附属医院的儿童医院。
64名发热（定义为口腔或直肠温度39摄氏度至40.5摄氏度）但其他方面健康的6个月至11岁7个月大的儿童，随机分配到四种药物治疗方案中的一种。
如上所述用布洛芬或对乙酰氨基酚治疗。仅在使用指定药物治疗至少24小时后才允许使用抗生素或静脉输液。
测量指标/主要结果：在64名可评估患者中的61名中，整个研究期间治疗有效且耐受性良好。接受10毫克/千克布洛芬治疗和15毫克/千克对乙酰氨基酚治疗的患者，初始剂量给药后的体温降低率和最大退热幅度相同，且两种治疗方案在退热方面均比小剂量布洛芬更有效，但在第二次给药后（直至研究结束），各治疗组之间的体温反应无统计学显著差异。6名儿童退出研究，2名因给药错误，3名因体温过低（体温低于35.6摄氏度；所有3名患者均在对乙酰氨基酚组），1名因胃肠道不适（该儿童在接受2.5毫克/千克布洛芬治疗组）。未观察到其他显著症状或不良实验室检查结果或体格检查发现。虽然需要进一步的验证性研究，但每6小时给予布洛芬液体制剂（10毫克/千克）和对乙酰氨基酚酏剂（15毫克/千克），持续24至48小时，似乎在降低体温方面最有效。这两种治疗方案在发热儿童中效果相同且耐受性相同。较低剂量的布洛芬（2.5毫克/千克和5毫克/千克）在初始剂量后不如对乙酰氨基酚和10毫克/千克布洛芬治疗有效，但此后至少与这两种高剂量方案效果相同。
