Lecomte J, Monti T, Pochobradsky M G
Institute of Pharmacology and Biomedical Investigations, Charleroi, Belgium.
Curr Med Res Opin. 1991;12(5):296-303. doi: 10.1185/03007999109112664.
A double-blind, multi-centre study was carried out in 42 hospitalized children, aged 6 months to 8 years, suffering from acute respiratory tract infections with fever, to investigate the antipyretic activity of nimesulide. On entry, patients were allocated at random to receive either nimesulide oral suspension, 5 mg/kg/day divided into 3 daily doses, for 5 days or placebo. Both groups were treated simultaneously with antibiotics: children under 5 years of age received 100 mg amoxycillin/kg/day, those over 5 years received 40 to 50 mg erythromycin/kg/day. Measurements of rectal temperature before and during the 6 hours after the first dose of nimesulide showed a significant mean decrease from a baseline value of 38.89 +/- 0.74 degrees C to 37.28 +/- 0.76 degrees C at 6 hours. In the placebo group, no significant changes were observed between baseline (38.82 +/- 0.67 degrees C) and the 6-hour value (38.28 +/- 1 degree C). Morning temperatures remained within the normal range on the following days. Nimesulide was well tolerated. The results indicate that nimesulide has a prompt antipyretic effect which may well be clinically helpful before the correct antibiotic therapy is effectively established.
一项双盲、多中心研究在42名6个月至8岁因急性呼吸道感染伴发热而住院的儿童中进行，以研究尼美舒利的退热活性。入院时，患者被随机分配接受尼美舒利口服混悬液，5mg/kg/天，分3次每日剂量，共5天，或接受安慰剂。两组同时接受抗生素治疗：5岁以下儿童接受100mg阿莫西林/kg/天，5岁以上儿童接受40至50mg红霉素/kg/天。首次服用尼美舒利后6小时内及之前的直肠温度测量显示，6小时时平均温度从基线值38.89±0.74℃显著下降至37.28±0.76℃。在安慰剂组中，基线（38.82±0.67℃）与6小时时的值（38.28±1℃）之间未观察到显著变化。随后几天早晨体温保持在正常范围内。尼美舒利耐受性良好。结果表明，在有效确立正确的抗生素治疗之前，尼美舒利具有迅速的退热作用，这在临床上可能很有帮助。
