Focan C, Hendrickx P, Meunier-Carpentier F, Servais J, Michos N, Stocker H
Arzneimittelforschung. 1985;35(11):1739-41.
The aim of the present study was to investigate the antipyretic effect of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol) 300 mg suppositories compared to placebo in patients with fever of various etiology. The trial was designed as a randomized double-blind study including 30 patients per treatment group. After insertion of the suppository, temperatures were measured after 30 min, 1, 2, 3, 31/2, 4, 5, and 6 h. The study was performed at four investigational centers. At the end of the study, a total of 61 patients could be evaluated: 27 on suprofen, 34 on placebo. There were no statistically significant differences in the anamnestic data. The mean age of the subjects on suprofen was 66.5 years, and on placebo 61.3 years. Prior to treatment, the mean temperatures in the two treatment groups were 38.8 and 38.9 degrees C, respectively. In the suprofen group, the temperature dropped to a mean of 37.9 degrees C within 3 h and to 37.6 degrees C within 6 h. The decrease in temperature was less marked in the placebo group; here the mean temperature was 38.4 degrees C after 3 h and 38.2 degrees C after 6 h. Suprofen was found to be superior to placebo throughout the study, the differences being statistically significant after 3 h up to 6 h. The only side effect experienced by a subject on suprofen was vomiting.
本研究的目的是调查α-甲基-4-(2-噻吩羰基)-苯乙酸（舒洛芬，Suprol）300mg栓剂与安慰剂相比，对各种病因引起发热患者的解热作用。该试验设计为随机双盲研究，每个治疗组包括30名患者。栓剂插入后，分别在30分钟、1小时、2小时、3小时、3.5小时、4小时、5小时和6小时测量体温。该研究在四个研究中心进行。研究结束时，共有61名患者可被评估：27名使用舒洛芬，34名使用安慰剂。既往史数据无统计学显著差异。使用舒洛芬的受试者平均年龄为66.5岁，使用安慰剂的为61.3岁。治疗前，两个治疗组的平均体温分别为38.8℃和38.9℃。在舒洛芬组，体温在3小时内降至平均37.9℃，6小时内降至37.6℃。安慰剂组体温下降不太明显；3小时后平均体温为38.4℃，6小时后为38.2℃。在整个研究过程中，发现舒洛芬优于安慰剂，3小时至6小时的差异具有统计学显著性。使用舒洛芬的一名受试者仅出现呕吐这一副作用。
