Burgio G R, Nespoli L, Michos N, Sarchi C
Arzneimittelforschung. 1986 Jun;36(6):968-71.
The aim of the study was to test the antipyretic effect and the tolerability of alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol) syrup in a sample of pediatric patients with fever of various etiology. The study was designed as an open multiple dose study including 41 hospitalized children (males and females) aged 6 months to 12 years. Temperature, pulse rate, and respiratory rate were measured immediately after consumption of the syrup, after 30 min, 1 h, 1 1/2, 2, 3, 4, 5, and 6 h. The study was performed at one investigational center. At the end of the study, data were evaluated for a total of 41 patients. 27 patients were 5 years or less, 14 patients were 6 to 12 years old. The mean age of the males (23 patients) was 4.5 years; the mean age of the females (18 patients) was 3.8 years. There was no significant sex dependence of the development of temperature, the pulse rate, and the respiratory rate. Prior to treatment the mean temperature was 38.6 degrees C. Temperature decreased to 37.7 degrees C within 1 h and to 37.2 degrees C within 2 h after treatment. From then on, the temperature increased to 37.7 degrees C at the end of the observation period. The decrease in temperature (compared to baseline) was significant throughout the trial. The mean pulse rate decreased from 131.2/min to 119.9/min within 1 h, and to 114.0/min within 2 h. At the end of the trial the mean pulse rate was 120.1/min.(ABSTRACT TRUNCATED AT 250 WORDS)
本研究旨在测试α-甲基-4-(2-噻吩基羰基)苯乙酸（舒洛芬，Suprol）糖浆对不同病因引起发热的儿科患者的退热效果和耐受性。该研究设计为开放性多剂量研究，纳入了41名年龄在6个月至12岁之间的住院儿童（男童和女童）。在服用糖浆后即刻、30分钟、1小时、1个半小时、2小时、3小时、4小时、5小时和6小时测量体温、脉搏率和呼吸频率。研究在一个研究中心进行。研究结束时，对总共41名患者的数据进行了评估。27名患者年龄在5岁及以下，14名患者年龄在6至12岁。男性（23名患者）的平均年龄为4.5岁；女性（18名患者）的平均年龄为3.8岁。体温、脉搏率和呼吸频率的变化不存在显著的性别差异。治疗前平均体温为38.6摄氏度。治疗后1小时内体温降至37.7摄氏度，2小时内降至37.2摄氏度。此后，在观察期结束时体温升至37.7摄氏度。在整个试验过程中，体温下降（与基线相比）具有显著性。平均脉搏率在1小时内从131.2次/分钟降至119.9次/分钟，2小时内降至114.0次/分钟。试验结束时平均脉搏率为120.1次/分钟。（摘要截断于250字）
