Weippl G, Michos N, Sundal E J, Stocker H
Arzneimittelforschung. 1985;35(11):1728-31.
Antipyretic effect and tolerability of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol), syrup and paracetamol (acetaminophen) were compared within the scope of the present randomized single-blind study; the test population included a total of 115 children ranging in age from 6 months to 12 years. All patients were admitted to the hospital with an average temperature of 39.3 degrees C, their disease being caused by bacterial or viral infections. The dose levels for treatment with syrup depended upon the children's age and body weight. Treatment was in most cases given for two days; a three-times-a-day schedule was used. The (rectal) temperature as well as pulse and respiratory rates were measured prior to treatment and 0.5, 1, 1.5, 2, 3, 4, 5, 6 h after first administration of the test preparations. The results showed that the antipyretic effect of suprofen was in both age groups at all rating times statistically significantly superior to that of paracetamol. Pulse and respiratory rates dropped in both age groups after treatment; the means were within the normal range at all rating times. Adverse drug reactions were seen in 5 patients on suprofen and in 3 cases on paracetamol. It is, however, questionable whether such reactions are drug-dependent.
在本随机单盲研究范围内,比较了α-甲基-4-(2-噻吩羰基)-苯乙酸(舒洛芬,Suprol)糖浆与对乙酰氨基酚(醋氨酚)的退热效果和耐受性;受试人群共有115名6个月至12岁的儿童。所有患者因细菌或病毒感染入院,平均体温为39.3摄氏度。糖浆治疗的剂量水平取决于儿童的年龄和体重。大多数情况下治疗为期两天,采用每日三次的给药方案。在治疗前以及首次服用受试制剂后0.5、1、1.5、2、3、4、5、6小时测量(直肠)体温以及脉搏和呼吸频率。结果显示,在所有评估时间点,舒洛芬在两个年龄组中的退热效果在统计学上均显著优于对乙酰氨基酚。治疗后两个年龄组的脉搏和呼吸频率均下降;在所有评估时间点,平均值均在正常范围内。舒洛芬组有5名患者出现药物不良反应,对乙酰氨基酚组有3例。然而,这些反应是否与药物有关尚存在疑问。