Fassolt A, Stocker H
Arzneimittelforschung. 1983;33(9):1327-30.
The present randomized double-blind study was performed to investigate the analgesic effects of single doses of suprofen (alpha-methyl-4-(2-thienylcarbonyl)benzene acetic acid; Suprol) 200 mg, suprofen 400 mg paracetamol (APAP, acetaminophen) 650 mg, and combination suprofen 100 mg + APAP 650 mg versus placebo. The five treatment groups were homogeneous as to their demographic features and comprised 28--32 subjects each. Data for a total of 146 patients were evaluated. There were statistically significant differences between the therapeutic effect of the test preparations containing active substance on the one hand and placebo and the other hand. Of the active substances, the best results were obtained with the combination suprofen 100 mg + APAP 650 mg, followed by suprofen 400 mg and APAP 650 mg; there were hardly any differences in the results obtained with the two latter substances. Suprofen 200 mg ranked third. Statistical significance was only seen for the parameter pain intensity (SPID) on comparison of suprofen 100 mg + APAP 650 mg versus suprofen 200 mg. Side effects, homogeneously distributed over the treatment groups, were observed in four cases.
本随机双盲研究旨在调查单剂量200毫克舒洛芬(α-甲基-4-(2-噻吩羰基)苯乙酸;Suprol)、400毫克舒洛芬、650毫克对乙酰氨基酚(APAP,醋氨酚)以及舒洛芬100毫克与APAP 650毫克联合用药相对于安慰剂的镇痛效果。五个治疗组在人口统计学特征方面具有同质性,每组有28 - 32名受试者。共对146例患者的数据进行了评估。一方面,含活性物质的试验制剂与另一方面的安慰剂之间的治疗效果存在统计学显著差异。在活性物质中,舒洛芬100毫克 + APAP 650毫克联合用药取得了最佳效果,其次是400毫克舒洛芬和650毫克APAP;后两种物质的结果几乎没有差异。200毫克舒洛芬排名第三。仅在比较舒洛芬100毫克 + APAP 650毫克与200毫克舒洛芬时,疼痛强度参数(SPID)具有统计学显著性。在四个病例中观察到副作用,在各治疗组中分布均匀。