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静脉注射单剂量舒洛芬与吲哚洛芬的临床对照比较研究。

Clinically controlled comparative study of intravenous single doses of suprofen versus indoprofen.

作者信息

Honig W J, Michos N

出版信息

Arzneimittelforschung. 1986 Jul;36(7):1104-7.

PMID:3533085
Abstract

The analgesic effects of single intravenous doses of alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol) 200 mg/ml and alpha-4-(2-isoindolinyl-2-one)-phenylpropionic acid (indoprofen) 200 mg were compared within the scope of a randomized single-blind study. The test population consisted of 87 patients for whom analgesic treatment was indicated as soon as severe to major pain set in following meniscectomy or disease of a ligament. The treatment groups were homogeneous with respect to demographic data and intensity of pain prior to treatment. In the pain models chosen both drugs resulted in rapid pain relief within 15 min following their application. As to decreased intensity of pain (SPID) and pain relief (TOTPAR), the results obtained 2 h after the test were with indoprofen statistically significantly superior to those obtained with suprofen. The investigator's global appreciation of effectiveness revealed no intergroup differences. Therapeutic results were seen in 95.5% of the subjects on suprofen and in 97.6% of those on indoprofen. The tolerability of suprofen was very good in 95.3% of the cases on suprofen and in 97.3% of those on indoprofen. Four patients in the suprofen group experienced adverse reactions that were, however, not drug related.

摘要

在一项随机单盲研究范围内,比较了单次静脉注射200毫克/毫升的α-甲基-4-(2-噻吩基羰基)苯乙酸(舒洛芬,Suprol)和200毫克的α-4-(2-异吲哚啉-2-酮)苯丙酸(吲哚洛芬)的镇痛效果。试验人群由87名患者组成,这些患者在半月板切除术或韧带疾病后一旦出现重度至剧痛,即需要进行镇痛治疗。治疗组在人口统计学数据和治疗前疼痛强度方面具有同质性。在所选的疼痛模型中,两种药物在应用后15分钟内均能迅速缓解疼痛。就疼痛强度降低(SPID)和疼痛缓解(TOTPAR)而言,试验后2小时获得的结果显示,吲哚洛芬在统计学上显著优于舒洛芬。研究者对有效性的总体评价未显示组间差异。舒洛芬组95.5%的受试者和吲哚洛芬组97.6%的受试者出现了治疗效果。舒洛芬组95.3%的病例和吲哚洛芬组97.3%的病例对舒洛芬的耐受性非常好。舒洛芬组有4名患者出现了不良反应,但与药物无关。

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