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[布洛芬在运动系统的风湿性、退行性和创伤性疾病中的应用。局部作用和耐受性]

[Ibuprofen in rheumatic, degenerative and traumatic disorders of the locomotor system. Local effects and tolerance].

作者信息

Pollter J

出版信息

Fortschr Med. 1983 Oct 27;101(40):1840-3.

PMID:6357976
Abstract

The clinical trials carried out on Dolgit Creme containing 5% of the nonsteroidal antirheumatic active principle ibuprofen were carried out by 12 clinical examiners. The experimental and clinical tests were carried out on a total of 464 patients and/or volunteers. It has been proved that the active principle ibuprofen of the tested creme penetrates throughout the skin without causing serum concentrations which could lead to the appearance of undesirable side effects. The metabolization of ibuprofen after topical administration coincides with that following oral administration. In comparative studies with nonsteroidal antirheumatic gel it has been possible to prove the efficacy of Dolgit Creme in the treatment of the different forms of rheumatic diseases and degenerative articular changes as well as in cases of accident and sports injuries. The efficacy of Dolgit Creme compared to Placebo in a double blind trial for the assessment of the onset of action, pain alleviation, decrease of swelling, improvement of motility was at the 1%-level significantly superior. The effective dosage assessed was three or more times daily to apply a 4-10 cm strip of the creme on the affected part of the tissue and massage. Undesirable side effects appeared in less than 4% of the cases in the form of allergic skin reactions.

摘要

对含有5%非甾体抗炎活性成分布洛芬的Dolgit乳膏进行的临床试验由12名临床检查人员开展。实验和临床测试共涉及464名患者和/或志愿者。已证实,受试乳膏中的活性成分布洛芬可穿透整个皮肤,且不会导致血清浓度升高而引发不良副作用。布洛芬局部给药后的代谢情况与口服给药后的代谢情况一致。在与非甾体抗炎凝胶的对比研究中,已证实Dolgit乳膏在治疗不同类型的风湿性疾病和退行性关节病变以及意外和运动损伤病例方面具有疗效。在一项双盲试验中,为评估起效时间、缓解疼痛、减轻肿胀和改善活动能力,Dolgit乳膏与安慰剂相比,在1%的水平上具有显著优势。评估的有效剂量为每天三次或更多次,在受影响的组织部位涂抹4 - 10厘米长的乳膏条并进行按摩。不到4%的病例出现了以皮肤过敏反应形式的不良副作用。

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