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[二甲基亚砜治疗活动期膝关节炎患者。一项双盲安慰剂对照的III期研究]

[DMSO in patients with active gonarthrosis. A double-blind placebo controlled phase III study].

作者信息

Eberhardt R, Zwingers T, Hofmann R

机构信息

Klinische Pharmakologie, Pharmalog, Institut für Klinische Forschung GmbH, München.

出版信息

Fortschr Med. 1995 Nov 10;113(31):446-50.

PMID:8529985
Abstract

BACKGROUND

For the patient, the most important aspect of gonarthrosis is pain and the associated impairment of movement.--

METHOD

In a randomized, placebo-controlled, double-blind study involving 112 patients (56 in each of the two groups test substance and placebo) the efficacy and tolerability of DMSO gel 25% applied over a period of three weeks were investigated in comparison with placebo. In addition to an assessment by the doctor of pain under loading while going about daily activities, rest pain, pain on palpation and of loss of mobility, the patient also kept a pain diary.--

RESULTS

In comparison with the gel base used as placebo, percutaneous treatment with DMSO proved to have a clinically relevant analgesic effect on the intensity of loading pain during everyday activities (p = 0.019). A positive effect of DMSO was also seen for pain intensity at rest (p = 0.015) and pressure pain (p = 0.029). The pain diary also reflected these observations. No serious adverse events or changes in laboratory values were observed.

摘要

背景

对于骨关节炎患者而言,最重要的方面是疼痛以及相关的运动功能障碍。

方法

在一项随机、安慰剂对照、双盲研究中,纳入了112名患者(两组各56名,分别使用受试物质和安慰剂),研究了为期三周的25%二甲基亚砜凝胶与安慰剂相比的疗效和耐受性。除了医生对日常活动负重时的疼痛、静息痛、触压痛和活动受限进行评估外,患者还记录了疼痛日记。

结果

与用作安慰剂的凝胶基质相比,二甲基亚砜经皮治疗对日常活动中负重疼痛的强度具有临床相关的镇痛作用(p = 0.019)。二甲基亚砜对静息时的疼痛强度(p = 0.015)和压痛(p = 0.029)也有积极作用。疼痛日记也反映了这些观察结果。未观察到严重不良事件或实验室值的变化。

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