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关节内注射利美索龙治疗类风湿性膝关节:一项三剂量的安慰剂对照、双盲、多中心试验

Intra-articular rimexolone in the rheumatoid knee: a placebo-controlled, double-blind, multicentre trial of three doses.

作者信息

van Vliet-Daskalopoulou E, Jentjens T, Scheffer R T

机构信息

Scientific Development Group, Organon International B.V., Oss, The Netherlands.

出版信息

Br J Rheumatol. 1987 Dec;26(6):450-3. doi: 10.1093/rheumatology/26.6.450.

DOI:10.1093/rheumatology/26.6.450
PMID:3318993
Abstract

One-hundred and thirty-seven patients with classical or definite rheumatoid arthritis, involving at least one knee joint, were randomly allocated to a single intra-articular injection of 10, 20 or 40 mg of rimexolone (Org 6216) or placebo. The follow-up period was 84 days, during which clinical and laboratory assessments were done. Clinical improvement of the treated knee joint was measured by the following variables: pain, tenderness, morning stiffness, swelling, range of movement and walking ability. Placebo response was considerable. However, clinical improvement with rimexolone at 20 mg and 40 mg was significantly superior to placebo for most of the variables, whilst with the 10 mg dose only reduction of tenderness was significantly superior. The duration of improvement was longest with 40 mg of rimexolone. One single, intra-articular injection of this dose into the affected knee joint provided significant reduction in pain, tenderness and stiffness and improved the range of movement and walking ability for a period of 8 to 12 weeks.

摘要

137例患有典型或确诊类风湿性关节炎且至少累及一个膝关节的患者被随机分配接受关节腔内单次注射10毫克、20毫克或40毫克的利美索龙(Org 6216)或安慰剂。随访期为84天,在此期间进行了临床和实验室评估。通过以下变量来衡量治疗膝关节的临床改善情况:疼痛、压痛、晨僵、肿胀、活动范围和行走能力。安慰剂效应相当明显。然而,20毫克和40毫克利美索龙在大多数变量上的临床改善显著优于安慰剂,而10毫克剂量仅在压痛减轻方面显著优于安慰剂。40毫克利美索龙的改善持续时间最长。向患侧膝关节单次关节腔内注射该剂量可使疼痛、压痛和僵硬显著减轻,并在8至12周内改善活动范围和行走能力。

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