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一项关于替诺昔康和吡罗昔康治疗髋或膝骨关节炎的长期随机试验:一份聚焦于12至24个月区间的24个月中期报告。

A long-term randomised trial on tenoxicam and piroxicam in osteoarthritis of the hip or knee: a 24-month interim report focusing on the 12-24 month interval.

作者信息

Lund B, Andersen R B, Fossgreen J, Holm P, Jensen E M, Kirchheiner B, Kryger J, Pichard J

机构信息

Department of Rheumatology, Hvidovre Hospital, Denmark.

出版信息

Eur J Rheumatol Inflamm. 1987;9(2):58-67.

PMID:3329110
Abstract

The long-acting antiphlogistics tenoxicam (Ro 12-0068, Tilcotil) and piroxicam in single daily oral doses of 20 mg are compared in a double-blind, group-comparative, randomised trial planned to last for five years. Results of 12 months' treatment of 108 patients with osteoarthritis of the hip or knee have been reported. This interim analysis focuses mainly on the 12 to 24 month interval. The clinical improvements obtained within the first 12 months persisted during the second year in the 55 patients remaining on treatment. After 24 months, 53 patients had been withdrawn prematurely, three-quarters because of inefficacy or intolerance. Only six patients were withdrawn between 12 and 24 months, three for lack of efficacy, two for side-effects and one for reasons unrelated to therapy. There was no difference between the treatment groups with regard to incidence, time or reason for withdrawal, and only small, insignificant differences in efficacy and tolerability. This trial shows that long-term treatment of osteoarthritis with tenoxicam and with piroxicam is beneficial. Once efficacy and tolerability have been established, maintenance of therapy is feasible.

摘要

在一项计划持续五年的双盲、组间比较、随机试验中,对长效抗炎药替诺昔康(Ro 12 - 0068,替洛昔定)和每日单次口服剂量为20 mg的吡罗昔康进行了比较。已报告了对108例髋或膝骨关节炎患者进行12个月治疗的结果。本次中期分析主要关注12至24个月的时间段。在继续接受治疗的55例患者中,前12个月取得的临床改善在第二年持续存在。24个月后,53例患者提前退出,其中四分之三是因为无效或不耐受。在12至24个月期间只有6例患者退出,3例因无效,2例因副作用,1例因与治疗无关的原因。治疗组在退出的发生率、时间或原因方面没有差异,在疗效和耐受性方面只有微小的、无显著意义的差异。该试验表明,用替诺昔康和吡罗昔康长期治疗骨关节炎是有益的。一旦确立了疗效和耐受性,维持治疗是可行的。

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