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对骨关节炎患者进行双盲交叉研究,比较两剂吲哚美辛与一种阿司匹林制剂及安慰剂的有效性和安全性。

Double-blind cross-over investigation of the effectiveness and safety of two doses of indoprofen compared with an ASA preparation and placebo in patients suffering from osteoarthritis.

作者信息

Valtonen E, Bergamini N, Groppi W, Mandelli V

出版信息

Eur J Rheumatol Inflamm. 1981;4(1):60-5.

PMID:7042363
Abstract

Eighty patients suffering from osteoarthritis of the large joints were admitted to the study and randomly allocated to a 4-treatment sequence, according to a multiple replication of a 4 x 4 Latin square design, with proper balancing of treatments, of periods and of the residual effects of drugs. Each treatment (indoprofen 300 or 600 mg/day, ASA 1500 + diazepam 6 mg/day, and matching placebo) was administered for 7 days. Examinations were carried out on admission, after a 3-4 day wash-out period, and then repeated at the end of each treatment period. Treatment with active drugs was significantly better than placebo in relieving overall pain, and in patient's and investigator's opinion on effectiveness. Treatment with indoprofen, at both dosages, was preferred more frequently than others. The incidence of adverse events during each period did not seem to depend either on the treatment being given during that period or on the previous one.

摘要

80名患有大关节骨关节炎的患者被纳入该研究,并根据4×4拉丁方设计的多次重复,随机分配到一个4种治疗方案的序列中,对治疗、疗程和药物残留效应进行了适当的平衡。每种治疗(吲哚美辛300或600毫克/天、阿司匹林1500毫克+地西泮6毫克/天,以及匹配的安慰剂)持续给药7天。在入院时、经过3 - 4天的洗脱期后进行检查,然后在每个治疗期结束时重复检查。在缓解总体疼痛方面,以及在患者和研究者对疗效的评价方面,使用活性药物治疗明显优于安慰剂。两种剂量的吲哚美辛治疗比其他治疗更常被首选。每个时期不良事件的发生率似乎既不取决于该时期所给予的治疗,也不取决于前一时期的治疗。

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1
Double-blind cross-over investigation of the effectiveness and safety of two doses of indoprofen compared with an ASA preparation and placebo in patients suffering from osteoarthritis.对骨关节炎患者进行双盲交叉研究,比较两剂吲哚美辛与一种阿司匹林制剂及安慰剂的有效性和安全性。
Eur J Rheumatol Inflamm. 1981;4(1):60-5.
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