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酮洛芬(奥鲁地)与安慰剂治疗类风湿性关节炎的双盲交叉评估及长期耐受性评价

A double-blind crossover evaluation of ketoprofen (Orudis) and placebo in rheumatoid arthritis with assessment of long-term tolerance.

作者信息

Howard D L

出版信息

J Int Med Res. 1978;6(4):300-5. doi: 10.1177/030006057800600407.

Abstract

A two-week double-blind crossover study of ketoprofen, a non-steroidal antiinflammatory agent, and placebo was done in ten patients with active rheumatoid arthritis in order to obtain a preliminary efficacy estimate of this new drug. Even after only one week of treatment, joint activity was significantly reduced while other parameters of disease activity showed strong clinical trends in favour of the drug. Only one adverse reaction (mild nausea) was reported during ketoprofen therapy. At the conclusion of the double-blind study, seven patients volunteered to continue on ketoprofen to evaluate the tolerance of the drug during proptracted administration. All patients completed over twelve months of treatment. Overall, ketoprofen gave good control of pain and inflammation, gastro-intestinal disturbance was reported in a single instance and laboratory values were not adversely affected by the drug.

摘要

对10例活动性类风湿性关节炎患者进行了一项为期两周的双盲交叉研究,以评估非甾体抗炎药酮洛芬和安慰剂的疗效,从而对这种新药的初步疗效进行评估。即使仅治疗一周后,关节活动度就显著降低,而疾病活动的其他参数也显示出明显有利于该药物的临床趋势。在酮洛芬治疗期间仅报告了1例不良反应(轻度恶心)。在双盲研究结束时,7名患者自愿继续服用酮洛芬,以评估长期给药期间该药物的耐受性。所有患者均完成了超过12个月的治疗。总体而言,酮洛芬能很好地控制疼痛和炎症,仅1例报告有胃肠道不适,且实验室检查值未受到该药物的不利影响。

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