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甲硝唑作为改善病情药物治疗类风湿关节炎的双盲、安慰剂对照研究。

Double blind, placebo controlled study of metronidazole as a disease modifying agent in the treatment of rheumatoid arthritis.

作者信息

Marshall D A, Hunter J A, Capell H A

机构信息

Centre for Rheumatic Diseases, Glasgow Royal Infirmary, United Kingdom.

出版信息

Ann Rheum Dis. 1992 Jun;51(6):758-60. doi: 10.1136/ard.51.6.758.

DOI:10.1136/ard.51.6.758
PMID:1616359
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1004741/
Abstract

Anecdotal reports suggest that metronidazole may have disease modifying activity in the treatment of rheumatoid arthritis. To assess possible beneficial effects a double blind, comparative trial of metronidazole and placebo was performed. Fifty patients with active rheumatoid arthritis were randomly allocated to receive active drug (n = 24) or placebo (n = 26) and reviewed at weeks 0, 1, 4, 8, 12, 16, and 24. Detailed assessment of drug safety, biochemical and haematological parameters, and efficacy was made at these dates. Dose regimen was 400 mg twice daily from weeks 0 to eight, increasing to 400 mg three times a day from weeks nine to 24 provided that no adverse effects were recorded. Most patients were unable to tolerate metronidazole because of side effects or lack of efficacy, with only five (21%) continuing to take the drug at 24 weeks. For those patients attaining 12 weeks of treatment an overall improvement in articular index and morning stiffness was found. No improvement in laboratory indices of disease activity was seen, however. In this study metronidazole did not have disease modifying properties and was unacceptably toxic.

摘要

轶事性报道表明,甲硝唑在类风湿关节炎治疗中可能具有改善病情的活性。为评估其可能的有益效果,进行了一项甲硝唑与安慰剂的双盲对照试验。50例活动性类风湿关节炎患者被随机分配接受活性药物(n = 24)或安慰剂(n = 26)治疗,并在第0、1、4、8、12、16和24周进行复查。在这些时间点对药物安全性、生化和血液学参数以及疗效进行了详细评估。剂量方案为:第0至8周每日两次,每次400 mg;若未记录到不良反应,则从第9至24周增加至每日三次,每次400 mg。由于副作用或缺乏疗效,大多数患者无法耐受甲硝唑,仅5例(21%)在24周时继续服用该药物。对于那些接受治疗达12周的患者,发现关节指数和晨僵总体有所改善。然而,疾病活动的实验室指标未见改善。在本研究中,甲硝唑不具有改善病情的特性,且毒性不可接受。

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本文引用的文献

1
A double-blind comparative study of metronidazole and placebo in rheumatoid arthritis.甲硝唑与安慰剂治疗类风湿关节炎的双盲对照研究。
Rheumatol Rehabil. 1982 Nov;21(4):231-4. doi: 10.1093/rheumatology/21.4.231.
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Metronidazole in rheumatoid arthritis.类风湿关节炎中的甲硝唑。
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Clinical studies with an articular index for the assessment of joint tenderness in patients with rheumatoid arthritis.一项使用关节指数评估类风湿关节炎患者关节压痛情况的临床研究。
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Metronidazole in rheumatoid arthritis.类风湿关节炎中的甲硝唑。
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Peripheral neuropathy in Crohn's disease patients treated with metronidazole.接受甲硝唑治疗的克罗恩病患者的周围神经病变。
Gastroenterology. 1985 Mar;88(3):681-4. doi: 10.1016/0016-5085(85)90137-4.
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Clinical and laboratory studies of levamisole in patients with rheumatoid arthritis.左旋咪唑用于类风湿性关节炎患者的临床及实验室研究。
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