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双氯芬酸钠(扶他林):成人类风湿性关节炎多中心对比试验结果

Diclofenac sodium (Voltaren): results of a multi-centre comparative trial in adult-onset rheumatoid arthritis.

作者信息

Dürrigl T, Vitaus M, Pucar I, Miko M

机构信息

Institute for Rehabilitation of Rheumatic Patients, Medical Faculty, University of Zagreb, Yugoslavia.

出版信息

J Int Med Res. 1975;3(3):139-44. doi: 10.1177/030006057500300301.

DOI:10.1177/030006057500300301
PMID:162669
Abstract

A short-term trial has been performed under double-blind conditions in 50 adult patients with rheumatoid arthritis to compare diclofenac sodium (Voltaren) with both indomethacin and placebo for efficacy and tolerability. The duration of the trial was two weeks and was a between-patient comparison of 25 mg t.i.d. diclofenac sodium, 25 mg t.i.d. indomethacin or placebo using a double-dummy technique. Forty-eight patients completed the trial. In the majority of parameters examined, diclofenac sodium was superior to placebo and indomethacin in therapeutic effect. One patient was withdrawn from the trial because of intolerance to indomethacin and one other because of severe joint pain under indomethacin therapy. Neither active compound caused clinically significant changes in blood picture or urine analysis.

摘要

在50名成年类风湿性关节炎患者中进行了一项双盲条件下的短期试验,以比较双氯芬酸钠(扶他林)与消炎痛及安慰剂在疗效和耐受性方面的差异。试验为期两周,采用双盲法对25毫克每日三次的双氯芬酸钠、25毫克每日三次的消炎痛或安慰剂进行患者间比较。48名患者完成了试验。在大多数检测参数中,双氯芬酸钠在治疗效果上优于安慰剂和消炎痛。一名患者因对消炎痛不耐受而退出试验,另一名患者因在消炎痛治疗下出现严重关节疼痛而退出。两种活性化合物均未引起血常规或尿液分析的临床显著变化。

相似文献

1
Diclofenac sodium (Voltaren): results of a multi-centre comparative trial in adult-onset rheumatoid arthritis.双氯芬酸钠(扶他林):成人类风湿性关节炎多中心对比试验结果
J Int Med Res. 1975;3(3):139-44. doi: 10.1177/030006057500300301.
2
The long-term efficacy and tolerability of Voltaren (diclofenac sodium) and indomethacin in rheumatoid arthritis.
Scand J Rheumatol Suppl. 1978(22):74-80. doi: 10.3109/03009747809097221.
3
Comparison of diclofenac and indomethacin suppositories in rheumatoid arthritis.双氯芬酸与吲哚美辛栓剂治疗类风湿关节炎的比较。
Clin Rheumatol. 1984 Mar;3(1):67-70. doi: 10.1007/BF02715698.
4
Diclofenac sodium (Voltaren) and indomethacin in the ambulatory treatment of rheumatoid arthritis: a double-blind multicentre study.双氯芬酸钠(扶他林)和吲哚美辛用于类风湿性关节炎门诊治疗:一项双盲多中心研究。
Scand J Rheumatol Suppl. 1978(22):51-6. doi: 10.3109/03009747809097217.
5
Controlled-release indomethacin and sustained-release diclofenac sodium in the treatment of rheumatoid arthritis: a comparative controlled clinical trial.控释吲哚美辛与缓释双氯芬酸钠治疗类风湿关节炎:一项对照临床试验
Curr Med Res Opin. 1990;12(3):143-50. doi: 10.1185/03007999009111495.
6
An open assessment of the efficacy and tolerability of diclofenac sodium (Voltarol) in patients with rheumatic disease and a comparative study of diclofenac sodium (Voltarol) with indomethacin in patients with osteoarthritis and rheumatoid arthritis.
Rheumatol Rehabil. 1979;Suppl 2:81-8.
7
Diclophenax sodium (Voltaren) in rheumatoid arthritis: a double-blind comparison with indomethacin and placebo.双氯芬酸钠(扶他林)治疗类风湿性关节炎:与吲哚美辛和安慰剂的双盲对照研究
Int J Clin Pharmacol Biopharm. 1976 Jun;13(4):292-7.
8
Diclofenac sodium (Voltarol) and indomethacin: a multicentre comparative study in rheumatoid arthritis and osteoarthritis.
Rheumatol Rehabil. 1979;Suppl 2:135-43.
9
[Comparative effectiveness of voltaren and indomethacin in rheumatoid arthritis (according to the data of a double-blind study)].[扶他林与消炎痛治疗类风湿性关节炎的疗效比较(根据双盲研究数据)]
Ter Arkh. 1978;50(9):26-30.
10
Diclofenac sodium (Voltaren) and ibuprofen in rheumatoid arthritis. A randomized double-blind study.双氯芬酸钠(扶他林)与布洛芬治疗类风湿性关节炎。一项随机双盲研究。
Scand J Rheumatol Suppl. 1980;35:1-8. doi: 10.3109/03009748009101380.

引用本文的文献

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Adoption of the double dummy trial design to reduce observer bias in testing treatments.采用双盲模拟试验设计以减少治疗测试中的观察者偏差。
J R Soc Med. 2013 May;106(5):196-8. doi: 10.1177/0141076813485350.
2
Which Anti-inflammatory?该用哪种消炎药?
Can Fam Physician. 1981 Feb;27(2):270-5.
3
The run-in period in trial design: a comparison of two non-steroidal anti-inflammatory agents in psoriatic arthropathy.试验设计中的导入期:两种非甾体抗炎药治疗银屑病关节炎的比较
Agents Actions. 1982 Apr;12(1-2):221-4. doi: 10.1007/BF01965150.
4
Diclofenac sodium: a review of its pharmacological properties and therapeutic use in rheumatic diseases and pain of varying origin.双氯芬酸钠:其药理特性及在风湿性疾病和各种原因引起的疼痛中的治疗应用综述
Drugs. 1980 Jul;20(1):24-48. doi: 10.2165/00003495-198020010-00002.
5
Diclofenac sodium. A reappraisal of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy.双氯芬酸钠。对其药效学和药代动力学特性以及治疗效果的重新评估。
Drugs. 1988 Mar;35(3):244-85. doi: 10.2165/00003495-198835030-00004.
6
International experience with etodolac therapy for rheumatoid arthritis: an interim report of comparative efficacy.依托度酸治疗类风湿性关节炎的国际经验:疗效比较中期报告
Clin Rheumatol. 1989 Mar;8 Suppl 1:63-72. doi: 10.1007/BF02214111.
7
A review of upper-gastrointestinal effects of the newer nonsteroidal antiinflammatory agents.新型非甾体抗炎药对上消化道影响的综述
Dig Dis Sci. 1979 Jan;24(1):53-64. doi: 10.1007/BF01297239.