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甲氯芬那酸钠和萘普生治疗类风湿性关节炎的临床治疗试验,并对临床试验中安慰剂的使用加以评论。

Clinical therapeutic trial of sodium meclofenamate and naproxen in rheumatoid arthritis, with comments on the use of placebos in clinical trials.

作者信息

Grace E M, Mewa A, Rooney P J, Buchanan W W

出版信息

Curr Med Res Opin. 1983;8(6):417-24. doi: 10.1185/03007998309111748.

DOI:10.1185/03007998309111748
PMID:6342956
Abstract

Forty patients with active rheumatoid arthritis were entered into a single-blind study of 12-weeks' duration to compare the efficacy and tolerance of 100 mg sodium meclofenamate 3-times daily and 250 mg naproxen twice daily. Disease activity was defined by the presence of a Ritchie Articular Index score of greater than 15. Patients were assessed at 4-week intervals. Analysis of variance of the data from those patients who completed 12 weeks in the trial showed that in the sodium meclofenamate group there was a significant improvement in articular index, left grip strength, pain severity and patients' global assessment over the course of the study. In the naproxen group, there was a significant improvement in articular index, grip strength and pain severity over the study. Pairwise comparisons showed that morning stiffness improved significantly from baseline to 12 weeks only, in both treatment groups. There were no significant differences between the two treatment groups for any of the measurements at any time period during the study. In the sodium meclofenamate group, there were 4 drop-outs due to inadequate efficacy and 6 in the naproxen group. Four patients in the sodium meclofenamate group and 2 patients in the naproxen group dropped out of the study because of side-effects, primarily nausea. These results suggest that sodium meclofenamate was equally well tolerated and as effective as naproxen in the treatment of rheumatoid arthritis in this group of patients.

摘要

40例活动性类风湿关节炎患者进入一项为期12周的单盲研究,以比较每日3次服用100毫克甲氯芬那酸钠与每日2次服用250毫克萘普生的疗效和耐受性。疾病活动度由里奇关节指数评分大于15来定义。患者每隔4周接受评估。对试验中完成12周的患者数据进行方差分析显示,在甲氯芬那酸钠组,在研究过程中关节指数、左手握力、疼痛严重程度和患者整体评估有显著改善。在萘普生组,研究期间关节指数、握力和疼痛严重程度有显著改善。两两比较显示,两个治疗组从基线到12周仅晨僵有显著改善。在研究期间的任何时间段,两个治疗组在任何测量指标上均无显著差异。在甲氯芬那酸钠组,有4例因疗效不佳退出,萘普生组有6例。甲氯芬那酸钠组有4例患者、萘普生组有2例患者因副作用(主要是恶心)退出研究。这些结果表明,在这组类风湿关节炎患者中,甲氯芬那酸钠的耐受性与萘普生相当,疗效也相同。

相似文献

1
Clinical therapeutic trial of sodium meclofenamate and naproxen in rheumatoid arthritis, with comments on the use of placebos in clinical trials.甲氯芬那酸钠和萘普生治疗类风湿性关节炎的临床治疗试验,并对临床试验中安慰剂的使用加以评论。
Curr Med Res Opin. 1983;8(6):417-24. doi: 10.1185/03007998309111748.
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Comparison of naproxen and piroxicam in the treatment of rheumatoid arthritis: a double-blind, crossover study.萘普生与吡罗昔康治疗类风湿性关节炎的比较:一项双盲交叉研究。
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Control of pain with meclofenamate sodium following removal of an impacted molar.拔除阻生磨牙后用甲氯芬那酸钠控制疼痛。
Oral Surg Oral Med Oral Pathol. 1985 May;59(5):446-8. doi: 10.1016/0030-4220(85)90078-7.

引用本文的文献

1
Naproxen. A reappraisal of its pharmacology, and therapeutic use in rheumatic diseases and pain states.萘普生。对其药理学以及在风湿性疾病和疼痛状态中的治疗用途的重新评估。
Drugs. 1990 Jul;40(1):91-137. doi: 10.2165/00003495-199040010-00006.