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吲哚美辛治疗类风湿性关节炎的双盲剂量反应研究。

Double-blind dose-response study of indomethacin in rheumatoid arthritis.

作者信息

Ekstrand R, Alván G, L'e Orme M, Lewander R, Palmér L, Sarby B

出版信息

Eur J Clin Pharmacol. 1980 Jun;17(6):437-42. doi: 10.1007/BF00570161.

Abstract

Indomethacin 0, 15, 25 and 35 mg t.i.d. was given in randomized order for two weeks to eight outpatients with rheumatoid arthritis in a double-blind study. At the end of each treatment period the clinical response was evaluated by subjective and objective methods and the plasma indomethacin concentration was measured by GLC-mass fragmentography. Compared with non-treatment periods, indomethacin had a statistically significant therapeutic effect as judged by global assessment, duration of morning stiffness, use of escape analgesia, articular index and pain score, but there was no relation between the clinical effect and the size of the dose or the plasma concentration of the drug. Technetium uptake over the affected joints did not change during indomethacin therapy, which might reflect a lack of effect on the local activity of the disease. Lower doses than those currently prescribed are probably sufficient to alleviate symptoms in this disease.

摘要

在一项双盲研究中,对8名类风湿性关节炎门诊患者随机给予每日3次、剂量分别为0、15、25和35毫克的吲哚美辛,持续两周。在每个治疗期结束时,通过主观和客观方法评估临床反应,并通过气相色谱-质谱碎片分析法测量血浆吲哚美辛浓度。与未治疗期相比,根据整体评估、晨僵持续时间、应急镇痛药物使用情况、关节指数和疼痛评分判断,吲哚美辛具有统计学上显著的治疗效果,但临床效果与药物剂量大小或血浆浓度之间没有关联。在吲哚美辛治疗期间,患关节的锝摄取没有变化,这可能反映出对疾病局部活动没有影响。比目前规定剂量更低的剂量可能足以缓解该病症状。

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