Rodríguez-de-la-Serna A, Geli-Ferrer C, Diaz-López C, Sánchez-García J
Unidad de Reumatologia, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Eur J Rheumatol Inflamm. 1991;11(4):35-44.
This randomized, controlled and double-blind clinical trial compares the efficacy of droxicam (20mg/day) with that of indomethacin (75mg/day) in 40 RA patients (11 male, 29 female) aged (+/- SD) 53 +/- 12.5 years. After a 7-day single-blind run-in placebo period, patients were divided into two groups and treated for 9 weeks. Assessments were done at baseline and at the end of the 1st, 2nd, 4th, 6th and 9th weeks. Both drugs improved significantly the articular pain, the duration of morning stiffness, the articular index, the functional status and the degree of fatigue. Patient's and doctor's opinions were in accordance with the above-mentioned results. The effect of both drugs was more noticeable in the first 2 weeks of treatment. Droxicam was found to be statistically more active than indomethacin in alleviating morning stiffness and improving the functional status. The improvement of the variables induced by droxicam increased progressively throughout the study whereas that induced by indomethacin remained unchanged after the 2nd or 4th week of treatment. One patient treated with indomethacin withdrew from the study due to staggering and dizziness and several patients reported dyspepsia. Droxicam seems to be as effective as indomethacin (75mg/day) in the symptomatic relief of RA patients. The possibility of the use of droxicam for the relief of morning stiffness is of particular interest.
这项随机、对照、双盲临床试验比较了40例类风湿关节炎（RA）患者（11例男性，29例女性），年龄（±标准差）53±12.5岁，服用多昔康（20mg/天）与吲哚美辛（75mg/天）的疗效。经过7天的单盲导入安慰剂期后，患者被分为两组并接受9周的治疗。在基线以及第1、2、4、6和9周结束时进行评估。两种药物均显著改善了关节疼痛、晨僵持续时间、关节指数、功能状态和疲劳程度。患者和医生的意见与上述结果一致。两种药物的效果在治疗的前2周更为明显。发现多昔康在缓解晨僵和改善功能状态方面在统计学上比吲哚美辛更有效。在整个研究过程中，多昔康引起的各项指标改善逐渐增加，而吲哚美辛引起的改善在治疗第2周或第4周后保持不变。一名接受吲哚美辛治疗的患者因蹒跚和头晕退出研究，几名患者报告有消化不良。多昔康在缓解RA患者症状方面似乎与吲哚美辛（75mg/天）一样有效。使用多昔康缓解晨僵的可能性尤其令人关注。
