de Queiroz M V, Beaulieu A, Kruger K, Woods E, Stead H, Geis S
Hospital de Santa Maria, Lisbon, Portugal.
Eur J Rheumatol Inflamm. 1994;14(2):5-13.
A double-blind, randomised, parallel-group study was conducted in eight countries to compare the efficacy of a fixed combination of diclofenac sodium (50 mg) and misoprostol (200 mcg) with a fixed combination of diclofenac sodium (50 mg) and placebo in treating the signs and symptoms of rheumatoid arthritis (RA). A total of 346 patients with RA who had been stabilised on diclofenac for at least 30 days were randomly assigned to receive either diclofenac/misoprostol BID or TID (n = 177) or diclofenac/placebo BID or TID (n = 169) for 12 weeks. Primary analyses of efficacy, made upon admission and at 4-week intervals, consisted of physician's global assessment of the arthritic condition, patient's global assessment of the arthritic condition, patient's global assessment of joint tenderness/pain, and physician's assessment of joint swelling. In this study, the fixed combination tablet of diclofenac sodium 50 mg/misoprostol 200 mcg administered BID or TID demonstrated no statistically significant difference in efficacy in the treatment of the signs and symptoms of RA compared with diclofenac sodium 50 mg/placebo administered BID or TID.
在八个国家开展了一项双盲、随机、平行组研究，以比较双氯芬酸钠（50毫克）与米索前列醇（200微克）的固定组合和双氯芬酸钠（50毫克）与安慰剂的固定组合在治疗类风湿性关节炎（RA）体征和症状方面的疗效。共有346名已使用双氯芬酸稳定治疗至少30天的RA患者被随机分配接受双氯芬酸/米索前列醇每日两次或三次（n = 177）或双氯芬酸/安慰剂每日两次或三次（n = 169），治疗12周。在入院时及每隔4周进行的疗效初步分析包括医生对关节炎病情的整体评估、患者对关节炎病情的整体评估、患者对关节压痛/疼痛的整体评估以及医生对关节肿胀的评估。在本研究中，与每日两次或三次服用双氯芬酸钠50毫克/安慰剂相比，每日两次或三次服用双氯芬酸钠50毫克/米索前列醇200微克的固定组合片剂在治疗RA体征和症状方面的疗效无统计学显著差异。
