Louthrenoo W, Nilganuwong S, Aksaranugraha S, Asavatanabodee P, Saengnipanthkul S
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Tambon Sriphum Amphur Muang, Chiang Mai, Thailand.
Osteoarthritis Cartilage. 2007 Jun;15(6):605-14. doi: 10.1016/j.joca.2007.02.021. Epub 2007 Apr 19.
To evaluate the efficacy, safety and carry-over effect of diacerein, in comparison to piroxicam, in the treatment of Thai patients with symptomatic knee osteoarthritis (OA).
This was a double-blind, randomised, piroxicam-controlled, parallel-group study. A 7-day non-steroidal anti-inflammatory drug washout period was followed by a 16-week treatment period with either diacerein 100mg/day or piroxicam 20mg/day, and an 8-week treatment-free observation period. The primary efficacy criterion was pain on Western Ontario and McMaster University Osteoarthritis (WOMAC) A. The secondary criteria included WOMAC B, C and total WOMAC, paracetamol intake, Short Form-36 questionnaire and global judgements on efficacy and tolerability by patients and investigators.
Of 171 randomised patients, 150 completed the study and 161 were analysed in the intent-to-treat population (diacerein: 82, piroxicam: 79). Pain (WOMAC A) decreased to a similar extent in both groups at Week 16 (diacerein: -69.7%+/-31.5%; piroxicam: -74.1+/-26.2%; P=n.s.). On treatment discontinuation, pain increased in the piroxicam group at Weeks 20 (-47%+/-47.8%) and 24 (-26.8%+/-60.6%) while improvements persisted in the diacerein group at Weeks 20 (-66.9%+/-35.9%) and 24 (-69.5%+/-33.7%), with a significant difference in favour of diacerein at Weeks 20 and 24, demonstrating the carry-over effects of the drug. The incidence of adverse events was similar in both groups but more patients from the piroxicam group dropped out of the study due to these events.
Diacerein was as effective as piroxicam in reducing pain and improving function but, unlike piroxicam, displayed a carry-over effect and a better safety profile.
与吡罗昔康相比，评估双醋瑞因治疗有症状的泰国膝骨关节炎（OA）患者的疗效、安全性及药物残留效应。
这是一项双盲、随机、吡罗昔康对照的平行组研究。经过7天的非甾体抗炎药洗脱期后，采用100mg/天双醋瑞因或20mg/天吡罗昔康进行为期16周的治疗，并进行为期8周的无治疗观察期。主要疗效标准为西安大略和麦克马斯特大学骨关节炎指数（WOMAC）A项疼痛。次要标准包括WOMAC B项、C项及总分、对乙酰氨基酚摄入量、简明健康状况调查问卷（Short Form-36）以及患者和研究者对疗效及耐受性的整体评价。
171例随机分组患者中，150例完成研究，161例纳入意向性分析人群（双醋瑞因组82例，吡罗昔康组79例）。第16周时两组疼痛（WOMAC A项）减轻程度相似（双醋瑞因组：-69.7%±31.5%；吡罗昔康组：-74.1%±26.2%；P值无统计学意义）。停药后，吡罗昔康组在第20周（-47%±47.8%）和第24周（-26.8%±60.6%）疼痛加重，而双醋瑞因组在第20周（-66.9%±35.9%）和第24周（-69.5%±33.7%）仍持续改善，第20周和第24周时双醋瑞因组有显著差异，表明该药物有残留效应。两组不良事件发生率相似，但吡罗昔康组因这些事件退出研究的患者更多。
双醋瑞因在减轻疼痛和改善功能方面与吡罗昔康效果相当，但与吡罗昔康不同，它具有残留效应且安全性更好。
