Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.
Clin Ther. 2013 Apr;35(4):431-9. doi: 10.1016/j.clinthera.2013.02.009. Epub 2013 Mar 6.
Diacerein is a drug used in osteoarthritis (OA) that elicits an inhibitory effect on interleukin-1 and metalloproteases. Although diacerein has shown modest efficacy and safety in the treatment of knee and hip OA, there have been no placebo-controlled clinical trials for hand OA.
The aim of the current study was to investigate the efficacy and tolerability of diacerein in patients with hand OA.
Patients fulfilling the American College of Rheumatology criteria for hand OA participated in this randomized, double-blind, placebo-controlled study. Eligible patients were >40 years of age, had at least 1 tender joint, and had a joint pain visual analog scale of >30 mm. Patients received diacerein (50 mg) or placebo BID for 12 weeks. The primary end point was the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score at 4 weeks. Secondary end points were AUSCAN pain score at 12 weeks and AUSCAN physical function and stiffness score, patient and physician global assessment, functional index of hand OA scores, and multidimensional health assessment questionnaire results at 4 weeks and 12 weeks.
Eighty-six Korean patients were enrolled (42 diacerein, 44 placebo). The intention-to-treat and per-protocol analyses revealed no significant differences between the 2 groups in terms of change in AUSCAN pain score at 4 weeks, except for improvement in physician global assessment at 4 weeks (per-protocol analysis, P = 0.004). The safety profile of diacerein was comparable to placebo, except for frequent discoloration of the urine (88% vs 20%).
These results suggest that diacerein 50 mg BID may be ineffective in controlling the symptoms of hand OA. ClinicalTrials.gov identifier: NCT00685542.
双醋瑞因是一种用于治疗骨关节炎（OA）的药物，它对白细胞介素-1 和金属蛋白酶有抑制作用。虽然双醋瑞因在治疗膝和髋关节 OA 方面显示出适度的疗效和安全性，但对手部 OA 尚未进行安慰剂对照的临床试验。
本研究旨在研究双醋瑞因治疗手部 OA 的疗效和耐受性。
符合美国风湿病学会手部 OA 标准的患者参与了这项随机、双盲、安慰剂对照研究。合格患者年龄>40 岁，至少有 1 个压痛关节，关节疼痛视觉模拟量表（VAS）>30mm。患者接受双醋瑞因（50mg）或安慰剂 bid 治疗 12 周。主要终点是治疗 4 周时澳大利亚/加拿大骨关节炎手部指数（AUSCAN）疼痛评分。次要终点是治疗 12 周时 AUSCAN 疼痛评分和 AUSCAN 躯体功能和僵硬评分、患者和医生总体评估、手部骨关节炎功能指数评分以及多维健康评估问卷结果，分别在治疗 4 周和 12 周时进行评估。
共有 86 例韩国患者入组（双醋瑞因组 42 例，安慰剂组 44 例）。意向治疗和符合方案分析显示，除了 4 周时医生总体评估改善外（符合方案分析，P=0.004），两组间 4 周时 AUSCAN 疼痛评分的变化无显著差异。双醋瑞因的安全性与安慰剂相当，除了尿液频繁变色（88%对 20%）。
这些结果表明，双醋瑞因 50mg bid 可能无法有效控制手部 OA 的症状。临床试验注册号：NCT00685542。
