Jaruthien Nonn, Tanavalee Aree, Ngarmukos Srihatach, Tanavalee Chotetawan, Amarase Chavarin, Somrak Pakpoom
Biologics for Knee Osteoarthritis Research Unit, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Department of Orthopaedics, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Medicine (Baltimore). 2024 Dec 6;103(49):e40810. doi: 10.1097/MD.0000000000040810.
Several studies have proved that diacerein effectively treats knee osteoarthritis (OA). All studies used branded diacerein. Recently, generic diacerein has been available in several countries, with limited studies comparing the efficacy of generic and branded diacerein for knee OA treatment.
Among 200 eligible patients, 94 were randomized to take a daily 50 mg of generic diacerein (Diaceric®); group A or branded diacerein (Artrodar®); group B for treating mild to moderate knee OA. All patients were assigned 5-visit assessments and followed until 24 weeks. The primary outcome was a visual analog scale (VAS) on the motion. The secondary outcomes were 2 patient-report outcome measures (PROMs): the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and the Short Form-12 (SF-12), as well as 3 performance-based measures (PBMs): 5-time sit to stand test (5 × SST), the time up and go test (TUGT), and the 3-minute walk test (3MWT).
There were 47 patients in group A and 47 in group B, with no patients lost for FU. Among all patients, 79.8% were female with a mean age of 63.2 years in group A and 64.8 years in group B. The Kellgren and Lawrence (KL) grade II was the most common in both groups. There were no differences in all demographic data. At 24-week follow-up (FU), both groups had significantly improved VAS, with a 12-week earlier improvement in the branded diacerein. In addition, the PBMs, including 5 × SST and 3MWT, significantly improved from 12-week FU in both groups, with insignificantly improved WOMAC and SF-12 and no serious adverse events in either group.
After a 24-week FU, the generic diacerein had similar efficacy as the branded diacerein in significantly improving VAS and PBMs: 5 × SST and 3MWT. However, the latter had a faster statistically improved VAS than the former.
多项研究已证明双醋瑞因可有效治疗膝骨关节炎（OA）。所有研究均使用品牌双醋瑞因。最近，通用型双醋瑞因在多个国家上市，比较通用型和品牌双醋瑞因治疗膝骨关节炎疗效的研究有限。
在200名符合条件的患者中，94名被随机分为两组，一组每日服用50毫克通用型双醋瑞因（Diaceric®）；A组，另一组服用品牌双醋瑞因（Artrodar®）；B组，用于治疗轻至中度膝骨关节炎。所有患者均接受5次访视评估，并随访至24周。主要结局指标是运动时的视觉模拟量表（VAS）。次要结局指标是2项患者报告结局指标（PROMs）：西安大略和麦克马斯特大学骨关节炎指数（WOMAC）以及简明健康调查量表（SF-12），以及3项基于表现的指标（PBMs）：5次坐立试验（5×SST）、计时起立行走试验（TUGT）和3分钟步行试验（3MWT）。
A组有47名患者，B组有47名患者，无失访患者。在所有患者中，79.8%为女性，A组平均年龄为63.2岁，B组平均年龄为64.8岁。两组中最常见的均为凯尔格伦和劳伦斯（KL）分级II级。所有人口统计学数据均无差异。在24周随访时，两组的VAS均有显著改善，品牌双醋瑞因的改善时间提前12周。此外，两组的PBMs，包括5×SST和3MWT，从12周随访时开始显著改善，WOMAC和SF-12改善不显著，两组均无严重不良事件。
经过24周的随访，通用型双醋瑞因在显著改善VAS和PBMs（5×SST和3MWT）方面与品牌双醋瑞因疗效相似。然而，品牌双醋瑞因在统计学上改善VAS的速度比通用型双醋瑞因更快。
