Efficacy of S-flurbiprofen plaster in knee osteoarthritis treatment: Results from a phase III, randomized, active-controlled, adequate, and well-controlled trial

Objectives: S-flurbiprofen plaster (SFPP) is a novel non-steroidal anti-inflammatory drug (NSAID) patch, intended for topical treatment for musculoskeletal diseases. This trial was conducted to examine the effectiveness of SFPP using active comparator, flurbiprofen (FP) patch, on knee osteoarthritis (OA) symptoms. Methods: This was a phase III, multi-center, randomized, adequate, and well-controlled trial, both investigators and patients were blinded to the assigned treatment. Enrolled 633 knee OA patients were treated with either SFPP or FP patch for two weeks. The primary endpoint was improvement in knee pain on rising from the chair as assessed by visual analogue scale (rVAS). Safety was evaluated through adverse events (AEs). Results: The change in rVAS was 40.9 mm in SFPP group and 30.6 mm in FP patch group (p p Conclusions: The superiority of SFPP in efficacy was demonstrated. Most of AEs were mild and few AEs led to treatment discontinuation. Therefore, SFPP provides an additional option for knee OA therapy.研究目的：S-氟比洛芬贴剂（S-flurbiprofen plaster, SFPP）是一种新型非甾体抗炎药（non-steroidal anti-inflammatory drug, NSAID）外用贴剂，拟用于肌肉骨骼疾病的局部治疗。本试验以活性对照药氟比洛芬（flurbiprofen, FP）贴剂为对照，旨在评估SFPP对膝骨关节炎（knee osteoarthritis, OA）症状的治疗效果。 研究方法：本研究为Ⅲ期多中心、随机、充分对照的双盲临床试验，研究者与受试者均对所分配的治疗方案处于盲态。共纳入633例膝骨关节炎患者，随机接受SFPP或FP贴剂治疗，疗程为2周。主要终点为采用视觉模拟评分法（visual analogue scale, VAS）评估的坐位站起时膝关节疼痛改善情况（rVAS）。安全性通过不良事件（adverse events, AEs）进行评价。 研究结果：SFPP组患者的rVAS评分变化为40.9 mm，FP贴剂组为30.6 mm（p p）。 研究结论：本试验证实SFPP的疗效优于对照药物。多数不良事件为轻度，仅极少数不良事件导致治疗中止。因此，SFPP为膝骨关节炎的临床治疗提供了新的选择。