Oregon Health & Science University, Division of Health Promotion & Sports Medicine, OR, Portland, USA.
Int J Sports Med. 2011 Aug;32(8):635-43. doi: 10.1055/s-0031-1275359. Epub 2011 May 11.
The diclofenac epolamine topical patch 1.3% was designed to deliver analgesic concentrations of diclofenac to an underlying soft tissue injury site, while limiting systemic exposure to diclofenac. This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of the diclofenac epolamine topical patch for the treatment of acute pain due to minor soft tissue injury. Patients (18-65 years, inclusive) with clinically significant minor soft tissue injuries (mild or moderate sprain, strain, or contusion) incurred within 7 days of study entry and having pain scores ≥ 5 on a Visual Analog Scale of 0-10 were enrolled. Patients were randomized to receive the diclofenac epolamine topical patch (n=207) or placebo patch (n=211) application twice daily for 14 days or until pain resolution. Patients recorded pain scores every 12 h at the time of patch removal using the Visual Analog Scale. Investigator-assessed global response to therapy was also evaluated. Safety data were collected throughout the study. Twice-daily treatment with diclofenac epolamine topical patch produced a statistically significant reduction in mean pain score relative to baseline by an additional 18.2% in the diclofenac epolamine topical patch group (0.435 ± 0.268) compared with the placebo group (0.532 ± 0.293) (p=0.002; overall) beginning after application of the second patch. Consistent with this treatment effect, median time to pain resolution was shortened by 2 days in the diclofenac epolamine topical patch group relative to the placebo group (p=0.007). These results were reinforced independently by investigators who reported treatment as good or excellent for 58% of diclofenac epolamine topical patch-treated patients compared with 49% in the placebo patch group (p=0.008). The most common adverse events were treatment site related (n=16, 7.9% diclofenac epolamine topical patch; n=12, 5.8% placebo patch). Most (80%) patients reported tolerability as excellent or good. In conclusion, the diclofenac epolamine topical patch provides effective, rapid pain relief for the treatment of acute pain from minor soft tissue injury and appears generally safe and well tolerated.
双氯芬酸依托咪酯贴剂 1.3%旨在将双氯芬酸的镇痛浓度递送至潜在的软组织损伤部位，同时限制双氯芬酸的全身暴露。这项随机、双盲、安慰剂对照研究评估了双氯芬酸依托咪酯贴剂治疗轻微软组织损伤引起的急性疼痛的安全性和有效性。患者（18-65 岁，含）在研究入组后 7 天内出现具有临床意义的轻微软组织损伤（轻度或中度扭伤、拉伤或挫伤），且视觉模拟量表（0-10）的疼痛评分≥5。患者被随机分配接受双氯芬酸依托咪酯贴剂（n=207）或安慰剂贴剂（n=211）每日两次应用 14 天，或直至疼痛缓解。患者在每次去除贴片时使用视觉模拟量表每 12 小时记录疼痛评分。研究者评估的治疗总体反应也进行了评估。在整个研究过程中收集了安全性数据。与安慰剂组（0.532±0.293）相比，双氯芬酸依托咪酯贴剂组的平均疼痛评分相对于基线下降了 18.2%（双氯芬酸依托咪酯贴剂组为 0.435±0.268）（p=0.002；总体），这是在第二次应用贴剂后开始的。与这种治疗效果一致，与安慰剂组相比，双氯芬酸依托咪酯贴剂组疼痛缓解的中位时间缩短了 2 天（p=0.007）。研究者独立报告的治疗结果为 58%的双氯芬酸依托咪酯贴剂治疗患者为良好或极好，而安慰剂贴剂组为 49%（p=0.008）。最常见的不良事件与治疗部位有关（双氯芬酸依托咪酯贴剂组 7.9%，安慰剂贴剂组 5.8%）。大多数（80%）患者报告的耐受性为极好或良好。总之，双氯芬酸依托咪酯贴剂为治疗轻微软组织损伤引起的急性疼痛提供了有效、快速的疼痛缓解，且似乎通常安全且耐受良好。
