Blahova Zuzana, Holm Janina Claudia, Weiser Thomas, Richter Erika, Trampisch Matthias, Akarachkova Elena
Boehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria.
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany.
J Pain Res. 2016 Dec 14;9:1221-1230. doi: 10.2147/JPR.S118329. eCollection 2016.
BACKGROUND/OBJECTIVE: Low back pain affects many patients and has a high socioeconomic impact. Topical capsaicinoids have been used for decades to treat musculoskeletal pain. This study investigated the effects of the fixed dose combination (FDC) of nonivamide (a capsaicinoid) and nicoboxil (a nicotinic acid ester) cream in the treatment of acute nonspecific low back pain.
This phase III randomized, double-blind, placebo-controlled, multinational, multi-center trial investigated efficacy, safety, and tolerability of topical nicoboxil 1.08%/nonivamide 0.17% (Finalgon cream) in treatment of acute nonspecific low back pain with the endpoints: pain intensity (PI) difference between pre-dose baseline and 8 hours after first application and the end of treatment, mobility score, and efficacy score.
Patients (n=138), 21-65 years of age, were treated for up to 4 days with FDC or placebo cream. Mean baseline PI was 6.8 on a 0-10 point numerical rating scale. After 8 hours, pain was more reduced with the FDC than with placebo (adjusted means: 2.824 vs. 0.975 points; <0.0001). On the last treatment day, mean pain reduction by the FDC was stronger than with placebo (adjusted means: 5.132 vs. 2.174 points; <0.0001). Mobility on Day 1 was in favor of the FDC when compared to placebo (odds ratio [95% confidence interval {CI}]: 7.200 [3.609, 14.363], <0.0001). At the end of treatment, patients treated with the FDC rated efficacy significantly higher than placebo (odds ratio [95% CI]: 11.370 [5.342, 24.199], <0.0001). Both treatments were tolerated well. No serious adverse events were reported.
Nicoboxil/nonivamide cream is an effective and safe treatment for acute nonspecific low back pain, adding a promising treatment option.
背景/目的：腰痛影响众多患者，具有较高的社会经济影响。局部用辣椒素类药物已用于治疗肌肉骨骼疼痛数十年。本研究调查了非那胺（一种辣椒素类药物）和尼可地尔（一种烟酸酯）乳膏固定剂量组合（FDC）治疗急性非特异性腰痛的效果。
这项III期随机、双盲、安慰剂对照、多国、多中心试验研究了局部用1.08%尼可地尔/0.17%非那胺（Finalgon乳膏）治疗急性非特异性腰痛的疗效、安全性和耐受性，终点指标包括：给药前基线与首次用药后8小时及治疗结束时的疼痛强度（PI）差异、活动度评分和疗效评分。
年龄在21 - 65岁的138例患者接受FDC或安慰剂乳膏治疗长达4天。在0 - 10分数字评分量表上，平均基线PI为6.8。8小时后，FDC组的疼痛缓解程度高于安慰剂组（调整后均值：2.824对0.975分；<0.0001）。在最后一个治疗日，FDC组的平均疼痛缓解程度强于安慰剂组（调整后均值：5.132对2.174分；<0.0001）。与安慰剂相比，第1天的活动度更有利于FDC组（优势比[95%置信区间{CI}]：7.200 [3.609, 14.363]，<0.0001）。治疗结束时，接受FDC治疗的患者对疗效的评分显著高于安慰剂组（优势比[95% CI]：11.370 [5.342, 24.199]，<0.0001）。两种治疗的耐受性均良好。未报告严重不良事件。
尼可地尔/非那胺乳膏是治疗急性非特异性腰痛的一种有效且安全的疗法，增加了一种有前景的治疗选择。
