局部治疗对急性踝关节扭伤有效且安全：多中心双盲随机安慰剂对照TRAUMED试验

Topical Treatment Is Effective and Safe for Acute Ankle Sprains: The Multi-Center Double-Blind Randomized Placebo-Controlled TRAUMED Trial.

作者信息

Gerdesmeyer Ludger, Vester Johannes, Schneider Christian, Wildemann Britt, Frank Christine, Schultz Myron, Seilheimer Bernd, Smit Alta, Kerkhoffs Gino

机构信息

Orthopedics and Trauma Surgery, Kiel Municipal Hospital, 24116 Kiel, Germany.

idv Data Analysis & Study Planning, 82131 Gauting, Germany.

出版信息

J Clin Med. 2024 Feb 1;13(3):841. doi: 10.3390/jcm13030841.

DOI:10.3390/jcm13030841

PMID:38337536

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10856131/

Abstract

BACKGROUND

Topical NSAIDs are widely used to treat ankle sprains. Traumed (Tr14) gel is a multicomponent formulation, demonstrating inflammation-resolution properties.

METHODS

This multicenter, double-blind trial investigated the efficacy and safety of Tr14 gel versus placebo gel and non-inferiority versus 1% diclofenac gel, applied 3×/day for 7 days after acute lateral ankle sprain (EudraCT Number: 2016-004792-50). The primary outcome was AUC for pain on passive movement, assessed by VAS from baseline to Days 4 and 7.

RESULTS

The trial population included 625 patients aged 18 to 78 years. The AUC scores were 187.88 and 200.75 on Day 4 ( = 0.02) and 294.14 and 353.42 on Day 7 ( < 0.001) for Tr14 and placebo, respectively. For Tr14 compared to diclofenac, the AUC scores were 187.50 and 197.19 on Day 4 ( = 0.3804) and 293.85 and 327.93 on Day 7 ( = 0.0017), respectively. On the FAAM-ADL subscale, Tr14 was superior to placebo and non-inferior to diclofenac at all time points. Time to 50% pain improvement was lowest for Tr14 (6.0 days), compared to placebo (7.1 days) and diclofenac (7.0 days). Adverse events were uncommon and minor.

CONCLUSIONS

Tr14 gel is effective and safe in acute ankle sprains, compared to placebo gel and diclofenac gel, and has faster pain resolution.

TRIAL REGISTRATION

The trial was registered in clinicaltrialsregister.eu, EudraCT number 2016-004792-50 on 07.06.2017.

摘要

背景

外用非甾体抗炎药广泛用于治疗踝关节扭伤。Traumed（Tr14）凝胶是一种多组分制剂，具有消炎作用。

方法

这项多中心、双盲试验研究了Tr14凝胶与安慰剂凝胶相比的疗效和安全性，以及与1%双氯芬酸凝胶相比的非劣效性，在急性外侧踝关节扭伤后每天涂抹3次，共7天（欧盟临床试验注册号：2016-004792-50）。主要结局是被动活动时疼痛的曲线下面积（AUC），通过视觉模拟评分法（VAS）从基线到第4天和第7天进行评估。

结果

试验人群包括625名年龄在18至78岁之间的患者。Tr14组和安慰剂组在第4天的AUC评分分别为187.88和200.75（P = 0.02），在第7天分别为294.14和353.42（P < 0.001）。与双氯芬酸相比，Tr14组在第4天的AUC评分分别为187.50和197.19（P = 0.3804），在第7天分别为293.85和327.93（P = 0.0017）。在FAAM-ADL子量表上，Tr14在所有时间点均优于安慰剂且不劣于双氯芬酸。Tr14达到50%疼痛改善的时间最短（6.0天），而安慰剂组为（7.1天），双氯芬酸组为（7.0天）。不良事件不常见且轻微。