Predel Hans-Georg, Giannetti Bruno, Connolly Mark P, Lewis Fraser, Bhatt Aomesh
a Department of Preventive and Rehabilitative Sports and Performance Medicine , Deutsche Sporthochschule Köln , Köln , Germany.
b Department of Biostatistics , Clinsearch GmbH , Zug , Switzerland.
Postgrad Med. 2018 Jan;130(1):24-31. doi: 10.1080/00325481.2018.1401422. Epub 2017 Nov 10.
Ibuprofen is used for the treatment of non-serious pain. This study assessed the efficacy and safety of a new ibuprofen plaster for the treatment of pain associated with acute sports impact injuries/contusions.
In this randomised, double-blind, multi-centre, placebo controlled, parallel group study, adults (n = 130; 18-58 years of age) diagnosed with acute sports-related blunt soft tissue injury/contusion were randomized to receive either ibuprofen 200 mg plaster or placebo plaster. Plasters were administered once daily for five consecutive days. The primary assessment was area under the visual analogue scale (VAS) of pain on movement (POM) over 0 to three days (VAS AUC). Other endpoints included algometry AUC from 0 to three days (AUC) and 0 to five days (AUC), to evaluate improvement of sensitivity at the injured site, and patient and investigator global assessment of efficacy. Safety was monitored throughout the study.
The ibuprofen plaster resulted in superior reduction in AUC compared with placebo; the Least Squares (LS) mean difference was 662.82 mmh in favour of the ibuprofen 200mg plaster (P = 0.0011). The greater improvement in VAS AUC of POM was also observed after 12 h, 24 h, and five days of therapy. Tenderness also significantly improved with the ibuprofen plaster compared with placebo; LS mean difference in algometry/tenderness AUC was 1.87 N/cmd and AUC was 1.87 N/cm*d (P values ≤0.0004). At all study timepoints, a greater percentage of patients and investigators rated the effectiveness of the ibuprofen 200 mg plaster as good/excellent than the placebo plaster. Treatment-emergent adverse events for the ibuprofen plaster were few (≤1.5%) and were mild in severity.
The results of this study indicate 200 mg plaster is effective and safe for the treatment of pain due to acute sports-related traumatic blunt soft tissue injury/contusion in adults.
布洛芬用于治疗非严重疼痛。本研究评估了一种新型布洛芬贴剂治疗急性运动撞击伤/挫伤相关疼痛的疗效和安全性。
在这项随机、双盲、多中心、安慰剂对照、平行组研究中，将诊断为急性运动相关钝性软组织损伤/挫伤的成年人（n = 130；18 - 58岁）随机分为接受200毫克布洛芬贴剂或安慰剂贴剂。贴剂连续五天每天给药一次。主要评估指标是0至三天内运动时疼痛视觉模拟量表（VAS）的曲线下面积（VAS AUC）。其他终点包括0至三天（AUC）和0至五天（AUC）的痛觉测定AUC，以评估受伤部位敏感性的改善情况，以及患者和研究者对疗效的整体评估。在整个研究过程中监测安全性。
与安慰剂相比，布洛芬贴剂使AUC的降低更显著；最小二乘（LS）均值差异为662.82毫米·小时，有利于200毫克布洛芬贴剂（P = 0.0011）。在治疗12小时、24小时和五天后，也观察到运动时疼痛的VAS AUC有更大改善。与安慰剂相比，布洛芬贴剂使压痛也显著改善；痛觉测定/压痛AUC的LS均值差异为1.87牛/平方厘米·天，AUC为1.87牛/平方厘米·天（P值≤0.0004）。在所有研究时间点，将200毫克布洛芬贴剂的有效性评为良好/优秀的患者和研究者比例高于安慰剂贴剂。布洛芬贴剂的治疗中出现的不良事件很少（≤1.5%），且严重程度较轻。
本研究结果表明，200毫克贴剂治疗成人急性运动相关创伤性钝性软组织损伤/挫伤引起的疼痛有效且安全。
