Technical University, Institute for Clinical Pharmacology, Medical Faculty, Dresden, Fiedlerstrasse 27, D-01307 Dresden, Germany.
Expert Opin Pharmacother. 2010 Mar;11(4):493-8. doi: 10.1517/14656560903535898.
To investigate the extent and time course of pain intensity upon treatment with a topical diclofenac patch compared with placebo in acute traumatic sport injury based on a validated and established end point.
Post hoc analysis of a randomized, placebo-controlled, double-blind, multicentre, 1-week study in 120 patients with traumatic blunt soft tissue injury. Visual analogue scale (VAS) scores (in millimetres) for pain on movement were analysed. The mean absolute VAS changes in pain intensity from baseline over the study course were calculated for the diclofenac patch formulation (active) and placebo; mean differences between active and placebo were assessed twice daily during the first 3 days after enrolment and then once daily up to day 7.
The diclofenac patch was consistently superior to placebo in relieving pain. The mean differences compared with placebo were greatest on day 2 (23.6 - 30.6 mm, p < 0.0001) and day 3 (24.5 - 24.6 mm, p < 0.0001). Diminishing differences were observed over the study course.
The investigated diclofenac sodium patch provides clinically relevant pain relief in patients with acute traumatic injuries. Maximum effects versus placebo are detected at 2 - 3 days post-injury. This analysis may serve as useful information for the planning of clinical trials in acute traumatic injury.
基于已验证和确立的终点，调查与安慰剂相比，在急性创伤性运动损伤中使用外用双氯芬酸钠贴剂治疗时的疼痛强度程度和时间进程。
对 120 例创伤性钝性软组织损伤患者进行的一项随机、安慰剂对照、双盲、多中心、为期 1 周的研究进行事后分析。对运动时疼痛的视觉模拟量表（VAS）评分（毫米）进行分析。计算双氯芬酸钠贴剂配方（活性）和安慰剂在研究过程中疼痛强度的平均绝对 VAS 变化；在入组后前 3 天每天两次评估活性与安慰剂之间的平均差异，然后每天一次评估至第 7 天。
与安慰剂相比，双氯芬酸钠贴剂始终能更有效地缓解疼痛。与安慰剂相比，第 2 天（23.6-30.6mm，p<0.0001）和第 3 天（24.5-24.6mm，p<0.0001）的平均差异最大。在研究过程中，差异逐渐减小。
研究中调查的双氯芬酸钠贴剂可为急性创伤性损伤患者提供临床相关的疼痛缓解。与安慰剂相比，在受伤后 2-3 天达到最大效果。该分析可作为急性创伤性损伤临床试验规划的有用信息。
