Predel Hans-Georg, Giannetti Bruno, Seigfried Bernd, Novellini Roberto, Menke Georg
DSHS Köln, Cologne, Germany.
J Int Med Res. 2013 Aug;41(4):1187-202. doi: 10.1177/0300060513487639.
A prospective, randomized, double-blind, placebo-controlled, parallel-group multicentre study to evaluate the efficacy and safety of diclofenac 4% spray gel for the treatment of acute, uncomplicated ankle sprain.
Outpatients with acute, uncomplicated, one-sided ankle sprain were randomly assigned to receive diclofenac 4% spray gel or placebo (vehicle) three times daily for 14 ± 1 days. The main efficacy endpoint was the intra-individual response to treatment (≥ 50% decrease in swelling of the injured ankle after a treatment period of ≤ 10 days).
The response rate was significantly higher in the diclofenac group (n = 118) than the placebo group (n = 114) (91.5% vs. 82.5%). After 3-4 days' treatment, diclofenac spray significantly reduced swelling, spontaneous pain, pain on active movement and tenderness compared with placebo. Diclofenac spray was well tolerated, with a low overall rate of adverse events.
Diclofenac 4% spray gel rapidly relieves pain and improves mobility in patients with acute, uncomplicated ankle sprain and is well tolerated. It may be a useful treatment option for other acute soft tissue injuries.
一项前瞻性、随机、双盲、安慰剂对照、平行组多中心研究，以评估4%双氯芬酸喷雾凝胶治疗急性、单纯性踝关节扭伤的疗效和安全性。
急性、单纯性、单侧踝关节扭伤的门诊患者被随机分配，接受4%双氯芬酸喷雾凝胶或安慰剂（赋形剂）治疗，每日3次，持续14±1天。主要疗效终点是个体对治疗的反应（在≤10天的治疗期后，受伤踝关节肿胀减少≥50%）。
双氯芬酸组（n = 118）的反应率显著高于安慰剂组（n = 114）（91.5%对82.5%）。治疗3 - 4天后，与安慰剂相比，双氯芬酸喷雾显著减轻了肿胀、自发痛、主动活动时的疼痛和压痛。双氯芬酸喷雾耐受性良好，不良事件总发生率较低。
4%双氯芬酸喷雾凝胶可迅速缓解急性、单纯性踝关节扭伤患者的疼痛并改善活动能力，且耐受性良好。它可能是其他急性软组织损伤的一种有效治疗选择。
