热熔压敏胶为基质制备的伤科贴膏临床有效性与安全性分析

Analysis on clinical efficacy and safety of Shangke plaster prepared by hot melt pressure sensitive adhesive as substrate

目的评价伤科贴膏治疗急性软组织损伤的有效性与安全性。方法采用临床随机对照试验方法,将急性软组织损伤患者124例随机分为伤科贴膏试验组(n=62)和好及施(冷感)对照组(n=62),观察及比较两组治疗效果和不良反应情况。结果试验组和对照组在改善软组织损伤患者疼痛、压痛、肿胀、功能障碍方面均有明显疗效,有效率均为100%,且受试者的性别和年龄对疗效无显著影响。结论伤科贴膏对瘀血阻滞型的急性软组织损伤引起的疼痛、压痛、肿胀、功能障碍四大临床症状均有较显著的改善效果,总体临床疗效与好及施(冷感)相当,且不受受试者的性别和年龄的干扰,同时皮肤过敏性和刺激性低,安全性高,适合在临床推广使用。

Objective To evaluate efficacy and safety of Shangke plaster in treatment of acute soft tissue injury. Methods Using a randomized controlled clinical trial, 124 patients with acute soft tissue injury were randomly divided into the Shangke plaster experimental group(n=62) and Haojishi(cold sensation) control group(n=62). The curative effects and adverse reactions of the two groups were observed and compared. Results The treatment group and the control group both had significant curative effects in improving pain, tenderness, swelling and dysfunction in patients with soft tissue injury, and the effective rate was 100%. The gender and age of the subjects had no significant effect on the curative effects. Conclusion The Shangke plaster has a significant improvement effect on four clinical symptoms of pain, tenderness, swelling and dysfunction caused by acute soft tissue injury of blood stasis type. The overall clinical curative effect is comparable to that of Haojishi(cold sensation) and it is not affected by the gender and age of the subject. At the same time, it has low skin irritability and irritation and high safety, which is suitable for clinical promotion and application.