消瘀散精简方贴膏治疗急性软组织损伤的临床随机对照研究

Simplified "Xiaoyu San" Plaster in the treatment of acute soft tissue injury: A randomized controlled trial

目的评价消瘀散精简方贴膏治疗急性踝关节软组织损伤的临床疗效和安全性,为进一步优化处方提供临床依据。方法将入选的90例患者随机分为消瘀散精简方贴膏组(精简方组)、消瘀散贴膏组及扶他林乳胶剂组,每组30例。均在肿胀疼痛部位贴敷用药,以覆盖整个病变部位为宜;每隔24 h换药1次,1周为1个疗程,观察2个疗程。结果精简方组与消瘀散组在减轻疼痛、缓解肿胀、改善活动度和消除瘀斑方面,疗效均明显优于扶他林组(P<0.05),且精简方组与消瘀散组在症状改善方面无显著性差异(P>0.05),仅在消除瘀斑方面略逊;各组均有较高的临床安全性。结论精简方与消瘀散全方疗效相当,在简化药物组成后基本达到良好的临床疗效。

Objective To observe the clinical efficacy and safety of Simplified ＂Xiaoyu San＂ Plaster in treating acute ankle joint soft tissue injury for optimizing the prescriptions in clinics. Methods Ninety cases were randomized into simplified ＂Xiaoyu San＂ group, ＂Xiaoyu San＂ group and Dichoienac Diethylammon group, 30 cases in each group. Medicines were pasted on the locations with edema, swelling or pain; pasting every 24h. One week as a course, and observed for 2 courses. Results Compared with the Dichofenac Diethylammon group, the clinical efficacy, such as pain relieving, swelling alleviation, range of motion and bruise resolving of the simplified ＂Xiaoyu San＂ group and ＂ Xiaoyu San＂ group were better （ P 〈 0.05 ）. No significant difference was found in symptom improvement between simplified ＂Xiaoyu San＂ group and ＂Xiaoyu San＂ group （P 〉 0.05 ）, while bruise resolving of simplified ＂Xiaoyu San＂ group was slightly inferior. All the groups have a higher clinical safety. Conclusion The effect of simplified ＂Xiaoyu San＂ is similar to ＂Xiaoyu San＂, and simplified ＂Xiaoyu San＂ has good clinical effect.