To assess the efficacy and safety of TongLuo liniment in treating acute soft tissue injury. Method: 172 patients with acute soft tissue injury were divided into TongLuo liniment treatment group and ZhengGu, Shui control group with a randomized, single-blind, parallel positive drug controlled method. Both groups were respectively applied with two kinds of drugs to the affected parts, three times/d, one course of treatment is 7 days. The changes of baseline including symptoms, signs and others of the patients were observed before and after the treatment. Result: The effects of treatment group were obviously superior to that of control group (P<0.05). Clinical points after the treatment of treatment group decreased remarkably than that of control group (P<0.05), There was no adverse effects occurred before and after the treatment. Conclusion: TongLuo liniment is effective, safe and reliable in treating acute soft tissue injury.%目的:评估通络搽剂治疗急性软组织损伤的临床有效性和安全性.方法:采用随机、单盲、阳性药物平行对照的方法将172例急性软组织损伤患者随机分为通络搽剂治疗组与正骨水对照组,2种药物均每日3次外搽患处,7天为1个疗程.观察患者治疗前后临床症状、体征等基线变化.结果:治疗组疗效明显优于对照组(P＜0.05);治疗组治疗后的临床积分较对照组下降明显(P＜0.05),患者用药前后无不良事件发生.结论:通络搽剂治疗急性软组织损伤疗效明确、安全可靠.
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