复方紫荆消伤巴布膏治疗急性软组织损伤(气滞血瘀证)的多中心临床试验

Multi-center Clinical Trial of Compound Zijingxiaoshang Ointment in Treating Acute Soft Tissue Injury

目的:采用随机、双盲、阳性药及安慰剂平行对照、多中心临床试验,进一步评价复方紫荆消伤巴布膏治疗急性软组织损伤的有效性和安全性。方法:选取十家试验中心医院共369例急性软组织损伤患者,复方紫荆消伤巴布膏组223例,骨通贴膏组72例,复方紫荆消伤巴布膏模拟剂74例。治疗后第3~4天及第6~8天采用疼痛强度差评定患者的临床疗效,并对安全性做出评价。结果:治疗3d后,复方紫荆消伤巴布膏组-骨通贴膏组疼痛强度差均数差值为0.30(FAS结果)和0.27(PPS结果);复方紫荆消伤巴布膏组-模拟剂组差值为0.40(FAS结果)和0.41(PPS结果),均为复方紫荆消伤巴布膏组疗效较好,非劣效检验结果显示差异有统计学意义(P<0.01)。治疗7d后,复方紫荆消伤巴布膏组-骨通贴膏组疼痛强度差均数差值为0.31(FAS结果)和0.19(PPS结果),复方紫荆消伤巴布膏组疗效较好,非劣效检验结果显示差异有统计学意义(P<0.01)。两组的VAS评分差值的差异无统计学意义(P>0.05),两组疗效相当。复方紫荆消伤巴布膏组-模拟剂组VAS评分均数差值为0.50(FAS结果)和0.49(PPS结果),非劣效检验结果显示差异有统计学意义(P<0.01),两组的VAS评分差值的差异有统计学意义(P<0.05),复方紫荆消伤巴布膏组优效于模拟剂组。结论:复方紫荆消伤巴布膏对急性损伤软组织疼痛强度差降低明显,并具有较好的安全性,值得临床推广应用。

Objective:To further evaluate the efficacy and safety of compound Zijingxiaoshang ointment in treating acute soft tissue injury with a randomized,double-blind,parallel control of positive drug and placebo,multi-center clinical trial.Methods:A total of 369 patients with acute soft tissue injury were selected from 10 centers,including 223 patients in the compound Zijingxiaoshang ointment group,72 patients in the gutong paste group and 74 patients in the compound Zijingxiaoshang ointment simulant group.The difference in pain intensity was used to evaluate the clinical efficacy and safety of the patients on the 3~4 and 6~8 dafter treatment.Results:After 3 dtreatment,the mean difference of pain intensity in the compound Zijingxiaoshang ointment group and gutong plaster group was 0.30(FAS result)and 0.27(PPS result).Results of compound Zijingxiaoshang ointment group and simulant group:0.40(FAS results),0.41(PPS results),all of which were good in efficacy of compound Zijingxiaoshang ointment group,and the non-inferior test results showed statistical significance(P<0.01).After 7 dtreatment,the mean difference of pain intensity in compound Zijingxiaoshang ointment group and gutong paste group was0.31(FAS result)and 0.19(PPS result).The efficacy of compound Zijingxiaoshang ointment group was better,and the non-inferior test results were statistically significant(P<0.01).There were no statistically significant difference in VAS scores between the two groups(P>0.05),and the efficacy of the two groups was similar.VAS score mean difference between compound Zijingxiaoshang ointment group and simulant group:0.50(FAS result),0.49(PPS result),non-inferior test results showed statistically significant difference(P<0.01).The difference of VAS scores between the two groups were statistically significant(P<0.05).The comp-ound Zijingxiaoshang ointment group was superior to the simulant group.Conclusion:Compound Zijingxiaoshang ointment can significantly reduce the intensity of pain in acute injured soft tissues,and has good safety.