[1]丁立 高宁阳 郑昱新 杜炯 詹红生.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[J].中国中医骨伤科杂志,2020,28(03):36-40.
　DING Li GAO Ningyang ZHENG Yuxin DU Jiong ZHAN Hongsheng.Multi-center Clinical Trial of Compound Zijingxiaoshang Ointment in Treating Acute Soft Tissue Injury[J].Chinese Journal of Traditional Medical Traumatology & Orthopedics,2020,28(03):36-40.
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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()
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《中国中医骨伤科杂志》[ISSN:1005-0205/CN:42-1340/R]

卷:
第28卷
期数:
2020年03期
页码:
36-40
栏目:
临床研究
出版日期:
2020-03-01

文章信息/Info

Title:
Multi-center Clinical Trial of Compound Zijingxiaoshang Ointment in Treating Acute Soft Tissue Injury
文章编号:
1005-0205(2020)03-0036-05
作者:
丁立1 高宁阳2 郑昱新2 杜炯2 詹红生2
1上海市光华中西医结合医院(上海,200052) 2上海中医药大学附属曙光医院
Author(s):
DING Li1 GAO Ningyang2 ZHENG Yuxin2 DU Jiong2 ZHAN Hongsheng2
1Shanghai Guanghua Hospitalof Integrated Traditional Chinese and Western Medicine,Shanghai 200052,China; 2Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203 China.
关键词:
复方紫荆消伤巴布膏;  急性软组织损伤;  随机;  双盲;  多中心临床试验
Keywords:
compound Zijingxiaoshang ointment;  acute soft tissue injury;  randomized double-blind multicenter clinical trial
分类号:
R685
文献标志码:
A
摘要:
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3 d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7 d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。
Abstract:
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 Zijing-xiaoshang 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 d after treatment.Results:After 3 d treatment,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 d treatment,the mean difference of pain intensity in compound Zijingxiaoshang ointment group and gutong paste group was 0.31(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.

参考文献/References:

[1] 林昭绒,章要在,张志坚.闭合性软组织运动损伤后的功能康复研究[J].佛山科学技术学院学报:自然科学版,2013,31(5):88-92.
[2] 陈晓琳.范蕊.邹佐强,等.急性闭合性软组织运动损伤的临床治疗研究进展[J].医学信息,2019,32(3):34-36.
[3] 戚轩路,田鸿来.浅谈石筱山气血兼顾理论的理论思想[J].世界最新医学信息文摘,2019,19(35):230-232.
[4] 俞秋纬,汤伟忠,邱德华,等.国医大师石仰山“以气为主、以血为先”理论在创伤骨科中的应用经验[J].上海中医药杂志,2016,50(1):5-8.
[5] 殷梦媛,石瑛,陈元川,等.传统膏药膜韧膏贴敷治疗内侧间室膝骨关节炎的临床研究[J].中医正骨,2018,30(9):22-29.
[6] 杨莉娅,谢松,吴云鸣,等.巴布剂复方紫荆消伤膏质量标准研究[J].中草药,2012,31(1):827-828.
[7] 吴宗明,唐献忠,陈智,等.复方紫荆消伤巴布膏辅助粘贴材料的临床疗效及安全性观察[J].中成药,2018,40(8):1883-1886.
[8] 吴在德.外科学[M].7版.北京:人民卫生出版社,2008.
[9] 国家食品药品监督管理局.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002.
[10] 孙燕,廖怀章,刘绪银,等.活血化瘀利水方对急性软组织损伤模型大鼠IL-1β和PGE-2影响的实验研究[J].中国中医骨伤科杂志,2015,23(12):6-8.
[11] 杨璐璐,宁亚功,钱子刚,等.中医药治疗军事训练软组织损伤的现状[J].云南中医学院学报,2011,34(3):64-66.
[12] 郑永周,谢春莲,李碧妍.中医药外治急性软组织损伤的研究现况及进展[J].光明中医,2013,28(3):626-628.
[13] 张德明,李佳帅,高丽娟.针灸推拿治疗运动性软组织损伤的研究进展[J].针灸临床杂志,2018,34(6):87-90.
[14] HOTFIEL T,CARL H D,SWOBODA B,et al.Current conservative treatment and management strategies of skeletal muscle injuries[J].Zeitschrift Fur Orthopadie Und Unfallchirurgie,2016,154(3):245-253.
[15] BLEAKLEY C M,O'CONNOR S,TULLY M A,et al.The PRICE study(Protection Rest Ice Compression Elevation):design of a randomised controlled trial comparing standard versus cryokinetic ice applications in the management of acute ankle sprain ISRCTN13903946[J].BMC Musculoskeletal Disorders,2007(8):8-19.
[16] 徐金成,矫玮,高颀,等.急性闭合性软组织运动损伤早期处理方法的发展:从PRICE 到POLICE[J].中国运动医学杂志,2013,3(4):360-363.
[17] 纪慧.非甾体抗炎药的临床应用及不良反应分析[J].中国现代药物应用,2018,12(24):127-128.
[18] SZWEDA M,SZAREK J,KIElBOWICZ Z,et al.Side-effects of non-steroidal anti-inflammatory drugs on the liver in dogs and hepatoprotective effect of plant remedies[J].Nephron Clinical Practice,2014,58(3):459-466.
[19] 张彩平,申慧珍.非甾体类抗炎药的不良反应表现及预防措施的探讨[J].世界最新医学信息文摘,2018,18(5):25-26.
[20] 李小雄.非甾体抗炎药的胃肠副作用临床分析[J].医学信息,2018,31(10):133-134.
[21] 邱德华,李浩钢,王敖明,等.石氏伤膏治疗软组织损伤的临床研究[J].中国骨伤,1996,9(3):47-48.

更新日期/Last Update: 2020-03-01