摘要
目的:评价新工艺制作的十一方药酒治疗软组织损伤的有效性及安全性。方法:将180例软组织损伤门诊患者,采用多中心分层区组随机对照的方法,按2∶1随机分配至试验组120例和对照组60例,试验组、对照组分别使用新工艺、传统工艺十一方药酒涂擦,并在治疗前、治疗4 d及7 d采用VAS、中医症候积分等评定其疗效及安全性。结果:组内治疗后不同时间点与治疗前比较,VAS、中医症候积分差异有统计学意义(P<0.05),组间治疗后VAS、中医症候积分差异均无统计学意义(P>0.05),两组总有效率差值的95%置信区间下限高于非劣效界值,非劣效检验成立。结论:新工艺制作的十一方药酒治疗急性软组织损伤安全、有效,其疗效并不劣于传统工艺十一方药酒。
Objective:To evaluate the clinical efficacy and safety of the new technology Shiyifang medicinal wine in treating acute soft tissue injury.Methods:180 cases of soft tissue injury patients from 5 hospitals were randomly divided into treatment group(120 cases)and control group(60 cases)at the ratio of 2∶1 by multi-center stratified randomized control method.The treatment group was treated with the new technology Shiyifang medicinal wine,while the control group was given the traditional technology Shiyifang medicinal wine.Visual analog scale(VAS)and TCM syndrome scores were used to evaluate the efficacy and safety before treatment,on the 4th and 7th day of medication,respectively.Results:There were statistically significant differences in VAS scores and TCM syndrome scores between the two groups at different time points after treatment and before treatment(P<0.05),but there was no statistically significant differences in VAS scores and TCM syndrome scores between the two groups(P>0.05).The lower limit of 95%confidence interval of the total effective rate difference between the two groups was higher than the non-inferiority margin,and the non-inferiority test was established.Conclusion:The new technology Shiyifang medicinal in treating acute soft tissue injury was safe and effective,not inferior to the traditional one.
作者
段戡
青恒臻
袁长深
梅其杰
岳星
陈跃平
唐葆青
李达鹏
陆桂生
毛德文
DUAN Kan;QING Hengzhen;YUAN Changshen;MEI Qijie;YUE Xing;CHEN Yueping;TANG Baoqing;LI Dapeng;LU Guisheng;MAO Dewen(The First Affiliated Hospital of Guangxi University of Chinese Medicine,Nanning 530023,China;Guangxi University of Chinese Medicine,Nanning 530200,China;Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine,Nanning 530012,China;4923 Hospital of PLA,Nanning 530021,China;Longzhou County Hospital of Traditional Chinese Medicine,Longzhou 532400,Guangxi China;Mengshan County Hospital of Traditional Chinese Medicine,Mengshan 546700,Guangxi China)
出处
《中国中医骨伤科杂志》
CAS
2022年第9期26-30,共5页
Chinese Journal of Traditional Medical Traumatology & Orthopedics
基金
广西科技重大专项(广西创新驱动发展专项资金项目)(桂科AA17202036)
改良十一方药酒涂擦治疗急性软组织挫伤的推广应用(GZSY22-23)。
关键词
十一方药酒
软组织损伤
气滞血瘀证
渗漉法
临床研究
Shiyifang medicinal wine
soft tissue injury
Qi stagnation and blood stasis syndrome
percolation
clinical study
