摘要
目的:观察复方紫荆消伤巴布膏治疗慢性软组织损伤的临床疗效和安全性。方法:采用区组随机、双盲、阳性药及安慰剂平行对照、多中心(10家医院)临床试验设计。试验设置复方紫荆消伤巴布膏组、骨通贴膏组和安慰剂组共3组,按照3∶1∶1的比例纳入患者分别采用复方紫荆消伤巴布膏、骨通贴膏及复方紫荆消伤巴布膏模拟剂治疗。治疗时将贴膏贴于患处,每天1贴,连续使用14 d。试验期间紧急用药选用布洛芬缓释胶囊。选取治疗开始后7 d和14 d两个时间点进行疗效评价。疗效评价指标选择疼痛视觉模拟量表(visual analogue scale,VAS)评分降低值和以中医证候疗效标准评定的有效率。同时观察治疗期间不良事件的发生情况。结果:①一般情况。共纳入221例患者,其中复方紫荆消伤巴布膏组133例、骨通贴膏组44例、安慰剂组44例。至试验结束时,复方紫荆消伤巴布膏组和安慰剂组分别有2例和4例因失访脱落。②疼痛VAS评分降低值。复方紫荆消伤巴布膏组和骨通贴膏组治疗开始后7 d时的疼痛VAS评分降低值比较,差异无统计学意义(协变量:F=33.010,P=0.000;区组因素:F=8.790,P=0.000;分组因素:F=0.900,P=0.345;协变量与分组因素交互作用:F=0.470,P=0.894;修正均数:试验组2.30分,阳性对照组2.13分)。复方紫荆消伤巴布膏组和骨通贴膏组治疗开始后14 d时的疼痛VAS评分降低值比较,差异无统计学意义(协变量:F=43.000,P=0.000;区组因素:F=40.480,P=0.000;分组因素:F=0.290,P=0.591;协变量与分组因素交互作用:F=0.230,P=0.990;修正均数:试验组4.08分,阳性对照组4.02分)。复方紫荆消伤巴布膏组和安慰剂组治疗开始后7 d时的疼痛VAS评分降低值比较,差异无统计学意义(协变量:F=18.120,P=0.000;区组因素:F=9.040,P=0.000;分组因素:F=0.620,P=0.434;协变量与分组因素交互作用:F=1.040,P=0.411;修正均数:试验组2.25分,阳性对照组2.04分)。复�
Objective:To observe the clinical curative effects and safety of Fufang Zijing Xiaoshang Babugao(复方紫荆消伤巴布膏,FFZJXSBBG)for treatment of chronic soft tissue injuries.Methods:A block randomized,double-blind,positive-and placebo-controlled,parallel-group,multicenter clinical trial was conducted by 10 hospitals.The patients included in the trial were divided into 3 groups with a ratio of 3∶1∶1 and were treated with FFZJXSBBG,Gutong(骨通,GT)plaster and FFZJXSBBG simulant respectively.The plaster were applied to the wounded parts once a day for consecutive 14 days.Ibuprofen sustained-release capsules were used as the emergency drug during the trial.The curative effects were evaluated at 7 and 14 days after the beginning of the treatment,and the decreased values of pain visual analogue scale(VAS)scores and effective rate that evaluated according to TCM symptom therapeutic effect standard were selected as the therapeutic effect evaluation indexes.The adverse reactions were observed during the treatment period.Results:Two hundred and twenty-one patients were included in the study,133 patients in FFZJXSBBG group,44 patients in GT plaster group and 44 patients in placebo group.By the end of the trial,2 patients in FFZJXSBBG group and 4 patients in placebo group lost to follow-up and dropped out of the trial.There was no statistical difference in decreased values of pain VAS scores between FFZJXSBBG group and GT plaster group at 7 days after the beginning of the treatment(Covariant:F=33.010,P=0.000;Block factor:F=8.790,P=0.000;Group factor:F=0.900,P=0.345;Interaction between covariant and group factor:F=0.470,P=0.894;Adjusted mean:2.30 points(experimental group),2.13 points(positive control group)).There was no statistical difference in decreased values of pain VAS scores between FFZJXSBBG group and GT plaster group at14 days after the beginning of the treatment(Covariant:F=43.000,P=0.000;Block factor:F=40.480,P=0.000;Group factor:F=0.290,P=0.591;Interaction between covariant and group factor:F=0.230,P=
作者
丁立
高宁阳
郑昱新
杜炯
詹红生
DING Li;GAON ingyang;ZHENG Yuxin;DU Jiong;ZHAN Hongsheng(Shanghai Guanghua Combinational Hospital of Traditional Chinese Medicine and Western Medicine,Shanghai 200052,China;Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
出处
《中医正骨》
2020年第3期21-25,38,共6页
The Journal of Traditional Chinese Orthopedics and Traumatology
关键词
软组织损伤
复方紫荆消伤巴布膏
临床试验
soft tissue injuries
compound Zijing Xiaoshang poultice
clinical trial
