[1]丁立,高宁阳,郑昱新,等.复方紫荆消伤巴布膏治疗慢性软组织损伤的多中心临床研究[J].中医正骨,2020,32(03):21-25.
　DING Li,GAO Ningyang,ZHENG Yuxin,et al.A multicenter clinical study of Fufang Zijing Xiaoshang Babugao(复方紫荆消伤巴布膏)for treatment of chronic soft tissue injuries[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2020,32(03):21-25.
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复方紫荆消伤巴布膏治疗慢性软组织损伤的多中心临床研究()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第32卷
期数:
2020年03期
页码:
21-25
栏目:
临床研究
出版日期:
2020-03-20

文章信息/Info

Title:
A multicenter clinical study of Fufang Zijing Xiaoshang Babugao(复方紫荆消伤巴布膏)for treatment of chronic soft tissue injuries
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,上海 201203)
Author(s):
DING Li1; GAO Ningyang2; ZHENG Yuxin2; DU Jiong2; ZHAN Hongsheng2
1.Shanghai Guanghua Combinational Hospital of Traditional Chinese Medicine and Western Medicine,Shanghai 200052,China 2.Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China
关键词:
软组织损伤;  复方紫荆消伤巴布膏;  临床试验
Keywords:
soft tissue injuries;  compound Zijing Xiaoshang poultice;  clinical trial
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)。复方紫荆消伤巴布膏组治疗开始后14 d时的疼痛VAS评分降低值高于安慰剂组(协变量:F=39.200,P=0.000; 区组因素:F=40.890,P=0.000; 分组因素:F=11.210,P=0.001; 协变量与分组因素交互作用:F=4.300,P=0.000; 修正均数:试验组4.00分,阳性对照组3.27分)。③中医证候疗效。治疗开始后7 d时,3组患者的有效率比较,差异无统计学意义(χ2=5.867,P=1.000)。治疗开始后14 d时,3组患者的有效率比较,差异有统计学意义(P=0.022); 复方紫荆消伤巴布膏组和骨通贴膏组的有效率比较,差异无统计学意义(χ2=0.000,P=1.000); 复方紫荆消伤巴布膏组和骨通贴膏组的有效率均高于安慰剂组(χ2=6.375,P=0.012; χ2=4.208,P=0.004)。④不良事件发生率。共有4例患者发生不良事件4件,其中复方紫荆消伤巴布膏组1例发生贫血、1例发生口腔溃疡,骨通贴膏组1例发生贫血,安慰剂组1例出现局部皮肤瘙痒。4例患者发生的不良事件均被判定为轻度,均未采取治疗措施,均无后遗症。3组患者的不良事件发生率比较,差异无统计学意义(P=1.000)。结论:复方紫荆消伤巴布膏可有效改善慢性软组织损伤患者的临床症状,疗效与骨通贴膏相当,且安全性较高。
Abstract:
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 at 14 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=0.990; Adjusted mean:4.08 points(experimental group),4.02 points(positive control group)).There was no statistical difference in decreased values of pain VAS scores between FFZJXSBBG group and placebo group at 7 days after the beginning of the treatment(Covariant:F=18.120,P=0.000; Block factor:F=9.040,P=0.000; Group factor:F=0.620,P=0.434; Interaction between covariant and group factor:F=1.040,P=0.411; Adjusted mean:2.25 points(experimental group),2.04 points(positive control group)).The decreased values of pain VAS scores were greater in FFZJXSBBG group compared to placebo group at 14 days after the beginning of the treatment(Covariant:F=39.200,P=0.000; Block factor:F=40.890,P=0.000; Group factor:F=11.210,P=0.001; Interaction between covariant and group factor:F=4.300,P=0.000; Adjusted mean:4.00 points(experimental group),3.27 points(positive control group)).There was no statistical difference in effective rate between the 3 groups at 7 days after the beginning of the treatment(χ2=5.867,P=1.000).There was statistical difference in effective rate between the 3 groups at 14 days after the beginning of the treatment(P=0.022).There was no statistical difference in effective rate between FFZJXSBBG group and GT plaster group(χ2=0.000,P=1.000).The effective rate was higher in FFZJXSBBG group and GT plaster group compared to placebo group(χ2=6.375,P=0.012; χ2=4.208,P=0.004).Anemia was found in 1 patient in FFZJXSBBG group and 1 patient in GT plaster group,oral ulcer was found in 1 patient in FFZJXSBBG group and local cutaneous pruritus was found in 1 patient in placebo group.The adverse reactions in the 4 patients belonged to mild-grade,and no special treatment were performed and no sequelae were found.There was no statistical difference in the incidence rate of adverse reactions between the 3 groups(P=1.000).Conclusion:FFZJXSBBG can effectively improve the clinical symptoms of patients with chronic soft tissue injuries,and it is similar to GT plaster in the curative effect,moreover,it has high safty.

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备注/Memo

备注/Memo:
(收稿日期:2019-06-10 本文编辑:李晓乐) 通讯作者:高宁阳 E-mail:sapphire512@163.com
更新日期/Last Update: 2020-03-10