[1]龚志兵,庄至坤,张焕堂,等.骨散外敷治疗急性踝关节扭伤气滞血瘀证的临床研究[J].中医正骨,2018,30(12):13-17，22.
　GONG Zhibing,ZHUANG Zhikun,ZHANG Huantang,et al.A clinical study of external application of Gusan(骨散)for treatment of qi-stagnation-blood-stasis-type acute ankle sprain[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2018,30(12):13-17，22.
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骨散外敷治疗急性踝关节扭伤气滞血瘀证的临床研究()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第30卷
期数:
2018年12期
页码:
13-17，22
栏目:
临床研究
出版日期:
2018-12-20

文章信息/Info

Title:
A clinical study of external application of Gusan(骨散)for treatment of qi-stagnation-blood-stasis-type acute ankle sprain
作者:
龚志兵; 庄至坤; 张焕堂; 张前进; 徐福东; 吴昭克
(福建省泉州市正骨医院,福建 泉州 362000)
Author(s):
GONG Zhibing; ZHUANG Zhikun; ZHANG Huantang; ZHANG Qianjin; XU Fudong; WU Zhaoke
Quanzhou Orthopedic Hospital,Quanzhou 362000,Fujian,China
关键词:
踝关节;  扭伤和劳损;  气滞血瘀;  中药外敷;  骨散;  双氯芬酸二乙胺乳胶剂;  临床试验
Keywords:
ankle joint;  sprains and strains;  qi stagnation blood stasis;  external applications(TCD);  Gusan;  diclofenac diethylamine emulgel;  clinical trial
摘要:
目的:观察骨散外敷治疗急性踝关节扭伤气滞血瘀证的临床疗效及安全性。方法:将符合要求的100例急性踝关节扭伤气滞血瘀证患者随机分为2组,每组50例,分别采用骨散外敷和双氯芬酸二乙胺乳胶剂外涂治疗。骨散外敷踝关节扭伤处,第1周每天更换1次药膏,第2周每2 d更换1次,连续外敷2周; 双氯芬酸二乙胺乳胶剂外涂踝关节扭伤处,每天3次,连续外涂2周。分别于治疗前及治疗开始后1 d、3 d、7 d,比较2组患者踝关节疼痛视觉模拟量表(visual analogue scale,VAS)评分; 于治疗2周后,采用Kofoed踝关节评分标准比较2组患者的综合疗效,并比较2组患者肿胀、瘀斑消退时间及并发症发生情况。结果:①随访结果。骨散外敷组3例、双氯芬酸二乙胺乳胶剂外涂组2例因发生严重过敏反应或未按时复诊而退出。②肿胀和瘀斑消退时间。骨散外敷组肿胀和瘀斑消退时间均短于双氯芬酸二乙胺乳胶剂外涂组[(6.69±1.20)d,(9.30±1.36)d,t=-9.914,P=0.000;(10.01±1.29)d,(12.52±0.97)d,t=-10.714,P=0.000]。③踝关节疼痛VAS评分。时间因素与分组因素存在交互效应(F=11.466,P=0.000); 2组患者踝关节疼痛VAS评分比较,组间差异有统计学意义,即存在分组效应(F=58.307,P=0.000); 治疗前后不同时间点踝关节疼痛VAS评分的差异有统计学意义,即存在时间效应(F=569.721,P=0.000); 2组踝关节疼痛VAS评分随时间均呈下降趋势,但2组的下降趋势不完全一致[(6.60±1.06)分,(3.51±0.75)分,(2.19±0.74)分,(0.91±0.88)分,F=387.163,P=0.000;(6.58±1.01)分,(4.15±0.85)分,(3.04±0.80)分,(2.38±0.98)分,F=203.139,P=0.000]; 治疗前2组患者踝关节疼痛VAS评分比较,差异无统计学意义(t=0.054,P=0.957); 治疗开始后1 d、3 d、7 d,骨散外敷组踝关节疼痛VAS评分均低于双氯芬酸二乙胺乳胶剂外涂组(t=-4.292,P=0.000; t=-5.378,P=0.000; t=-6.689,P=0.000)。④综合疗效。治疗2周后,骨散外敷组优35例、良10例、及格2例,双氯芬酸二乙胺乳胶剂外涂组优20例、良19例、及格9例; 骨散外敷组的综合疗效优于双氯芬酸二乙胺乳胶剂外涂组(Z=-3.346,P=0.001)。⑤安全性。骨散外敷组2例患者和双氯芬酸二乙胺乳胶剂外涂组1例患者出现轻度过敏反应,未给予特殊处理,停药后症状消失; 2组并发症发生率比较,差异无统计学意义(χ2=0.366,P=0.545)。结论:采用骨散外敷治疗急性踝关节扭伤气滞血瘀证,能缓解踝关节疼痛,消除踝关节肿胀和瘀斑,且并发症少,其疗效优于双氯芬酸二乙胺乳胶剂外涂。
Abstract:
Objective:To observe the clinical curative effects and safety of external application of Gusan(骨散,GS)for treatment of qi-stagnation-blood-stasis-type acute ankle sprain.Methods:One hundred patients with qi-stagnation-blood-stasis-type acute ankle sprain enrolled in the study were randomly divided into 2 groups,50 cases in each group,and were treated with external application of GS(group A)and external application of diclofenac diethylamine emulgel(group B)respectively.The GS was applied to the sprained spots of ankle for consecutive 2 weeks,once a day in the 1st week and every other day in the 2nd week; while the diclofenac diethylamine emulgel was applied to the sprained spots of ankle,3 times a day for consecutive 2 weeks.The ankle pain visual analogue scale(VAS)scores were compared between the 2 groups before treatment and at 1,3 and 7 days after the beginning of the treatment respectively.The total clinical curative effects were compared between the 2 groups after 2-week treatment by using Kofoed ankle scoring standards,and the extinction time of swelling and ecchymoses and complication incidences were also compared between the 2 groups.Results:Three patients in group A dropped out of the study for severe allergic reactions or delayed return-visit and 2 patients in group B dropped out of the study for delayed return-visit.The extinction time of swelling and ecchymoses were shorter in group A compared to group B(6.69+/-1.20 vs 9.30+/-1.36 days,t=-9.914,P=0.000; 10.01+/-1.29 vs 12.52+/-0.97 days,t=-10.714,P=0.000).There was interaction between time factorand group factor in ankle pain VAS scores(F=11.466,P=0.000).There was statistical difference in ankle pain VAS scores between the 2 groups,in other words,there was group effect(F=58.307,P=0.000).There was statistical difference in ankle pain VAS scores between different timepoints before and after the treatment,in other words,there was time effect(F=569.721,P=0.000).The ankle pain VAS scores presented a time-dependent decreasing trend in the 2 groups,while the 2 groups were inconsistent with each other in the decreasing trend of ankle pain VAS scores(6.60+/-1.06,3.51+/-0.75,2.19+/-0.74,0.91+/-0.88 points,F=387.163,P=0.000; 6.58+/-1.01,4.15+/-0.85,3.04+/-0.80,2.38+/-0.98 points,F=203.139,P=0.000).There was no statistical difference in ankle pain VAS scores between the 2 groups before treatment(t=0.054,P=0.957).The ankle pain VAS scores were lower in group A compared to group B at 1,3 and 7 days after the beginning of the treatment(t=-4.292,P=0.000; t=-5.378,P=0.000; t=-6.689,P=0.000).After 2-week treatment,35 patients obtained an excellent result,10 good and 2 fair in group A; while 20 patients obtained an excellent result,19 good and 9 fair in group B.The group A surpassed the group B in the total clinical curative effects(Z=-3.346,P=0.001).The mild allergic reaction was found in 2 patients in group A and 1 patient in group B,and the symptoms disappeared after GS and diclofenac diethylamine emulgel were withdrawed and no special treatment were performed.There was no statistical difference in complication incidences between the 2 groups(χ2=0.366,P=0.545).Conclusion:External application of GS can relieve ankle pain and remove ankle swelling and ecchymoses in the treatment of qi-stagnation-blood-stasis-type acute ankle sprain,and it has less complications,moreover,it surpasses external application of diclofenac diethylamine emulgel in the clinical curative effect.

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备注/Memo

备注/Memo:
通讯作者:吴昭克 E-mail:wuzhaoke987@126.com (收稿日期:2018-08-20 本文编辑:时红磊) 本文第一作者为福建中医药大学在读硕士研究生
更新日期/Last Update: 2019-05-30