[1]郭天旻,李浩钢,吴军豪,等.石氏三色敷药外敷治疗早中期膝骨关节炎瘀血阻滞证的临床研究[J].中医正骨,2018,30(11):21-27.
　GUO Tianmin,LI Haogang,WU Junhao,et al.A clinical study of external application of Shi's Sanse Fuyao for treatment of blood-stasis-stagnation-type early-middle knee osteoarthritis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2018,30(11):21-27.
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石氏三色敷药外敷治疗早中期膝骨关节炎瘀血阻滞证的临床研究()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第30卷
期数:
2018年11期
页码:
21-27
栏目:
临床研究
出版日期:
2018-11-20

文章信息/Info

Title:
A clinical study of external application of Shi's Sanse Fuyao for treatment of blood-stasis-stagnation-type early-middle knee osteoarthritis
作者:
郭天旻; 李浩钢; 吴军豪; 石琤; 屠安琪; 余益群; 吴海洋; 桂璟
(上海市黄浦区中心医院,上海 200002)
Author(s):
GUO Tianmin; LI Haogang; WU Junhao; SHI Cheng; TU Anqi; YU Yiqun; WU Haiyang; GUI Jing
Huangpu District Central Hospital,Shanghai 200002,China
关键词:
骨关节炎; 膝;  瘀血阻滞;  中药外敷;  石氏三色敷药;  双氯芬酸二乙胺乳胶剂
Keywords:
osteoarthritis; knee;  blood stasis stagnation;  external applications(TCD);  Shi's Sanse Fuyao;  diclofenac diethylamine emulgel
摘要:
目的:观察石氏三色敷药外敷治疗早中期膝骨关节炎瘀血阻滞证的临床疗效和安全性。方法:将符合要求的90例早中期膝骨关节炎瘀血阻滞证患者随机分为2组,每组45例,分别采用石氏三色敷药外敷和双氯芬酸二乙胺乳胶剂外涂治疗。石氏三色敷药外敷患膝疼痛处,每2 d更换1次,连续贴敷28 d; 双氯芬酸二乙胺乳胶剂外涂患膝疼痛处,每天3～4次,连续外涂28 d。分别于治疗前、治疗开始后7 d、14 d、28 d,比较2组患者西安大略和麦克马斯特大学(Western Ontario and McMaster universities,WOMAC)骨关节炎指数量表疼痛评分、僵硬评分、躯体功能评分; 于治疗前及治疗开始后28 d,比较2组患者膝关节活动度; 于治疗开始后28 d,比较2组患者的膝关节肿胀消退率和综合疗效,并比较2组患者并发症发生情况。结果:①WOMAC疼痛评分。时间因素和分组因素存在交互效应(F=14.266,P=0.000); 2组患者WOMAC疼痛评分比较,组间差异有统计学意义,即存在分组效应(F=10.648,P=0.001); 治疗前后不同时间点间WOMAC疼痛评分的差异有统计学意义,即存在时间效应(F=222.342,P=0.000); 2组患者WOMAC疼痛评分随时间均呈下降趋势,但2组的下降趋势不完全一致[(38.77±16.60)分,(26.05±12.92)分,(17.48±10.84)分,(7.85±10.19)分,F=9.192,P=0.000;(37.40±13.08)分,(30.72±12.78)分,(25.23±14.02)分,(19.11±15.15)分,F=23.720,P=0.000]; 治疗前和治疗开始后7 d,2组患者的WOMAC疼痛评分比较,组间差异均无统计学意义(t=0.189,P=0.665; t=2.976,P=0.088); 治疗开始后14 d、28 d,石氏三色敷药外敷组WOMAC疼痛评分均低于双氯芬酸二乙胺乳胶剂外涂组(t=8.617,P=0.004; t=17.089,P=0.000)。②WOMAC僵硬评分。时间因素和分组因素不存在交互效应(F=1.918,P=0.248); 2组患者WOMAC僵硬评分比较,组间差异无统计学意义,即不存在分组效应(F=0.630,P=0.428); 2组患者治疗前后不同时间点WOMAC僵硬评分的差异有统计学意义,即存在时间效应(F=1 149.425,P=0.000); 2组患者WOMAC僵硬评分随时间均呈下降趋势,且2组的下降趋势完全一致[(46.57±25.22)分,(30.88±21.96)分,(22.09±17.56)分,(11.35±14.97)分,F=6.107,P=0.000;(39.31±18.04)分,(31.09±18.10)分,(26.93±18.44)分,(20.86±18.45)分,F=6.864,P=0.000]。③WOMAC躯体功能评分。时间因素和分组因素存在交互效应(F=26.460,P=0.000); 2组患者WOMAC躯体功能评分比较,组间差异有统计学意义,即存在分组效应(F=7.405,P=0.007); 2组患者治疗前后不同时间点WOMAC躯体功能评分的差异有统计学意义,即存在时间效应(F=268.812,P=0.000); 2组患者WOMAC躯体功能评分随时间均呈下降趋势,但2组的下降趋势不完全一致[(44.32±14.73)分,(31.87±14.59)分,(22.52±12.50)分,(11.57±12.41)分,F=6.429,P=0.000;(41.11±13.84)分,(34.98±14.40)分,(29.69±15.77)分,(23.62±18.82)分,F=5.142,P=0.000]; 治疗前和治疗开始后7 d,2组患者的WOMAC躯体功能评分比较,组间差异均无统计学意义(t=1.131,P=0.290; t=1.036,P=0.312); 治疗开始后14 d、28 d,石氏三色敷药外敷组WOMAC躯体功能评分均低于双氯芬酸二乙胺乳胶剂外涂组(t=5.710,P=0.019; t=16.252,P=0.000)。④膝关节活动度。治疗前2组患者膝关节活动度比较,差异无统计学意义(t=-0.041,P=0.967); 治疗开始后28 d,2组患者膝关节活动度均大于治疗前(99.44°±13.24°,120.11°±13.88°,t=-5.739,P=0.000; 98.89°±11.33°,111.20°±13.21°,t=-5.125,P=0.000),石氏三色敷药外敷组膝关节活动度大于双氯芬酸二乙胺乳胶剂外涂组(t=-4.027,P=0.000)。⑤膝关节肿胀消退率。治疗前,石氏三色敷药外敷组33例膝关节肿胀,双氯芬酸二乙胺乳胶剂外涂组36例膝关节肿胀; 治疗开始后28 d,石氏三色敷药外敷组膝关节肿胀消退12例,双氯芬酸二乙胺乳胶剂外涂组膝关节肿胀消退5例; 石氏三色敷药外敷组膝关节肿胀消退率高于双氯芬酸二乙胺乳胶剂外涂组(χ2=4.684,P=0.030)。⑥综合疗效。治疗开始后28 d,石氏三色敷药外敷组临床痊愈11例、显效23例、有效6例、无效5例,双氯芬酸二乙胺乳胶剂外涂组临床痊愈5例、显效12例、有效18例、无效10例; 石氏三色敷药外敷组综合疗效优于双氯芬酸二乙胺乳胶剂外涂组(Z=-3.177,P=0.001)。⑦安全性。石氏三色敷药外敷组3例出现皮肤潮红、瘙痒,在三色敷药膏上加用红玉膏后皮肤过敏症状缓解; 双氯芬酸二乙胺乳胶剂外涂组未出现不良反应; 组患者并发症发生率比较,差异无统计学意义(χ2=1.379,P=0.240)。结论:采用石氏三色敷药外敷与双氯芬酸二乙胺乳胶剂外涂治疗早中期KOA瘀血阻滞证,均能缓解膝关节疼痛和僵硬,改善膝关节活动度和躯体功能,且并发症少,但前者在改善膝关节疼痛、活动度和躯体功能,消除肿胀及综合疗效方面优于后者。
Abstract:
Objective:To observe the clinical curative effects and safety of external application of Shi's Sanse Fuyao(三色敷药,SSFY)for treatment of blood-stasis-stagnation-type early-middle knee osteoarthritis(KOA).Methods:Ninety patients with blood-stasis-stagnation-type early-middle KOA enrolled in the study were randomly divided into 2 groups,45 cases in each group,and were treated with external application of Shi's SSFY(group A)and external application of diclofenac diethylamine emulgel(group B)respectively.The Shi's SSFY was applied to the pain spots of affected knee every other day for consecutive 28 days; while the diclofenac diethylamine emulgel was applied to the pain spots of affected knee,3-4 times a day for consecutive 28 days.The Western Ontario and McMaster universities(WOMAC)osteoarthritis index pain scores,stiffness scores and physical function scores were compared between the 2 groups before treatment and at 7,14 and 28 days after the beginning of the treatment respectively.The range of motion(ROM)of knee was compared between the 2 groups before treatment and at 28 days after the beginning of the treatment respectively.The knee swelling subsidence rate,total clinical curative effects and complication incidences were compared between the 2 groups at 28 days after the beginning of the treatment.Results:There was interaction between time factor and group factor in WOMAC pain scores(F=14.266,P=0.000).There was statistical difference in WOMAC pain scores between the 2 groups,in other words,there was group effect(F=10.648,P=0.001). There was statistical difference in WOMAC pain scores between different timepoints before and after the treatment,in other words,there was time effect(F=222.342,P=0.000).The WOMAC pain 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 WOMAC pain scores(38.77+/-16.60,26.05+/-12.92,17.48+/-10.84,7.85+/-10.19 points,F=9.192,P=0.000; 37.40+/-13.08,30.72+/-12.78,25.23+/-14.02,19.11+/-15.15 points,F=23.720,P=0.000).There was no statistical difference in WOMAC pain scores between the 2 groups before treatment and at 7 days after the beginning of the treatment(t=0.189,P=0.665; t=2.976,P=0.088).The WOMAC pain scores were lower in group A compared to group B at 14 and 28 days after the beginning of the treatment(t=8.617,P=0.004; t=17.089,P=0.000).There was no interaction between time factor and group factor in WOMAC stiffness scores(F=1.918,P=0.248).There was no statistical difference in WOMAC stiffness scores between the 2 groups,in other words,there was no group effect(F=0.630,P=0.428).There was statistical difference in WOMAC stiffness scores between different timepoints before and after the treatment,in other words,there was time effect(F=1 149.425,P=0.000).The WOMAC stiffness scores presented a time-dependent decreasing trend in the 2 groups and the 2 groups were consistent with each other in the decreasing trend of WOMAC stiffness scores(46.57+/-25.22,30.88+/-21.96,22.09+/-17.56,11.35+/-14.97 points,F=6.107,P=0.000; 39.31+/-18.04,31.09+/-18.10,26.93+/-18.44,20.86+/-18.45 points,F=6.864,P=0.000).There was interaction between time factor and group factor in WOMAC physical function scores(F=26.460,P=0.000).There was statistical difference in WOMAC physical function scores between the 2 groups,in other words,there was group effect(F=7.405,P=0.007).There was statistical difference in WOMAC physical function scores between different timepoints before and after the treatment,in other words,there was time effect(F=268.812,P=0.000).The WOMAC physical function 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 WOMAC physical function scores(44.32+/-14.73,31.87+/-14.59,22.52+/-12.50,11.57+/-12.41 points,F=6.429,P=0.000; 41.11+/-13.84,34.98+/-14.40,29.69+/-15.77,23.62+/-18.82 points,F=5.142,P=0.000).There was no statistical difference in WOMAC physical function scores between the 2 groups before treatment and at 7 days after the beginning of the treatment(t=1.131,P=0.290; t=1.036,P=0.312).The WOMAC physical function scores were lower in group A compared to group B at 14 and 28 days after the beginning of the treatment(t=5.710,P=0.019; t=16.252,P=0.000).There was no statistical difference in ROM of knee between the 2 groups before treatment(t=-0.041,P=0.967).The ROM of knee was greater at 28 days after the beginning of the treatment compared to pre-treatment in both of the 2 groups(99.44+/-13.24 vs 120.11+/-13.88 degrees,t=-5.739,P=0.000; 98.89+/-11.33 vs 111.20+/-13.21 degrees,t=-5.125,P=0.000),and was greater in group A compared to group B(t=-4.027,P=0.000).The knee swelling was found in 33 patients in group A and 36 patients in group B before treatment,and the knee swelling subsided in 12 patients in group A and 5 patients in group B at 28 days after the beginning of the treatment.The knee swelling subsidence rate was higher in group A compared to group B(χ2=4.684,P=0.030).At 28 days after the beginning of the treatment,11 patients was cured,23 good,6 fair and 5 poor in group A; while 5 patients was cured,12 good,18 fair and 10 poor in group B.The group A surpassed the group B in the total clinical curative effects(Z=-3.177,P=0.001).Skin allergic reactions such as erubescence and pruritus were found in 3 patients in group A and the symptoms were relieved after application of Hongyugao(红玉膏).No adverse reactions were found in group B.There was no statistical difference in complication incidences between the 2 groups(χ2=1.379,P=0.240).Conclusion:Both external application of Shi's SSFY and external application of diclofenac diethylamine emulgel can relieve knee pain and stiffness and improve ROM of knee and physical function in treatment of blood-stasis-stagnation-type early-middle KOA,and both of them have less complications,however,the former surpasses the latter in improvement of knee pain,ROM of knee and physical function and swelling relief and total clinical curative effects.

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(总828)中医正骨2018年11月第30卷第11期 J Trad Chin Orthop Trauma,2018,Vol.30,No.11
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备注/Memo

备注/Memo:
基金项目:上海市卫生和计划生育委员会中医药科研基金项目(2014LP042A)
通讯作者:桂璟 E-mail:guijing2004@126.com
更新日期/Last Update: 2018-11-30