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[1]郭天旻,李浩鋼,吳軍豪,等.石氏三色敷藥外敷治療早中期膝骨關(guān)節(jié)炎瘀血阻滯證的臨床研究[J].中醫(yī)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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石氏三色敷藥外敷治療早中期膝骨關(guān)節(jié)炎瘀血阻滯證的臨床研究()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第30卷
期數(shù):
2018年11期
頁(yè)碼:
21-27
欄目:
臨床研究
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; 李浩鋼; 吳軍豪; 石琤; 屠安琪; 余益群; 吳海洋; 桂璟
(上海市黃浦區(qū)中心醫(yī)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
關(guān)鍵詞:
骨關(guān)節(jié)炎; 膝;  瘀血阻滯;  中藥外敷;  石氏三色敷藥;  雙氯芬酸二乙胺乳膠劑
Keywords:
osteoarthritis; knee;  blood stasis stagnation;  external applications(TCD);  Shi's Sanse Fuyao;  diclofenac diethylamine emulgel
摘要:
目的:觀察石氏三色敷藥外敷治療早中期膝骨關(guān)節(jié)炎瘀血阻滯證的臨床療效和安全性。方法:將符合要求的90例早中期膝骨關(guān)節(jié)炎瘀血阻滯證患者隨機(jī)分為2組,每組45例,分別采用石氏三色敷藥外敷和雙氯芬酸二乙胺乳膠劑外涂治療。石氏三色敷藥外敷患膝疼痛處,每2 d更換1次,連續(xù)貼敷28 d; 雙氯芬酸二乙胺乳膠劑外涂患膝疼痛處,每天3～4次,連續(xù)外涂28 d。分別于治療前、治療開(kāi)始后7 d、14 d、28 d,比較2組患者西安大略和麥克馬斯特大學(xué)(Western Ontario and McMaster universities,WOMAC)骨關(guān)節(jié)炎指數(shù)量表疼痛評(píng)分、僵硬評(píng)分、軀體功能評(píng)分; 于治療前及治療開(kāi)始后28 d,比較2組患者膝關(guān)節(jié)活動(dòng)度; 于治療開(kāi)始后28 d,比較2組患者的膝關(guān)節(jié)腫脹消退率和綜合療效,并比較2組患者并發(fā)癥發(fā)生情況。結(jié)果:①WOMAC疼痛評(píng)分。時(shí)間因素和分組因素存在交互效應(yīng)(F=14.266,P=0.000); 2組患者WOMAC疼痛評(píng)分比較,組間差異有統(tǒng)計(jì)學(xué)意義,即存在分組效應(yīng)(F=10.648,P=0.001); 治療前后不同時(shí)間點(diǎn)間WOMAC疼痛評(píng)分的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=222.342,P=0.000); 2組患者WOMAC疼痛評(píng)分隨時(shí)間均呈下降趨勢(shì),但2組的下降趨勢(shì)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]; 治療前和治療開(kāi)始后7 d,2組患者的WOMAC疼痛評(píng)分比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義(t=0.189,P=0.665; t=2.976,P=0.088); 治療開(kāi)始后14 d、28 d,石氏三色敷藥外敷組WOMAC疼痛評(píng)分均低于雙氯芬酸二乙胺乳膠劑外涂組(t=8.617,P=0.004; t=17.089,P=0.000)。②WOMAC僵硬評(píng)分。時(shí)間因素和分組因素不存在交互效應(yīng)(F=1.918,P=0.248); 2組患者WOMAC僵硬評(píng)分比較,組間差異無(wú)統(tǒng)計(jì)學(xué)意義,即不存在分組效應(yīng)(F=0.630,P=0.428); 2組患者治療前后不同時(shí)間點(diǎn)WOMAC僵硬評(píng)分的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=1 149.425,P=0.000); 2組患者WOMAC僵硬評(píng)分隨時(shí)間均呈下降趨勢(shì),且2組的下降趨勢(shì)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軀體功能評(píng)分。時(shí)間因素和分組因素存在交互效應(yīng)(F=26.460,P=0.000); 2組患者WOMAC軀體功能評(píng)分比較,組間差異有統(tǒng)計(jì)學(xué)意義,即存在分組效應(yīng)(F=7.405,P=0.007); 2組患者治療前后不同時(shí)間點(diǎn)WOMAC軀體功能評(píng)分的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=268.812,P=0.000); 2組患者WOMAC軀體功能評(píng)分隨時(shí)間均呈下降趨勢(shì),但2組的下降趨勢(shì)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]; 治療前和治療開(kāi)始后7 d,2組患者的WOMAC軀體功能評(píng)分比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義(t=1.131,P=0.290; t=1.036,P=0.312); 治療開(kāi)始后14 d、28 d,石氏三色敷藥外敷組WOMAC軀體功能評(píng)分均低于雙氯芬酸二乙胺乳膠劑外涂組(t=5.710,P=0.019; t=16.252,P=0.000)。④膝關(guān)節(jié)活動(dòng)度。治療前2組患者膝關(guān)節(jié)活動(dòng)度比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(t=-0.041,P=0.967); 治療開(kāi)始后28 d,2組患者膝關(guān)節(jié)活動(dòng)度均大于治療前(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),石氏三色敷藥外敷組膝關(guān)節(jié)活動(dòng)度大于雙氯芬酸二乙胺乳膠劑外涂組(t=-4.027,P=0.000)。⑤膝關(guān)節(jié)腫脹消退率。治療前,石氏三色敷藥外敷組33例膝關(guān)節(jié)腫脹,雙氯芬酸二乙胺乳膠劑外涂組36例膝關(guān)節(jié)腫脹; 治療開(kāi)始后28 d,石氏三色敷藥外敷組膝關(guān)節(jié)腫脹消退12例,雙氯芬酸二乙胺乳膠劑外涂組膝關(guān)節(jié)腫脹消退5例; 石氏三色敷藥外敷組膝關(guān)節(jié)腫脹消退率高于雙氯芬酸二乙胺乳膠劑外涂組(χ2=4.684,P=0.030)。⑥綜合療效。治療開(kāi)始后28 d,石氏三色敷藥外敷組臨床痊愈11例、顯效23例、有效6例、無(wú)效5例,雙氯芬酸二乙胺乳膠劑外涂組臨床痊愈5例、顯效12例、有效18例、無(wú)效10例; 石氏三色敷藥外敷組綜合療效優(yōu)于雙氯芬酸二乙胺乳膠劑外涂組(Z=-3.177,P=0.001)。⑦安全性。石氏三色敷藥外敷組3例出現(xiàn)皮膚潮紅、瘙癢,在三色敷藥膏上加用紅玉膏后皮膚過(guò)敏癥狀緩解; 雙氯芬酸二乙胺乳膠劑外涂組未出現(xiàn)不良反應(yīng); 組患者并發(fā)癥發(fā)生率比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(χ2=1.379,P=0.240)。結(jié)論:采用石氏三色敷藥外敷與雙氯芬酸二乙胺乳膠劑外涂治療早中期KOA瘀血阻滯證,均能緩解膝關(guān)節(jié)疼痛和僵硬,改善膝關(guān)節(jié)活動(dòng)度和軀體功能,且并發(fā)癥少,但前者在改善膝關(guān)節(jié)疼痛、活動(dòng)度和軀體功能,消除腫脹及綜合療效方面優(yōu)于后者。
Abstract:
Objective:To observe the clinical curative effects and safety of external application of Shi's Sanse Fuyao(三色敷藥,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(紅玉膏).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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備注/Memo

備注/Memo:
基金項(xiàng)目:上海市衛(wèi)生和計(jì)劃生育委員會(huì)中醫(yī)藥科研基金項(xiàng)目(2014LP042A)
通訊作者:桂璟 E-mail:[email protected]
更新日期/Last Update: 2018-11-30