[1]殷梦媛,石瑛,陈元川,等.传统膏药膜韧膏贴敷治疗内侧间室膝骨关节炎的临床研究[J].中医正骨,2018,30(09):22-29.
 YIN Mengyuan,Shi Ying,CHEN Yuanchuan,et al.A clinical study of external application of Moren Gao(膜韧膏)for treatment of medial compartment knee osteoarthritis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2018,30(09):22-29.
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传统膏药膜韧膏贴敷治疗内侧间室膝骨关节炎的临床研究()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第30卷
期数:
2018年09期
页码:
22-29
栏目:
骨关节炎
出版日期:
2018-09-20

文章信息/Info

Title:
A clinical study of external application of Moren Gao(膜韧膏)for treatment of medial compartment knee osteoarthritis
作者:
殷梦媛石瑛陈元川庞坚熊轶喆张旻
1.上海中医药大学附属曙光医院,上海市中医药研究院骨伤科研究所,上海 201203
Author(s):
YIN MengyuanShi YingCHEN YuanchuanPANG JianXIONG YizheZHANG Min
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,The Institute of Traumatology and Orthopedics Affiliated to Shanghai Academy of Traditional Chinese Medicine, Shanghai 201203,China
关键词:
骨关节炎 膏药疗法 膜韧膏 复方紫荆消伤巴布膏
Keywords:
osteoarthritisknee emplastrum therapy Moren Gao Fufang Zijing Xiaoshang Babugao
摘要:
观察传统膏药膜韧膏贴敷治疗内侧间室膝骨关节炎(knee osteoarthritis,KOA)的临床疗效和安全性。方法:将118例内侧间室KOA患者随机分为2组,每组59例,分别采用传统膏药膜韧膏贴敷和复方紫荆消伤巴布膏贴敷治疗。因步态检测设备测试时间过长的限制,分别从每组中随机抽取14例患者纳入三维步态分析。膜韧膏和复方紫荆消伤巴布膏均贴敷于膝关节内侧疼痛处,每天贴1次,每次12 h,连用4周。分别于治疗前、治疗开始后2周、4周、6周,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、躯体功能评分及总评分; 于治疗前及治疗开始后2周、4周,采用三维步态分析比较2组患者膝关节屈曲范围; 于治疗开始后4周,比较2组患者的综合疗效,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不存在交互效应(F=1.183,P=0.304); 2组患者WOMAC疼痛评分比较,组间差异无统计学意义,即不存在分组效应(F=-0.540,P=0.590); 2组患者治疗前后不同时间点WOMAC疼痛评分的差异有统计学意义,即存在时间效应(F=184.478, P=0.000),2组患者WOMAC疼痛评分随时间均呈下降趋势,且2组的下降趋势完全一致[(17.49±8.90)分,(11.64±6.01)分,(8.59±3.94)分,(7.80±3.48)分,F=13.460,P=0.000;(16.10±7.85)分,(11.68±5.93)分,(8.41±4.22)分,(7.69±4.10)分,F=23.720,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=0.163,P=0.875); 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=0.480,P=0.663); 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=36.914,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[(5.95±2.24)分,(4.98±2.47)分,(4.08±3.83)分,(3.66±1.74)分,F=3.710,P=0.012;(6.27±4.41)分,(5.31±2.06)分,(4.14±2.83)分,(3.76±1.69)分,F=3.200,P=0.024]。③WOMAC躯体功能评分。时间因素和分组因素不存在交互效应(F=0.413,P=0.617); 2组患者WOMAC躯体功能评分比较,组间差异无统计学意义,即不存在分组效应(F=1.510,P=0.132); 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=137.806,P=0.000),2组患者WOMAC躯体功能评分随时间均呈下降趋势,且2组的下降趋势完全一致[(54.07±20.54)分,(45.41±27.21)分,(33.27±18.29)分,(30.34±18.72)分,F=6.960,P=0.000;(57.31±26.22)分,(48.98±22.76)分,(39.03±17.21)分,(33.83±24.05)分,F=12.120,P=0.000]。④WOMAC总评分。时间因素和分组因素不存在交互效应(F=0.344,P=0.657); 2组患者WOMAC总评分比较,组间差异无统计学意义,即不存在分组效应(F=1.070,P=0.286); 2组患者治疗前后不同时间点WOMAC总评分的差异有统计学意义,即存在时间效应(F=169.210 P=0.000),2组患者WOMAC总评分随时间均呈下降趋势,且2组的下降趋势完全一致[(77.51±29.38)分,(62.03±24.39)分,(45.95±18.27)分,(41.80±25.57)分,F=8.810,P=0.000;(79.68±28.47)分,(65.97±26.18)分,(51.58±21.22)分,(45.29±20.66)分,F=14.670,P=0.000]。⑤三维步态分析中测量的膝关节屈曲范围。时间因素和分组因素存在交互效应(F=3.247,P=0.031); 2组患者膝关节屈曲范围比较,组间差异有统计学意义,即存在分组效应(F=5.116,P=0.043); 治疗前后不同时间点膝关节屈曲范围的差异有统计学意义,即存在时间效应(F=2.376,P=0.048),2组患者膝关节屈曲范围随时间均呈上升趋势,但2组的上升趋势不完全一致[12.25°±9.68°,17.13°±9.44°,17.97°±4.25°,F=3.854,P=0.039; 11.57°±8.00°,12.94°±4.77°,13.39°±5.12°,F=2.036,P=0.043]; 治疗前2组患者膝关节屈曲范围比较,差异无统计学意义(t=0.991,P=0.331); 治疗开始后2周、4周膜韧膏组膝关节屈曲范围均大于复方紫荆消伤巴布膏组(t=7.468,P=0.003; t=5.213,P=0.041)。⑥综合疗效。治疗开始后4周,膜韧膏组治愈1例、显效1例、有效45例、无效12例,复方紫荆消伤巴布膏组显效2例、有效42例、无效15例; 2组患者综合疗效比较,差异无统计学意义(Z=-0.651,P=0.515)。⑦安全性。膜韧膏组2例出现瘙痒、红疹等皮肤过敏现象,复方紫荆消伤巴布膏组5例出现瘙痒、红疹等皮肤过敏现象,嘱患者暂停用药后症状消失; 2组患者并发症发生率比较,差异无统计学意义(P=0.439)。结论:采用膜韧膏贴敷与复方紫荆消伤巴布膏贴敷治疗内侧间室KOA,均能缓解膝关节疼痛和僵硬,改善躯体功能,且并发症少,但前者在改善膝关节屈曲范围方面优于后者。
Abstract:
To observe the clinical curative effects and safety of external application of Moren Gao(膜韧膏,MRG)for treatment of medial compartment knee osteoarthritis(KOA).Methods:One hundred and eighteen patients with medial compartment KOA were randomly divided into 2 groups,59 cases in each group.The patients were treated with external application of MRG(MRG group)and external application of Fufang Zijing Xiaoshang Babugao(复方紫荆消伤巴布膏,FFZJXSBBG)(FFZJXSBBG group)respectively.Fourteen patients were randomly selected from each group for three-dimensional gait analysis because the time of gait analysis was too long.MRG and FFZJXSBBG were applied to the pain spots of medial knee joint,once a day,12 hours at a time for consecutive 4 weeks.The Western Ontario and McMaster universities(WOMAC)osteoarthritis index pain scores,stiffness scores,physical function scores and total scores were compared between the 2 groups before treatment and at 2,4 and 6 weeks after the beginning of the treatment respectively.The knee flexion-extension range measured using three-dimensional gait analyser was compared between the 2 groups before treatment and at 2 and 4 weeks after the beginning of the treatment respectively.The total clinical curative effects and complications were compared between the 2 groups at 4 weeks after the beginning of the treatment.Results:There was no interaction between time factor and group factor in WOMAC pain scores(F=1.183,P=0.304).There was no statistical difference in WOMAC pain scores between the 2 groups,in other words,there was no group effect(F=-0.540,P=0.590).There was statistical difference in WOMAC pain scores between different timepoints before and after the treatment,in other words,there was time effect(F=184.478, P=0.000).The WOMAC pain 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 pain scores(17.49+/-8.90,11.64+/-6.01,8.59+/-3.94,7.80+/-3.48 points,F=13.460,P=0.000; 16.10+/-7.85,11.68+/-5.93,8.41+/-4.22,7.69+/-4.10 points,F=23.720,P=0.000).There was no interaction between time factor and group factor in WOMAC stiffness scores(F=0.163,P=0.875).There was no statistical difference in WOMAC stiffness scores between the 2 groups,in other words,there was no group effect(F=0.480,P=0.663).There was statistical difference in WOMAC stiffness scores between different timepoints before and after the treatment,in other words,there was time effect(F=36.914,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(5.95+/-2.24,4.98+/-2.47,4.08+/-3.83,3.66+/-1.74 points,F=3.710,P=0.012; 6.27+/-4.41,5.31+/-2.06,4.14+/-2.83,3.76+/-1.69 points,F=3.200,P=0.024).There was no interaction between time factor and group factor in WOMAC physical function scores(F=0.413,P=0.617).There was no statistical difference in WOMAC physical function scores between the 2 groups,in other words,there was no group effect(F=1.510,P=0.132).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=137.806,P=0.000).The WOMAC physical function 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 physical function scores(54.07+/-20.54,45.41+/-27.21,33.27+/-18.29,30.34+/-18.72 points,F=6.960,P=0.000; 57.31+/-26.22,48.98+/-22.76,39.03+/-17.21,33.83+/-24.05 points,F=12.120,P=0.000).There was no interaction between time factor and group factor in WOMAC total scores(F=0.344,P=0.657).There was no statistical difference in WOMAC total scores between the 2 groups,in other words,there was no group effect(F=1.070,P=0.286).There was statistical difference in WOMAC total scores between different timepoints before and after the treatment,in other words,there was time effect(F=169.210,P=0.000).The WOMAC total 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 total scores(77.51+/-29.38,62.03+/-24.39,45.95+/-18.27,41.80+/-25.57 points,F=8.810,P=0.000; 79.68+/-28.47,65.97+/-26.18,51.58+/-21.22,45.29+/-20.66 points,F=14.670,P=0.000).There was interaction between time factor and group factor in knee flexion-extension range measured using three-dimensional gait analyser(F=3.247,P=0.031).There was statistical difference in knee flexion-extension range between the 2 groups,in other words,there was group effect(F=5.116,P=0.043).There was statistical difference in knee flexion-extension range between different timepoints before and after the treatment,in other words,there was time effect(F=2.376,P=0.048).The knee flexion-extension range presented a time-dependent increasing trend in the 2 groups and the 2 groups were inconsistent with each other in the increasing trend of knee flexion-extension range(12.25+/-9.68,17.13+/-9.44,17.97+/-4.25 degrees,F=3.854,P=0.039; 11.57+/-8.00,12.94+/-4.77,13.39+/-5.12 degrees,F=2.036,P=0.043).There was no statistical difference in knee flexion-extension range between the 2 groups before the treatment(t=0.991,P=0.331).The knee flexion-extension range was greater in MRG group compared to FFZJXSBBG group at 2 and 4 weeks after the beginning of the treatment(t=7.468,P=0.003; t=5.213,P=0.041).At 4 weeks after the beginning of the treatment,1 patient was cured,1 good,45 fair and 12 poor in MRG group; while 2 obtained a good result,42 fair and 15 poor in FFZJXSBBG group.There was no statistical difference in the total curative effects between the 2 groups(Z=-0.651,P=0.515).Skin allergic reactions such as pruritus and erythema were found in 2 patients in MRG group and 5 patients in FFZJXSBBG group,and the symptoms disappeared after the plaster was suspended according to doctor's advice.There was no statistical difference in complication incidences between the 2 groups(P=0.439).Conclusion:Both external application of MRG and external application of FFZJXSBBG can relieve knee pain and stiffness and improve physical function in treatment of medial compartment KOA,and both of them have less complications,however,the former surpasses the latter in improving the knee flexion-extension range.

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备注/Memo

备注/Memo:
基金项目: 上海市进一步加快中医药事业发展三年行动计划项目(ZY3-CCCX-1-1003); 上海市重中之重临床医学中心和重点学科建设项目(2017ZZ02024) 通讯作者:石瑛 E-mail:shiying1974@126.com
更新日期/Last Update: 2018-09-20