三色膏治疗早中期原发性膝骨关节炎的临床研究
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摘要
目的:观察三色膏外敷治疗早中期膝骨关节炎(KOA)的疗效,比较三色膏外敷与美洛昔康口服治疗早中期KOA的临床疗效差异。方法:纳入136例早中期KOA患者,随机分为治疗组和对照组,每组各68例。治疗组采用三色膏外敷治疗,对照组给予美洛昔康片口服,两组均治疗6周。分别于治疗前及治疗3周、6周、12周、24周时,评定患者的WOMAC(Western Ontario and Mc Master Universities Arthritis Index)量表评分、膝关节疼痛视觉模拟评分(visual analog score,VAS)、5次坐-立试验时间及健康调查简表(SF-36)评分;比较两组患者的临床疗效。结果:治疗后,两组患者的WOMAC各项评分、疼痛VAS评分均明显降低,SF-36量表评分明显升高,5次坐-立试验时间明显缩短,与治疗前比较差异均有统计学意义(P<0.05,P<0.01)。治疗3周、6周、12周、24周时,治疗组患者的WOMAC各项评分均低于对照组(P<0.05,P<0.01);治疗6周、12周、24周时,治疗组患者的VAS评分均低于对照组(P<0.05),5次坐-立试验时间较对照组明显缩短(P<0.05,P<0.01),SF-36量表评分高于对照组(P<0.05,P<0.01)。治疗3周、6周、12周、24周时,治疗组的临床总有效率分别为71.21%、90.91%、80.30%、74.24%,对照组分别为61.76%、76.47%、72.06%、64.71%;各时间点的临床疗效比较,治疗组均优于对照组(P<0.05)。结论:三色膏与美洛昔康治疗早中期KOA均有效,三色膏既可明显缓解患者的疼痛症状,又可改善其膝关节活动度,提高生活质量,在恢复膝关节的力学平衡方面疗效优于美洛昔康。
Objective: To observe the effects of three-color paste in the treatment of knee osteoarthritis( KOA) at early and middle stages; and compare the clinical efficacy on KOA at early and middle stages between external application of three-color paste and oral administration of meloxicam. Methods: 136 patients with knee osteoarthritis at the early and middle stages were selected and randomly divided into the treatment group and the control group,68 cases in each group. The patients in the treatment group were treated with threecolor paste for external application and the patients in the control group were orally treated with meloxicam,with a course of 6 weeks.Before treatment and 3 weeks,6 weeks,12 weeks and 24 weeks after treatment,the Western Ontario and Mc Master University Arthritis Index( WOMAC) score,visual analog scale( VAS) score for knee pain,5-time sit-to-stand test and the quality of life score( 36-item short form health survey,SF-36) were evaluated,and the clinical effects of both groups were compared. Results: After treatment,all items scores of WOMAC and the VAS score in both groups were obviously decreased,the SF-36 score was increased,and the time of 5-time sitto-stand test was shortened,compared with before treatment there were statistically significant differences( P<0.05,P<0.01). Three weeks,6 weeks,12 weeks and 24 weeks after treatment,all items scores of WOMAC in the treatment group were lower than those in the control group( P<0.05,P<0.01); 6 weeks,12 weeks and 24 weeks after treatment,the VAS scores in the treatment group were lower than those in the control group( P<0.05),the time of 5-time sit-to-stand test was shorter than that in the control group( P<0.05,P<0.01),and the SF-36 scores were higher than those in the control group( P<0.05,P<0.01). Three weeks,6 weeks,12 weeks and 24 weeks after treatment,the total clinical effective rates of the treatment group were 71. 21%,90. 91%,80. 30% and 74. 24% respectively,and the total clinical effective rates of the control group were 61.76%,76.47%,72.06% and 64.71% respectively; the effects of the treatment group were better than those of the control group at different time points( P<0.05). Conclusion: Both three-color paste and meloxicam are effective in the treatment of KOA at the early and middle stages. The three-color paste can obviously relieve the pain,improve the knee motion range and enhance the quality of life for patients with KOA. The efficacy of three-color paste on recovering the mechanics balance of knee is better than that of meloxicam.
Objective: To observe the effects of three-color paste in the treatment of knee osteoarthritis( KOA) at early and middle stages; and compare the clinical efficacy on KOA at early and middle stages between external application of three-color paste and oral administration of meloxicam. Methods: 136 patients with knee osteoarthritis at the early and middle stages were selected and randomly divided into the treatment group and the control group,68 cases in each group. The patients in the treatment group were treated with threecolor paste for external application and the patients in the control group were orally treated with meloxicam,with a course of 6 weeks.Before treatment and 3 weeks,6 weeks,12 weeks and 24 weeks after treatment,the Western Ontario and Mc Master University Arthritis Index( WOMAC) score,visual analog scale( VAS) score for knee pain,5-time sit-to-stand test and the quality of life score( 36-item short form health survey,SF-36) were evaluated,and the clinical effects of both groups were compared. Results: After treatment,all items scores of WOMAC and the VAS score in both groups were obviously decreased,the SF-36 score was increased,and the time of 5-time sitto-stand test was shortened,compared with before treatment there were statistically significant differences( P<0.05,P<0.01). Three weeks,6 weeks,12 weeks and 24 weeks after treatment,all items scores of WOMAC in the treatment group were lower than those in the control group( P<0.05,P<0.01); 6 weeks,12 weeks and 24 weeks after treatment,the VAS scores in the treatment group were lower than those in the control group( P<0.05),the time of 5-time sit-to-stand test was shorter than that in the control group( P<0.05,P<0.01),and the SF-36 scores were higher than those in the control group( P<0.05,P<0.01). Three weeks,6 weeks,12 weeks and 24 weeks after treatment,the total clinical effective rates of the treatment group were 71. 21%,90. 91%,80. 30% and 74. 24% respectively,and the total clinical effective rates of the control group were 61.76%,76.47%,72.06% and 64.71% respectively; the effects of the treatment group were better than those of the control group at different time points( P<0.05). Conclusion: Both three-color paste and meloxicam are effective in the treatment of KOA at the early and middle stages. The three-color paste can obviously relieve the pain,improve the knee motion range and enhance the quality of life for patients with KOA. The efficacy of three-color paste on recovering the mechanics balance of knee is better than that of meloxicam.
引文
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[2]廖德发.我国骨性关节炎流行病学调查现状[J].微创医学,2017,12(4):521-524.
[3]MATSUZAKI T,ALVAREZ-GARCIA O,MOKUDA S,et al.Fox O transcription factors modulate autophagy and proteoglycan 4 in cartilage homeostasis and osteoarthritis[J].Sci Transl Med,2018,10(428).pii:eaan0746.
[4]MALEMPATI C,JACOBS C A,LATTERMANN C.The Early Osteoarthritic Knee:Implications for Cartilage Repair[J].Clin Sports Med,2017,36(3):587-596.
[5]BENNELL K,HUNT M A,WRIGLEY T,et al.Role of muscle in the genesis and management of knee osteoarthritis[J].Rheum Dis Clin North Am,2008,34(3):731-754.
[6]MCALINDON T E,BANNURU R R,SULLIVAN M C,et al.OARSI guidelines for the non-surgical management of knee osteoarthritis[J].Osteoarthritis Cartilage,2014,22(3):363-388.
[7]田晓美,赵紫砚,侯丽.膝关节骨性关节炎中西医结合康复治疗进展[J].现代中西医结合杂志,2016,25(1):105-108.
[8]许理忠,侯宝兴.中医药治疗退行性膝关节骨关节炎80例[J].上海中医药杂志,2000,34(9):31.
[9]赵敏辉.石氏三色敷药治疗膝关节骨关节炎140例疗效分析[J].中成药,2005,27(7):867-868.
[10]中华医学会骨科学分会.骨关节炎诊治指南(2007年版)[J].中华关节外科杂志(电子版),2007,1(4):254-256.
[11]国家中医药管理局.中医病证诊断疗效标准[S].南京:南京大学出版社,1994:20,30-31,186-187.
[12]KELLGREN J H,LAWRENCE J S.Atlas of standard radiographs.Vol.2[M].Oxford:Blackwell Scientific,1963.
[13]BELLAMY N,BUCHANAN W W,GOLDSMITH C H,et al.Validation study of WOMAC:a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee[J].J Rheumatol,1988,15(12):1833-1840.
[14]孙海花,何良志,董延芬,等.员利针治疗腰椎间盘突出症110例[J].针灸临床杂志,2012,28(3):28-30.
[15]焦伟国,郭燕梅,朱才兴,等.5次坐-立试验在膝骨关节炎患者功能评估中的价值[J].中国康复理论与实践,2010,16(1):21-22.
[16]蒋生云,杨鸿珠,朱虹,等.电针推拿并用对膝关节骨关节炎患者生存质量的研究[J].世界临床药物,2014,35(1):25-28.
[17]胥少汀,葛宝丰,徐印坎.实用骨科学[M].北京:人民军医出版社,2012:1677.
[18]崔宝甲,于庆巍,张明磊,等.膝关节骨性关节炎关节镜清理术手术时机的选择[J].吉林大学学报(医学版),2011,37(1):127-129.
[19]蒋云霞,莫文,王国权,等.三色膏联合几丁糖治疗膝骨关节炎临床观察[J].上海中医药杂志,2015,49(5):73-74.
[20]司志平,夏建龙.膝关节骨性关节炎中医体质学特征探讨[J].实用中医药杂志,2010,26(4):260-261.
[21]吴权,李启运,王素英,等.活血、温经、补益肝肾类中药对膝骨关节炎兔关节软骨形态的影响[J].中医正骨,2014,26(6):15-18.
[22]黄丰肖,何良志.员利针合阳和汤治疗膝关节骨性关节炎临床研究[J].中医学报,2016,31(4):606-608.
[23]何汉戊,吴龙章.布洛芬缓释胶囊内服配合中药外敷治疗膝骨性关节炎40例疗效观察[J].中国临床新医学,2015,8(1):44-46.
[24]刚嘉鸿,宓轶群,王华敏.电针与美洛昔康治疗早中期膝骨关节炎临床疗效比较:随机对照研究[J].中国针灸,2016,36(5):467-470.
[25]梁永瑛,郭艳明,顾钧青,等.三色膏联合微波治疗急性踝关节扭伤临床观察[J].中国中医骨伤科杂志,2015,23(2):18-20.
[26]李浩钢,郭天旻,王翔.三色膏对骨骼肌损伤修复过程中组织形态学的影响[J].上海中医药杂志,2008,42(2):60-62.
[27]SEKIYA I,OJIMA M,SUZUKI S,et al.Human mesenchymal stem cells in synovial fluid increase in the knee with degenerated cartilage and osteoarthritis[J].J Orthop Res,2012,30(6):943-949.
[28]KOYAMA N,OKUBO Y,NAKAO K,et al.Pluripotency of mesenchymal cells derived from synovial fluid in patients with temporomandibular joint disorder[J].Life Sci,2011,89(19-20):741-747.
[29]BOYDEN L M,MAO J,BELSKY J,et al.High bone density due to a mutation in LDL-receptor-related protein 5[J].N Engl J Med,2002,346(20):1513-1521.
[30]HUNTER D J,GERSTENFELD L,BISHOP G,et al.Bone marrow lesions from osteoarthritis knees are characterized by sclerotic bone that is less well mineralized[J].Arthritis Res Ther,2009,11(1):R11.
[31]侯筱魁,石关桐,赵敏辉,等.外敷中药对家兔桡骨骨折愈合的影响[J].中国中医骨伤科杂志,1992,8(2):10-12.
[32]PULJAK L,MARIN A,VRDOLJAK D,et al.Celecoxib for osteoarthritis[J].Cochrane Database Syst Rev,2017,5:CD009865.
[33]彭谊,王志义.中药外敷促进骨折愈合作用机制的实验研究进展[J].中国中医药科技,2012,19(2):191-192.
[34]KRAUS M A,FLUCK R J,WEINHANDL E D,et al.Intensive Hemodialysis and Health-Related Quality of Life[J].Am J Kidney Dis,2016,68(5S1):S33-S42.
[2]廖德发.我国骨性关节炎流行病学调查现状[J].微创医学,2017,12(4):521-524.
[3]MATSUZAKI T,ALVAREZ-GARCIA O,MOKUDA S,et al.Fox O transcription factors modulate autophagy and proteoglycan 4 in cartilage homeostasis and osteoarthritis[J].Sci Transl Med,2018,10(428).pii:eaan0746.
[4]MALEMPATI C,JACOBS C A,LATTERMANN C.The Early Osteoarthritic Knee:Implications for Cartilage Repair[J].Clin Sports Med,2017,36(3):587-596.
[5]BENNELL K,HUNT M A,WRIGLEY T,et al.Role of muscle in the genesis and management of knee osteoarthritis[J].Rheum Dis Clin North Am,2008,34(3):731-754.
[6]MCALINDON T E,BANNURU R R,SULLIVAN M C,et al.OARSI guidelines for the non-surgical management of knee osteoarthritis[J].Osteoarthritis Cartilage,2014,22(3):363-388.
[7]田晓美,赵紫砚,侯丽.膝关节骨性关节炎中西医结合康复治疗进展[J].现代中西医结合杂志,2016,25(1):105-108.
[8]许理忠,侯宝兴.中医药治疗退行性膝关节骨关节炎80例[J].上海中医药杂志,2000,34(9):31.
[9]赵敏辉.石氏三色敷药治疗膝关节骨关节炎140例疗效分析[J].中成药,2005,27(7):867-868.
[10]中华医学会骨科学分会.骨关节炎诊治指南(2007年版)[J].中华关节外科杂志(电子版),2007,1(4):254-256.
[11]国家中医药管理局.中医病证诊断疗效标准[S].南京:南京大学出版社,1994:20,30-31,186-187.
[12]KELLGREN J H,LAWRENCE J S.Atlas of standard radiographs.Vol.2[M].Oxford:Blackwell Scientific,1963.
[13]BELLAMY N,BUCHANAN W W,GOLDSMITH C H,et al.Validation study of WOMAC:a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee[J].J Rheumatol,1988,15(12):1833-1840.
[14]孙海花,何良志,董延芬,等.员利针治疗腰椎间盘突出症110例[J].针灸临床杂志,2012,28(3):28-30.
[15]焦伟国,郭燕梅,朱才兴,等.5次坐-立试验在膝骨关节炎患者功能评估中的价值[J].中国康复理论与实践,2010,16(1):21-22.
[16]蒋生云,杨鸿珠,朱虹,等.电针推拿并用对膝关节骨关节炎患者生存质量的研究[J].世界临床药物,2014,35(1):25-28.
[17]胥少汀,葛宝丰,徐印坎.实用骨科学[M].北京:人民军医出版社,2012:1677.
[18]崔宝甲,于庆巍,张明磊,等.膝关节骨性关节炎关节镜清理术手术时机的选择[J].吉林大学学报(医学版),2011,37(1):127-129.
[19]蒋云霞,莫文,王国权,等.三色膏联合几丁糖治疗膝骨关节炎临床观察[J].上海中医药杂志,2015,49(5):73-74.
[20]司志平,夏建龙.膝关节骨性关节炎中医体质学特征探讨[J].实用中医药杂志,2010,26(4):260-261.
[21]吴权,李启运,王素英,等.活血、温经、补益肝肾类中药对膝骨关节炎兔关节软骨形态的影响[J].中医正骨,2014,26(6):15-18.
[22]黄丰肖,何良志.员利针合阳和汤治疗膝关节骨性关节炎临床研究[J].中医学报,2016,31(4):606-608.
[23]何汉戊,吴龙章.布洛芬缓释胶囊内服配合中药外敷治疗膝骨性关节炎40例疗效观察[J].中国临床新医学,2015,8(1):44-46.
[24]刚嘉鸿,宓轶群,王华敏.电针与美洛昔康治疗早中期膝骨关节炎临床疗效比较:随机对照研究[J].中国针灸,2016,36(5):467-470.
[25]梁永瑛,郭艳明,顾钧青,等.三色膏联合微波治疗急性踝关节扭伤临床观察[J].中国中医骨伤科杂志,2015,23(2):18-20.
[26]李浩钢,郭天旻,王翔.三色膏对骨骼肌损伤修复过程中组织形态学的影响[J].上海中医药杂志,2008,42(2):60-62.
[27]SEKIYA I,OJIMA M,SUZUKI S,et al.Human mesenchymal stem cells in synovial fluid increase in the knee with degenerated cartilage and osteoarthritis[J].J Orthop Res,2012,30(6):943-949.
[28]KOYAMA N,OKUBO Y,NAKAO K,et al.Pluripotency of mesenchymal cells derived from synovial fluid in patients with temporomandibular joint disorder[J].Life Sci,2011,89(19-20):741-747.
[29]BOYDEN L M,MAO J,BELSKY J,et al.High bone density due to a mutation in LDL-receptor-related protein 5[J].N Engl J Med,2002,346(20):1513-1521.
[30]HUNTER D J,GERSTENFELD L,BISHOP G,et al.Bone marrow lesions from osteoarthritis knees are characterized by sclerotic bone that is less well mineralized[J].Arthritis Res Ther,2009,11(1):R11.
[31]侯筱魁,石关桐,赵敏辉,等.外敷中药对家兔桡骨骨折愈合的影响[J].中国中医骨伤科杂志,1992,8(2):10-12.
[32]PULJAK L,MARIN A,VRDOLJAK D,et al.Celecoxib for osteoarthritis[J].Cochrane Database Syst Rev,2017,5:CD009865.
[33]彭谊,王志义.中药外敷促进骨折愈合作用机制的实验研究进展[J].中国中医药科技,2012,19(2):191-192.
[34]KRAUS M A,FLUCK R J,WEINHANDL E D,et al.Intensive Hemodialysis and Health-Related Quality of Life[J].Am J Kidney Dis,2016,68(5S1):S33-S42.