骨通贴膏治疗类风湿关节炎寒湿痹阻型临床疗效研究
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摘要
目的通过随机对照试验,观察骨通贴膏治疗类风湿关节炎(RA)寒湿痹阻型关节症状的疗效。方法将140例RA患者随机分为空白组(n=40)、试验组(n=50)、对照组(n=50),空白组维持原内服药治疗方案不变,不予其他治疗;试验组给予骨通贴膏外用每日1贴;对照组给予电热式蜡疗每日1次。记录并统计分析患者治疗前、治疗3d、14d后视觉模拟评分(VAS评分)、握力、晨僵时间、中医证候积分,治疗前及治疗14d后类风湿因子(RF)、C反应蛋白(CRP)、血沉(ESR)情况。评价临床疗效,观察不良反应。结果 (1)治疗3d后,试验组在VAS评分、晨僵时间、握力及中医证候积分上较治疗前有好转,差异有统计学意义(P<0.05)。2周后,空白组各观察指标无明显变化(P>0.05),试验组、对照组在VAS评分、握力、晨僵时间(h)、中医证候积分、CRP、ESR上较治疗前均有改善(P<0.05);组间比较,试验组改善情况优于空白组及对照组(P<0.05),差异有统计学意义;治疗14d后试验组RF轻度下降,但差异无统计学意义(P>0.05)。(2)试验组总有效率(94%)、临床控制率及显效率(控显率)83%均优于对照组总有效率(81%)、控显率(69%),差异有统计学意义(P<0.05)。(3)试验组及对照组各有2例轻微不良反应,均未退出试验。结论骨通贴膏能有效缓解RA寒湿痹阻型小关节晨僵、疼痛、肿胀的临床症状,具有起效快、作用持久、携带及使用方便的优势,对类风湿关节炎患者临床疗效肯定。
Objective To study the effectiveness of Gutong Plaster for the treatment of Rheumatoid arthritis joint pain with Cold dampness syndrome based on RCT.Methods 140 cases of RA patients were randomly divided into blank group(n=40),test group(n=50),control group(n=50).Blank group maintained the original medication therapies.Test group received Gutong plaster once daily.Control group received electric therapy once daily.VAS,grip strength,morning stiffness,TCM syndrome integral were recorded for all the patients before treatment,3 and 14 days after treatment.Patients' RF,CRP and ESR were obtained before treatment and 14 days after treatment.Clinical efficacy was evaluated,and adverse reactions were recorded.Results 1.After 3-day treatment,VAS,morning stiffness,grip strength and TCM syndrome integral were improved in test group compared with pre-treatment(P<0.05).After two weeks,no significant changes were observed in blank group(P>0.05),while both test group and control group exhibited better VAS,grip strength morning stiffness,TCM syndrome integral,CRP and ESR compared with the data before treatment(P<0.05).Test group had better improvement than blank group and control group(P<0.05).There was no statistically significant decline of RF in test group(P>0.05).2.The total effective rate(94%)and the control rate(83%)for test group are better than control group(81%and 69%)(P<0.05).3.There were two patients having mild adverse reactions in test group and control group,which were not statistically significant.Conclusion Gutong plaster can effectively relieve joints pain for RA patients with Cold dampness syndrome with fast onset and persistent effect.It is convenient to carry and administration.Its effectiveness was clinically confirmed.
Objective To study the effectiveness of Gutong Plaster for the treatment of Rheumatoid arthritis joint pain with Cold dampness syndrome based on RCT.Methods 140 cases of RA patients were randomly divided into blank group(n=40),test group(n=50),control group(n=50).Blank group maintained the original medication therapies.Test group received Gutong plaster once daily.Control group received electric therapy once daily.VAS,grip strength,morning stiffness,TCM syndrome integral were recorded for all the patients before treatment,3 and 14 days after treatment.Patients' RF,CRP and ESR were obtained before treatment and 14 days after treatment.Clinical efficacy was evaluated,and adverse reactions were recorded.Results 1.After 3-day treatment,VAS,morning stiffness,grip strength and TCM syndrome integral were improved in test group compared with pre-treatment(P<0.05).After two weeks,no significant changes were observed in blank group(P>0.05),while both test group and control group exhibited better VAS,grip strength morning stiffness,TCM syndrome integral,CRP and ESR compared with the data before treatment(P<0.05).Test group had better improvement than blank group and control group(P<0.05).There was no statistically significant decline of RF in test group(P>0.05).2.The total effective rate(94%)and the control rate(83%)for test group are better than control group(81%and 69%)(P<0.05).3.There were two patients having mild adverse reactions in test group and control group,which were not statistically significant.Conclusion Gutong plaster can effectively relieve joints pain for RA patients with Cold dampness syndrome with fast onset and persistent effect.It is convenient to carry and administration.Its effectiveness was clinically confirmed.
引文
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[14]金永健.温针灸治疗类风湿性关节炎56例临床观察[J].临床和实验医学杂志,2007,6(3):140.
[15]陈谦.复方丁公藤胶囊治疗风寒湿痹症344例临床疗效观察[J].中成药研究,1988(1)18-19.
[16]叶惠珍,范椰新,刘植蔚.丁公藤抗风湿有效成分的研究[J].中草药,1984,15(10):30.
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[19]杨志平,宋志军,宁耀瑜,等.丁公藤注射液雾化吸入对大鼠呼吸道和全身免疫功能的影响[J].广西中医药,1998,21(5):45-46.
[20]方琴.肉桂的研究进展[J].中药新药与临床药理,2007,18(3):249-252.
[21]孙凤娇,李振麟,钱士辉,等.干姜化学成分和药理作用研究进展.中国野生植物资源,2015,34(3):34-37.
[22]夏菁,谢媛媛,张宗璇,等.骨通贴膏指纹图谱及化学成分研究[J].中成药,2014,36(3):571-576.
[2]王振刚.近10年类风湿关节炎治疗及预后的变化趋势[J].中国医刊,2013,48(7):10-12.
[3]钱丽萍,戴桂兰,阙慧卿,等.治疗类风湿性关节炎外用制剂的研究概况[J].海峡药学,2010,22(8):140-143.
[4]孙振球.医学统计学[M].第2版.北京:人民卫生出版社,2002:832-833.
[5]ACR,EULAR.2010Rheumatoid arthritis classification criteria:an American College of Rheumatology/European League Against Rheumatism Collaborative Initiative[J].Ann Rheum Dis,2010,69(9):1580.
[6]国家中医药管理局.中华人民共和国中医药行业标准·中医病证诊断疗效标准[M].南京:南京大学出版社,1995:125-128.
[7]曹卉娟,邢建民,刘建平.视觉模拟评分法在症状类结局评价测量中的应用[J].中医杂志,2009,50(7):600-602.
[8]郑筱萸.中药新药临床研究指导原则[S].北京:中国医药科技出版社,2002:115-117.
[9]史晓飞,付建斌.应重视类风湿关节炎流行病学伴发疾病致残率及就医行为的研究[J].中华风湿病学杂志,2014,18(7):433-436.
[10]田鑫,晏铭洋,王伟钢.中药外治法治疗类风湿关节炎的Meta分析[J].中华中医药杂志,2014,29(10):3282-3285.
[11]顾文,周春祥.中医外治法研究思路[J].中医杂志,2012,53(19):1642-1644.
[12]郭齐,李献平,王蕊,等.中医治疗类风湿性关节炎的药物探讨[J].世界中医药,2010,5(2):136-137.
[13]吴士杰.温经蠲痹汤治疗类风湿性关节炎108例[J].陕西中医,2011,32(9):1192-1193.
[14]金永健.温针灸治疗类风湿性关节炎56例临床观察[J].临床和实验医学杂志,2007,6(3):140.
[15]陈谦.复方丁公藤胶囊治疗风寒湿痹症344例临床疗效观察[J].中成药研究,1988(1)18-19.
[16]叶惠珍,范椰新,刘植蔚.丁公藤抗风湿有效成分的研究[J].中草药,1984,15(10):30.
[17]全国中草药汇编编写组.全国中草药汇编[M].北京:人民卫生出版社,1975.
[18]周名璐,许少伟,程新敏.复方丁公藤胶囊的消炎镇痛作用[J].中成药,1993,15(7):29-30.
[19]杨志平,宋志军,宁耀瑜,等.丁公藤注射液雾化吸入对大鼠呼吸道和全身免疫功能的影响[J].广西中医药,1998,21(5):45-46.
[20]方琴.肉桂的研究进展[J].中药新药与临床药理,2007,18(3):249-252.
[21]孙凤娇,李振麟,钱士辉,等.干姜化学成分和药理作用研究进展.中国野生植物资源,2015,34(3):34-37.
[22]夏菁,谢媛媛,张宗璇,等.骨通贴膏指纹图谱及化学成分研究[J].中成药,2014,36(3):571-576.