电子温灸仪治疗膝骨关节炎的随机对照、非劣效性临床研究
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摘要
目的以传统艾灸疗法为对照,采用电子温灸仪(DZWJY-1型)治疗膝骨关节炎,评价该仪器的临床疗效及安全性。方法将124例膝骨关节炎患者随机分为电子温灸仪组与传统艾灸组,每组62例。电子温灸仪组采用DZWJY-1型电子温灸仪治疗,传统艾灸组采用传统艾灸疗法。两组疗程均为4周,观察临床疗效及安全性,比较膝痛VAS评分、WOMAC评分(总分及分项评分)的变化情况。结果 (1)试验期间,电子温灸仪组完成试验60例,脱落2例;传统艾灸组完成试验58例,脱落3例,剔除1例。(2)FAS分析结果显示,电子温灸仪组的显效率为75.81%、有效率为91.94%,传统艾灸组的显效率为68.85%、有效率为90.16%;组间临床疗效比较,差异无显著统计学意义(P>0.05)。电子温灸仪组与传统艾灸组有效率差值的95%可信区间为-9.05～12.77,按照预设15%非劣标准,非劣效检验合格。(3)治疗前及治疗2周、治疗4周组内分别比较,两组膝痛VAS评分差异均有统计学意义,均明显下降(P<0.01)。组间治疗2周、治疗4周比较,膝痛VAS评分差异均无统计学意义(P>0.05)。(4)治疗前及治疗2周、治疗4周组内分别比较,两组WOMAC总分及疼痛评分、僵直评分、活动难度评分差异均有统计学意义,均明显下降(P<0.01)。组间治疗2周、治疗4周比较,WOMAC总分及疼痛评分、僵直评分、活动难度评分差异均无统计学意义(P>0.05)。(5)两组不良反应发生率均为0%。结论电子温灸仪(DZWJY-1型)治疗膝骨关节炎的临床疗效不劣于传统艾灸疗法,可明显缓解疼痛,改善关节功能。
Objective To evaluate efficacy and safety of DZWJY-type 1 electronic moxibustion apparatus in treating patients of knee osteoarthritis with traditional moxibustion therapy as control. Methods One hundred and twenty-four patients with knee osteoarthritis were randomly divided intoelectronic moxibustion group and traditional moxibustion group with62 cases in each group. The electronic moxibustion group was treated with DZWJY-1 electronic moxibustion apparatus,and the traditional moxibustion group with traditional moxibustion therapy.The course of treatment in both groups was 4 weeks. The clinical efficacy and safety were observed and the changes of VAS score,WOMAC score( total score and sub-score) of knee pain were compared between the two groups. Results(1)The remarkablyeffective rate was 75.81% and the effective rate was 91.94%% in the electronic moxibustion group,and the remarkably effective rate was 68.85% and the effective rate was 90. 16% in the traditional moxibustion group. There was no significant difference between the two groups( P>0.05). The 95%confidence interval of the effective rate difference between the electronic moxibustion group and the traditional moxibustion group was-9. 05-12. 77.According to the 15% non-inferiority standard,the non-inferiority test was qualified.(2)There were significant differences in VAS scores between the two groups before and after 2 weeks and 4 weeks of treatment( P<0.01). But there was no significant difference in VAS score of knee pain between the two groups after 2 weeks and 4 weeks of treatment( P>0.05).(3)There were significant differences in total WOMAC score,pain score,rigidity score and activity difficulty score between the two groups before and after treatment for 2 weeks and 4 weeks( P<0.01). There was no significant difference in total WOMAC score,pain score,rigidity score and activity difficulty score between the two groups after 2 weeks and 4 weeks of treatment( P>0.05).(4)There were no adverse reactions occurring in both groups. Conclusion The clinical effect of electronic moxibustion apparatus( DZWJY-1) in the treatment of knee osteoarthritis is not inferior to that of traditional moxibustion therapy,which can obviously relieve pain and improve joint function.
Objective To evaluate efficacy and safety of DZWJY-type 1 electronic moxibustion apparatus in treating patients of knee osteoarthritis with traditional moxibustion therapy as control. Methods One hundred and twenty-four patients with knee osteoarthritis were randomly divided intoelectronic moxibustion group and traditional moxibustion group with62 cases in each group. The electronic moxibustion group was treated with DZWJY-1 electronic moxibustion apparatus,and the traditional moxibustion group with traditional moxibustion therapy.The course of treatment in both groups was 4 weeks. The clinical efficacy and safety were observed and the changes of VAS score,WOMAC score( total score and sub-score) of knee pain were compared between the two groups. Results(1)The remarkablyeffective rate was 75.81% and the effective rate was 91.94%% in the electronic moxibustion group,and the remarkably effective rate was 68.85% and the effective rate was 90. 16% in the traditional moxibustion group. There was no significant difference between the two groups( P>0.05). The 95%confidence interval of the effective rate difference between the electronic moxibustion group and the traditional moxibustion group was-9. 05-12. 77.According to the 15% non-inferiority standard,the non-inferiority test was qualified.(2)There were significant differences in VAS scores between the two groups before and after 2 weeks and 4 weeks of treatment( P<0.01). But there was no significant difference in VAS score of knee pain between the two groups after 2 weeks and 4 weeks of treatment( P>0.05).(3)There were significant differences in total WOMAC score,pain score,rigidity score and activity difficulty score between the two groups before and after treatment for 2 weeks and 4 weeks( P<0.01). There was no significant difference in total WOMAC score,pain score,rigidity score and activity difficulty score between the two groups after 2 weeks and 4 weeks of treatment( P>0.05).(4)There were no adverse reactions occurring in both groups. Conclusion The clinical effect of electronic moxibustion apparatus( DZWJY-1) in the treatment of knee osteoarthritis is not inferior to that of traditional moxibustion therapy,which can obviously relieve pain and improve joint function.
引文
[1]沈雪勇,丁光宏,褚君浩,等.传统艾灸与替代物灸和人体穴位红外辐射光谱比较[J].红外与毫米波学报,2003,22(2):123-126.
[2]欧阳海燕,刁作彬,李玉梅,等.一种实用电子灸疗仪的研制[J].中国自然医学杂志,2002,4(1):48-49.
[3]杨旭明,汤家铭.一种模拟传统艾灸电子温灸仪的研制:应用安全及环保效应[J].中国组织工程研究,2016,20(42):6337-6342.
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[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] SIVRIKAYA A,CELO F,SIVRIKAYA N,et al.The effect of diclofenac soditim and papaverine on isolated human ureteric smooth muscle[J].Int Urol Nephrol,2003,35(4):479-483.
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[11]余卫华,符文彬,战晓农,等.电子艾灸仪和温和灸治疗胃脘痛的比较[J].辽宁中医杂志,2007,34(6):814-815.
[12] WU Y C,WANG C M,ZHANG J F,et al.Clinical study on electronic moxibustion for shoulder periarthritis[J]. J Acupunct Tuina Sci,2012,10(6):377-382.
[13]冉海燕.电子艾灸仪治疗肺结核54例临床效果分析[J].西部医学,2014,26(1):56-57.
[14]蒋玲.电子艾灸仪和艾灸罐治疗老年患者习惯性便秘的效果观察[J].世界最新医学信息文摘,2015,15(72):102.
[15]林龄.电子艾灸仪和温和灸治疗痛经患者的疗效[J].医疗装备,2017,30(21):104-105.
[16]袁望舒,刘忠良,乔士兴,等.中、西医治疗膝骨性关节炎疗效的临床对比观察[J].中国老年杂志,2011,31(20):3931-3933.
[17]孙正平,聂斌,林晓洁,等.中医健康管理配合扶阳火艾灸治疗阳虚血瘀质膝骨性关节炎的疗效观察[J].按摩与康复医学,2017,8(11):9-11.
[18]苏兰芳,陈涛,阚仁惠.刮痧联合艾灸治疗非急性期膝关节炎的疗效观察[J].实用临床护理学杂志,2017,2(26):72-81.
[2]欧阳海燕,刁作彬,李玉梅,等.一种实用电子灸疗仪的研制[J].中国自然医学杂志,2002,4(1):48-49.
[3]杨旭明,汤家铭.一种模拟传统艾灸电子温灸仪的研制:应用安全及环保效应[J].中国组织工程研究,2016,20(42):6337-6342.
[4] American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee:2000 update[J]. Arthritis Rheum,2000,43(9):1905-1915.
[5]郑青山,孙瑞元,陈志杨.新药临床非劣性及等效性试验中的例数估计和等效标准[J].中国新药杂志,2003,12(5):369-371.
[6]中华人民共和国技术监督局.中华人民共和国国家标准·经穴部位(GB12346-90)[S].北京:中国标准出版社,1990:9.
[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] SIVRIKAYA A,CELO F,SIVRIKAYA N,et al.The effect of diclofenac soditim and papaverine on isolated human ureteric smooth muscle[J].Int Urol Nephrol,2003,35(4):479-483.
[9]协远,王大伟.骨科临床疗效评价标准[M].北京:人民卫生出版社,2005:275-277.
[10]李从林.多功能艾灸仪治疗腰腿痛60例[J].湖北中医杂志,1999,22(2):1.
[11]余卫华,符文彬,战晓农,等.电子艾灸仪和温和灸治疗胃脘痛的比较[J].辽宁中医杂志,2007,34(6):814-815.
[12] WU Y C,WANG C M,ZHANG J F,et al.Clinical study on electronic moxibustion for shoulder periarthritis[J]. J Acupunct Tuina Sci,2012,10(6):377-382.
[13]冉海燕.电子艾灸仪治疗肺结核54例临床效果分析[J].西部医学,2014,26(1):56-57.
[14]蒋玲.电子艾灸仪和艾灸罐治疗老年患者习惯性便秘的效果观察[J].世界最新医学信息文摘,2015,15(72):102.
[15]林龄.电子艾灸仪和温和灸治疗痛经患者的疗效[J].医疗装备,2017,30(21):104-105.
[16]袁望舒,刘忠良,乔士兴,等.中、西医治疗膝骨性关节炎疗效的临床对比观察[J].中国老年杂志,2011,31(20):3931-3933.
[17]孙正平,聂斌,林晓洁,等.中医健康管理配合扶阳火艾灸治疗阳虚血瘀质膝骨性关节炎的疗效观察[J].按摩与康复医学,2017,8(11):9-11.
[18]苏兰芳,陈涛,阚仁惠.刮痧联合艾灸治疗非急性期膝关节炎的疗效观察[J].实用临床护理学杂志,2017,2(26):72-81.