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  

Treatment of knee arthritis by electronic moxibustion apparatus: a randomized,controlled,noninferiority clinical trial

作　　者：汤家铭[1] 黄继汉[2] 杨旭明[3] 张倩[4] 郑奉周 李璟[4] 鲁望[5] 薛堃 赵海音[5] TANG Jiaming;HUANG Jihan;YANG Xuming;ZHANG Qian;ZHENG Fengzhou;LI Jing;LU Wang;XUE Kun;ZHAO Haiyin(Laboratory Animal Center,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Center of Drug Clinical Research,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Acupuncture and Massage College,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Department of Acupuncture,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China;Department of Traditional therapy,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China)

机构地区：[1]上海中医药大学实验动物中心,上海201203 [2]上海中医药大学药物临床研究中心,上海201203 [3]上海中医药大学针推学院,上海201203 [4]上海中医药大学附属岳阳中西医结合医院针灸科,上海200437 [5]上海中医药大学附属龙华医院中医传统治疗部,上海200032

出　　处：《上海中医药杂志》2019年第1期57-61,共5页Shanghai Journal of Traditional Chinese Medicine

基　　金：国家"十二五"第二轮张江高科技园区中医药发展扶持项目(PZC2014-5)

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 moxibu

关 键 词：电子温灸仪 膝骨关节炎 临床试验 膝痛 膝关节功能 艾灸标准化 

分 类 号：R246.9[医药卫生—针灸推拿学]