| 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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| 引用本文： | 汤家铭,黄继汉,杨旭明,张倩,郑奉周,李璟,鲁望,薛堃,赵海音.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[J].上海中医药杂志,2019,53(1):55-61. |
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| 作者姓名： | 汤家铭 黄继汉 杨旭明 张倩 郑奉周 李璟 鲁望 薛堃 赵海音 |
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| 作者单位： | 上海中医药大学实验动物中心;上海中医药大学药物临床研究中心;上海中医药大学针推学院;上海中医药大学附属岳阳中西医结合医院针灸科;上海中医药大学附属龙华医院中医传统治疗部 |
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| 基金项目： | 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) |
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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(P0.05)。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(P0.01)。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(P0.05)。(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(P0.01)。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(P0.05)。(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。
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| 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 |
| 收稿时间： | 2018/6/8 0:00:00 |
Treatment of knee arthritis by electronic moxibustion apparatus:a randomized, controlled, non-inferiority clinical trialRandom control,non-inferiority clinical studies on treatment of knee arthritis by Electronic Moxibustion Apparatus |
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| TANG Jiaming,HUANG Jihan,YANG Xuming,ZHANG Qian,ZHENG Fengzhou,LI Jing,LU Wang,XUE Kun and ZHAO Haiyin.Treatment of knee arthritis by electronic moxibustion apparatus:a randomized, controlled, non-inferiority clinical trialRandom control,non-inferiority clinical studies on treatment of knee arthritis by Electronic Moxibustion Apparatus[J].Shanghai Journal of Traditional Chinese Medicine,2019,53(1):55-61. |
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| Authors: | TANG Jiaming HUANG Jihan YANG Xuming ZHANG Qian ZHENG Fengzhou LI Jing LU Wang XUE Kun and ZHAO Haiyin |
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| Institution: | 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 Acupuncture,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,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,Department of Traditional therapy,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China and Department of Traditional therapy,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China |
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