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Trials:循证中医推拿治疗与扶他林乳胶剂外用治疗膝骨关节炎的随机、平行对照多中心临床试验

2022-07-28 紫菀款冬 MedSci原创

为临床医生提供膝骨关节炎(KOA)患者的补充和替代治疗方法,并评估循证中医推拿治疗KOA与外用双氯芬酸二乙胺乳胶剂(扶他林)的疗效和安全性。

背景:推拿和局部应用非甾体抗炎药是治疗膝骨关节炎(KOA)的安全有效的方法;然而,中国不同的推拿技术流派给KOA的治疗带来了评估困难。为了规范推拿技术和程序,该研究在中国组织了多学科专家,以获取基于循证证据的中医推拿治疗膝骨关节炎的专家共识技术手法

目的:为临床医生提供KOA患者的补充和替代治疗,并评估循证中医推拿治疗KOA与外用双氯芬酸二乙胺乳胶剂(扶他林)的疗效和安全性。

方法和设计:一项随机对照试验,招募300名确诊为KOA的参与者,并按2:1的比例随机分配到实验组或对照组。200名参与者作为实验组,每周接受2次循证中医推拿,持续10周;100名参与者作为对照组,每天接受3-4次双氯芬酸二乙胺乳胶剂外用,持续10周。

两组患者分别在治疗开始后5周和10周的两个时间点接受随访。在基线检查和干预结束时进行MRI扫描和X射线检查。主要结局指标是美国西大略湖和麦克马斯特大学骨关节炎指数(WOMAC)的变化。次要结局指标将通过基于中医辨证思路构建的膝骨关节炎PRO量表[中国膝骨关节炎量表(CSKO)]、X射线评估和MRI扫描评估来衡量。

分析在基线检查时、治疗开始后5周和10周WOMAC和CSKO的数据。分析在基线检查时和干预结束时来自MRI扫描和X射线的数据。显著性水平设定为5%。每次治疗后评估干预措施的安全性。

讨论:该研究将通过对照试验为临床医生提供治疗KOA急需的知识。

文献来源:

Wen-Yue W, Ying-Peng X, Quan-Mao D, et al. A randomized, parallel control and multicenter clinical trial of evidence-based traditional Chinese medicine massage treatment VS External Diclofenac Diethylamine Emulgel for the treatment of knee osteoarthritis. Trials. 2022;23(1):555. Published 2022 Jul 8. doi:10.1186/s13063-022-06388-5

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    2022-09-05 zhzhxiang
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createdBy=21015, createdName=heli0118, createdTime=Tue Oct 25 11:44:20 CST 2022, time=2022-10-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2056950, encodeId=f5652056950de, content=<a href='/topic/show?id=bcb11e80913' target=_blank style='color:#2F92EE;'>#trials#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17809, encryptionId=bcb11e80913, topicName=trials)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4ba8129, createdName=zhzhxiang, createdTime=Mon Sep 05 05:44:20 CST 2022, time=2022-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1747061, encodeId=85981e470619c, content=<a href='/topic/show?id=495385896b5' target=_blank style='color:#2F92EE;'>#膝骨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85896, encryptionId=495385896b5, topicName=膝骨)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a9de34, createdName=zhangpaul93, createdTime=Thu Sep 15 09:44:20 CST 2022, time=2022-09-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1775656, encodeId=9f4d1e756561d, content=<a href='/topic/show?id=937d46650bf' target=_blank style='color:#2F92EE;'>#对照#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46650, encryptionId=937d46650bf, topicName=对照)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8ae138776909, createdName=amyloid, createdTime=Tue Sep 13 17:44:20 CST 2022, time=2022-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2026741, encodeId=bd702026e4135, content=<a href='/topic/show?id=e0b110159578' target=_blank style='color:#2F92EE;'>#骨关节#</a>, beContent=null, objectType=article, 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631333, encodeId=34b4163133392, content=<a href='/topic/show?id=ae581e80805' target=_blank style='color:#2F92EE;'>#Trial#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17808, encryptionId=ae581e80805, topicName=Trial)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c1ad21715548, createdName=feifers, createdTime=Thu Jul 14 14:44:20 CST 2022, time=2022-07-14, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1722663, encodeId=4e4b1e226633b, content=<a href='/topic/show?id=c97856e71ff' target=_blank style='color:#2F92EE;'>#推拿治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56771, encryptionId=c97856e71ff, topicName=推拿治疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=83c433283387, createdName=医生2405, createdTime=Mon Jun 19 23:44:20 CST 2023, time=2023-06-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1904140, encodeId=820619041406b, content=<a href='/topic/show?id=7d454302945' target=_blank style='color:#2F92EE;'>#多中心#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43029, encryptionId=7d454302945, topicName=多中心)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=21015, createdName=heli0118, createdTime=Tue Oct 25 11:44:20 CST 2022, time=2022-10-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2056950, encodeId=f5652056950de, content=<a href='/topic/show?id=bcb11e80913' target=_blank style='color:#2F92EE;'>#trials#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17809, encryptionId=bcb11e80913, topicName=trials)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4ba8129, createdName=zhzhxiang, createdTime=Mon Sep 05 05:44:20 CST 2022, time=2022-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1747061, encodeId=85981e470619c, content=<a href='/topic/show?id=495385896b5' target=_blank style='color:#2F92EE;'>#膝骨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85896, encryptionId=495385896b5, topicName=膝骨)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a9de34, createdName=zhangpaul93, createdTime=Thu Sep 15 09:44:20 CST 2022, time=2022-09-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1775656, encodeId=9f4d1e756561d, content=<a href='/topic/show?id=937d46650bf' target=_blank style='color:#2F92EE;'>#对照#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46650, encryptionId=937d46650bf, topicName=对照)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8ae138776909, createdName=amyloid, createdTime=Tue Sep 13 17:44:20 CST 2022, time=2022-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2026741, encodeId=bd702026e4135, content=<a href='/topic/show?id=e0b110159578' target=_blank style='color:#2F92EE;'>#骨关节#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101595, encryptionId=e0b110159578, topicName=骨关节)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=373b263, createdName=lisa438, createdTime=Tue Jun 27 19:44:20 CST 2023, time=2023-06-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1266500, encodeId=967e126650032, content=<a href='/topic/show?id=57a53011364' target=_blank style='color:#2F92EE;'>#关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30113, encryptionId=57a53011364, topicName=关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f90281, createdName=lmm397, createdTime=Thu Jul 14 14:44:20 CST 2022, time=2022-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1269269, encodeId=5226126926972, content=<a href='/topic/show?id=59088589e97' target=_blank style='color:#2F92EE;'>#膝骨关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85897, encryptionId=59088589e97, topicName=膝骨关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f5e185, createdName=zlawrance, createdTime=Thu Jul 14 14:44:20 CST 2022, time=2022-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1449818, encodeId=b8401449818fc, content=<a href='/topic/show?id=0bd850468be' target=_blank style='color:#2F92EE;'>#循证#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50468, encryptionId=0bd850468be, topicName=循证)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fca95510093, createdName=xjy04, createdTime=Thu Jul 14 14:44:20 CST 2022, time=2022-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631333, encodeId=34b4163133392, content=<a href='/topic/show?id=ae581e80805' target=_blank style='color:#2F92EE;'>#Trial#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17808, encryptionId=ae581e80805, topicName=Trial)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c1ad21715548, createdName=feifers, createdTime=Thu Jul 14 14:44:20 CST 2022, time=2022-07-14, status=1, ipAttribution=)]
    2022-09-13 amyloid
  6. [GetPortalCommentsPageByObjectIdResponse(id=1722663, encodeId=4e4b1e226633b, content=<a href='/topic/show?id=c97856e71ff' target=_blank style='color:#2F92EE;'>#推拿治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56771, encryptionId=c97856e71ff, topicName=推拿治疗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=83c433283387, createdName=医生2405, createdTime=Mon Jun 19 23:44:20 CST 2023, time=2023-06-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1904140, encodeId=820619041406b, content=<a href='/topic/show?id=7d454302945' target=_blank style='color:#2F92EE;'>#多中心#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43029, encryptionId=7d454302945, topicName=多中心)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=21015, createdName=heli0118, createdTime=Tue Oct 25 11:44:20 CST 2022, time=2022-10-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2056950, encodeId=f5652056950de, content=<a href='/topic/show?id=bcb11e80913' target=_blank style='color:#2F92EE;'>#trials#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17809, encryptionId=bcb11e80913, topicName=trials)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4ba8129, createdName=zhzhxiang, createdTime=Mon Sep 05 05:44:20 CST 2022, time=2022-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1747061, encodeId=85981e470619c, content=<a href='/topic/show?id=495385896b5' target=_blank style='color:#2F92EE;'>#膝骨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85896, encryptionId=495385896b5, topicName=膝骨)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a9de34, createdName=zhangpaul93, createdTime=Thu Sep 15 09:44:20 CST 2022, time=2022-09-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1775656, encodeId=9f4d1e756561d, content=<a href='/topic/show?id=937d46650bf' target=_blank style='color:#2F92EE;'>#对照#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46650, encryptionId=937d46650bf, topicName=对照)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8ae138776909, createdName=amyloid, createdTime=Tue Sep 13 17:44:20 CST 2022, time=2022-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2026741, encodeId=bd702026e4135, content=<a href='/topic/show?id=e0b110159578' target=_blank style='color:#2F92EE;'>#骨关节#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101595, encryptionId=e0b110159578, topicName=骨关节)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=373b263, createdName=lisa438, createdTime=Tue Jun 27 19:44:20 CST 2023, time=2023-06-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1266500, encodeId=967e126650032, content=<a href='/topic/show?id=57a53011364' target=_blank style='color:#2F92EE;'>#关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30113, encryptionId=57a53011364, topicName=关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f90281, createdName=lmm397, createdTime=Thu Jul 14 14:44:20 CST 2022, time=2022-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1269269, encodeId=5226126926972, content=<a href='/topic/show?id=59088589e97' target=_blank style='color:#2F92EE;'>#膝骨关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85897, encryptionId=59088589e97, topicName=膝骨关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f5e185, createdName=zlawrance, createdTime=Thu Jul 14 14:44:20 CST 2022, time=2022-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1449818, encodeId=b8401449818fc, content=<a href='/topic/show?id=0bd850468be' target=_blank style='color:#2F92EE;'>#循证#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50468, encryptionId=0bd850468be, topicName=循证)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fca95510093, createdName=xjy04, createdTime=Thu Jul 14 14:44:20 CST 2022, time=2022-07-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631333, encodeId=34b4163133392, content=<a href='/topic/show?id=ae581e80805' target=_blank style='color:#2F92EE;'>#Trial#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17808, encryptionId=ae581e80805, topicName=Trial)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c1ad21715548, createdName=feifers, createdTime=Thu Jul 14 14:44:20 CST 2022, time=2022-07-14, status=1, ipAttribution=)]
    2023-06-27 lisa438
  7. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1631333, encodeId=34b4163133392, content=<a href='/topic/show?id=ae581e80805' target=_blank style='color:#2F92EE;'>#Trial#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17808, encryptionId=ae581e80805, topicName=Trial)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c1ad21715548, createdName=feifers, createdTime=Thu Jul 14 14:44:20 CST 2022, time=2022-07-14, status=1, ipAttribution=)]
    2022-07-14 lmm397
  8. 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    2022-07-14 xjy04
  10. 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    2022-07-14 feifers

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