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中国临床药理学与治疗学 ›› 2005, Vol. 10 ›› Issue (8): 953-956.

• 研究原著 • 上一篇    下一篇

麝香通痹巴布膏治疗骨性关节炎(肝肾不足,筋脉瘀滞证)的临床研究

张琼, 肖京1, 邓磊1   

  1. 中国中医研究院西苑医院国家药品临床研究基地, 1骨科, 北京 100091
  • 收稿日期:2005-03-30 修回日期:2005-06-20 发布日期:2020-11-22
  • 通讯作者: 张琼,女,副主任医师,主要从事临床药理学研究。Tel:010-62875599-6486 E-mail:zhangq810@263.net

Clinical trial of shexiang tongbi babu mastic in treatment of patients with bony arthritis

ZHANG Qiong, XIAO Jing, DENG Lei   

  1. Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine, 1Department of orthopaedics, Beijing 100091, China
  • Received:2005-03-30 Revised:2005-06-20 Published:2020-11-22

摘要: 目的: 评价麝香通痹巴布膏治疗骨性关节炎(肝肾不足,筋脉瘀滞证)的临床有效性和安全性。方法: 试验采用分层区组、随机、单盲、阳性药平行对照、多中心临床试验方法,以通络祛痛膏作为对照药。本试验入组病例240例,脱落病例9例,脱落率为3.75%,剔除病例3例,剔除率为1.25%,完成病例228例。结果: 麝香通痹巴布膏组总有效率为88.70%,优于对照组通络祛痛膏组(79.65%)(P<0.05)。麝香通痹巴布膏组中医症状积分减少(P<0.01),夜间卧床休息时疼痛或不适、晨僵、起床后疼痛加重、日常活动膝关节疼痛症状明显改善,优于对照组(P<0.01)。结论: 麝香通痹巴布膏治疗骨性关节炎疗效确切,未发现毒副作用。

关键词: 麝香通痹巴布膏, 骨性关节炎, 肝肾不足, 筋脉瘀滞证, 中药疗法, 临床试验

Abstract: AIM: To evaluate the efficacy and safety of the shexiang tongbi babu mastic (STBM) in treatment of patients with bony arthritis.METHODS: 240 trail subjects were involved in a multi-center randomized, signal-blinded, and positive drug parallel-controlled clinical trail (the trial group treated with STBM, and the control group treated with the tongluo qutong mastic).115 patients were enrolled in the trial group, and 113 cases enrolled in the control group.RESULTS: The total effective rate of the trial group was 88.70%, and better than that in the control group (79.65%) (P <0.05).Compare with the trial group, there was a significant decrease on the level of symptom score in the trial group (P < 0.01).The trial group improved the symptoms, such as the pains and uncomfortable feelings and arthritis pains (P <0.01).CONCLUSION: STBM is an effective and safe agent against bony arthritis.

Key words: the shexiang tongbi babu mastic, bony arthritis, deficiency of liver and kidney, stasis of the channels, TCD therapy, clinical trial

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