[1]高景华 王宝剑 高春雨△ 杨克新 罗杰 许劲羽 张陆.舒筋健腰丸治疗腰椎间盘突出症(肝肾不足,风湿瘀阻证)的多中心随机对照试验[J].中国中医骨伤科杂志,2019,27(09):11-14.
　GAO Jinghua WANG Baojian GAO Chunyu YANG Kexin LUO Jie XU Jinyu.Multicenter Randomized Controlled Trial of Shujinjianyao Pill in the Treatment of Lumbar Disc Herniation (Ganshenbuzu and Fengshiyuzu Syndrome)[J].Chinese Journal of Traditional Medical Traumatology & Orthopedics,2019,27(09):11-14.
点击复制

舒筋健腰丸治疗腰椎间盘突出症(肝肾不足,风湿瘀阻证)的多中心随机对照试验()
分享到：

《中国中医骨伤科杂志》[ISSN:1005-0205/CN:42-1340/R]

卷:
第27卷
期数:
2019年09期
页码:
11-14
栏目:
临床研究
出版日期:
2019-09-08

文章信息/Info

Title:
Multicenter Randomized Controlled Trial of Shujinjianyao Pill in the Treatment of Lumbar Disc Herniation (Ganshenbuzu and Fengshiyuzu Syndrome)
文章编号:
1005-0205(2019)09-0011-04
作者:
高景华1 王宝剑1 高春雨1△ 杨克新1 罗杰1 许劲羽2 张陆3
1中国中医科学院望京医院(北京,100102)2阳江市中医医院
Author(s):
GAO Jinghua1 WANG Baojian1 GAO Chunyu1△ YANG Kexin1 LUO Jie1 XU Jinyu2
1Wangjing Hospital,Chinese Academy of Chinese Medicine,Beijing 100102,China; 2Yangjiang Hospital of Chinese Medicine,Yangjiang 529500,Guangdong China; 3Zhengzhou People's Hospital,Zhengzhou 450053,China; 4Hebei University Affiliated Hospital,Baoding 071000,Hebei China;
关键词:
腰椎间盘突出症;  舒筋健腰丸;  临床研究
Keywords:
Shujinjianyao pill;  lumbar disc herniation;  randomized controlled trial
分类号:
R681.5
文献标志码:
A
摘要:
目的:观察舒筋健腰丸治疗腰椎间盘突出症(肝肾不足,风湿瘀阻证)的临床疗效及安全性。方法:采用多中心、随机、对照临床研究方案,将符合纳入标准的腰椎间盘突出症患者240例随机分为两组,试验组180例,对照组60例。两组患者基本资料差异无统计学意义(P>0.05),具有可比性。试验组口服舒筋健腰丸与腰痹通胶囊模拟剂,对照组口服舒筋健腰丸模拟剂与腰痹通胶囊,两组疗程均为4周。观察治疗前第14天和第28天的腰痛及下肢窜痛VAS评分、中医证候积分、简化McGill疼痛量表评分、JOA评分、Oswestry功能障碍指数(ODI),并记录不良反应。结果:两组在腰痛及下肢窜痛VAS评分、中医证候总积分、简化McGill疼痛量表评分、JOA评分、ODI评分方面基线、第14天和第28天的组内比较差异均有统计学意义(P<0.01),两组在第28天腰痛及下肢窜痛VAS评分和中医证候总积分的组间比较差异有统计学意义(P<0.05); 两组在腰痛及下肢窜痛VAS评分和中医证候总积分的变化上(治疗前减第28天)组间比较差异有统计学意义(P<0.05); 第28天两组中医证候总有效率的差异有统计学意义(P<0.05),而JOA评分总有效率差异无统计学意义(P>0.05)。两组不良事件以及严重不良事件的发生率差异均无统计学意义(P>0.05)。结论:舒筋健腰丸用于治疗肝肾不足,风湿瘀阻型腰椎间盘突出症的疗效确切,尤其在改善腰腿疼痛程度以及中医证候积分方面具有优势,且具有较高的安全性。
Abstract:
Objective:To observe the clinical efficacy and safety of Shujinjianyao Pill in the treatment of LDH(lumbar disc herniation)(Ganshenbuzu and Fengshiyuzu syndrome).Methods:240 LDH patients who met the inclusion criteria were randomly divided into two groups,180 in the experimental group and 60 in the control group.There was no significant difference in the basic data between the two groups,which was comparable.The experimental group was given Shujinjianyao pill and Yaobitong capsule simulator orally,while the control group was given Shujinjianyao pill simulator and Yaobitong capsule orally.The treatment course of the two groups was 4 weeks.The VAS score,TCM(Traditonal Chinese Medcine)syndrome total score,simplified McGill pain scale score,JOA score,ODI(Oswestry dysfunction index)on day 0,14 and 28 of treatment were observed,and adverse reactions were recorded.Results:There were significant differences in VAS score,TCM syndrome total score,simplified McGill pain scale score,JOA score,ODI between two groups at baseline,14 d and 28 d(P<0.01).

参考文献/References:

[1] 胥少汀,葛宝丰,徐印坎.实用骨科学[M].北京:人民军医出版社,2005:1021-1030. [2] 唐福宇,黄承军,徐敏,等.腰椎间盘突出症的中医药治疗进展[J].中国中医骨伤科杂志,2009,13(5):68-70. [3] 国家食品药品监督管理局.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:356-359. [4] 国家中医药管理局.中医病症诊断疗效标准[M].南京:南京大学出版社,1994:201. [5] 贾龙,张华.手法结合其他中医疗法治疗腰椎间盘突出症的研究进展[J].中国中医骨伤科杂志,2016,24(10):75-78. [6] 刘志超,张帆,祝永刚,等.身痛逐瘀汤方对椎间盘退变中PI3K/AKT通路影响的研究[J].中国中医骨伤科杂志,2018,26(10):14-19. [7] 朱宇,刘锦涛,姜宏.益气活血方促进破裂型腰椎间盘突出重吸收的机制研究[J].中国中医骨伤科杂志,2015,23(9):1-4. [8] 石洪超,欧慧瑜,何风雷,等.舒筋健腰丸对坐骨神经痛大鼠坐骨神经组织及血清细胞因子的影响[J].中国医药导报,2017,14(22):11-15. [9] 谢琳,吴启富,王笑丹,等.舒筋健腰丸对骨关节炎大鼠关节软骨和血清中细胞因子的影响[J].今日药学,2014,24(12):862-865.

备注/Memo

备注/Memo:
基金项目:广东省科技计划项目(2013A032500020)△通信作者 E-mail:gaochunyu8526@qq.com(收稿日期:2019-04-08)
更新日期/Last Update: 2019-09-08