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

卷:

第34卷

期数:

2026年01期

页码:

20-27

栏目:

脊柱脊髓疾病

出版日期:

2026-01-15

文章信息/Info

Title:

A Multi-Center Randomized Controlled Clinical Trial on Guizhi Decoction-Based Formulations for Treating Cervical Spondylotic Radiculopathy(Taiyang Disease)

文章编号:

1005-0205(2026)01-0020-08

作者:

段嘉豪1; 杨雷1; 陈龙1; 杨少锋1△; 冯帅华2; 伍星3; 段建辉4; 伍玉元8; 李巍6; 周新5; 胡耀祖7; 赵敏9; 孙江波10; 尹书东11; 杨勋波12

¹湖南中医药大学第一附属医院(长沙,410007)
²湖南省中西医结合医院
³长沙市中医医院
⁴常德市第一中医医院
⁵邵阳市中医医院
⁶湘潭市中医医院
⁷益阳市第一中医医院
⁸怀化市中医医院
⁹湘潭县中医医院
¹⁰正大邵阳骨伤科医院
¹¹常宁市中医医院
¹²株洲市中医伤科医院

Author(s):

DUAN Jiahao1; YANG Lei1; CHEN Long1; YANG Shaofeng1△; FENG Shuaihua2; WU Xing3; DUAN Jianhui4; WU Yuyuan8; LI Wei6; ZHOU Xin5; HU Yaozu7; ZHAO Min9; SUN Jiangbo10; YIN Shudong11; YANG Xunbo12

1.The First Hospital of Hunan University of Chinese Medicine,Changsha 410007, China; 2.Hunan Provincial Hospital of Integrated Traditional Chinese and Western Medicine,Changsha 410006,China; 3.Changsha Hospital of Traditional Chinese Medicine,Changsha 410100,China; 4.The First Hospital of Traditional Chinese Medicine of Changde,Changde 415000,Hunan China; 5.Shaoyang Hospital of Traditional Chinese Medicine,Shaoyang 422000,Hunan China; 6.Xiangtan Chinese Medicine Hospital,Xiangtan 411110,Hunan China; 7.Yiyang First Hospital of Traditional Chinese Medicine,Yiyang 413000,Hunan China; 8.Huaihua Hospital of Traditional Chinese Medicine,Huaihua 418000,Hunan China; 9.Xiangtan County Hospital of Traditional Chinese Medicine,Xiangtan 411228,Hunan China; 10.Zhengda Shaoyang Orthopedics Hospital,Xinshao 422999,Hunan China; 11.Changning Hospital of Traditional Chinese Medicine,Changning 421500,Hunan China; 12.Zhuzhou Hospital of Traditional Chinese Orthopedics,Zhuzhou 412007,Hunan China.

关键词:

神经根型颈椎病;  六经辨证;  桂枝汤类方;  随机对照试验;  临床疗效

Keywords:

cervical spondylotic radiculopathy;  six-meridian syndrome differentiation;  Guizhi decoction-based formulations;  randomized controlled trial;  clinical efficacy

分类号:

R681.5

DOI:

10.20085/j.cnki.issn1005-0205.260104

文献标志码:

A

摘要:

目的:采用多中心随机对照临床试验,探讨桂枝汤类方治疗神经根型颈椎病(CSR)的临床疗效及安全性。方法:在湖南省12家医疗机构开展多中心、分层随机、对照临床试验,纳入440例神经根型颈椎病患者,按六经辨证分为五个证型,每证型内患者按1:1随机分配至经方组(桂枝加葛根汤、桂枝新加汤、桂枝附子汤、麻黄附子细辛汤或柴胡桂枝汤)或对照组(塞来昔布+甲钴胺)。主要结局终点为治疗第4周疼痛视觉模拟量表(VAS)评分变化,次要结局终点包括第1周和第2周VAS评分、颈椎功能障碍指数(NDI)评分、中医证候评分、复发率及安全性。不良事件按CTCAE v5.0分级。结果:各组基线资料可比,差异无统计学意义(P>0.05)。治疗第1周对照组VAS评分与NDI评分下降幅度显著优于经方组,差异有统计学意义(P<0.05); 第2周组间差异缩小; 第4周及第12周随访,经方组VAS评分与NDI评分改善幅度显著优于对照组,差异有统计学意义(P<0.05)。中医证候评分经方组改善优于对照组,差异自第2周起显著,差异有统计学意义(P<0.05)。意向性治疗集(ITT)分析显示,经方组总有效率为78.9%～86.2%,对照组为71.1%～79.3%,差异有统计学意义(χ²检验,P<0.05)。第12周随访,经方组复发率为5.3%～7.9%,显著低于对照组的10.5%～15.8%,差异有统计学意义(P=0.022)。不良事件发生率低且两组差异无统计学意义(P>0.05)。结论:六经辨证指导下桂枝汤类方治疗神经根型颈椎病(太阳病及太阳少阳/少阴合病)在缓解疼痛、改善功能与证候方面具有确切优势,且安全性良好,为中医临床治疗提供了循证依据。

Abstract:

Objective:To investigate the clinical efficacy and safety of Guizhi Decoction-based formulations in treating cervical spondylotic radiculopathy(CSR)through a multicenter,randomized controlled trial.Methods:This multicenter,stratified,randomized,controlled clinical trial enrolled 440 CSR patients from 12 medical institutions in Hunan Province.Patients were classified into five syndrome types according to six-meridian syndrome differentiation.Within each syndrome type,patients were randomly assigned(1:1)to either the Jingfang group(receiving Guizhi+Gegen decoction,Guizhi Xinjia decoction,Guizhi Fuzi decoction,Mahuang Fuzi Xixin decoction,or Chaihu Guizhi decoction)or the control group(receiving celecoxib and mecobalamin).The primary endpoint was the change in visual analogue scale(VAS)score at week 4.Secondary endpoints included VAS scores at weeks 1 and 2,neck disability index(NDI),TCM syndrome score,recurrence rate,and safety.Adverse events were graded according to CTCAE v5.0.Results:Baseline characteristics were comparable between groups(P>0.05).At week 1,the reduction in VAS scores and NDI scores was significantly greater in the control group than in the Jingfang group(P<0.05).The intergroup difference narrowed by week 2.At week 4 and at the 12-week follow-up,the improvement in VAS and NDI scores was significantly greater in the Jingfang group than in the control group(all P<0.05).Improvement in TCM syndrome scores was superior in the Jingfang group,with the difference becoming significant from week 2 onwards(P<0.05).Intention-to-treat(ITT)analysis showed that the total effective rate was 78.9%86.2% in the Jingfang group,significantly higher than that in the control group(71.1%79.3%)(χ² test,P<0.05).At the 12-week follow-up,the recurrence rate was 5.3%7.9% in the Jingfang group,significantly lower than the 10.5%15.8% in the control group(P=0.022).The incidence of adverse events was low and not significantly different between the two groups.Conclusion:Guizhi decoction-based formulations,guided by six-meridian syndrome differentiation,demonstrate definite advantages in alleviating pain,improving function,and relieving TCM syndromes in patients with cervical spondylotic radiculopathy(Taiyang disease),with a favorable safety profile,providing evidence-based support for clinical treatment with traditional Chinese medicine.

备注/Memo

备注/Memo:

基金项目:湖南省中医药管理局委托课题(D2023004)
^△通信作者 E-mail: 574996585@qq.com

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更新日期/Last Update: 2026-01-15