[1]刘志伟 银河 陈忻 金哲峰 于杰 魏戌 王平 徐凡平 孙凯 唐彬 朱立国△.益肾养髓方治疗轻中度脊髓型颈椎病的疗效研究[J].中国中医骨伤科杂志,2022,30(08):36-40+45.
　LIU Zhiwei YIN He CHEN Xin JIN Zhefeng YU Jie WEI Xu WANG Ping XU Fanping SUN Kai TANG Bin ZHU Liguo.Efficacy of Yishenyangsui Granule on the Treatment of Mild to Moderate Cervical Spondylotic Myelopathy[J].Chinese Journal of Traditional Medical Traumatology & Orthopedics,2022,30(08):36-40+45.
点击复制

益肾养髓方治疗轻中度脊髓型颈椎病的疗效研究()
分享到：

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

卷:
第30卷
期数:
2022年08期
页码:
36-40+45
栏目:
临床研究
出版日期:
2022-08-15

文章信息/Info

Title:
Efficacy of Yishenyangsui Granule on the Treatment of Mild to Moderate Cervical Spondylotic Myelopathy
文章编号:
1005-0205(2022)08-0036-05
作者:
刘志伟1; 2 银河2; 3 陈忻2; 3 金哲峰2; 3 于杰2; 3 魏戌2; 3 王平4 徐凡平5 孙凯2; 3 唐彬2 朱立国2; 3△
1北京中医药大学(北京,100029) 2中国中医科学院望京医院 3中医正骨技术北京市重点实验室 4天津中医药大学第一附属医院 5首都医科大学附属北京中医医院
Author(s):
LIU Zhiwei1; 2 YIN He2; 3 CHEN Xin2; 3 JIN Zhefeng2; 3 YU Jie2; 3 WEI Xu2; 3 WANG Ping4 XU Fanping5 SUN Kai2; 3 TANG Bin2 ZHU Liguo2; 3△
1Beijing University of Chinese Medicine,Beijing 100029,China; 2Wangjing Hospital,China Academy of Chinese Medical Sciences,Beijing,100102,China; 3Beijing Key Laboratory of Orthopaedics of Traditional Chinese Medicine,Beijing 100102,China; 4First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300073,China; 5Beijing Hospital of Traditional Chinese Medicine,Beijing 100010,China.
关键词:
益肾养髓方;  脊髓型颈椎病;  轻中度;  多中心
Keywords:
Yishenyangsui granule;  cervical spondylotic myelopathy;  mild and moderate;  multi-center
分类号:
R681.5
文献标志码:
A
摘要:
目的:通过随机对照临床试验,评价益肾养髓方治疗轻中度脊髓型颈椎(CSM)病的疗效,并通过人群分层亚组分析益肾养髓方对轻度及中度脊髓型颈椎病患者的疗效。方法:2016年12月至2018年2月在3家医院共纳入152例病例,随机分为治疗组和对照组。两组均以甲钴胺片作为基础治疗,在此基础上治疗组口服益肾养髓方作为试验药物,对照组口服益肾养髓方模拟剂作为对照药物。两组均连续治疗8周,观察疗效。结果:治疗组受试者JOA评分为治疗后第8周(14.657±0.225)分,治疗后第32周(14.500±0.227)分,与治疗前(13.186±0.209)分比较均有增高,差异有统计学意义(P<0.01)。对照组受试者JOA评分为治疗后第8周(14.149±0.218)分,治疗后第32周(14.149±0.220)分,与治疗前(13.716±0.204)分比较均有增高,差异有统计学意义(P<0.01)。治疗组总有效率为71.64%,明显高于对照组的30.99%,差异有统计学意义(P<0.01)。治疗后第8周、第32周,治疗组轻度、中度CSM受试者JOA评分改善差值均明显高于对照组,差异有统计学意义(P<0.05)。治疗后第8周、第32周,治疗组组内比较,中度脊髓型颈椎病受试者JOA评分改善差值均大于轻度受试者,但差异无统计学意义(P>0.05)。结论:益肾养髓方可明显改善轻中度CSM患者功能,益肾养髓方对轻度及中度脊髓型颈椎病患者JOA评分改善差值差异不明显。
Abstract:
Objective:To evaluate the efficacy of Yishen-yangsui granule on the treatment of mild to moderate cervical spondylotic myelopathy through randomized controlled double-blind clinical trial and to explore the efficacy of Yishen- yangsui granule for stratified sample based on myelopathy severity.Methods:152 patients were enrolled in 3 hospitals from December 2016 to February 2018 and randomly divided into treatment group and control group.Both groups were treated with mecobalamin tablets as basic treatment.Furthermore,the treatment group took Yishenyangsui granule orally as the experimental intervention,and the control group took placebo orally as the control.Both groups were treated for 8 weeks and the efficacy was observed.Results:The JOA scores of subjects in the treatment group were(14.657±0.225)at week 8 and(14.500±0.227)at week 32,which were higher than baseline scores(13.186±0.209),and the differences were statistically significant(P<0.01).The JOA scores of the control group were(14.149±0.218)at week 8 and(14.149±0.220)at week 32,which were higher than baseline scores(13.716±0.204),and the differences were statistically significant(P<0.01).The total effective rate of the treatment group was 71.64%,which was significantly higher than that of the control group(30.99%),the difference was statistically significant(P<0.01).At week 8 and 32 after treating,the JOA score improvement in mild and moderate CSM patients in the treatment group was significantly higher than that in the control group(P<0.05).At week 8 and 32 after treating in the treatment group,the improvement of JOA score in subjects with moderate CSM was greater than that in subjects with mild CSM in the treatment group,but there was no statistical significance between the two groups(P>0.05).Conclusion:Yishenyangsui granule can obviously improve the function of patients with mild to moderate CSM,and there was no significant difference in the efficacy of Yishenyangsui granule for mild and moderate cervical spondylotic myelopathy.

参考文献/References:

[1] 吴亮,王强,王文博,等.脊髓型颈椎病发生创伤性颈髓中央综合征的危险因素分析[J].中国组织工程研究,2021,26(9):1388-1394.
[2] 宋永嘉,鲍嘉敏,周龙云,等.从“脊髓耐受性”视角探讨脊髓型颈椎病的治疗选择[J].中国中医骨伤科杂志,2021,29(10):77-80.
[3] KADAÑKA Z,BEDNAÍK J,NOVOTN O,et al.Cervical spondylotic myelopathy:conservative versus surgical treatment after 10 years[J].Eur Spine J,2011,20(9):1533-1538.
[4] 朱立国,唐彬,银河,等.益肾养髓方治疗脊髓型颈椎病35例[J].中国中医骨伤科杂志,2018,26(6):56-58.
[5] FEHLINGS M G,TETREAULT L A,RIEW K D,et al.A clinical practice guideline for the management of patients with degenerative cervical myelopathy:recommendations for patients with mild,moderate,and severe disease and nonmyelopathic patients with evidence of cord compression[J].Global Spine J,2017,7(3 Suppl):70S-83S.
[6] 中国康复医学会.颈椎病诊治与康复指南[M].北京:中国康复医学会,2010:1-13.
[7] KHAN I,ARCHER K R,WANNER J P,et al.QOD vanguard sites.trajectory of improvement in myelopathic symptoms from 3 to 12 months following surgery for degenerative cervical myelopathy[J].Neurosurgery,2020,86(6):763-768.
[8] OKADA Y,IKATA T,YAMADA H,et al.Magnetic resonance imaging study on the results of surgery for cervical compression myelopathy[J].Spine(Phila Pa 1976),1993,18(14):2024-2029.
[9] TETREAULT L,WILSON J R,KOTTER M R,et al.Predicting the minimum clinically important difference in patients undergoing surgery for the treatment of degenerative cervical myelopathy[J].Neurosurg Focus,2016,40(6):E14.
[10] 吴兴,李婵娟,丁伯福,等.两均数比较的优效性临床试验样本量估计[J].数理医药学杂志,2013,26(5):517-519.
[11] ZILELI M,BORKAR S A,SINHA S,et al.Cervical spondylotic myelopathy:natural course and the value of diagnostic techniques-WFNS spine committee recommendations[J].Neurospine,2019,16(3):386-402.
[12] 游景扬,郑勇,陈明,等.颈椎前路与后路手术治疗多节段脊髓型颈椎病疗效的Meta分析[J].中国骨伤,2017,30(1):71-78.
[13] LEES F,TURNER J W.Natural history and prognosis of cervi-cal spondylosis[J].Br Med J,1963,2(5373):1607-1610.
[14] TETREAULT L A,KARADIMAS S,WILSON J R,et al.The natural history of degenerative cervical myelopathy and the rate of hospitalization following spinal cord injury:an updated systematic review[J].Global Spine,2017,7(3 Suppl):28S-34S.
[15] MILLIGAN J,RYAN K,FEHLINGS M,et al.Degenerative cervical myelopathy:diagnosis and management in primary care[J].Can Fam Physician,2019,65(9):619-624.
[16] 张雪,罗汉华.颈椎病中西医病因病机研究[J].吉林中医药,2011,31(12):1177-1178.
[17] 张丽美,师彬.颈椎病中医辨证分型及中药治疗研究进展[J].中成药,2013,35(7):1522-1525.
[18] 秦晓宽,孙凯,朱立国,等.基于数据挖掘的中医药治疗脊髓型颈椎病用药规律探析[J].中国医药导报,2021,18(5):150-154.
[19] 齐保玉,孙凯,银河,等.益肾养髓方治疗脊髓损伤作用机制的网络药理学研究[J].世界科学技术-中医药现代化,2020,22(9):3178-3190.

备注/Memo

备注/Memo:
基金项目:中医药行业科研专项(201407001-11)
国家中医药管理局中医药创新团队及人才支持计划项目(ZYYCXTD-C-202003)
中国中医科学院优秀青年科技人才(创新类)培养专项(ZZ14-YQ-022)
△通信作者 E-mail:zhlg95@aliyun.com
更新日期/Last Update: 2022-08-15