[1]王晓东,于杰,李嘉钰,等.益肾养髓方联合甲钴胺治疗脊髓型颈椎病肝肾亏虚证的临床研究[J].中医正骨,2019,31(02):26-30.
　WANG Xiaodong,YU Jie,LI Jiayu,et al.A clinical study of oral applications of Yishen Yangsui Fang(益肾养髓方)and mecobalamin for treatment of cervical spondylotic myelopathy with liver-kidney deficiency syndrome[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2019,31(02):26-30.
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益肾养髓方联合甲钴胺治疗脊髓型颈椎病肝肾亏虚证的临床研究()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第31卷
期数:
2019年02期
页码:
26-30
栏目:
临床研究
出版日期:
2019-02-20

文章信息/Info

Title:
A clinical study of oral applications of Yishen Yangsui Fang(益肾养髓方)and mecobalamin for treatment of cervical spondylotic myelopathy with liver-kidney deficiency syndrome
作者:
王晓东1; 于杰2; 李嘉钰1; 张玉亮1; 金鸿宾3
(1.天津中医药大学第一附属医院,天津 300193; 2.中国中医科学院望京医院,北京 100102; 3.天津市天津医院,天津 300211)
Author(s):
WANG Xiaodong1; YU Jie2; LI Jiayu1; ZHANG Yuliang1; JIN Hongbin3
1.The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China 2.Wangjing Hospital of China Academy of Chinese Medical Sciences,Beijing 100102,China; 3.Tianjin Hospital,Tianjin 30021,China
关键词:
颈椎病;  益肾养髓方;  甲钴胺;  临床试验
Keywords:
cervical spondylosis;  Yishen Yangsui decoction;  Mecobalamin;  clinical trial
摘要:
目的:观察益肾养髓方和甲钴胺联合应用治疗脊髓型颈椎病肝肾亏虚证的临床疗效和安全性。方法:将符合要求的脊髓型颈椎病肝肾亏虚证患者随机分为2组,益肾养髓方组口服益肾养髓方颗粒和甲钴胺片,甲钴胺组口服甲钴胺片和安慰剂。益肾养髓方颗粒每次口服10 g,每日2次,连服8周; 甲钴胺片每次口服0.5 mg,每日3次,连服8周; 安慰剂每次口服10 g,每日2次,连服8周。分别于治疗前、治疗开始4周后、治疗结束后进行观察。观察指标包括日本骨科学会(Japanese Orthopedic Association,JOA)脊髓型颈椎病评分、颈椎功能障碍指数(the neck disability index,NDI)、心率、血压、脉搏、呼吸及不良反应。治疗结束后参照《中药新药临床研究指导原则(试行版)》中颈椎病的疗效判定标准评定总体疗效。结果:①一般情况。纳入研究的患者共100例,每组各50例。试验过程中有8例患者被剔除,其中益肾养髓方组2例、甲钴胺组6例,原因均为患者未按要求服药或未能坚持治疗。2组最终纳入的患者在各观察时点的心率、血压、脉搏、呼吸指标均未见异常,也未出现其他不良反应。②JOA评分。时间因素与分组因素存在交互效应(F=1.612,P=0.002)。2组JOA评分总体比较,差异无统计学意义,即不存在分组效应(F=0.746,P=0.325)。治疗前后不同时点之间JOA评分的差异有统计学意义,即存在时间效应(F=0.878,P=0.034)。2组JOA评分随时间变化均呈增加趋势,但2组的增加趋势不完全一致; 治疗前及治疗开始4周后,2组的JOA评分比较,组间差异均无统计学意义[(12.86±2.25)分,(13.63±1.63)分,t=0.520,P=0.660;(14.53±2.16)分,(14.06±1.71)分,t=0.720,P=0.367]; 治疗结束后益肾养髓方组的JOA评分高于甲钴胺组[(15.60±2.18)分,(14.21±1.75)分,t=0.976,P=0.031]。③NDI。时间因素与分组因素存在交互效应(F=1.601,P=0.000)。2组NDI总体比较,差异有统计学意义,即存在分组效应(F=1.021,P=0.000)。治疗前后不同时点之间NDI的差异有统计学意义,即存在时间效应(F=1.018,P=0.001)。2组NDI随时间变化均呈降低趋势,但2组的降低趋势不完全一致; 治疗前2组的NDI比较,差异无统计学意义[(26.80±9.65)%,(30.55±14.19)%,t=0.766,P=0.304]; 治疗开始4周后及治疗结束后,益肾养髓方组的NDI均低于甲钴胺组[(18.41±9.89)%,(27.82±14.34)%,t=0.989,P=0.014;(12.61±7.87)%,(23.87±13.26)%,t=0.999,P=0.000]。④总体疗效。治疗结束时益肾养髓方组的总体疗效优于甲钴胺组((-overR)益肾养髓方组=29.83,(-overR)甲钴胺组=64.68,Z=-6.580,P=0.000)。结论:益肾养髓方联合甲钴胺口服可有效改善脊髓型颈椎病肝肾亏虚证患者的临床症状和体征,安全性较高,疗效优于单纯口服甲钴胺治疗。
Abstract:
Objective:To observe the clinical curative effects and safety of oral applications of Yishen Yangsui Fang(益肾养髓方,YSYSF)and mecobalamin for treatment of cervical spondylotic myelopathy(CSM)with liver-kidney deficiency syndrome.Methods:The patients with liver-kidney-deficiency type CSM enrolled in the study were randomly divided into 2 groups,and were treated with combination therapy of oral applications of YSYSF granules and mecobalamin tablets(YSYSF group)and combination therapy of oral applications of mecobalamin tablets and placebos(mecobalamin group)respectively.The YSYSF granules were taken for consecutive 8 weeks,two times a day,10 g at a time.The mecobalamin tablets were taken for consecutive 8 weeks,three times a day,0.5 mg at a time.The placebos were taken for consecutive 8 weeks,two times a day,10 g at a time.Japanese Orthopedic Association(JOA)CSM scores,the neck disability index(NDI),heart rate,blood pressure,pulse,respiration and adverse reactions were observed before treatment,after 4-week treatment and after the end of the treatment respectively.The total curative effects were evaluated after the end of the treatment according to the therapeutic effect evaluation standard of cervical spondylopathy which was extracted from Guiding principles of clinical research on new Chinese medicine(try out).Results:One hundred patients were enrolled in the study,50 cases in each group.Two patients in YSYSF group and 6 patients in mecobalamin group were excluded for failing to take medication or finish the treatment as required.The examination results of heart rate,blood pressure,pulse and respiration were normal and no adverse reactions were found at each observation timepoint in patients of the 2 groups.There was interaction between time factor and group factor in JOA scores(F=1.612,P=0.002).There was no statistical difference in JOA scores between the 2 groups in general,in other words,there was no group effect(F=0.746,P=0.325).There was statistical difference in JOA scores between different timepoints before and after the treatment,in other words,there was time effect(F=0.878,P=0.034).The JOA scores presented a time-dependent increasing trend in both of the 2 groups,while the 2 groups were inconsistent with each other in the increasing trend of JOA scores.There was no statistical difference in JOA scores between the 2 groups before treatment and after 4-week treatment(12.86+/-2.25 vs 13.63+/-1.63 points,t=0.520,P=0.660; 14.53+/-2.16 vs 14.06+/-1.71 points,t=0.720,P=0.367).The JOA scores were higher in YSYSF group compared to mecobalamin group after the end of the treatment(15.60+/-2.18 vs 14.21+/-1.75 points,t=0.976,P=0.031).There was interaction between time factor and group factor in NDI(F=1.601,P=0.000).There was statistical difference in NDI between the 2 groups in general,in other words,there was group effect(F=1.021,P=0.000).There was statistical difference in NDI between different timepoints before and after the treatment,in other words,there was time effect(F=1.018,P=0.001).The NDI presented a time-dependent decreasing trend in both of the 2 groups,while the 2 groups were inconsistent with each other in the increasing trend of NDI.There was no statistical difference in NDI between the 2 groups before treatment(26.80+/-9.65 vs 30.55+/-14.19%,t=0.766,P=0.304).The NDI was lower in YSYSF group compared to mecobalamin group after 4-week treatment and after the end of the treatment(18.41+/-9.89 vs 27.82+/-14.34%,t=0.989,P=0.014; 12.61+/-7.87 vs 23.87+/-13.26%,t=0.999,P=0.000).The YSYSF group surpassed the mecobalamin group in total curative effect at the end of treatment((-overR)YSYSF group=29.83,(-overR)mecobalamin group=64.68,Z=-6.580,P=0.000).Conclusion:Oral applications of YSYSF and mecobalamin can effectively improve clinical symptoms and signs of patients with liver-kidney-deficiency type CSM,and its curative effect is better than that of monotherapy of oral application of mecobalamin,meanwhile it has high safty.

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备注/Memo

备注/Memo:
基金项目:国家中医药管理局中医药行业科研专项项目(201407001) 通讯作者:李嘉钰 E-mail:9889266@qq.com(收稿日期:2018-10-04 本文编辑:李晓乐)
更新日期/Last Update: 2019-02-20