筋痹颗粒治疗神经根型颈椎病的随机、双盲、双模拟、非劣效性平行对照临床研究  

Clinical study on Jinbi granules in treating cervical spondylosis radiculopathy: a randomized,double-blind and double-dummy controlled trail

作　　者：许金海[1] 王国栋[1] 沈琪幸 陈妮[1] 匡昱林 乔娇娇 叶洁[1,2] 莫文 施杞[1,2,3] XU Jinhai;WANG Guodong;SHEN Qixing;CHEN Ni;KUANG Yulin;QIAO Jiaojiao;YE Jie;MO Wen;SHI Qi(Department of Orthopedics and Traumatology,Longhua Hospital Affiliated to Shanghai University of TCM,Shanghai 200032,China;Shi Qi’s Studio for Inheritance of Prestigious and Veteran TCM Doctors,Shanghai 200032,China;Research Institute of Spine Diseases,Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China)

机构地区：[1]上海中医药大学附属龙华医院骨伤科,上海200032 [2]全国名老中医传承施杞工作室,上海200032 [3]上海中医药大学脊柱病研究所,上海200032

出　　处：《上海中医药杂志》2020年第2期54-60,共7页Shanghai Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金青年基金项目(81603635);上海市科委科研计划项目(16401930600,17401934400,18401903200,19401901100);上海市卫计委科研项目[20164Y0081,ZYKC201701003,ZY(2018-2020)-FWTX-2006,ZY(2018-2020)-FWTX-6024,ZY(2018-2020)-FWTX-4002].

摘　　要：目的观察筋痹颗粒治疗神经根型颈椎病的临床疗效与安全性。方法将72例神经根型颈椎病患者随机分为试验组和对照组,每组36例,试验组服用筋痹颗粒和塞来昔布模拟胶囊,对照组服用塞来昔布胶囊和筋痹颗粒安慰剂。治疗前、治疗7 d、治疗14 d、治疗后2个月时,观察用药安全性,比较疼痛视觉模拟评分(VAS)、颈椎功能障碍评分(NDI)、生活质量SF-36评分的变化情况。结果①试验期间,试验组脱落1例,对照组脱落2例。②组内治疗后不同时间点与治疗前比较,两组疼痛VAS评分差异均有统计学意义(P<0.05),且VAS评分逐渐降低,即存在时间效应;两组组间不同时间点疼痛VAS评分差异无统计学意义(P>0.05),即不存在分组效应。时间因素和分组因素之间不存在交互效应(P>0.05)。治疗14 d与治疗前两组疼痛VAS评分差值的95%可信区间为2.45~2.81,按照预设20%的非劣标准,非劣效检验合格。③组内治疗后不同时间点与治疗前比较,两组NDI评分差异均有统计学意义(P<0.05),且NDI评分逐渐降低,即存在时间效应;两组组间不同时间点NDI评分差异无统计学意义(P>0.05),即不存在分组效应。时间因素和分组因素之间不存在交互效应(P>0.05)。治疗14 d与治疗前两组NDI评分差值的95%可信区间为4.88~9.78,按照预设20%的非劣标准,非劣效检验合格。④组内治疗后不同时间点与治疗前比较,两组SF-36-PCS评分差异均有统计学意义(P<0.05),且SF-36-PCS评分逐渐升高,即存在时间效应;两组组间不同时间点SF-36-PCS评分差异无统计学意义(P>0.05),即不存在分组效应。时间因素和分组因素之间不存在交互效应(P>0.05)。⑤组内治疗后不同时间点与治疗前比较,两组SF-36-MCS评分差异均有统计学意义(P<0.05),且SF-36-MCS评分逐渐升高,即存在时间效应。组间治疗前和治疗7 d的SF-36-MCS评分差异无统计学意义(P>0.05);组间治疗14 d、随访2个月的SF-36-PObjective To observe the clinical efficacy and safety of Jinbi granules in the treatment of cervical spondylosis radiculopathy(CSR).Methods A randomized,double-blind and double-dummy controlled clinical trial was conducted with 72 patients being randomly divided into 2 groups(36 patients per group).The experimental group was administered the Jinbi granules and Celebrex simulated capsules,while the control group was given the Celebrex capsules and the Jinbi granules placebo.VAS,NDI and SF-36 quality of life scores were recorded before treatment,and at 1 week,2 weeks and 8 weeks after treatment respectively.Patients’adverse reactions were recorded and their clinical efficacy and safety were evaluated.Results①There was one drop-out case in the experimental group and two drop-out cases in the control group.②The difference between VAS scores of pain in the two groups before and after treatment was statistically significant(P<0.05),and the VAS scores gradually decreased,indicating a time effect;There was no significant difference in VAS scores between the two groups at different time points(P>0.05),indicating there was no grouping effect.There was no interaction between time factor and grouping factor(P>0.05).The 95%confidence interval of the VAS scores difference between the two groups after 14 days of treatment and before treatment was in the range from 2.45 to 2.81.According to the preset non-inferiority standard of 20%,the non-inferiority test was passed.③The difference of NDI scores between the two groups compared before and after treatment at different time points was statistically significant(P<0.05),and NDI scores gradually decreased,suggesting a time effect.There was no significant difference in NDI scores between the two groups at different time points(P>0.05),i.e.,there was no grouping effect.There was no interaction between time and grouping factors(P>0.05).The 95%confidence interval of NDI score difference between the two groups after 14 days of treatment and before treatment was in the range from

关 键 词：神经根型颈椎病 筋痹颗粒 塞来昔布 安慰剂对照 双盲 临床试验 心身同治 

分 类 号：R274.9[医药卫生—中西医结合]