筋痹颗粒治疗腰椎间盘突出症气虚血瘀证的随机、双盲、双模拟、非劣效性平行对照临床研究  

A randomized,double-blind,double-dummy,non-inferiority parallel-controlled clinical study of Jinbi Keli(筋痹颗粒)for treatment of qi-deficiency-blood-stasis-type lumbar disc herniation

作　　者：金坤 童正一[1] 韩坤 沈琪幸 陈妮[1] 乔娇娇 王国栋[1] 许金海[1] 叶洁[1] 莫文[1] 施杞[1] JIN Kun;TONG Zhengyi;HAN Kun;SHEN Qixing;CHEN Ni;QIAO Jiaojiao;WANG Guodong;XU Jinhai;YE Jie;MO Wen;SHI Qi(Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Fengxian District Hospital of Traditional Chinese Medicine,Shanghai 201400,China)

机构地区：[1]上海中医药大学附属龙华医院,上海200032 [2]上海市奉贤区中医医院,上海201400

出　　处：《中医正骨》2020年第9期28-34,共7页The Journal of Traditional Chinese Orthopedics and Traumatology

基　　金：上海市科学技术委员会科研计划项目(16401930600,18401903200);上海市进一步加快中医药事业发展三年行动计划项目(ZY(2018-2020)-FWTX-6024,ZY(2018-2020)-FWTX-4002);上海市浦东新区卫生和计划生育委员会卫生计生科研项目(PW2018D-07)。

摘　　要：目的:评价筋痹颗粒治疗腰椎间盘突出症气虚血瘀证的临床疗效与安全性。方法:采用前瞻性、随机、双盲、双模拟、非劣效性平行对照试验设计,将72例符合要求的腰椎间盘突出症气虚血瘀证患者随机分为2组,每组36例。筋痹颗粒组患者服用筋痹颗粒和塞来昔布胶囊模拟药,塞来昔布组患者服用塞来昔布胶囊和筋痹颗粒模拟药。筋痹颗粒和筋痹颗粒模拟药均每日2次口服,每次1袋(8.8 g),连续服用2周;塞来昔布胶囊和塞来昔布胶囊模拟药均每日1次口服,每次1粒(200 mg),连续服用2周。分别采用腰腿疼痛视觉模拟量表(visual analogue scale,VAS)、Oswestry功能障碍指数(Oswestry disability index,ODI)量表及简明健康状况调查表(short form 36 health survey questionnaire,SF-36)评价患者的腰腿疼痛程度、腰部功能障碍情况及生活质量,评定时间均为治疗前、治疗结束后当天、治疗结束后2周及治疗结束后6周。详细记录患者治疗及随访期间出现的不良反应。结果:①一般情况。治疗结束后,6例患者因工作原因拒绝随访,其中筋痹颗粒组4例、塞来昔布组2例;塞来昔布组1例患者治疗开始后间断性出现胃部不适,坚持完成2周治疗后退出研究。②腰腿疼痛VAS评分。时间因素和分组因素不存在交互效应(F=3.483,P=0.051)。2组患者腰腿疼痛VAS评分总体比较,组间差异无统计学意义,即不存在分组效应(F=0.681,P=0.413)。治疗前后不同时间点腰腿疼痛VAS评分的差异无统计学意义,即不存在时间效应(F=1.215,P=0.292)。③ODI。时间因素和分组因素存在交互效应(F=5.263,P=0.017)。2组患者ODI总体比较,组间差异无统计学意义,即不存在分组效应(F=3.776,P=0.058)。治疗前后不同时间点ODI的差异无统计学意义,即不存在时间效应(F=0.386,P=0.594)。治疗前和治疗结束后当天,2组患者的ODI比较,组间差异均无统计学意义(t=-0.744,P=0.461;t=-1.378,P=0.175);�Objective:To evaluate the clinical curative effects and safety of Jinbi Keli(筋痹颗粒,JBKL)for treatment of qi-deficiency-blood-stasis-type lumbar disc herniation(LDH).Methods:A prospective,randomized,double-blind,double-dummy non-inferiority parallel-controlled clinical trial was conducted.Seventy-two patients with qi-deficiency-blood-stasis-type LDH included in the trial were divided into JBKL group and celecoxib group,36 patients in each group.The patients in JBKL group were treated with oral application of JBKL and simulated celecoxib capsule,while the patients in celecoxib group were treated with oral application of celecoxib capsule and simulated JBKL.The JBKL and simulated JBKL were taken twice a day,1 bag(8.8 g)at a time for 2 consecutive weeks.The celecoxib capsule and simulated celecoxib capsule were taken once a day,1 capsule(200 mg)at a time for 2 consecutive weeks.The lumbago-leg pain degree,low back dysfunction and life quality were evaluated by using lumbago-leg pain visual analogue scale(VAS),Oswestry disability index(ODI)and short form 36 health survey questionnaire(SF-36)respectively before the treatment,on the day after the end of the treatment,at 2 and 6 weeks after the end of the treatment,and the adverse reactions were recorded detailedly during the treatment and follow-up period.Results:After the end of the treatment,4 patients in JBKL group and 2 patients in celecoxib group refused to be followed up for working reasons,and 1 patient in celecoxib group dropped out of the trial after 2-week treatment for intermittent gastric discomfort occured after the beginning of the treatment.There was no interaction between time factor and group factor in lumbago-leg pain VAS scores(F=3.483,P=0.051).There was no statistical difference in lumbago-leg pain VAS scores between the 2 groups in general,in other words,there was no group effect(F=0.681,P=0.413).There was no statistical difference in lumbago-leg pain VAS scores between different timepoints before and after the treatment,in other words,there

关 键 词：腰腿痛 椎间盘移位 气虚血瘀 筋痹颗粒 塞来昔布 临床试验 

分 类 号：R274.9[医药卫生—中西医结合]