[1]金坤,童正一,韩坤,等.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[J].中医正骨,2020,32(09):28-34.
　JIN Kun,TONG Zhengyi,HAN Kun,et al.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[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2020,32(09):28-34.
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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()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第32卷
期数:
2020年09期
页码:
28-34
栏目:
临床研究
出版日期:
2020-09-20

文章信息/Info

Title:
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1; 童正一1; 韩坤2; 沈琪幸1; 陈妮1; 乔娇娇1; 王国栋1; 许金海1; 叶洁1; 莫文1; 施杞1
(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)
Author(s):
JIN Kun1; TONG Zhengyi1; HAN Kun2; SHEN Qixing1; CHEN Ni1; QIAO Jiaojiao1; WANG Guodong1; XU Jinhai1; YE Jie1; MO Wen1; SHI Qi1
1.Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China2.Fengxian District Hospital of Traditional Chinese Medicine,Shanghai 201400,China
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
Keywords:
lumbago-leg pain;  intervertebral disc displacement;  qi deficiency blood stasis;  Jinbi Keli;  celecoxib;  clinical trial
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); 治疗结束后2周、6周,筋痹颗粒组的ODI均低于塞来昔布组(t=-2.195,P=0.033; t=-2.512,P=0.016)。④SF-36躯体健康评分。时间因素和分组因素不存在交互效应(F=2.992,P=0.070)。2组患者SF-36躯体健康评分总体比较,组间差异有统计学意义,即存在分组效应; 筋痹颗粒组的SF-36躯体健康评分高于塞来昔布组[(55.95±17.64)分,(43.59±16.47)分,F=10.665,P=0.002]。治疗前后不同时间点SF-36躯体健康评分的差异有统计学意义,即存在时间效应(F=11.016,P=0.001); 筋痹颗粒组的SF-36躯体健康评分随时间变化呈逐渐升高的趋势(F=8.439,P=0.001),塞来昔布组治疗前后不同时间点的SF-36躯体健康评分无明显差异(F=2.227,P=0.120)。⑤SF-36心理健康评分。时间因素和分组因素不存在交互效应(F=2.871,P=0.071)。2组患者SF-36心理健康评分总体比较,组间差异有统计学意义,即存在分组效应; 筋痹颗粒组的SF-36心理健康评分高于塞来昔布组[(68.79±21.04)分,(56.29±19.59)分,F=14.336,P=0.000]。治疗前后不同时间点SF-36心理健康评分的差异有统计学意义,即存在时间效应(F=9.427,P=0.000); 筋痹颗粒组的SF-36心理健康评分随时间变化呈逐渐升高的趋势(F=5.883,P=0.000),塞来昔布组治疗前后不同时间点的SF-36心理健康评分无明显差异(F=0.278,P=0.759)。⑥不良反应。塞来昔布组1例患者治疗开始后间断性出现胃部不适,改为饭后30 min服药后胃部不适症状未见明显改善,坚持完成2周治疗后退出研究。其余患者均未发生不良反应。2组患者不良反应的发生率比较,差异无统计学意义(χ2=0.000)。结论:筋痹颗粒能有效改善腰椎间盘突出症气虚血瘀证患者的腰部功能,提高生活质量,效果优于塞来昔布,安全性与塞来昔布相当。
Abstract:
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 was no time effect(F=1.215,P=0.292).There was interaction between time factor and group factor in ODI(F=5.263,P=0.017).There was no statistical difference in ODI between the 2 groups in general,in other words,there was no group effect(F=3.776,P=0.058).There was no statistical difference in ODI between different timepoints before and after the treatment,in other words,there was no time effect(F=0.386,P=0.594).There was no statistical difference in ODI between the 2 groups before the treatment and on the day after the end of the treatment(t=-0.744,P=0.461; t=-1.378,P=0.175).The ODI was lower in JBKL group compared to celecoxib group at 2 and 6 weeks after the end of the treatment(t=-2.195,P=0.033; t=-2.512,P=0.016).There was no interaction between time factor and group factor in SF-36 physical health scores(F=2.992,P=0.070).There was statistical difference in SF-36 physical health scores between the 2 groups in general,in other words,there was group effect.The SF-36 physical health scores were higher in JBKL group compared to celecoxib group(55.95+/-17.64 vs 43.59+/-16.47 points,F=10.665,P=0.002).

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备注/Memo

备注/Memo:
基金项目: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)
通讯作者:王国栋 E-mail:gdwang12-24@163.com
更新日期/Last Update: 2020-09-20