转腰汤颗粒治疗退行性腰椎管狭窄症临床研究  

Clinical Study on Zhuanyaotang Granules for the Treatment of Degenerative Lumbar Spinal Stenosis

作　　者：刘代远 高春雨[2] 李路广 杨克新[2] 孙武[2] 罗杰[2] 冯敏山[2] 李建国 李磊 冯蓬 伏敏睿 温海宝 高景华(指导)[2] LIU Daiyuan;GAO Chunyu;LI Luguang;YANG Kexin;SUN Wu;LUO Jie;FENG Minshan;LI Jianguo;LI Lei;FENG Peng;FU Minrui;WEN Haibao;GAO Jinghua(Instructor)(Beijing University of Chinese Medicine,Beijing 100012,China;Wangjing Hospital,China Academy of Chinese Medical Sciences,Beijing 100102,China)

机构地区：[1]北京中医药大学,北京100012 [2]中国中医科学院望京医院,北京100102

出　　处：《中国中医药信息杂志》2024年第1期159-163,共5页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：北京市中医药科技发展资金项目(JJ-2020-72);国家中医药传承创新团队项目(ZYYCXTD-C-202003)。

摘　　要：目的观察转腰汤颗粒治疗退行性腰椎管狭窄症(DLSS)的临床疗效。方法采用随机双盲对照设计,以随机数字表法将104例DLSS患者分为试验组和对照组各52例。试验组予转腰汤颗粒、甲钴胺片及塞来昔布胶囊模拟剂,口服;对照组予转腰汤颗粒模拟剂、甲钴胺片及塞来昔布胶囊,口服。2组均连续治疗3周,于治疗后1、3个月随访。于治疗前,治疗1、2、3周及治疗后1、3个月观察2组间歇性跛行距离、疼痛视觉模拟评分法(VAS)评分和日本骨科协会腰痛疾患疗效评定标准(JOA)评分。记录2组治疗期间的不良反应情况。结果试验组脱落5例、剔除2例,对照组脱落5例、剔除1例。与本组治疗前比较,2组患者治疗及随访各时点间歇性跛行距离、VAS评分、JOA评分差异均有统计学意义(P<0.05);2组治疗前及治疗1、2周比较,试验组间歇性跛行距离、VAS评分、JOA评分与对照组差异均无统计学意义(P>0.05);2组治疗3周及治疗后1、3个月比较,试验组间歇性跛行距离、JOA评分均低于对照组(P<0.05);2组治疗3周,试验组VAS评分与对照组差异无统计学意义(P>0.05)。试验组不良反应2例(4.4%),对照组不良反应5例(10.8%),2组比较差异无统计学意义(P>0.05)。结论转腰汤颗粒可有效缓解DLSS患者疼痛,改善腰椎功能,相较于口服塞来昔布胶囊和甲钴胺片效果更优,安全性较好。Objective To observe the clinical efficacy of Zhuanyaotang Granules for the treatment of degenerative lumbar spinal stenosis(DLSS).Methods Using a randomized double blind controlled design,104 DLSS patients were divided into an experimental group and a control group using a random number table method,with 52 patients in each group.The treatment group took oral Zhuanyaotang Granules,methylcobalamin tablets and celecoxib capsule simulants.The control group used Zhuanyaotang Granules simulants,methylcobalamin tablets and celecoxib capsules.The course of treatment was 3 weeks for both groups.The follow-ups were conducted at 1 month and 3 months after treatment.The intermittent claudication distance,visual analogue scale(VAS)score and JOA efficacy rating criteria for low back pain score were observed in both groups before treatment,1,2,3 weeks of treatment and 1 month after treatment and 3 months after treatment.Adverse reactions during treatment were recorded.Results There were 5 cases of detachment and 2 cases of exclusion in the experimental group,and 5 cases of detachment and 1 case of exclusion in the control group.Compared with before treatment,there were statistically significant differences in intermittent claudication distance,VAS score,and JOA score between the two groups of patients at various time points during treatment and follow-up(P<0.05);there was no statistically significant difference in intermittent claudication distance,VAS score,and JOA score between the experimental group and the control group before treatment and 1 and 2 weeks of treatment(P>0.05);compared with the two groups at 3 weeks of treatment and 1 and 3 months after treatment,the intermittent claudication distance and JOA score in the experimental group were lower than those in the control group(P<0.05);There was no significant difference in VAS score between the two groups and the control group after 3 weeks of treatment(P>0.05).There were 2 adverse reactions(4.4%)in the experimental group and 5 adverse reactions(10.8%)in the control g

关 键 词：转腰汤颗粒 退行性腰椎管狭窄症 间歇性跛行 随机对照 

分 类 号：R274.9[医药卫生—中西医结合]