舒筋健腰丸治疗腰椎管狭窄症(肝肾不足,风湿瘀阻证)的中医证候疗效观察  

Observation on TCM syndromes effect of Shujinjianyao pill in the treatment of lumbar spinal stenosis(Ganshenbuzu and Fengshiyuzu syndrome)

作　　者：王宝剑 高景华[1] 高春雨[1] 杨克新[1] 罗杰[1] 孙武[1] 郑开达 高文山[3] 董建文[4] 张天生[5] 王铠[6] 韩雪松[7] 郭荣光 WANG Bao-jian;GAO Jing-hua;GAO Chun-yu;YANG Ke-xin;LUO Jie;SUN Wu;ZHENG Kai-da;GAO Wen-shan;DONG Jian-wen;ZHANG Tian-sheng;WANG Kai;HAN Xue-song;GUO Rong-guang(Wangjing Hospital, Chinese Academy of Chinese Medicine, Beijing, 100102, China;Yangjiang Hospital of Chinese Medicine, Yangjiang, Guangdong, 529500, China;Hebei University Affiliated Hospital, Baoding, Hebei, 071000, China;Second Affiliated Hospital of Shandong University of Chinese Medicine, Jinan, Shandong, 250000, China;Third Affiliated Hospital of Shanxi College of Chinese Medicine, Taiyuan, Shanxi, 030006, China;Taizhou Hospital of Traditional Chinese Medicine, Jiangsu, Taizhou, 225300, China;Daqing People's Hospital, Daqing, Heilongjiang, 163316, China;Jilin People's Hospital, Changchun, Jilin, 130021, China)

机构地区：[1]中国中医科学院望京医院,北京100102 [2]阳江市中医医院,广东阳江529500 [3]河北大学附属医院,河北保定071000 [4]山东中医药大学第二附属医院,山东济南250000 [5]山西中医学院第三中医院,山西太原030006 [6]泰州市中医院,江苏泰州225300 [7]大庆市人民医院,黑龙江大庆163316 [8]吉林省人民医院,吉林长春130021

出　　处：《海南医学院学报》2020年第7期519-523,共5页Journal of Hainan Medical University

基　　金：广东省科技计划项目(2013A032500020)。

摘　　要：目的:观察舒筋健腰丸治疗腰椎管狭窄症(肝肾不足,风湿瘀阻证)的中医证候临床疗效及安全性。方法:采用多中心、随机、对照临床研究方案,将符合纳入标准的腰椎管狭窄症患者120例随机分为两组,试验组90例,对照组30例。试验组口服舒筋健腰丸与丹鹿通督片模拟剂,对照组口服舒筋健腰丸模拟剂与丹鹿通督片,两组疗程均为4周。观察治疗前、第14天、第28天的中医证候总积分、中医证候单项症状评分,并记录不良反应。结果:两组中医证候总积分在治疗前、第14天、第28天的组内比较,差异均具有统计学意义(P<0.01);第28天中医证候总积分的组间比较,差异具有统计学意义(P<0.05);第28天中医证候总有效率、中医单项证候中腰膝酸痛及腰膝酸软症状有效率比较,差异具有统计学意义(P<0.05)。结论:舒筋健腰丸用于治疗肝肾不足,风湿瘀阻型腰椎管狭窄症的中医证候疗效确切,尤其在改善中医证候总积分及中医单项腰膝酸痛及腰膝酸软症状方面具有明显优势,且具有较高的安全性。Objective:To observe the TCM(Traditonal Chinese Medcine)syndromes effect and safety of Shujinjianyao Pill in the treatment of lumbar spinal stenosis.Methods:Totally 120 LSS patients fit the inclusion criteria were divided into two groups with 90 in the experimental group and 30 in the control group.Basic data of two groups had no significant difference.The experimental group was given Shujinjianyao Pill and Danlutongdu Tablet Simulator orally,while the control group was given Shujinjianyao Pill Simulator and Danlutongdu Tablet orally for 4 weeks.The VAS score,total TCM syndrome score and single TCM symptom score on day 0,14 and 28 were observed,and adverse reactions were recorded.Result:There were significant differences in total TCM syndrome score between the two groups at baseline,14 d and 28 d(P<0.01).There was a significant difference in total TCM syndrome score between two groups at 28 d(P<0.05).Significant differences were existed between two groups in total effective rate of total TCM syndromes and waist-knee pain-weak in single TCM syndromes on the 28 d(P<0.05).There was no significant difference in the incidence of adverse events and serious adverse events between the two groups(P>0.05).Conclusion:Shujinjianyao Pill is effective on TCM syndromes in the treatment of Ganshenbuzu and fengshiyuzu syndrome LSS,especially in improving the score of total TCM syndromes and waist-knee pain-weak of single TCM syndrome,and has high safety.

关 键 词：舒筋健腰丸 腰椎管狭窄症 临床研究 中医证候疗效 

分 类 号：R274.9[医药卫生—中西医结合]