白术转腰汤治疗脾肾阳虚、痰瘀互结证退行性腰椎管狭窄症随机双盲对照试验  

Baizhu Zhuanyao Decoction for Degenerative Lumbar Spinal Stenosis Patients with Pi-Shen Yang Deficiency and Inter-coagulation of Phlegm-Blood Stasis Syndrome:A Randomized Double-blinded Controlled Trial

作　　者：温海宝 李路广 高春雨[1] 杨克新[1] 冯敏山[1,2] 孙武 罗杰[1] 李建国[1] 李磊 冯蓬 朱立国 高景华[1,2] WEN Hai-bao;LI Lu-guang;GAO Chun-yu;YANG Ke-xin;FENG Min-shan;SUN Wu;LUO Jie;LI Jian-guo;LI Lei;FENG Peng;ZHU Li-guo;GAO Jing-hua(The Second Department of Spine,Wangjing Hospital,China Academy of Chinese Medical Sciences,Beijing 100102;Beijing Key Laboratory of Osteopathic Technology of Traditional Chinese Medicine,Beijing 100102)

机构地区：[1]中国中医科学院望京医院脊柱二科,北京100102 [2]中医正骨技术北京市重点实验室,北京100102

出　　处：《中国中西医结合杂志》2024年第6期670-676,共7页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：北京市中医药科技发展资金项目(No.JJ-2020-72);国家中医药传承创新团队项目(No.ZYYCXTD-C-202003);中国中医科学院望京医院高水平中医医院建设项目(No.WJZJ-202318)。

摘　　要：目的观察白术转腰汤治疗退行性腰椎管狭窄症(DLSS)脾肾阳虚、痰瘀互结证的疗效及安全性。方法采用随机、双盲、双模拟、平行对照试验方法,从130例患者中筛选符合纳入标准的104例DLSS患者,按照1:1比例随机分为2组,治疗组和对照组各52例,治疗组予以白术转腰汤+甲钴胺片模拟剂+塞来昔布胶囊模拟剂,对照组予以白术转腰汤模拟剂+甲钴胺片+塞来昔布胶囊,两组疗程均为3周。记录患者治疗前、治疗后、疗程结束后1个月随访的疼痛评分(VAS)功能障碍指数评分(ODI)中医主、次症及证候评分及治疗前后的腰椎活动度的变化情况。结果治疗组脱落7例,对照组脱落6例,完成治疗及随访患者91例。治疗组45例中临床控制3例,显效5例,有效30例,无效7例,总有效率为84.5%(38/45);对照组46例中临床控制2例,显效2例,有效33例,无效9例,总有效率为80.5%(37/46)。治疗组总有效率高于对照组,但差异无统计学意义(χ^(2)=0.252,P>0.05)。与本组治疗前比较,两组治疗后VAS、ODI评分明显下降(P<0.05);中医主、次症及证候积分均下降(P<0.05)。随访后对照组VAS、ODI评分升高(P<0.05);中医主、次症及证候积分均明显升高(P<0.05)。治疗组间歇性跛行程度、下肢麻木评分明显升高(P<0.05)。治疗后两组患者腰椎前屈、后伸、左侧弯、右侧弯、左侧旋、右侧旋活动度均增大(P<0.05)。与对照组同期比较,治疗组治疗后ODI评分下降(P<0.05);随访后VAS、ODI评分均下降(P<0.05);且治疗后除下肢疼痛、下肢麻木外,随访后除下肢麻木外,中医主、次症及证候积分均降低(P<0.05);腰椎后伸活动度增大更明显(P<0.05),两组不良反应发生率[分别为4.4%(2/45)及10.8%(5/46)]比较,差异无统计学意义(χ^(2)=0.572,P>0.05)。结论白术转腰汤治疗DLSS(牌肾阳虚、痰痧互结证)患者,能有效缓解腰腿疼痛及中医证候、改善腰椎功能,且疗效稳定持久,安全性好。中Objective To observe the efficacy and safety of Baizhu Zhuanyao Decoction(BZZYD)in treating degenerative lumbar spinal stenosis(DLss)patients with Pi-Shen yang deficiency and inter-coagulation of phlegm and blood stasis syndrome(PSYD-IPBSs).Methods Randomized double-blinded double-simulated parallel controlled trial was adopted.Totally 104 DLSS patients in line with inclusion criteria were selected from 130 patients,and randomly assigned to two groups by 1:1 ratio,52 patients in the treatment group and 52 patients in the control group.Patients in the treatment group took BZZYD+Mecobalamin Tablet simulant+Celecoxib Capsule simulant.Those in the control group took BZZYD simulant+Mecobalamin Tablet+Celecoxib Capsule.The treatment course of both groups was 3 weeks.Visual Analogue Scale(VAS)score and Oswestry disability index(ODI)score,symptoms score of Chinese medicine and changes of lumbar motion were recorded before treatment,after treatment,and 1 month follow-up after treatment,respectively.Results In the treatment group 7 cases dropped out and 6 in the control group.Totally 91 patients completed the treatment and follow-ups.Among the 45 cases in the treatment group,clinical control were obtained in 3 cases,markedly effective in 5,effective in 30,ineffective in 7,and the total effective rate of was 84.5%(38/45).Among the 46 cases in the control group clinical control were obtained in 2 cases,markedly effective in 2,effective in 33,ineffective in 9,and the total effective rate of was 80.5%(37/46).The total effective rate in the treatment group was higher than that in the control group,but the difference was not statistically significant(χ^(2)=0.252,P>0.05).Compared with before treatment in the same group,VAS and ODI scores significantly decreased after treatment in the two groups(P<0.05).Scores for primary and secondary Chinese medicine symptoms and syndromes significantly decreased(P<0.05).After follow-ups VAS and ODI scores increased in the control group(P<0.05).Scores for primary and secondary Chinese medicine

关 键 词：白术转腰汤 退行性腰椎管狭窄症 脾肾阳虚 痰瘀互结 随机对照试验 中药复方 中西医结合 

分 类 号：R274.9[医药卫生—中西医结合]