复元填髓方治疗小脑共济失调综合征的单臂临床试验  

A Single-Arm Clinical Trial of Fuyuan Tiansui Decoction in the Treatment of Cerebellar Ataxia Syndrome

作　　者：赵圣 严凯雯 王钜为 林烜宇 李爽 林修齐 朱文宗 ZHAO Sheng;YAN Kaiwen;WANG Juwei(Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Zheji-ang Chinese Medical University,Wenzhou(325000),China)

机构地区：[1]浙江中医药大学附属温州中西医结合医院浙江,温州325000 [2]浙江中医药大学

出　　处：《浙江中医药大学学报》2025年第3期279-284,共6页Journal of Zhejiang Chinese Medical University

基　　金：温州市科技计划项目(Y20180212);浙江省自然科学基金项目(LY18H27001)。

摘　　要：[目的]观察复元填髓方治疗小脑共济失调综合征患者的疗效。[方法]纳入2024年2月至10月温州市中西医结合医院门诊就诊的小脑共济失调综合征患者29例,予以复元填髓方汤剂治疗12周,对比治疗前后患者国际合作共济失调量表(International Cooperative Ataxia Scale,ICARS)、共济失调等级量表(Scale for the Assessment and Rating of Ataxia,SARA)、日常生活活动能力(Activities of Daily Living,ADL)评分及中医证候量表的变化。[结果]共29例患者入组,其中27例完成12周疗程(脱落2例),治疗后患者ICARS评分缓解率为55.6%,维持率为25.9%;治疗前ICARS评分为(35.85±12.90)分,治疗后为(34.33±13.10)分,差异有统计学意义(P<0.05);SARA评分及中医症候量表评分均显著降低(P<0.05)。治疗期间,患者不良反应率为11.1%,其中腹泻3例。[结论]复元填髓方能够改善小脑共济失调综合征患者的共济失调症状以及肾虚髓亏证候。[ObjectiveObjective]To observe the efficacy of Fuyuan Tiansui Decoction in the treatment of cerebellar ataxia syndrome(CAS).[MethodsMethods]A total of 29 patients with CAS treated at Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine outpatient clinics from February to October 2024 were enrolled.All participants received Fuyuan Tiansui Decoction treatment for 12 weeks.Before and after treatment,the changes of International Cooperative Ataxia Scale(ICARS),Scale for the Assessment and Rating of Ataxia(SARA),Activities of Daily Living(ADL)score and traditional Chinese medicine(TCM)syndrome scale were compared.[ResultsResults]A total of 29 patients were enrolled,with 27 completing the 12-week treatment course(2 withdrawals).Post-treatment analysis revealed an ICARS score improvement rate of 55.6%and a stabilization rate of 25.9%.The ICARS score was 35.85±12.90 before treatment and 34.33±13.10 after treatment(P<0.05).The SARA score and TCM syndrome scale score were significantly decreased(P<0.05).During the treatment,the adverse reaction rate was 11.1%,including 3 cases of diarrhea.[ConclusionConclusion]Fuyuan Tiansui Decoction can relieve the ataxia symptoms and the syndrome of kidney deficiency and marrow deficiency in patients with CAS.

关 键 词：复元填髓汤 遗传性小脑共济失调 多系统萎缩-小脑型 散发性成人共济失调 肾精亏虚证 异病同治 中医证候量表 单臂试验 

分 类 号：R259[医药卫生—中西医结合]