摘要
目的观察中医辨证治疗早期帕金森病(PD)自主神经功能障碍的临床疗效。方法纳入292例早期PD患者,采用随机、双盲、安慰剂、多中心对照原则,通过SAS软件产生4种中医证型的区组随机分配表,中药组和对照组按照1∶1比例分组。2组均予左旋多巴(LD)基础治疗。中药组根据气血不足型、气滞血瘀型、痰热动风型、肝肾不足型分别予黄芪平颤颗粒、逐瘀平颤颗粒、涤痰平颤颗粒、熟地平颤颗粒,对照组予相应证型安慰剂颗粒,疗程均为24周,12周随访1次。观察自主神经症状量表(SCOPA-AUT)和帕金森病综合评分量表(UPDRS)Ⅱ、Ⅲ评分及LD用量,评价2组及中药组不同证型的有效性及安全性。结果最终完成258例,2组各129例。中药组治疗后SCOPA-AUT及UPDRSⅡ、Ⅲ评分明显低于对照组(P<0.01),其中胃肠道症状、心血管症状评分明显优于对照组(P<0.05,P<0.01)。中药组气滞血瘀型和肝肾不足型治疗后SCOPA-AUT总分优于对照组(P<0.05),其中气滞血瘀型胃肠道症状、心血管症状评分优于对照组(P<0.05),气血不足型泌尿道症状评分优于对照组(P<0.05),肝肾不足型胃肠道症状评分优于对照组(P<0.05)。2组不良事件发生率比较差异无统计学意义(P>0.05)。结论中医辨证施治可有效改善早期PD患者自主神经各项功能障碍,不同证型患者自主神经症状均有不同程度改善,且不良反应少。
Objective To observe the clinical efficacy of TCM syndrome differentiation in the treatment of autonomic dysfunction in early Parkinson disease(PD).Methods Totally 292 cases of early PD patients were included in the study.Using the principles of randomization,double blinding,placebo,and multi-center control,a block randomized allocation table for four types of TCM syndromes was generated using SAS software.TCM group and the control group were grouped in a 1:1 ratio.Both groups received basic treatment with levodopa(LD).TCM group was given Huangqi Pingchan Granules,Zhuyu Pingchan Granules,Ditan Pingchan Granules and Shudi Pingchan Granules according to the types of qi and blood deficiency,qi stagnation and blood stasis,phlegm heat moving wind type and liver and kidney deficiency,respectively,while the control group was given placebo granules with corresponding syndrome types,with a course of treatment of 24 weeks and a follow-up of once every 12 weeks.Autonomic symptoms scale(SCOPA-AUT),unified Parkinson disease rating scale(UPDRS)II and III scores,and LD dosage were observed.The effectiveness and safety in the two groups and different syndrome types of TCM group were evaluated.Results Totally 258 cases were ultimately completed,including 129 cases in each group.SCOPA-AUT,UPDRSⅡand UPDRSⅢscores in TCM group were significantly lower than the control group(P<0.01);gastrointestinal symptoms and cardiovascular symptoms scores were better than the control group(P<0.05,P<0.01).After treatment,the SCOPA-AUT score of TCM group was better than that of the control group(P<0.05)for the types of qi stagnation and blood stasis and liver and kidney deficiency.Among them,the scores of gastrointestinal symptoms and cardiovascular symptoms in the type of qi stagnation and blood stasis was better than that in the control group(P<0.05);the score of qi and blood deficiency type in urinary symptoms was better than that of the control group(P<0.05),while the score of liver and kidney deficiency type in gastrointestinal symptoms was
作者
李慧
袁晓蕾
叶青
胡钰卿
谢治国
秦立云
袁灿兴
张煜
王长德
施荣
LI Hui;YUAN Xiaolei;YE Qing;HU Yuqing;XIE Zhiguo;QIN Liyun;YUAN Canxing;ZHANG Yu;WANG Changde;SHI Rong(Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai 200092,China;Shanghai Integrated Traditional Chinese and Western Medicine Hospital,Shanghai 200082,China;Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
出处
《中国中医药信息杂志》
CAS
CSCD
2023年第7期162-169,共8页
Chinese Journal of Information on Traditional Chinese Medicine
基金
上海市科学技术委员会项目(21Y31920300)
国家自然科学基金面上项目(82074355)
上海市浦江人才项目(2020PJD066)。
关键词
早期帕金森病
自主神经功能障碍
中医辨证分型
多中心
early Parkinson disease
autonomic dysfunction
TCM syndrome differentiation typing
multi-center