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补肾活血颗粒治疗帕金森病患者的帕金森病问卷-39多维分析:一项多中心、随机、双盲、安慰剂对照试验

Multi-dimensional analysis on Parkinson's disease questionnaire-39 in Parkinson's patients treated with Bushen Huoxue Granule: A multicenter, randomized, double-blinded and placebo controlled trial.

作者信息

Li Min, Yang Hui Ming, Luo Dong Xiao, Chen Jian Zong, Shi Heng Jun

机构信息

Institute o f Traditional Chinese Medicine, General Hospital of People s Liberation Army, Beijing 100853, China.

Institute o f Traditional Chinese Medicine, General Hospital of People s Liberation Army, Beijing 100853, China.

出版信息

Complement Ther Med. 2016 Dec;29:116-120. doi: 10.1016/j.ctim.2016.09.008. Epub 2016 Sep 14.

DOI:10.1016/j.ctim.2016.09.008
PMID:27912935
Abstract

OBJECTIVES

To preliminarily assess the effects of Bushen Huoxue Granule (BHG) on Parkinson's Patients with Parkinson's Disease Questionnaire-39 (PDQ-39)and to provide data for further research.

DESIGN

A randomized, double-blinded, placebo controlled study with a 3-month intervention period and a 6-month follow-up.

INTERVENTIONS

Participants were patients with Parkinson's Disease (PD) of age ranging from 50 to 80 years and Hoehn and Yahr (H-Y) stage I-IV of the disease.120 participants were allocated to BHG group or placebo group at a 1:1 ratio. The BHG group received BHG twice a day for 3 months, and was followed-up for 6 months after treatment; the placebo group did not receive any Chinese Herb treatment for 9 months. All the patients were given the conventional therapy of levodopa (Madopar).

MAIN OUTCOME MEASURES

Primary outcome measure was PDQ-39 comprises 39 questions with five different options of answer related to the frequency of the disease manifestation.

RESULTS

Significant statistical difference appeared in the following PDQ-39 dimensions: mobility; emotional well-being; stigma; cognition (P<0.01) and bodily discomfort (P<0.05).There was no statistical difference in the dimensions of social support, ADL and communication between the data of these two group patients (P≥0.05). We found that the sum index of PDQ-39 was significantly different between two groups.

CONCLUSION

The results of this study show that BHG treatment makes significant effects in most domains of PD patients life quality,especially in mobility, emotional well-being, stigma and cognition. The affected factors should be confirmed in larger studies.

摘要

目的

初步评估补肾活血颗粒(BHG)对帕金森病患者帕金森病问卷-39(PDQ-39)的影响,为进一步研究提供数据。

设计

一项随机、双盲、安慰剂对照研究,干预期为3个月,随访期为6个月。

干预措施

参与者为年龄在50至80岁之间、疾病 Hoehn 和 Yahr(H-Y)分期为 I-IV 期的帕金森病(PD)患者。120名参与者按1:1的比例分配到BHG组或安慰剂组。BHG组每天服用两次BHG,持续3个月,并在治疗后随访6个月;安慰剂组9个月内未接受任何中药治疗。所有患者均接受左旋多巴(美多芭)的常规治疗。

主要观察指标

主要观察指标为PDQ-39,包括39个问题,有五个与疾病表现频率相关的不同答案选项。

结果

在以下PDQ-39维度上出现了显著的统计学差异:运动能力;情绪健康;耻辱感;认知(P<0.01)和身体不适(P<0.05)。两组患者在社会支持、日常生活活动能力和沟通维度的数据上没有统计学差异(P≥0.05)。我们发现两组之间PDQ-39的总和指数有显著差异。

结论

本研究结果表明,BHG治疗对PD患者生活质量的大多数领域有显著影响,尤其是在运动能力、情绪健康、耻辱感和认知方面。这些影响因素应在更大规模的研究中得到证实。

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