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[中药补肾活血颗粒对帕金森病患者生活质量的影响:一项随机、双盲、安慰剂对照试验]

[Effects of Chinese herbal medicine Bushen Huoxue Granule on quality of life of patients with Parkinson disease: a randomized, double-blinded and placebo-controlled trial].

作者信息

Li Min, Yang Ming-hui, Liu Yi

机构信息

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

出版信息

Zhong Xi Yi Jie He Xue Bao. 2012 Mar;10(3):310-7. doi: 10.3736/jcim20120310.

DOI:10.3736/jcim20120310
PMID:22409921
Abstract

BACKGROUND

The main clinical symptoms of Parkinson disease (PD) are resting tremor, muscle rigidity and bradykinesia. There is currently no effective treatment for PD, and dyskinesia symptoms affect the quality of life of patients with PD. The Chinese medicine therapy used for reinforcing kidney and activating blood circulation in treatment of PD was reported to achieve good clinical effects.

OBJECTIVE

To study the effects of Bushen Huoxue Granule, a compound traditional Chinese herbal medicine, on the quality of life of patients with PD.

DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: A total of 120 patients were enrolled from General Hospital of the People's Liberation Army in China and divided into two groups randomly. Patients in the control group were treated with a placebo and in the treatment group with Bushen Huoxue Granule based on treating with levodopa. A double-blinded clinical trial was adopted over a 3-month treatment with a follow-up period lasting 6 months.

MAIN OUTCOME MEASURES

Unified Parkinson Disease Rating Scale II (UPDRS II), questionnaire-39 (PDQ-39) and Parkinson's disease sleep scale (PDSS) were adopted to measure the quality of life at baseline, after 3 months of treatment and at a 6-month follow-up.

RESULTS

Bushen Huoxue Granule showed a higher efficacy than the control in improving life quality of patients with PD by improving scores of UPDRS II, PDQ-39 and PDSS (P<0.05). No adverse effects were found in this trial.

CONCLUSION

Bushen Huoxue Granule can markedly improve the quality of life of patients with PD.

摘要

背景

帕金森病(PD)的主要临床症状为静止性震颤、肌肉强直和运动迟缓。目前尚无治疗PD的有效方法,且异动症症状会影响PD患者的生活质量。据报道,用于治疗PD的补肾活血中医疗法取得了良好的临床效果。

目的

研究复方中药补肾活血颗粒对PD患者生活质量的影响。

设计、地点、参与者和干预措施:从中国人民解放军总医院招募了120例患者,随机分为两组。对照组患者服用安慰剂,治疗组患者在服用左旋多巴的基础上服用补肾活血颗粒。采用双盲临床试验,治疗3个月,随访6个月。

主要观察指标

采用统一帕金森病评定量表II(UPDRS II)、39项问卷(PDQ-39)和帕金森病睡眠量表(PDSS)在基线、治疗3个月后和6个月随访时测量生活质量。

结果

补肾活血颗粒在改善UPDRS II、PDQ-39和PDSS评分方面,在提高PD患者生活质量方面显示出比对照组更高的疗效(P<0.05)。本试验未发现不良反应。

结论

补肾活血颗粒可显著提高PD患者的生活质量。

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