[Effects of Bushen Huoxue Granule on motor function in patients with Parkinson's disease: a multicenter, randomized, double-blind and placebo-controlled trial].
[Effects of Bushen Huoxue Granule on motor function in patients with Parkinson's disease: a multicenter, randomized, double-blind and placebo-controlled trial].
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DOI：
10.3736/jcim20100306
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发表时间：
2010-03-01
期刊：
影响因子：
--
通讯作者：
Shi, Heng-jun
中科院分区：
文献类型：
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作者：
Yang, Ming-hui;Li, Min;Shi, Heng-jun
背景：帕金森病(PD)的主要临床症状为静止性震颤、肌肉僵硬、运动迟缓等。目前对帕金森病尚无有效的治疗方法，运动障碍症状严重影响患者的生活质量。目的：评价补肾活血颗粒治疗帕金森病的疗效和安全性。设计、地点、对象和干预：多中心、随机、双盲、安慰剂对照的临床研究。选择解放军总医院门诊部、广东省中医院、西安西京医院、唐都医院的帕金森病患者120例，随机分为补肾活血颗粒组和安慰剂组。补肾活血颗粒组55例，失访5例；安慰剂组51例，排除1例，失访8例。主要观察指标：观察治疗前后的运动评分、运动试验、肌张力，对临床疗效进行综合评价。结果：治疗后1个月、2个月、3个月，补肾活血颗粒组帕金森病统一评定量表(UPDRS)Ⅲ评分、10m往返运动上升时间、静息肌张力均较治疗前改善(P
BACKGROUND: The main clinical symptoms of Parkinson's disease (PD) are resting tremor, muscle rigidity, bradykinesia, and so on. There is no effective treatment for PD yet, and dyskinesia symptoms affect the life qualities of PD patients. The therapy used for reinforcing kidney and activating blood circulation in treatment of PD can achieve good clinical effects.OBJECTIVE: To evaluate the efficacy and safety of Bushen Huoxue Granule (BSHXG), a compound traditional Chinese herbal medicine for reinforcing kidney and activating blood circulation in treatment of PD.DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: A multi-center, randomized, double-blind, placebo-controlled clinical study was undertaken. A total of 120 PD patients from Outpatient Department of General Hospital of People's Liberation Army, Guangdong Provincial Hospital of Traditional Chinese Medicine, and Xijing Hospital and Tangdu Hospital in Xi'an, were randomly divided into BSHXG group and placebo group. There were 55 cases in BSHXG group, for 5 cases lost to follow-up, and 51 cases in placebo group, for 1 case was excluded and 8 cases lost to follow-up. The patients in two groups were all treated for three months.MAIN OUTCOME MEASURES: The movement scale, exercise testing, and muscle tension were observed before and after treatment to make a comprehensive evaluation for clinical efficacy. One month follow-up was also made.RESULTS: At three different times (one, two and three months) after treatment, the score of Unified Parkinson's Disease Rating Scale (UPDRS) III, rise time of 10-meter back and forth exercise and resting muscle tension in BSHXG group were improved as compared with before treatment (P