补肾活血颗粒改善帕金森病患者生活质量的随机安慰剂对照临床研究  

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：李敏[1] 杨明会[1] 刘毅[1] 

机构地区：[1]解放军总医院中医研究所,北京100853

出　　处：《中西医结合学报》2012年第3期310-317,共8页Journal of Chinese Integrative Medicine

基　　金："十一五"国家科技支撑计划重大项目(No.2006BAI04A11)

摘　　要：背景:帕金森病(Parkinson disease,PD)以静止性震颤、肌强直和动作迟缓等运动障碍为主要临床表现,目前缺乏有效的治疗手段,严重影响患者的生活质量。我们既往运用补肾活血法治疗PD取得了较好疗效。目的:研究补肾活血颗粒对帕金森病患者生活质量的影响。设计、场所、对象和干预措施:采用随机双盲、安慰剂对照临床试验方法,将在解放军总医院就诊的120例PD患者用在线随机系统分成治疗组60例和对照组60例。其中治疗组服用补肾活血颗粒,对照组服用安慰剂,2次/d,均以美多巴等西药为基础治疗。前3个月为治疗观察期,疗程结束后带药随访6个月。主要结局指标:采用统一帕金森病评定量表第3版第二部分、帕金森病生存质量量表、帕金森病睡眠量表从几个方面分别评定患者治疗前后生活质量的变化。结果:补肾活血颗粒组治疗不同时间后统一帕金森病评定量表第3版第二部分评分、生存质量量表及睡眠量表评分在治疗观察期及随访观察期中均较安慰剂组改善(P<0.05,P<0.01)。研究过程中未发现不良反应。结论:补肾活血颗粒可明显改善PD患者生活质量。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 UPDRSⅡ, 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.

关 键 词：帕金森病 中草药 生活质量 随机对照试验 双盲法 安慰剂 

分 类 号：R277.7[医药卫生—中医学]