补肾活血颗粒对帕金森病患者睡眠质量的影响

Effects of Bushenhuoxue Granules on Sleep Quality in Parkinson′s Patients

目的:研究补肾活血颗粒对帕金森病(Parkinson's Disease,PD)患者睡眠量表(Parkinson's disease sleepscale,PDSS)评分的影响。方法:将120例PD患者网上在线随机分成治疗组60例和安慰剂对照组60例。其中治疗组服用补肾活血中药,对照组服用安慰剂,2次/d,两组均以美多芭等西药为基础治疗。两组患者均以3个月为治疗观察期,采用双盲设计,疗程结束后带药随访6个月观察。采用PDSS量表评定患者治疗过程中睡眠状况的变化。结果:对照组患者睡眠质量在治疗9个月中均未有改善(P>0.05)。治疗组患者无论在治疗观察期还是随访观察期中,PDSS的评分均显著下降(P<0.01)。研究过程中未发现明显不良反应。结论:补肾活血中药可以改善PD患者睡眠质量,且疗效稳定、不易反弹。

Objective：To study the effects of Bushenhuoxue Granules on Parkinson′s disease sleep scale（PDSS）score in Parkinson′s patients.Methods：120 patients were enrolled and divided into two groups randomly,the control group were treated with placebo and treatment group with Bushenhuoxue Granules,both group based on Madopar treatment.Double-blinded clinical trial was adopted in treatment period.Follow-up period for 6 months,PDSS was adopted to measure sleep condition of PD patients at baseline time,after 3 months and after 9 months.Results：Bushenhuoxue Granules treatment group showed a higher efficacy than the placebo group in relieving the sleep disorders of Parkinson disease patients,both in treatment and follow-up period（P0.01）.No adverse effects were found in this trial.Conclusions：Bushenhuoxue Granules can markedly improve sleep disorders in Parkinson＇s patients.The effects are stable and obvious along with the process of treatment.