乌灵胶囊治疗帕金森病患者抑郁症状的疗效——一项多中心、随机、双盲、安慰剂对照研究  

Efficacy of Wuling capsule for depressive symptoms in patients with Parkinson's disease—a multicenter,randomized,double-blind,placebo-controlled study

作　　者：何婧[1] 薛峥 顾平[3] 王晓平[4] 金莹[1] 李淑华[1] 龙云飞 陈海波[1] 苏闻[1] HE Jing;XUE Zheng;GU Ping;WANG Xiaoping;JIN Ying;LI Shuhua;LONG Yunfei;CHEN Haibo;SU Wen(不详;Department of Neurology,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]北京医院神经内科、国家老年医学中心、中国医学科学院老年医学研究院,100730 [2]华中科技大学同济医学院附属同济医院神经内科,430030 [3]河北医科大学附属第一医院神经内科,050000 [4]上海交通大学医学院附属同仁医院神经内科,200336

出　　处：《中国神经免疫学和神经病学杂志》2024年第4期258-264,共7页Chinese Journal of Neuroimmunology and Neurology

基　　金：北京医院临床研究121项目(121-2016009)。

摘　　要：目的观察乌灵胶囊治疗帕金森病(PD)患者抑郁症状的疗效及安全性。方法本研究为一项多中心、随机、双盲、安慰剂对照的临床试验(ClinicalTrials平台注册号:NCT03195231)。在国内四家三甲医院运动障碍性疾病专病门诊筛选符合抑郁发作诊断标准且汉密尔顿抑郁量表(Hamilton Depression Scale,HAMD-17)总分≥13分的PD患者,由四家医院分别进行随机化入组,将患者随机分为安慰剂组或乌灵胶囊组,分别给予安慰剂或乌灵胶囊3粒(0.33 g/粒)3次/d治疗,疗程12周。主要观察疗效指标为治疗12周后HAMD-17总分与基线HAMD-17总分的差值,次要观察疗效指标是治疗12周后帕金森病睡眠量表(Parkinson s disease sleep scale,PDSS)总分与基线PDSS总分的差值。结果82例符合入组条件者进入随机化分组,66例患者完成全部随访,其中安慰剂组28例,乌灵胶囊组38例。治疗12周后,安慰剂组HAMD-17总分〔差值中位数(四分位数)为-3.0(-0.3,-6.0)分〕、乌灵胶囊组HAMD-17总分〔差值中位数(四分位数)为-6.0(-3.0,-8.3)分〕均下降,以乌灵胶囊组HAMD-17总分降低更明显(Z=1.321,P=0.036);安慰剂组PDSS总分〔差值中位数(四分位数)2.0(-2.8,12.8)分〕、乌灵胶囊组PDSS总分〔差值中位数(四分位数)7.5(0,17.3)分〕均增加,以乌灵胶囊组PDSS总分增加幅度更大(Z=1.753,P=0.048)。用药期间未发生严重不良反应事件。结论乌灵胶囊可以改善PD患者的抑郁症状,亦可以改善睡眠障碍,用药安全性较好。Objective To observe the therapeutic effect and safety of Wuling capsule on depressive symptoms in patients with Parkinson's disease(PD).Methods We conducted a multicenter,randomized,double-blind,placebo-controlled clinical trial(Clinical Trials Registration Number:NCT03195231).Patients with PD and depressive symptoms who had a Hamilton Depression Scale(HAMD-17)score≥13 were screened from four tertiary hospitals in China.Randomization was performed by four hospitals.The PD patients were randomly assigned to either Wuling group or placebo group,and were taken Wuling capsule or placebo three capsules three times a day for 12 weeks.The primary efficacy outcome was the difference in the total HAMD-17 scores from baseline to week 12.Results Eighty-two eligible patients were randomized into two groups,and 66 patients completed all follow-up,including 28 cases in the placebo group and 38 cases in the Wuling capsule group.After 12 weeks of treatment,the total score of HAMD-17 decreased in both placebo group[-3.0(-0.3,-6.0)in the median difference(quartile)]and Wuling capsule group[-6.0(-3.0,-8.3)in the median difference(quartile)],and the decrease was more significantly in Wuling capsule group(Z=1.321,P=0.036).The total score of Parkinson's disease sleep scale(PDSS)increased in both placebo group[2.0(-2.8,12.8)points in the median difference(quartile)]and Wuling capsule group[7.5(0.0,17.3)points in the median difference(quartile)],and the increase of score was more significantly in Wuling capsule group(Z=1.753,P=0.048).No serious adverse reaction events were reported during the study.Conclusions Wuling capsules could improve depressive symptoms and sleep disturbances in PD patients,and show good medication safety.

关 键 词：乌灵胶囊 帕金森病 抑郁 睡眠障碍 

分 类 号：R742.5[医药卫生—神经病学与精神病学]