国产可充电式脑起搏器治疗帕金森病的临床试验研究  

Clinical trial with domestic rechargeable stimulator system for patients with Parkinson＇s disease

作　　者：孟凡刚[1] 张凯[2] 胡文瀚[1] 刘焕光[2] 葛燕[1] 王慧敏[2] 张鑫[1] 张建国[2] 

机构地区：[1]首都医科大学北京市神经外科研究所,100050 [2]首都医科大学附属北京天坛医院神经外科

出　　处：《中华神经外科杂志》2014年第7期698-702,共5页Chinese Journal of Neurosurgery

基　　金：基金项目：“十二五”国家科技支撑计划课题（2011BA112807）;北京市医院管理局临床医学发展专项经费资助（ZY201305）;首都卫生发展科研专项（2009-1039）;北京市卫生系统高层次卫生技术人才培养计划（2011-3-032）

摘　　要：目的 评价清华大学研发的国产可充电式脑起搏器治疗帕金森病（PD）的临床疗效.方法 对入组的31例PD患者进行国产可充电式脑起搏器手术.患者按随机化原则分为试验组（n=15）和对照组（n=16）,术后1个月试验组开机,调整脉宽、频率、电压等刺激参数进行刺激,对照组模拟开机但不刺激,术后3个月揭盲,比较两组开期和关期PD评分量表（UPDRS）运动评分、日常生活能力评分以及开期无异动时间的差异,揭盲后对照组开机刺激,至术后6个月再次进行评价.同时检测充电时起搏器的温度变化、充电能力和充电稳定性.结果 术后1个月试验组开机后,症状逐渐改善.术后3个月揭盲前,试验组关期和开期UPDRS运动评分、日常生活能力评分以及开期无异动时间较对照组和基线明显改善（P＜0.05）,而对照组较基线相比差异无统计学意义（P＞0.05）;对照组开机后症状逐渐改善,术后6个月,对照组的疗效逐渐与试验组趋同,疗效较基线相比均明显改善（P＜0.05）.结论 国产可充电式脑起搏器能显著改善PD患者开期和关期UPDRS运动评分和日常生活能力评分,延长开期无异动时间,减少左旋多巴等效剂量,可用于PD的手术治疗.Objective To investigate the efficacy of domestic rechargeable neurostimulator system for the treatment of patients with Parkinson＇s disease （PD）.Methods Totally 31 patients with PD were enrolled in this clinical trial who were treated with domestic rechargeable neurostimulator system.The PD patients were divided into treatment group （n =15） and sham group （n =16） randomly.The neurostimulator of treatment group was turned on and the stimulus parameter （amplitude,pulse width and frequency） were modulated at 1 month after the operation,whereas the sham group was turned on without stimulation.Scores on the Unified Parkinson＇s Disease Rating Scale,part Ⅲ （UPDRS-Ⅲ）,for the assessment of motor function （on/off medication）,scores on the UPDRS-Ⅱ,for the assessment of activities of daily living （on/off medication） and the number of hours per day spent in the ＂on＂ state were assessed at 1,3,and 6 month of follow-up with stimulation in the absence or presence of medicatior.The changes of temperature were detected during battery charging,and the recharging ability and stability of the rechargeable neurostimulator was assessed during the stage.Results UPDRS-Ⅲ and UPDRS-Ⅱ scores （on/off medication） and the number of hours per day spent in the ＂on＂ state in the treatment group were improved significantly than baseline at 1,3 month post operation （P 〈 0.05）,whereas the sham group was similar with baseline （P 〉 0.05）.The scores in the sham group were similar with treatment group at 6 month post-operation,both groups were improved significantly than baseline （P 〈 0.05）.Conclusions The domestic rechargeable neurostimulator system could improve the UPDRS-Ⅲ,UPDRS-]Ⅱ scores （on/off medication） significantly and the number of hours per day spent in the ＂on＂ state.The system was efficacy for the treatment of patients with PD.

关 键 词：脑深部电刺激术 帕金森病 可充电脑起搏器 临床试验 

分 类 号：R742.5[医药卫生—神经病学与精神病学]