CAJ | 학술논문

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.
목적 평개청화대학연발적국산가충전식뇌기박기치료파금삼병(PD)적림상료효.방법 대입조적31례PD환자진행국산가충전식뇌기박기수술.환자안수궤화원칙분위시험조(n=15)화대조조(n=16),술후1개월시험조개궤,조정맥관、빈솔、전압등자격삼수진행자격,대조조모의개궤단불자격,술후3개월게맹,비교량조개기화관기PD평분량표(UPDRS)운동평분、일상생활능력평분이급개기무이동시간적차이,게맹후대조조개궤자격,지술후6개월재차진행평개.동시검측충전시기박기적온도변화、충전능력화충전은정성.결과 술후1개월시험조개궤후,증상축점개선.술후3개월게맹전,시험조관기화개기UPDRS운동평분、일상생활능력평분이급개기무이동시간교대조조화기선명현개선(P＜0.05),이대조조교기선상비차이무통계학의의(P＞0.05);대조조개궤후증상축점개선,술후6개월,대조조적료효축점여시험조추동,료효교기선상비균명현개선(P＜0.05).결론 국산가충전식뇌기박기능현저개선PD환자개기화관기UPDRS운동평분화일상생활능력평분,연장개기무이동시간,감소좌선다파등효제량,가용우PD적수술치료.
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.