国产脑深部电刺激器治疗帕金森病的长期疗效观察

Deep brain stimulation with a PINS device in Parkinson＇s disease： long-term follow-up

目的探讨国产脑深部电刺激器治疗原发性帕金森病（PD）的长期有效性及安全性。方法回顾性纳入2009年11月至2012年8月在首都医科大学附属北京天坛医院神经外科采用双侧丘脑底核植入国产脑深部电刺激器治疗的PD患者50例。术后6个月、1年、2年及5年，采用统一PD评定量表（UPDRS）评估药物“关”期状态下症状的改善程度，观察左旋多巴等效剂量变化及相关并发症。结果50例患者随访5．0-7．5年。与术前比较，术后6个月、1年、2年及5年，药物“关”期的运动评分量表评分（UPDRSⅢ）均下降，差异均有统计学意义（均P〈0．01），改善率（中位数）分别为71％、69％、69％及62％；日常生活能力评分量表评分（UPDRSⅡ）也均下降（均P〈0．01），改善率（中位数）分别为71％、71％、71％及62％；左旋多巴等效剂量减少率（中位数）分别为31％、37％、35％及27％。无死亡及颅内出血的患者，5例（10％）出现一过性精神症状，皮肤破溃感染2例（4．0％），脑脊液漏、眼睑下垂、构音障碍各1例（各占2．0％）。术前有异动的2例患者术后异动症无明显缓解，经调整参数后，1例（2．0％）基本消失，1例（2．0％）持续存在。结论植入国产脑深部电刺激器可以明显改善PD患者的运动症状和生命质量，长期随访安全、有效。

Objective To evaluate the long-term safety and efficacy of subthalamic nucleus deep brain stimulation （STN-DBS） with a PINS stimulator in Parkinson＇s disease （PD）. Methods Fifty patients received PINS device implantation in the subthalamic nucleus from November 2009 to August 2012 at Neurosurgery Department of Beijing Tiantan Hospital, Capital Medical University and were retrospectively enrolled into this study. The effects of stimulation on motor score, activities of daily living, the levodopa-equivalent dose, and the side effects were analyzed for all 50 patients with PD undergoing bilateral STN-DBS based on the Unified Parkinson＇s Disease Rating Scale （UPDRS）. The scores were collected at baseline in two conditions （off medication） and at 6 months, 1, 2, and 5 years of follow-up with stimulation in the absence or presence of medication. Results The 50 patients were followed up for 5.0 - 7.5 years. At 6 months, 1,2, and 5 years of follow-up, our results showed a significant decrease from baseline in both activities of daily living and motor scores （ P 〈 0.01 ） ; the daily levodopa-equivalent dose decreased compared with baseline （ P 〈 0.01 ）. In the condition of medication off, the UPDRS m scores decreased by 71%, 69%, 69%, 62% at 6 months, 1 year, 2 years, 5 years, respectively; and the improvement rates of UPDRS II scores were 71%, 71%, 71%, 62%, at 6 months, 1 year, 2 years, 5 years, respectively. The daily levodopa-equivalent dose decreased by 31%, 37%, 35%, 27% at 6 months, 1 year, 2 years, 5 years, respectively. There was no death or intracranial hemorrhage in the study. Five patients suffered from transient mental and psychiatric disturbances. Two cases of infection, 1 case of cerebrospinal fluid leakage, 1 case of ptosis, and 1 case of dysphonia were observed during the follow-up. The 2 cases with preoperative dyskinesia had no significant improvement including 1 reported disappearance of dyskinesia and 1 with remaining dyskinesia following adjustment of programming parameters. Conclusion STN-DBS with the PINS device could significantly improve the motor symptoms and life quality of PD patients, which demonstrated safety and efficacy in long-term study.