普拉克索治疗早期帕金森疾病的效果综合评价

Comprehensive evaluation on the efficacy of Pramipexole in Early Parkinson 's Disease

目的:对普拉克索在早期帕金森疾病中的治疗作用进行综合全面地评价。方法:将早期帕金森病60例患者,按服不同的药物分为美多巴治疗组(30例)和普拉克索治疗组(30例),在0年、0.5年、1、2年内比较2组运动症状及运动并发症、非运动症状及不良反应发生率。对2组采用统一评定相关量表进行评估。结果:在0.5年、1年、2年观察窗内,美多巴组的UPDRSII评分、UPDRSⅢ评分、H-Y分期和普拉克索组的UPDRSⅢ评分,较基线相比均获得明显改善(P<0.05),普拉克索组从1年开始,UPDRSII评分和H-Y分期较基线相比获得明显改善(P<0.05)。在第1年和第2年时,美多巴组的H-Y分期和UPDRSⅢ评分明显低于普拉克索组(P<0.05)。在观察终点时,美多巴组症状波动发生率较普拉克索组明显增加,非运动症状发生率美多巴组明显高于普拉克索组(P<0.05)。在0.5年、1年、2年观察窗内普拉克索组的UPDRSI评分、HAMD-24、HAMA-14、PDSS、FSS、SCOPA-AUT均明显改善(P<0.05),而美多巴组无改善。观察终点普拉克索组嗜睡、视幻觉、体位性低血压发生率均高于美多巴组(P<0.05)。结论:在早期帕金森疾病中普拉克索和美多巴都能改善运动症状。虽然普拉克索对运动症状的改善不如美多巴,但可延缓运动并发症的发生,且对部分非运动症状的发生具有良好改善作用。

Objective：To evaluate the efficacy of Pramipexole in Early Parkinson＇s Disease Comprehensively. Methods：60 early PD patients were randomly assigned to receive Madopar（n=30）or pramipexole alone（n=30）. Parkinson diseases rating scale I-Ⅲ（UPDRS I-Ⅲ）,H-Y staging, 24-items of Hamilton Rating Scale for Depression（HAMD-24）, Hamilton Rating Scale for Anxiety（HAMA-14）,Parkinson Disease Sleep Scale（PDSS）,Fatigue Severity Scale（FSS）,Scales for Outcomes in Parkinson＇s Disease-AUT（SCOPA-AUT）, mini mental state examination（MMSE）and Questionnaire of non-motor symptoms in patients with PD were performed to estimate the degree of patient＇s motor symptoms and non—motor symptoms in all follow up windows; and analyze the motor fluctuation incidence, movement disorders incidence, non-motor symptom incidence and the adverse reactions incidence with statistics. Results：Compared to the baseline levels,the scores of UPDRS II,UPDRSⅢand H-Y staging in the Madopar group and the score of UPDRSⅢ in the pramipexole group were significantly improved in all follow up windows（P0.05）,and the scores of UPDRS II and H-Y staging were significantly improved in the pramipexole group at the end of 1st year（P0.05）, the scores of UPDRSⅢand H-Y staging in the Madopar group were significantly lower than those in the pramipexole group at the end of 1st and 2nd year（P0.05）.The motor of fluctuation incidence and the non-motor symptom incidence in the Madopar group were significantly higher than those in the pramipexole group at the end of 2nd year（P0.05）.The scores of UPDRS I, HAMD-24, HAMA-14,PDSS,FSS and SCOPA-AUT were significantly improved in all follow up windows（P0.05）,but no significant difference was found in the Madopar group compared to the baseline levels. Incidence of drowsiness, visual hallucination and orthostatic hypotension in the pramipexole group were significantly higher than those in the Madopar group at the end of 2nd year. Conclusion：Pramipexole and Madopar can improve the motor symptom in Early Parkinson＇s Disease. Madopar may be superior to Pramipexole in terms of improvement of motor symptoms,but Pramipexole can delay the occurrence of motor complications and can improve some non-motor symptoms.