普拉克索缓释片治疗原发性帕金森病的临床疗效及安全性观察  

Safety and efficacy of pramipexole hydrochloride extended-release tablets in treatment of idiopathic Parkinson′s disease

作　　者：李志霞[1] 马义鹏 梁蔚俊 胡为民[2] Li Zhixia;Ma Yipeng;Liang Weijun;Hu Weimin(Shanxi Medical University,Taiyuan 030001,China;Department of Neurology,the Second Hospital of Shanxi Medical University,Taiyuan 030001,China)

机构地区：[1]山西医科大学,太原030001 [2]山西医科大学第二医院,太原030001

出　　处：《中华临床医师杂志（电子版）》2017年第19期2263-2267,共5页Chinese Journal of Clinicians(Electronic Edition)

基　　金：山西省国际科技合作项目(2014081057)

摘　　要：目的比较普拉克索缓释片、普拉克索平片及左旋多巴治疗原发性帕金森病疗效。方法选取2015年10月至2016年7月就诊于山西大医院和山西医科大学第二医院神经内科门诊和住院的帕金森病患者共110例,将其分为普拉克索缓释片合用左旋多巴组(ER组)、普拉克索平片合用左旋多巴组(IR组)和左旋多巴组。比较治疗前后各组运动症状及左旋多巴剂量变化;汉密尔顿抑郁量表(HAMD)-17项、帕金森病睡眠量表(PDSS)、健康调查简表(SF-36)评分的变化,并记录不良反应发生情况。结果 ER组和IR组在改善运动症状方面疗效相似,差异无统计学意义(P>0.05),但均优于左旋多巴组(P<0.05);ER组在HAMD-17项、PDSS评分改善上均优于IR组和左旋多巴组,差异有统计学意义(P<0.05)。3组间不良反应发生率相似,差异无统计学意义(P>0.05)。结论普拉克索缓释片与普拉克索平片改善帕金森病患者运动症状的疗效是相似的,但缓释片能更好地改善抑郁和睡眠症状;二者联合左旋多巴较左旋多巴单用疗效更优,且安全可靠。Objective To explore whether the curative effect of the extended-release form of pramipexole is better than that of the immediate-release form and levodopa in treating idiopathic Parkinson′s disease. Methods One hundred and ten Parkinson′s disease patients treated at the Second Hospital of Shanxi Medical University and Shanxi Dayi Hospital from October 2015 to July 2017 were randomly divided into three groups to receive the extended-release form of pramipexole plus levodopa, the immediate-release form plus levodopa, and levodopa alone, respectively. Motor symptoms, levodopa dosage, Hamilton depression rating scale-17（HAMD-17） score, Parkinson′s disease sleep scale（PDSS） score, and the 36-item short form health survey（SF-36） score were compared between the three groups. Results The extended-release form plus levodopa had similar efficacy to the immediate-release form plus levodopa in improving motor symptoms（P〉0.05）, but was better than levodopa alone. The extended-release form plus levodopa was significantly better than the immediate-release form plus levodopa and levodopa alone in improving depression and sleep（P〈0.05）. The safety was similar between the three groups（P〉0.05）. Conclusion The extended-release form plus levodopa is similar to the immediate-release form in improving motor symptom in patients with idiopathic Parkinson′s disease, but can significantly better improve depressive and sleep symptoms. The combination treatment with pramipexole and levodopa has better curative effect than levodopa alone. Pramipexole extended-release tablets is safe and reliable in the treatment of patients with idiopathic Parkinson′s disease.

关 键 词：普拉克索缓释片 原发性帕金森病 临床疗效 安全性 

分 类 号：R742.5[医药卫生—神经病学与精神病学]