多中心、随机、开放性观察思吉宁治疗帕金森病的临床疗效及安全性

<TITLE>THE EFFICACY AND SAFETY OF SELEGILINE IN TREATMENT OF PARKINSON’S DISEASE: MULTI-CENTER, RANDOMIZED AND OPEN CLINICAL TRIAL

目的研究单胺氧化酶B(MAO-B)抑制剂思吉宁治疗帕金森病(PD)的临床疗效和安全性。方法采用多中心、随机、开放性对照试验,对140例PD患者随机分为两组,分别服用思吉宁或维生素E12周,比较两组用药第4、8、12周末UPDRS评分和用药第12周汉密尔顿抑郁量表(HMD)评分下降程度,评估其治疗效果,同时记录试验过程中可能发生的不良反应。结果思吉宁组在用药第4、8、12周末的UPDRS评分下降与维生素E组比较有统计学意义(P<0.01)。思吉宁组在改善患者UPDRS评分方面的有效率高于维生素E组。常见不良反应为纳差、恶心等消化道症状和头晕。而失眠、体位性低血压虽少见,却容易导致停药。结论思吉宁作为MAO-B抑制剂是治疗PD的有效药物,耐受性良好。

Objective To investigate the efficacy and safety of Selegiline, one of the monoamine oxidase type B （MAOB） inhibitors, in the treatment of Parkinson＇ s disease （PD）. Methods The multi-center, randomized and open clinical trial was performed in the present study. 140 patients with idiopathic PD were divided randomly into 2 groups, i.e., Selegilinetrealed group（u=69） and Vitamine E-treated group （n=71）. lasting for 12 weeks. The efficacy was evaluated by the Unified Parkinson＇s Disease Rating Scale （UPDRS） scores and Hamilton Depression Raling Scale （HMD） scores. The side reactions were also recorded. Results The significant reduction of UPDRS scores in Selegiline-treated group was found at the end of the 4th, 8th and 12th weeks, compared with that of the Vitamine E-treated group,（P〈0.01）. The HMD scores examined at the 12th week were not changed. Cardinal side effects were digestive tract discomfort, dizziness, sleeplessness and postural hypotension. Conclusions Selegiline has a satisfactory effect and tolerance on the management of PD symptoms.