雷沙吉兰联合普拉克索治疗帕金森病患者的临床研究  

Clinical trial of rasagiline combined with pramipexole in the treatment of Parkinson’s disease patients

作　　者：程世宏 林强 郑俊俊 CHENG Shi-hong;LIN Qiang;ZHENG Jun-jun(Department of Neurology,Shangrao Municipal Hospital,Shangrao 334000,Jiangxi Province,China;Department ofNeurology,Shangrao People's Hospital,Shangrao 334000,Jiangxi Province,China)

机构地区：[1]上饶市立医院神经内科,江西上饶334000 [2]上饶市人民医院神经内科,江西上饶334000

出　　处：《中国临床药理学杂志》2024年第15期2174-2177,共4页The Chinese Journal of Clinical Pharmacology

基　　金：江西省卫生健康委科技计划基金资助项目(20202014)。

摘　　要：目的 观察雷沙吉兰片联合普拉克索片治疗帕金森病患者的临床疗效及安全性。方法 将帕金森病患者随机分为试验组和对照组。对照组接受普拉克索片,初始剂量为每天每次0.375 mg,后续每5~7 d增加每次0.75 mg,最终剂量为每天每次1.5 mg,对于病情持续控制不佳者,用药次数可调整为每天2次,每天最大剂量≤4.5 mg;试验组在对照组治疗的基础上,联合口服雷沙吉兰每天1.0 mg,qd。2组患者均治疗6个月。比较2组患者的临床疗效、炎症因子和血清学指标的水平、改良Webster症状评分,以及药物不良反应的发生情况。结果 对照组入组67例,试验组入组68例,2组均无患者脱落。治疗后,试验组和对照组的总有效率分别为88.24%(60例/68例)和74.63%(50例/67例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的干扰素-γ分别为(4.38±0.74)和(5.20±1.06)mg·L^(-1),白细胞介素-1β分别为(0.33±0.05)和(0.59±0.12)ng·L^(-1),谷胱甘肽过氧化物酶分别为(108.24±11.30)和(92.88±9.79)U·μg^(-1),改良Webster症状评分分别为(7.26±1.05)和(13.15±3.25)分,γ-氨基丁酸(GABA)分别为(278.14±41.32)和(241.86±35.04)mmol·L^(-1),胰岛素生长因子-1(IGF-1)分别为(170.25±20.34)和(145.18±16.51)ng·L^(-1),在统计学上差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以恶心呕吐、嗜睡、头昏为主。试验组和对照组的总药物不良反应发生率分别为11.76%和8.96%,在统计学上差异无统计学意义(P>0.05)。结论 雷沙吉兰片联合普拉克索片治疗帕金森病患者的临床疗效确切,其可减轻氧化应激反应和炎症反应,缓解运动症状,调节血清GABA和IGF-1表达水平,且不会明显增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of the combination of rasagiline tablets and pramipexole tablets in the treatment of patients with Parkinson's disease.Methods The Parkinson's disease patients were randomly divided into treatment and control groups.The control group received pramipexole tablets,starting at a dose of 0.375 mg per day,with subsequent increases of 0.75 mg per time every 5-7 days,reaching a final dose of 1.5 mg per day.For patients with persistent poor disease control,the frequency of administration could be adjusted to twice a day,with a maximum daily dose of≤4.5 mg.The treatment group received oral rasagiline in addition to the treatment in the control group,at a dose of 1.0 mg per day,once daily(qd).Both groups of patients were treated for 6 months.The clinical efficacy,inflammatory factors,serological indicators and related scales,as well as the occurrence of adverse drug reactions were compared between the two groups.Results The control group consisted of 67 participants,and the treatment group consisted of 68 participants,with no dropouts in either group.After treatment,the total effective rates of the treatment and control groups were 88.24%(60 cases/68 cases)and 74.63%(50 cases/67 cases)with significant difference(P<0.05).After treatment,the levels of interferon-γ in treatment and control groups were(4.38±0.74)and(5.20±1.06)mg·L^(-1);the levels of interleukin-1β were(0.33±0.05)and(0.59±0.12)ng·L^(-1);the levels of glutathione peroxidase were(108.24±11.30)and(92.88±9.79)U·μg^(-1);the modified Webster symptom scores were(7.26±1.05)and(13.15±3.25)points;the levels of γ-aminobutyric acid(GABA)were(278.14±41.32)and(241.86±35.04)mmol·L^(-1);the levels of insulin growth factor-1(IGF-1)were(170.25±20.34)and(145.18±16.51)ng·L^(-1),and the differences were statistically significant(allP<0.05).The main adverse drug reactions of 2 groups were nausea and vomiting,drowsiness and dizziness.The total incidences of adverse drug reactions in treatment and control gro

关 键 词：甲磺酸雷沙吉兰片 盐酸普拉克索片 多巴丝肼片 帕金森病 临床疗效 安全性评价 

分 类 号：R971[医药卫生—药品]