帕罗西汀片联合普拉克索片治疗帕金森病伴抑郁的临床研究

Clinical trial of paroxetine tablets combined with pramipexole tablets in the treatment of Parkinson's disease with depression

目的观察普拉克索片联合帕罗西汀片治疗帕金森病伴抑郁的临床疗效及安全性。方法将96例帕金森病伴抑郁患者随机分为对照组和试验组,每组48例。对照组予以普拉克索治疗,第1周每次0.125 mg,tid,口服,第2周每次0.25 mg,tid,口服,第3~8周每次0.5 mg,tid,口服;试验组在对照组治疗的基础上,予以帕罗西汀每次20 mg,qd,口服。2组患者均治疗8周。比较2组患者的临床疗效、汉密顿抑郁量表(HAMD)评分和帕金森氏病综合评分量表(UPDRS)评分,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为93.75%(45例/48例)和72.92%(35例/48例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的HAMD评分分别为(7.11±0.79)和(9.17±1.34)分,UPDRS评分分别为(33.15±2.89)和(41.15±5.32)分,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头部不适、恶心和嗜睡为主,试验组和对照组的总药物不良反应发生率分别为20.83%和14.58%,差异无统计学意义(P>0.05)。结论普拉克索片联合帕罗西汀片治疗帕金森病伴抑郁的临床疗效确切,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of paroxetine tablets combined with pramipexole tablets in the treatment of Parkinson＇s disease with depression. Methods A total of 96 patients of Parkinson＇s disease with depression were divided into treatment and control groups with 48 cases per group. Control group was treated with pramipexole,the first week was 0. 125 mg per time,tid,orally,the second weeks was 0. 25 mg per time,tid,orally,the 3 th-8 th weeks was0. 5 mg per time,tid,orally. Treatment group was treated with paroxetine 20 mg per time,qd,orally,on the basis of control group. Two groups were treated for 8 weeks. The clinical efficacy,Hamilton depression scale（ HAMD）, Parkinson ＇s disease comprehensive scale（ UPDRS）,and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 93. 75%（ 45 cases/48 cases） and 72. 91%（ 35 cases/48 cases） with significant differences（ P 0. 05）. After treatment,the main indexes of treatment and control groups were compared：HAMD scores were（ 7. 11 ± 0. 79） and（ 9. 17 ± 1. 34）,UPDRS were（ 33. 15 ± 2. 89） and（ 41. 15 ± 5. 32）,the differences were statistically significant（ all P 0. 05）. The adverse drug reactions of two groups were head discomfort,nausea and lethargy. The total incidences of adverse drug reactions in treatment and control groups were 20. 83% and 14. 58% without significant difference（ P 0. 05）. Conclusion Paroxetine tablets combined with pramipexole tablets have a definitive clinical efficacy in the treatment of Parkinson＇s disease with depression,without increasing the incidence of adverse drug reactions.