摘要目的 评价普拉克索对帕金森病患者抑郁症状的疗效及安全性. 方法 对门诊50例帕金森病合并抑郁症患者随机接受普拉克索或氟两汀治疗12周,不同时间点进行疗效和安全性评估. 结果 普拉克索组和氟西汀组患者汉密尔顿抑郁量表(HAMD)评分均呈下降趋势;12周末HAMD总评分较基线下降50%的患者比例普拉克索组为56.0%,氟西汀组为48.0%,(χ~2=0.321,P>O.05);12周末HAMD总评分低于或等于8分(治愈标准)的患者比例普拉克索组为52.0%,氟西汀组为32.0%,组间差异均无统计学意义(χ~2=2.053,P>0.05).普拉克索组患者12周末统一帕金森评定量表(UPDRS)第Ⅱ部分与第Ⅲ部分评分分别较基线下降了(2.9±3.7)分(t=2.366,P<0.05)分和(7.2±5.1)分(t=2.654,P<0.05);Spearman相关分析提示,12周末HAMD评分变化值与UPDRS-Ⅱ和UPDRS-Ⅲ的评分变化值之间无相关性.符合方案人群分析结果与以上一致,但12周末达治愈标准的患者比例普拉克索组明显高于氟西汀组(χ~2=5.021,P<0.05).普拉克索组与氟西汀组患者不良反应主要为轻度头晕和消化道症状,不良反应发生频率组间差异无统计学意义.结论普拉克索用于帕金森病合并抑郁症的治疗是安全而有效的.

abstractsObjective To investigate the efficacy and safety of pramipexole versus fluoxetine in the treatment of depression in Parkinson's disease ( PD). Methods A randomized, clinical trial of pramipexole versus fluoxetine treatment for 12 weeks in 50 patients suffering from combined PD and depression was accomplished. The efficacy and safety assessments of the treatments were performed at different time points. Results For the intent-to-treat (ITT) population, the Hamilton Depression Rating Scale (HAMD) scores decreased progressively in both the pramipexole and the fluoxetine group, and a between-time statistical analysis was significant for both groups. The efficacy proportion of patients who responded to the treatment, as defined by at least a 50% reduction in HAMD score, was 56. 0% in the pramipexole group versus 48. 0% in the fluoxetine group (χ~2 =0. 321, P>0. 05). Similarly, the proportion of patients who recovered, as defined by a final HAMD score ≤8, was 52. 0% in the pramipexole group versus 32. 0% in the fluoxetine group (χ~2 =2. 053, P>0. 05) , but the difference between the two treatments showed no statistical significance. At the endpoint, both the Unified Parkinson's Disease Rating Scale (UPDRS) part Ⅱ and part Ⅲ subscores improved in the pramipexole group, by a mean of 2. 9±3. 7 (t= 2.366, P<0.05) and7.2±5.1 (t=2.654, P< 0.05), respectively, and the latter was significantly different from the change in this variable of the fluoxetine group (P<0. 05). Spearman analysis showed that no relationship between HAMD score and UPDRS Part II or Part III subscore. The findings for the per-protocol (PP) population were consistent with the above results, except that the proportion of patients who recovered in the pramipexole group was significantly larger than that in the fluoxetine group. The adverse events in both groups were mild dizziness, nausea and anorexia. No significant difference was found in the frequencies of the adverse events between the pramipexole and fluoxetine group. Conclusions Pramipexole is effective and safe in the treatment of Chinese PD patients combined with depression.