丙炔苯丙胺治疗帕金森病的临床研究

Clinical Study of Selegiline for Parkinson's Disease

目的观察丙炔苯丙胺治疗帕金森病(PD)的临床有效性和安全性。方法采用随机对照的研究方法,对68例PD病人,分别给予丙炔苯丙胺和维生素E或单独维生素E治疗12周。治疗前后对所有PD病人进行统一PD评分量表(UPDRS-Ⅲ)评分、Hoehn-Yahr分级和Hamilton抑郁量表评分以评估药物疗效,同时观察不良反应。结果丙炔苯丙胺治疗组UPDRS-Ⅲ各项评分均较治疗前显著改善。治疗组12周后UPDRS-Ⅲ总分为(20.2±10.8)分与对照组(26.3±11.7)分比较有统计学意义。治疗组12周后总有效率(61.8%)显著高于对照组(14.7%,P<0.01)治疗组Hoehn-Yahr分级减级≥1级者15例(44.1%),与对照组3例(8.9%)相比有统计学意义(P<0.01)。丙炔苯丙胺对PD病人的部分抑郁症状有明显改善(P<0.01)。治疗组副反应的发生率(35.3%)显著高于对照组(5.9%P<0.01),但多数症状轻微,不影响治疗。结论丙炔苯丙胺对PD的主要症状震颤、少动和强直及伴随的抑郁症状有明显疗效,副反应主要为失眠、头晕等主观症状,多数较轻微。

Objective To investigate the clinic efficacy and safety of Selegiline as adjunctive treatment for patients （pts） with Parkinson＇ s disease （PD）. Methods Sixty-eight patients （pts） with PD were divided into treatment group treated by Selegiline with vitamin E and control group treated by vitamin E. Efficacy of Selegiline was assessed by Unified Parkinson＇s Disease Rating Scale, Part Ⅲ （UPDRS- Ⅲ ）, Hoehn - Yahr Staging Scale and Hamilton Depression Scale（HAMD）. The adverse effects were also observed. Results Following treatment for 12 weeks, the scores of most UPDRS- Ⅲ items were improved significantly in the treatment group. There was a significant difference in the changes of UPDRS overall score between these two groups（P 〈 0.01 ）, The effective rate at 12 weeks after medication was higher in treatment group （61.8%） than that in control group（14.7%）. with bascline,the≥1 reduction Hoehn - Yahr stage was significantly higher in the treatment group （44.1% ） than that in control group （8.9%）. The total score and most subscores of HAMD were also decreased significantly in PD pts with depressive symptoms. The occurrence of side - effects in treatment group was significantly higher than that in control group. But the most of the side - effects were mild. Conclusion The study showed that Selegiline was effective for the main motor symptoms and concurrent depressive symptoms of PD. The side - effects included insomnia and dizziness were found, but most of them were slight.