丙炔苯丙胺治疗帕金森病多中心、随机、对照开放临床研究

A multi-center, randomized, vitamin E controlled and opening clinical trial of selegiline in patients with 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 采用多中心、随机、对照开放研究方法 ,对已使用PD治疗药物但疗效不佳的 14 3例PD患者 ,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患者进行统一帕金森病评分量表(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 ,除右上肢动作治疗前后比较无显著性差异外 ,其他各项均较治疗前显著改善。与对照组比较 ,治疗组患者静止性震颤、强直、手指拍打、手运动、手部轮替动作等症状的改善差异有显著性意义。治疗组 12周后UPDRS Ⅲ总分为 (19 9± 10 7)与对照组(2 7 6± 12 0 )比较差异有显著性意义。治疗组 12周后总有效率为 4 8 5 % ,显著高于对照组的 8 3%(P <0 0 1)。治疗组Hoehn Yahr分级减级≥ 1者 2 5例 (39 0 % ) ,与对照组 (4 0 % )相比有显著差异(P <0 0 1)。丙炔苯丙胺对帕金森病患者的部分抑郁症状有明显改善 (P <0 0 1)。治疗组副作用的发生率为 31 0 % ,显著高于对照组 4 2 % (P <0 0 1) ,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 ,副作用?

Objective To investigate the clinic efficacy and safety of selegiline as adjunctive treatment on patients with Parkinson's disease (PD).Methods 143 PD patients participated in the multi-center 12-weeks randomized, vitamin E controlled, opening clinical trial. 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 After treating for 4 and 12 weeks, the scores of most UPDRS- Ⅲ items were significantly improved in the selegiline-treated group, except the right arm movement. The UPDRS-Ⅲ items including tremor at rest, rigidity, finger taps, hand movements and rapid alternating movements of hands were significantly improved in selegiline-treated group than in vitamin E-treated group. There existed a significant difference (P<0.01) in the changes of UPDRS overall score between these two groups. The effective rate at 12 weeks after medication was higher in selegiline-treated group (48.5%) than in vitamin E-treated group(8.3%). Compared with baseline, the ≥1 reduction Hoehn-Yahr stage was significantly higher in selegiline-treated group (39%) than in vitamin E-treated group (4%). The total score and most subscores of HAMD were also significantly decreased in PD patients with depressive symptoms. The occurrence of side-effects in selegiline-treated group was significantly higher than in vitamin E-treated group. But most of the side-effects were mild. Conclusions The study showed that selegiline should be effective for the main motor symptoms andconcurrentdepressive symptoms of PD. The side-effects, insomnia and dizziness were found, but most of them were slight.