金刚烷胺单用及与复方丹参或丙炔苯丙胺合用治疗早期帕金森病的临床观察

Open-label and non-randomized study of therapeutic effect of amantadine monotherapy and concomitant amantadine with salvia miltiorrhiza compound or selegiline on early Parkinson's disease

目的评定单用金刚烷胺、金刚烷胺与复方丹参或丙炔苯丙胺合用对早期帕金森病 (PD)患者治疗的效果和安全性。方法采用多中心、开放式分组 ,单用金刚烷胺组 (金刚烷胺组 ) 3 5例 ,金刚烷胺 +复方丹参组 (复方丹参组 ) 3 4例 ,金刚烷胺 +丙炔苯丙胺 (丙炔苯丙胺 )组 2 9例。临床疗效采用改良Webster量表和帕金森病运动功能 (MDRSPD)量表 ,在治疗前及以后每 2个月进行 1次评定 ,期限为 1年 ,观察药物的临床疗效及副作用。同时在治疗前后取血查肝肾功能、血糖及血常规、尿常规。结果Webster量表和MDRSPD量表的临床有效率 ,单用金刚烷胺组分别为 42 9%和 3 7 1% ,复方丹参组分别为 3 4 2 %和 2 6 5 % ,丙炔苯丙胺组分别为 5 1 1%和 48 3 % ,经t检验差异无显著性。MDRSPD量表的临床显效率 ,金刚烷胺组为 2 8% ,复方丹参组为 11 8% ,丙炔苯丙胺组为 2 7 6%。复方丹参组与金刚烷胺组相比 ,差异无显著性 ;丙炔苯丙胺组与金刚烷胺组相比 ,差异有显著性。不良反应的发生率在以上 3组分别为 2 7 8%、8 8%和 3 1% ,但均较轻微 ,持续时间短 ,不影响治疗。结论 3组方案对早期PD患者均有一定的疗效 。

Objective To assess the clinical efficacy and safety of amantadine monotherapy and concomitant amantadine with salvia miltiorrhiza compound or selegiline of the treatment of Parkinson's disease.Methods The clinical trial was performed in the multicenter, open label study. Amantadine group: 35 cases, amantadine plus salvia miltiorrhiza compound group: 34 cases and amantadine plus selegiline group: 29 cases. The clinical efficacy had been assessed with modified Webster scale (WR) and motor dysfunction rating scale for Parkinson's disease (MDRSPD) with interval of two months for one year. The safety data included blood glucose, hepatic and renal function tests, blood and urine routine tests.Results The clinical improved rates were 42 9% (WR) and 37 1% (MDRSPD) in amantadine group, respectively. The clinical score was improved in 34 2% (WR) and 26 5% (MDRSPD) in amantadine plus salvia miltiorrhiza compound group, respectively. The clinical improvement was 51 1% (WR)and 48 3% (MDRSPD) in amantadine plus selegiline group, respectively. There were no significant differences among these three groups ( t test, P >0 05). The clinical marked efficacy rates in assessment of MDRSPD were 2 8% in amantadine group, 11 8% in amantadine plus salvia miltiorrhiza compound group and 27 6% in amantadine plus selegiline group, respectively. There was significant difference between amantadine group and amantadine plus selegiline group, but no significant difference between amantadine group and amantadine plus salvia miltiorrhiza compound group. The adverse event rates were 27 8% in amantadine group, 8 8% in amantadine plus salvia miltiorrhiza compound group and 31 0% in amantadine plus selegiline group, respectively. All these events were mild, of short duration and resolved without treatment. Conclusion There was some efficacy rate in all three groups. Comparing with amantadine group, there was higher marked efficacy rate in amantadine plus selegiline group.