Abstract: 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.

Key words: Parkinson's disease, amantadine monotherapy, salvia miltiorrhiza compound, selegiline, drug combination