The Efficacy And Safety Of Tolcapone In Patients With Parkinson's Disease

Objective: To assess the efficacy and safety of Tolcapone in treatment ofParkinson's disease (PD).Methods: 80 patients with PD were followed up in a multicentre, double-blind,placebo-controlled, with randomized study for 26 weeks. UPDRS score wasused to evaluate efficacy of tolcapone in treatment of PD.Results:1. 80 cases were randomly divided into tolcapone Group and Placebo Group. Patients' characters, history, initial symptoms UPDRS had no significant difference.2. Application in stable PD patients: We applied tolcapone l00mg or placebo to patients, t.i.d, for 26 weeks. Tolcapone group had significantly lower UPDRS score than placebo group (p<0.01). We compared the cognition ability, muscle rigidity, tremor, hypokinesia and the function of autonomic nerve with UPDRS score. The results showed that the improvements in cognition ability, muscle rigidity, and hypokinesia were statistically significantly lower with tolcapone than with placebo (p<0.05, 0.05, 0.05) . But there were no significant differences between tolcapone group and placebo group in the aspects of tremor and the function of autonomic nerve (p>0.05, 0.05).3. Patients with motor fluctuations: among the 80 PD cases, 21 cases had "on /off". Compared with placebo group, the "off time of patients in tolcapone group reduced 38% averagely, the "on" time prolonged 22% averagely. The wearing-off phenomenon reduced in 68% patients of tolcapone group, but it reduced hi only37% patients of p placebo group. Among the 12 cases who took levodopa, 5 patients reduced their levodopa dosage after taking tolcapone additionally. 4. We observed 80 PD patients who took tolcapone for 6 months regularly, and found that blood and urine routine test, hepatic and renal function, heart rate, blood pressure, and ECG were all in normal state after taking tolcapone. There were 48 patients showing side-effect in 80 cases, and their appearance was significantly higher in tolcapone group (p<0.01), such as sleeplessness, nausea, vomiting, diarrhea, but no malignant accident occurred.Conclusion:Tolcapone could greatly improve PD patients' motor function, especially in hypokinesia, muscle rigidity, and it could also improve the cognition ability. Tolcapone was an effective adjunctive drug. It could significantly reduce the "off' time hi PD patients with motor fluctuations, and prolong the "on" time. It could also improve wearing-off phenomenon. In a word, tolcapone was a safe and effective drug in treating patients with PD.