恩他卡朋添加治疗症状波动的帕金森病的随机、双盲、安慰剂对照临床研究

目的:探讨添加恩他卡朋治疗PD患者剂末现象的疗效和安全性。方法:40例伴有剂末现象的PD患者进行随机、双盲、安慰剂、平行分组临床对照试验。根据患者日记记录的"开"、"关"期时间、UPDRS各部分评分、研究者总体评估变化量表和左旋多巴每日剂量来评定疗效。结果:恩他卡朋治疗12周时能显著延长"开"期时间、缩短"关"期时间,降低UPDRS评分,减少每日左旋多巴用量,研究者主观感觉65%的患者病情好转,与安慰剂组相比差异有显著意义。不良事件的发生率与安慰剂组相比差异无显著意义。结论:添加恩他卡朋治疗伴有剂末现象的PD患者安全、有效。

A Randomized Placebo-controlled,Double-blind,Parallel-group Trial of Entacapone in Patients with Fluctuation Parkinson's Disease

Aim: To explore the efficacy and safety of entacapone as a adjunct to levodopa treatment in parkinsonian patients with wearing-off motor fluctuations. Methods: A total 40 parknsonian patients with end-of-dose deterioration took part in a 12-week randomized, placebo-controlled, double-blind, parallel-group trial. The efficacy of entacapone was assessed by using the patients' diary card, the Unified Parkinson's Disease Rating Scale (UPDRS) score, the daily levodopa dosage, and the global assessment of changes. Results: When treated for 12 weeks, in comparison to placebo-treated patients, entacapone had significantly increased the " on" time, reduced " off" time, decreased the UPDRS and the daily levodopa dosage, and neurologists found through global change assessment the symptoms of 65% of the patients treated with entacapone improved. There was no significant difference in the frequency of adverse event and serious laboratory abnormalities between entacapone and placebo groups. Conclusion: Entacapone is a safe and effective extender of levodopa treatment for parkinsonian patients with wearing-off motor fluctuations.