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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。
Objective: To investigate the efficacy and safety of adding entacapone in treating end-stage PD in patients with PD. Methods: Forty PD PD patients with end-point syndrome were randomized, double-blind, placebo and parallel controlled clinical trial. The curative effect was assessed according to the “on”, the “off” time of the patient’s diary records, the scores of the UPDRS components, the researchers’ overall assessment of change scale and the daily dose of levodopa. Results: Entecavan treatment at 12 weeks significantly prolonged the “on” period, shortened the “off” period, decreased the UPDRS score, and decreased the daily dosage of levodopa. The subjective perception was 65% in patients Condition improved, compared with the placebo group had significant significance. There was no significant difference in the incidence of adverse events between the placebo group and the placebo group. Conclusion: Adding entacapone in the treatment of PD patients with dosing agent is safe and effective.