甲磺酸雷沙吉兰治疗原发性帕金森病的随机双盲安慰剂对照临床.docVIP

甲磺酸雷沙吉兰治疗原发性帕金森病的随机、双盲、安慰剂对照临床试验 李 凤1，陈 明2，马勋泰1，李小刚1，谭华1，何晓英1，袁 平1（646000四川 泸州,泸州医学院附属医院：神经内科1，放射科2） [摘要]目的：观察甲磺酸雷沙吉兰治疗应用左旋多巴治疗但运动症状有波动的原发性帕金森病患者的疗效和安全性。方法：采用随机、双盲、安慰剂平行对照临床试验观察甲磺酸雷沙吉兰对应用左旋多巴治疗但运动症状有波动的44例原发性帕金森病患者的疗效，观察16周。根据患者日记记录的“关”和“开”期时间、统一帕金森评定量表（UPDRS）各部分评分相对于基线的变化评定疗效。安全性指标为不良反应、血压、心率、实验室检查值和心电图。结果：甲磺酸雷沙吉兰组治疗16周后“关”期时间自基线的(3.18±0.65)h/d缩短至(1.90±0.85)h/d，“开”期时间自基线的(10.74±1.44)h/d延长至(12.05±1.72)h/d，与安慰剂组相比差异均有统计学意义（P0.05）；甲磺酸雷沙吉兰治疗16周后UPDRSⅡ-Ⅳ各量表总评分及各单项评分均得到显著改善。未出现严重不良事件及不良反应。结论：甲磺酸雷沙吉兰治疗应用左旋多巴治疗但运动症状有波动的原发性帕金森病患者有效、安全。 [关键词]：甲磺酸雷沙吉兰；帕金森病；临床试验 Efficacy and safety of Rasagiline mesylate in patients with fluctuating Parkinsons disease: a randomized, double-blind, parallel-controlled, a single center trial Li Feng1，Chen Ming2，Ma Xuntai1，Tan Hua1，Li Xiaogang1，Yuan Ping1，He Xiaoying1.(The Affiliated Hospital of Lu zhou Medical college:1 Department of Neurology. 2 Department of Radiology, Luzhou 646000,China) [Abstract] Objective: To study the efficacy and safety of Rasagiline mesylate in levodopa-treated patients with Pakinson’s disease and motor fluctuations. Methods: A total 44 pakinsonian patients with motor fluctuations participated in a single center,16 weeks randomized, double-blind, parallel-controlled trial. The efficacy of Rasagiline mesylate was assessed using the patient’s diary card,the Unified Parkinson’s Disease Rating Scale (UPDRS) score. The safety was assessed on the basis of adverse events, blood pressure, pulse, laboratory measurements and ECG recordings. Results: In 41 cases, in comparision to the placebo-treated patients, Rasagiline mesylate had decreased the mean “off” time(h/d) from3.18±0.65h/d in base-line to 1.90?0.85h/d in week 16, increased the “on” time (from10.74?1.44h/d in base-line to 12.05?1.72h/d in week 16), improved the UPDRSⅡ-Ⅳ scores (from 64.00±16.30 in base-line to 45.80±11.54 in week 16). There was no adverse events between Rasagiline mesylate and placebo groups. Conclusion: Rasagiline mesylate should be regarded as an