Krüger Rejko, Lingor Paul, Doskas Triantafyllos, Henselmans Johanna M L, Danielsen Erik H, de Fabregues Oriol, Stefani Alessandro, Sensken Sven-Christian, Parra Juan Carlos, Onuk Koray, Yegin Ashley, Antonini Angelo
Luxembourg Center for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg.
Centre Hospitalier de Luxembourg, Luxembourg-City, Luxembourg.
Adv Ther. 2017 Jul;34(7):1741-1752. doi: 10.1007/s12325-017-0571-2. Epub 2017 Jun 19.
Continuous delivery of levodopa-carbidopa intestinal gel (LCIG) by percutaneous endoscopic gastrojejunostomy (PEG-J) in advanced Parkinson's disease (PD) patients reduces variability in plasma levels, providing better control of motor fluctuations ("on" and "off" states). The MONOTREAT study assessed the effect of LCIG on activities of daily living, motor and non-motor symptoms, and quality of life in advanced PD patients.
This prospective, observational study included patients with advanced, levodopa-responsive PD with either 2-4 h of "off" time or 2 h of dyskinesia daily. Patients received LCIG via PEG-J for 16 h continuously. Effectiveness was assessed using Unified PD Rating Scale parts II and III, the Non-Motor Symptom Scale, and the PD Questionnaire-8.
The mean (SD) treatment duration was 275 (157) days. Patients experienced significant improvement from baseline in activities of daily living at final visit (p < 0.05) as well as at months 3 and 6 (p < 0.0001). Patients also experienced significant improvements from baseline in quality of life and non-motor symptoms at all time points (p < 0.001 for all). Specifically, patients manifested significant improvements in mean change from baseline at every study visit in five of nine non-motor symptom score domains: sleep/fatigue, mood/cognition, gastrointestinal tract, urinary, and miscellaneous. One-third of patients (32.8%) experienced an adverse event; 21.9% experienced a serious adverse event; 11.1% discontinued because of an adverse event.
This study demonstrated significant and clinically relevant improvements in measures of activities of daily living, quality of life, and a specific subset of non-motor symptoms after treatment with LCIG.
AbbVie Inc.
对于晚期帕金森病（PD）患者，通过经皮内镜下胃空肠造口术（PEG-J）持续输注左旋多巴-卡比多巴肠凝胶（LCIG）可降低血浆水平的变异性，更好地控制运动波动（“开”和“关”状态）。MONOTREAT研究评估了LCIG对晚期PD患者日常生活活动、运动和非运动症状以及生活质量的影响。
这项前瞻性观察性研究纳入了晚期、对左旋多巴有反应的PD患者，这些患者每天有2 - 4小时的“关”期或2小时的异动症。患者通过PEG-J持续16小时接受LCIG治疗。使用统一PD评定量表第二部分和第三部分、非运动症状量表以及PD问卷-8评估疗效。
平均（标准差）治疗持续时间为275（157）天。患者在末次随访时以及第3个月和第6个月时，日常生活活动较基线有显著改善（p < 0.05）。在所有时间点，患者的生活质量和非运动症状较基线也有显著改善（所有p < 0.001）。具体而言，在九个非运动症状评分领域中的五个领域，患者在每次研究访视时较基线的平均变化均有显著改善：睡眠/疲劳、情绪/认知、胃肠道、泌尿和其他。三分之一的患者（32.8%）发生了不良事件；21.9%经历了严重不良事件；11.1%因不良事件停药。
本研究表明，LCIG治疗后，患者在日常生活活动、生活质量以及特定的非运动症状亚组方面有显著且具有临床意义的改善。
艾伯维公司
