INTRODUCTION The GLORIA registry included 375 advanced Parkinson's disease (PD) patients and evaluated the efficacy and safety of a 24-month levodopa-carbidopa intestinal gel (LCIG) treatment in routine medical care. This analysis focuses on the Italian population, 60 patients treated with LCIG in 7 specialised PD care centres. METHODS Hours of "Off" and "On" time were assessed with a modified version of the Unified Parkinson's Disease Rating Scale (UPDRS) part IV items 39 and 32. Motor fluctuations, dyskinesia, non-motor symptoms, quality of life and safety were evaluated. RESULTS Overall, 42 (70%) out of 60 patients completed the registry. LCIG treatment reduced "Off" time (- 3.3 ± 2.7 h at month 24 (M24), P < 0.0001), increased "On" time with dyskinesia (- 2.6 ± 5.2 h at M12, P = 0.0160), and improved UPDRS II and UPDRS III total scores at M24 (- 4.5 ± 10.6, P = 0.0333 and - 4.9 ± 11.7, P = 0.0229, respectively), Non-Motor Symptom Scale (NMSS) total score (- 21.8 ± 28.5, P < 0.0001) and Parkinson's Disease Questionnaire-8 item (PDQ-8) total score (- 12.5 ± 23.9, P = 0.0173) versus previous oral therapy. Adverse drug reactions (ADR) possibly or probably related to treatment were reported in 16 (28.6%) patients. Decreased weight (7.1%), polyneuropathy (7.1%) and abdominal pain (5.4%) were the most frequent ADRs while device malfunction (5.4%) and medical device change (5.4%) were the most reported device complaints. CONCLUSIONS LCIG improved motor fluctuations, non-motor symptoms and quality of life over 24 months while tolerability was consistent with the established safety profile.

中文翻译：

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左旋多巴-卡比多巴肠凝胶对晚期帕金森病患者运动和非运动症状的长期有效性：意大利GLORIA患者群体的结果。

简介GLORIA注册中心包括375名帕金森氏病（PD）晚期患者，并评估了常规医疗中24个月左旋多巴-卡比多巴肠凝胶（LCIG）治疗的有效性和安全性。这项分析的重点是意大利人口，在7个专门的PD护理中心接受了LCIG治疗的60名患者。方法使用修改后的帕金森氏疾病评分量表（UPDRS）第IV部分39和32评估“关闭”和“开启”时间的小时数。运动波动，运动障碍，非运动症状，生活质量和安全性评估。结果总体而言，60例患者中有42例（70％）完成了注册。LCIG治疗减少了“关闭”时间（在第24个月（M24）为-3.3±2.7 h，P <0.0001），运动障碍的“开启”时间增加了（在M12为-2.6±5.2 h，P = 0.0160），以及M24的UPDRS II和UPDRS III的总得分有所提高（分别为-4.5±10.6，P = 0.0333和-4.9±11.7，P = 0.0229），非运动症状量表（NMSS）总得分（-21.8±28.5，P <0.0001）和帕金森氏病问卷8（PDQ-8）总得分（-12.5±23.9，P = 0.0173）与以前的口服治疗相比。在16名（28.6％）患者中报告了可能或可能与治疗有关的药物不良反应（ADR）。体重减轻（7.1％），多发性神经病（7.1％）和腹痛（5.4％）是最常见的ADR，而设备故障（5.4％）和医疗设备更换（5.4％）是报告最多的设备投诉。结论LCIG在24个月内改善了运动波动，非运动症状和生活质量，而耐受性与既定的安全性一致。