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The TANDEM investigation: efficacy and tolerability of levodopa-carbidopa intestinal gel in (LCIG) advanced Parkinson's disease patients.
Journal of Neural Transmission ( IF 3.2 ) Pub Date : 2020-03-24 , DOI: 10.1007/s00702-020-02175-1
Angelo Antonini 1 , Giovanni Abbruzzese 2 , Alfredo Berardelli 3 , Nicola Modugno 4 , Italo Stroppa 5 , Filippo Tamma 6 , Mariachiara Sensi 7 , Francesca Mancini 8 , Giovanni Cossu 9 , Alessandro Stefani 10 , Nicola Tambasco 11 , Alessandro Tessitore 12 , Giovanni Fabbrini 3 , Francesco E Pontieri 13 , Paolo Solla 14 , Anna Rita Bentivoglio 15, 16 , Cristoforo Comi 17 , Brigida Minafra 18 , Giulio Riboldazzi 19 , Donato Melchionda 20 , Tommaso Martino 20 , Leonardo Lopiano 21
Affiliation  

The TANDEM investigation was carried out in 17 Italian Movement Disorder centers on behalf of a joint initiative of neurologist members of the Italian Academy for Parkinson’s disease and Movement Disorders (LIMPE-DISMOV Academy) and gastroenterologist members of the Italian Society of Digestive Endoscopy (SIED) to evaluate the efficacy and tolerability of levodopa-carbidopa intestinal gel (LCIG) in patients with advanced Parkinson's disease (PD) in routine medical care. Motor scores in “ON” and OFF” state (UPDRS-III), complications of therapy (UPDRS-IV), activities of daily living, sleep disorders and quality of life were evaluated at baseline and at two follow-up assessments (FUV1 and FUV2) within the initial 12-month LCIG treatment. In 159 patients (55% males) with a mean age of 69.1 ± 6.6 years and a diagnosis of PD since 13.6 ± 5.5 years, the UPDRS-III total score (in “OFF”) decreased from baseline (45.8 ± 13.2) to FUV1 (41.0 ± 17.4; p < 0.001) and FUV2 (40.5 ± 15.5; p < 0.001), the UPDRS-IV total score decreased from baseline (8.8 ± 2.9) to FUV1 (5.1 ± 3.4; p < 0.001) and FUV2 (5.5 ± 3.2; p < 0.001). The percentage of patients exhibiting freezing, dystonia, gait/walking disturbances, falls, pain and sleep disorders was significantly reduced. Twenty-eight device complications were reported and 11 (6.9%) patients prematurely terminated the study. LCIG after 12-month treatment led to sustained improvement of time spent in “OFF”, complications of therapy, PD-associated symptoms and sleep disorders. LCIG tolerability was consistent with the established safety profile of LCIG.



中文翻译:

TANDEM 调查:左旋多巴-卡比多巴肠凝胶在 (LCIG) 晚期帕金森病患者中的疗效和耐受性。

TANDEM 调查是代表意大利帕金森病和运动障碍学会 (LIMPE-DISMOV 学会) 的神经学家成员和意大利消化内镜学会 (SIED) 的胃肠病学家成员的联合倡议在 17 个意大利运动障碍中心进行的评估左旋多巴-卡比多巴肠凝胶 (LCIG) 在常规医疗护理中对晚期帕金森病 (PD) 患者的疗效和耐受性。在基线和两次随访评估(FUV1 和FUV2) 在最初的 12 个月 LCIG 治疗中。在 159 名平均年龄为 69.1 ± 6.6 岁且自 13.6 ± 5.5 岁起诊断为 PD 的患者(55% 为男性)中,p  < 0.001) 和 FUV2 (40.5 ± 15.5; p  < 0.001),UPDRS-IV 总分从基线 (8.8 ± 2.9) 下降到 FUV1 (5.1 ± 3.4; p  < 0.001) 和 FUV2 (5.5 ± 3.2; p  < 0.001)。出现冰冻、肌张力障碍、步态/行走障碍、跌倒、疼痛和睡眠障碍的患者百分比显着降低。报告了 28 种设备并发症,11 名 (6.9%) 患者提前终止了研究。LCIG 经过 12 个月的治疗,持续改善了“OFF”时间、治疗并发症、PD 相关症状和睡眠障碍。LCIG 耐受性与既定的 LCIG 安全性一致。

更新日期:2020-03-24
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