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西替考林研究:胞磷胆碱联合胆碱酯酶抑制剂治疗老年阿尔茨海默病患者的研究。

The Citicholinage Study: Citicoline Plus Cholinesterase Inhibitors in Aged Patients Affected with Alzheimer's Disease Study.

作者信息

Gareri Pietro, Castagna Alberto, Cotroneo Antonino Maria, Putignano Daria, Conforti Raffaele, Santamaria Francesco, Marino Saverio, Putignano Salvatore

机构信息

Center for Cognitive Disorders and Dementia - Distretto Socio-Sanitario Catanzaro Lido - ASP Catanzaro, Catanzaro, Italy.

Director Department of Elderly Health Care - Birago di Vische Hospital and Botticelli Territorial Geriatrics - ASL TO 2, Turin, Italy.

出版信息

J Alzheimers Dis. 2017;56(2):557-565. doi: 10.3233/JAD-160808.

DOI:10.3233/JAD-160808
PMID:28035929
Abstract

BACKGROUND

Citicoline can have beneficial effects both in degenerative and in vascular cognitive decline in a variety of ways (apoptosis inhibition, neuroplasticity potentiation, phospholipid, and acetylcholine (ACh) synthesis). Acetylcholinesterase inhibitors (AChEIs) have been used for treatment of Alzheimer's disease (AD). When co-administered with cholinergic precursors, they are able to increase the intrasynaptic levels of ACh more than when the single drugs given alone.

OBJECTIVE

The aim of the present study was to show the effectiveness of oral citicoline plus AChEIs in patients affected with AD.

METHODS

This was a retrospective multi-centric case-control study, involving seven Centers for Cognitive Impairment and Dementia in Italy, on 448 consecutive patients aged 65 years old or older affected with AD. 197 patients were treated with an AChEI while 251 were treated with an AchEI + citicoline 1000 mg/day given orally. Cognitive functions were assessed by MMSE, daily life functions by ADL and IADL, behavioral symptoms by NPI, comorbidities by CIRS, and mood by GDS-short form. Tests were administered at baseline (T0), after 3 (T1), and 9 months (T2). The primary outcomes were effects of combined administration versus AChEIs given alone on cognitive functions assessed by MMSE. The secondary outcomes were possible side effects or adverse events of combination therapy versus AChEIs alone.

RESULTS

Patients treated with citicoline plus an AChEI showed a statistically significant increase in MMSE between T0 and T1 (16.88±3.38 versus 17.62±3.64; p = 0.000) and between T1 and T2 (17.62±3.64 versus 17.89±3.54; p = 0.000).

CONCLUSION

The present study encourages the role of combined administration in disease management by slowing disease progression.

摘要

背景

胞磷胆碱可通过多种方式(抑制细胞凋亡、增强神经可塑性、促进磷脂和乙酰胆碱(ACh)合成)对退行性和血管性认知功能减退产生有益影响。乙酰胆碱酯酶抑制剂(AChEIs)已用于治疗阿尔茨海默病(AD)。与胆碱能前体联合使用时,它们比单独使用单一药物更能提高突触内乙酰胆碱水平。

目的

本研究旨在证明口服胞磷胆碱加AChEIs对AD患者的有效性。

方法

这是一项回顾性多中心病例对照研究,涉及意大利七个认知障碍和痴呆中心,纳入448例65岁及以上的AD连续患者。197例患者接受AChEI治疗,251例患者接受口服1000mg/天的AChEI加胞磷胆碱治疗。通过简易精神状态检查表(MMSE)评估认知功能,通过日常生活活动能力量表(ADL)和工具性日常生活活动能力量表(IADL)评估日常生活功能,通过神经精神症状量表(NPI)评估行为症状,通过累积疾病严重程度量表(CIRS)评估合并症,通过简易老年抑郁量表(GDS-简表)评估情绪。在基线(T0)、3个月(T1)和9个月(T2)时进行测试。主要结局是联合用药与单独使用AChEIs相比对MMSE评估的认知功能的影响。次要结局是联合治疗与单独使用AChEIs相比可能的副作用或不良事件。

结果

接受胞磷胆碱加AChEI治疗的患者在T0和T1之间(16.88±3.38对17.62±3.64;p = 0.000)以及T1和T2之间(17.62±3.64对17.89±3.54;p = 0.000)的MMSE有统计学显著增加。

结论

本研究通过减缓疾病进展鼓励联合用药在疾病管理中的作用。

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