CITIDEMAGE研究:痴呆患者胆碱能前体联合治疗

P. Gareri, A. Cotroneo, G. Orsitto, N. Veronese, Salvatore Putignano
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摘要

先前的一些研究已经证明,在乙酰胆碱酯酶抑制剂(AchEIs)或美金刚中添加胆碱能前体胞磷胆碱对阿尔茨海默病(AD)患者有好处。本研究显示了口服胞磷胆碱加AchEIs加美金刚对门诊AD患者的有效性。这是一项回顾性病例对照研究,涉及169名65岁或65岁以上AD患者(平均年龄:78.7±4.9岁)。此外,84名患者接受AchEIs加美金刚胺加胞磷胆碱1g/天口服治疗(A组),85名患者接受AchEIs加美金刚胺治疗(B组)。在两组中,美金刚和AchEIs均以最高耐受剂量使用。在基线(T0)、6个月(T1)和12个月(T2)进行测试,包括MMSE、ADL、IADL、NPI、CIRS、GDS简表、EuroQoL和睡眠问卷。主要结果是联合治疗与AchEIs加美金刚对MMSE评估的认知功能的影响。次要结果是两组治疗的可能副作用,对日常生活功能、行为症状、生活质量和睡眠的影响。A组患者在6个月(15.85±2.86 vs.16.39±2.93)和12个月(16.39±29.3 vs.16.43±3.08)时MMSE轻度增加。比较两组患者,MMSE评分在T1(p=0.003)和T2(p=0.011)时均有显著差异。此外,观察到GDS和EuroQoL评分有显著改善。两组之间未观察到次要结果(包括副作用)的差异。本研究加强了胞磷胆碱加AchEIs加美金刚胺在AD患者中的作用。
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The CITIDEMAGE Study: Combined Treatment with a Cholinergic Precursor in Dementia Patients
Certain previous studies have demonstrated the benefits of the addition of citicoline, a cholinergic precursor, to acetylcholinesterase inhibitors (AchEIs) or memantine in patients with Alzheimer’s disease (AD). The present study showed the effectiveness of oral citicoline plus AchEIs plus memantine in outpatients with AD. This was a retrospective case-control study involving 169 patients aged 65 years old or older having AD (mean age: 78.7 ±4.9 years). In addition, 84 patients were treated with AchEIs plus memantine plus citicoline 1 g/day given orally (group A), and 85 patients were treated with AchEIs plus memantine (group B). In both groups, memantine and AchEIs were used at the highest dosage tolerated. Tests were administered at baseline (T0), after 6 (T1), and 12 months (T2) and included MMSE, ADL, IADL, NPI, CIRS, GDS-short form, the EuroQoL, and the Sleep questionnaire. The primary outcomes were the effects of combined treatment versus AchEIs plus memantine on cognitive functions assessed by MMSE. The secondary outcomes were possible side effects of treatment in both groups, the influence on daily life functions, behavioral symptoms, quality of life, and sleep. Patients in group A showed a mild increase in MMSE at 6 (15.85 ±2.86 vs. 16.39 ±2.93) and 12 months (16.39 ±2.93 vs. 16.43 ±3.08). On comparing the two groups, the difference in MMSE score was significant, both at T1 (p = 0.003) and T2 (p = 0.011). Moreover, a significant improvement in GDS and EuroQoL scores was observed. No differences in secondary outcomes, including side effects, were observed between the two groups. This study strengthens the role of citicoline plus AchEIs plus memantine in patients with AD.
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