Post-marketing survey of donepezil hydrochloride in Japanese patients with Alzheimer's disease with behavioral and psychological symptoms of dementia (BPSD)
Post-marketing survey of donepezil hydrochloride in Japanese patients with Alzheimer's disease with behavioral and psychological symptoms of dementia (BPSD)
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DOI：
10.1111/j.1479-8301.2008.00250.x
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发表时间：
2008-09-01
期刊：
影响因子：
2
通讯作者：
Takeda, Masatoshi
中科院分区：
文献类型：
--
作者：
Tanaka, Toshihisa;Kazui, Hiroaki;Takeda, Masatoshi
背景：为了调查盐酸多奈哌齐(Aricept(R)；卫材株式会社，日本东京)的有效性和安全性，我们对日本阿尔茨海默病(AD)患者进行了上市后调查，这些患者也有痴呆(BPSD)的行为和心理症状，如幻觉/妄想、游荡和攻击性，这些症状给照顾者带来了最大的负担。方法：通过常规临床环境进行前瞻性、集中登记的调查，被诊断为轻至中度AD的患者表现为幻觉/妄想、游荡和/或攻击性。结果：末次观察时BPSD改善率为幻觉/妄想60.1%，游荡59.6%，攻击性65.6%。对于所有症状，改善率随着治疗时间的延长而增加。LOCF的BPSD恶化率为幻觉/妄想的1.3%，游荡的3.4%，攻击性的1.6%。用修订的长谷川痴呆量表(HDS-R)和简易智力状态检查(MMSE)对认知功能的评估均显示治疗后有显著改善。幻觉/妄想或游荡得到改善的患者与症状未改善的患者HDS-R评分的变化有显著差异。此外，数据表明，幻觉/妄想与HDS-R分数的变化，幻觉/妄想与MMSE分数的变化，以及流浪和MMSE分数的变化之间可能存在关联。与BPSD没有改善的患者相比，BPSD改善的患者在认知功能方面也有更大的改善。LOCF的护理者的护理负担中，有3.6%的人认为没有负担，有54.1%的人认为有负担，有4.5%的人认为有负担。随着疗程的延长，“无负担”与“负担减轻”的比例成比例增加。BPSD改善的患者“无负担”+“减负”的比例(88.5-94.4%)显著高于BPSD无改善的患者。结论：这些结果提示多奈哌齐不仅可以改善AD患者的认知功能障碍，还可以减轻这些患者的BPSD。多奈哌齐的治疗也被发现减轻了大约60%患者照顾者的负担。此外，结果表明，多奈哌齐不太可能引发BPSD过度恶化的潜在风险，这将导致更重的护理负担。
Background: To investigate the efficacy and safety of donepezil hydrochloride (Aricept (R); Eisai Co., Ltd, Tokyo, Japan), we conducted a post-marketing survey in Japanese patients with Alzheimer's disease (AD) who also had behavioral and psychological symptoms of dementia (BPSD), such as hallucinations/delusions, wandering, and aggression, which cause the greatest burden on caregivers.Methods: A prospective, centrally registered investigation was conducted through regular clinical settings with patients diagnosed as mild to moderate AD presenting with hallucinations/delusions, wandering, and/or aggression. The treatment period was 12 weeks and no restrictions were placed on concomitant medications.Results: The BPSD improvement rates at last-observation-carried-forward (LOCF) were 60.1% for hallucinations/delusions, 59.6% for wandering, and 65.6% for aggression. For all symptoms, improvement rates increased with the duration of the treatment period. The BPSD deterioration rates at LOCF were 1.3% for hallucinations/delusions, 3.4% for wandering, and 1.6% for aggression. Assessment of cognitive function with both the revised Hasegawa Dementia Scale (HDS-R) and Mini-Mental State Examination (MMSE) indicated significant improvements after treatment. There were significant differences in the changes in HDS-R scores between patients whose hallucinations/delusions or wandering were improved and patients whose symptoms were not improved. Moreover, the data suggested a possible correlation between changes in hallucinations/delusions and HDS-R scores, changes in hallucinations/delusions and MMSE scores, and changes in wandering and MMSE scores. Patients in whom BPSD improved also demonstrated a greater improvement in cognitive function compared with patients in whom no improvement in BPSD was noted. Nursing burden on caregivers at LOCF showed 3.6% for 'No burden', 54.1% for 'Burden decreased', and 4.5% for 'Burden increased.' There was an increase in the combined ratio of 'No burden' and 'Burden decreased' in proportion with prolonged treatment period. Patients with improved BPSD had a significantly greater ratio (88.5-94.4%) of 'No burden' plus 'Burden decreased' than those patients in whom no improvement in BPSD was noted.Conclusions: These results suggest that donepezil not only improves the cognitive dysfunction of AD patients, but may also relieve BPSD in these patients. Treatment with donepezil was also found to alleviate the burden of caregivers for approximately 60% of patients. Moreover, the results indicate that donepezil is unlikely to trigger potential risks of excessive deterioration of BPSD, which would result in a heavier burden of nursing care.