Jiang Deqi, Yang Xiujuan, Li Mingxing, Wang Yan, Wang Yong
Department of Pharmacy, Zhu Jiang Hospital, Southern Medical University, Guangzhou, 510282, People's Republic of China.
J Neural Transm (Vienna). 2015 Aug;122(8):1157-66. doi: 10.1007/s00702-014-1358-0. Epub 2014 Dec 30.
Cholinesterase inhibitors treatment is considered as a common therapeutic approach for Alzheimer's disease (AD) by numerous reported studies, but the role of currently available drugs for AD is still controversial. Our study aimed to evaluate the efficacy and safety of galantamine for the treatment of AD, and provide the basis and reference for clinical rational drug use. Randomized controlled trials (RCTs) of galantamine for AD published up to April 30, 2014 were searched. A random or fixed-effect model was used to analyze outcomes which were expressed as risk ratios (RRs) or mean difference (MD) with a 95 % confidence interval (CI). Heterogeneity was assessed by Q test and I(2) statistic. The outcome measurements were as follows: the changes of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), Mini-Mental State Examination (MMSE), Activities of Daily Living (ADL), Neuropsychiatric Inventory (NPI), Clinicians' Interview-Based Impression of Change with Caregiver's Input (CIBIC+), adverse effects and dropouts. Eleven articles with 4,074 participants were included. Administration of galantamine for 8-28 weeks (16-40 mg daily) led to significant improvements in ADAS-cog score [P < 0.00001, MD = -2.95, 95 % CI (-3.32, -2.57)], MMSE score [P = 0.003, MD = 2.50, 95 % CI (0.86, 4.15)], NPI score [P = 0.001, MD = -1.58, 95 % CI (-2.54, -0.62)], and CIBIC+ scale [P < 0.00001, RR = 1.26, 95 % CI (1.15, 1.39)], but not in ADL score [P = 0.43, MD = 0.71, 95 % CI (-1.07, 2.48)]. More adverse events and dropouts occurred in the galantamine group than that in the placebo group, the differences were statistically significant (all P < 0.05). Galantamine could significantly improve cognitive, behavioral, and global performances in patients with AD. In addition, we need to use it with caution in the clinical treatment.
众多已发表的研究认为，胆碱酯酶抑制剂治疗是阿尔茨海默病（AD）的一种常用治疗方法，但目前可用药物对AD的作用仍存在争议。我们的研究旨在评估加兰他敏治疗AD的疗效和安全性，为临床合理用药提供依据和参考。检索截至2014年4月30日发表的加兰他敏治疗AD的随机对照试验（RCT）。采用随机或固定效应模型分析结果，结果以风险比（RRs）或均数差（MD）表示，并给出95%置信区间（CI）。通过Q检验和I²统计量评估异质性。结局测量指标如下：阿尔茨海默病评估量表认知分量表（ADAS-cog）、简易精神状态检查表（MMSE）、日常生活活动能力（ADL）、神经精神科问卷（NPI）、基于临床医生访谈的伴有照料者反馈的变化印象量表（CIBIC+）、不良反应和脱落情况。纳入11篇文章，共4074名参与者。加兰他敏治疗8 - 28周（每日16 - 40 mg）可使ADAS-cog评分显著改善[P < 0.00001，MD = -2.95，95%CI（-3.32，-2.57）]、MMSE评分[P = 0.003，MD = 2.50，95%CI（0.86，4.15）]、NPI评分[P = 0.001，MD = -1.58，95%CI（-2.54，-0.62）]以及CIBIC+量表[P < 0.00001，RR = 1.26，95%CI（1.15，1.39）]，但对ADL评分无显著改善[P = 0.43，MD = 0.71，95%CI（-1.07，2.48）]。加兰他敏组的不良事件和脱落情况比安慰剂组更多，差异具有统计学意义（均P < 0.05）。加兰他敏可显著改善AD患者的认知、行为和整体表现。此外，临床治疗中需谨慎使用。
