Abstract：
BACKGROUND: Current evidence for the management of symptoms associated with dementia with Lewy bodies (DLB) using donepezil is limited. We conducted a meta-analysis of three randomised controlled trials of donepezil in patients with DLB to investigate the overall efficacy of donepezil on Mini-Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), and Clinician\'s Interview-Based Impression of Change-plus Caregiver Input (CIBIC-plus).
METHODS: A meta-analysis was performed using the data of 312 patients administered placebo or 10 mg donepezil. Overall mean score differences for MMSE, NPI-2, and NPI-10 from baseline to week 12 and their 95% confidence intervals (CI) were estimated. For CIBIC-plus, which was transformed from a seven-point grade to a dichotomous outcome (improvements/no improvements), odds ratio (OR) and its 95% CI were estimated. Random-effects models were used, and heterogeneity was evaluated using the Cochrane\'s Q test and I2 statistic.
RESULTS: Heterogeneity was suspected for NPI-2 (P < 0.05; I2 = 87.2%) and NPI-10 (P < 0.05; I2 = 67.7%) while it was not suspected for MMSE (P = 0.23; I2 = 32.4%) and CIBIC-plus (P = 0.26; I2 = 19.8%). The overall mean MMSE score difference (mean difference: 1.50; 95% CI, 0.67-2.34) and the overall odds of improving CIBIC-plus (OR: 2.20; 95% CI, 1.13-4.26) from baseline to week 12 were higher in the donepezil group than in the placebo group.
CONCLUSIONS: Results of our meta-analysis indicated overall efficacy of donepezil on cognitive impairment and global clinical status in patients with DLB.
METHODS: A meta-analysis was performed using the data of 312 patients administered placebo or 10 mg donepezil. Overall mean score differences for MMSE, NPI-2, and NPI-10 from baseline to week 12 and their 95% confidence intervals (CI) were estimated. For CIBIC-plus, which was transformed from a seven-point grade to a dichotomous outcome (improvements/no improvements), odds ratio (OR) and its 95% CI were estimated. Random-effects models were used, and heterogeneity was evaluated using the Cochrane\'s Q test and I2 statistic.
RESULTS: Heterogeneity was suspected for NPI-2 (P < 0.05; I2 = 87.2%) and NPI-10 (P < 0.05; I2 = 67.7%) while it was not suspected for MMSE (P = 0.23; I2 = 32.4%) and CIBIC-plus (P = 0.26; I2 = 19.8%). The overall mean MMSE score difference (mean difference: 1.50; 95% CI, 0.67-2.34) and the overall odds of improving CIBIC-plus (OR: 2.20; 95% CI, 1.13-4.26) from baseline to week 12 were higher in the donepezil group than in the placebo group.
CONCLUSIONS: Results of our meta-analysis indicated overall efficacy of donepezil on cognitive impairment and global clinical status in patients with DLB.
摘要：
背景：目前使用多奈哌齐治疗路易体痴呆（DLB）相关症状的证据有限。我们对DLB患者使用多奈哌齐的三项随机对照试验进行了荟萃分析，以研究多奈哌齐在简易精神状态检查（MMSE）中的总体疗效。神经精神量表（NPI），和临床医生基于访谈的变化加照顾者输入印象(CIBIC加)。
方法：使用安慰剂或10mg多奈哌齐的312例患者的数据进行了荟萃分析。MMSE的总体平均得分差异，估计从基线到第12周的NPI-2和NPI-10及其95％置信区间（CI）。ForCIBIC-plus,从7分的成绩转变为二分结果（改善/无改善），估计比值比(OR)及其95%CI.使用随机效应模型，异质性使用Cochrane的Q检验和I2统计量进行评估。
结果：怀疑NPI-2（P<0.05；I2=87.2％）和NPI-10（P<0.05；I2=67.7％）存在异质性，而未怀疑MMSE（P=0.23；I2=32.4％）和CIBIC-plus（P=0.26；I2=19.8％）。多奈哌齐组的总体平均MMSE评分差异（平均差异：1.50;95％CI，0.67-2.34）和从基线到第12周改善CIBIC-plus的总体几率（OR：2.20;95％CI，1.13-4.26）高于安慰剂组。
结论：我们的荟萃分析结果表明多奈哌齐对DLB患者认知障碍的总体疗效和总体临床状况。
方法：使用安慰剂或10mg多奈哌齐的312例患者的数据进行了荟萃分析。MMSE的总体平均得分差异，估计从基线到第12周的NPI-2和NPI-10及其95％置信区间（CI）。ForCIBIC-plus,从7分的成绩转变为二分结果（改善/无改善），估计比值比(OR)及其95%CI.使用随机效应模型，异质性使用Cochrane的Q检验和I2统计量进行评估。
结果：怀疑NPI-2（P<0.05；I2=87.2％）和NPI-10（P<0.05；I2=67.7％）存在异质性，而未怀疑MMSE（P=0.23；I2=32.4％）和CIBIC-plus（P=0.26；I2=19.8％）。多奈哌齐组的总体平均MMSE评分差异（平均差异：1.50;95％CI，0.67-2.34）和从基线到第12周改善CIBIC-plus的总体几率（OR：2.20;95％CI，1.13-4.26）高于安慰剂组。
结论：我们的荟萃分析结果表明多奈哌齐对DLB患者认知障碍的总体疗效和总体临床状况。
