■Gantenerumab是一种针对早期阿尔茨海默病(AD)的淀粉样β蛋白(Aβ)的单克隆抗体。作者试图评估gantenerumab在早期AD患者中的安全性和有效性。
■MEDLINE,Embase,和Cochrane数据库进行了系统搜索,直到2023年12月2日。使用Mantel-Haenszel方法和95%置信区间(CI)检查数据。进行荟萃回归分析,以评估基线临床痴呆评定量表-方框总和(CDR-SB)与随访时淀粉样蛋白相关成像异常(ARIA)之间的可能联系。R,版本4.2.3,用于统计分析。
■共纳入4个RCT和2848名患者,其中1580人(55%)接受了gantenerumab皮下治疗。关于临床评分,安慰剂组的疾病评估量表(ADAS-Cog13)的变化率较好(SMD-0.11;95%CI-0.19--0.03;p=0.008569;I2=0%).Gantenerumab与ARIA-E和ARIA-H的发生密切相关:(19.67%vs.2.31%;RR9.46;95%CI5.55-16.11;p=<0.000001;I2=10%)和(21.95%vs.12.38%;RR1.79;95%CI1.50-2.13;p=<0.000001;I2=0%),分别。
■在此荟萃分析中,一致的结果表明,甘特纳单抗对早期AD并不安全有效,显示AD的临床评分没有改善,并且与ARIA-E和ARIA-H的发生有关。
UNASSIGNED: Gantenerumab is a monoclonal antibody targeting amyloid β protein (Aβ) in early Alzheimer\'s disease (AD). The authors sought to evaluate gantenerumab safety and efficacy in early AD patients.
UNASSIGNED: MEDLINE, Embase, and Cochrane databases were systematically searched until 2 December 2023. Data were examined using the Mantel-Haenszel method and 95% confidence intervals (CIs). Meta-regression analysis was conducted to evaluate a possible link between baseline Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) and amyloid-related imaging abnormalities (ARIA) at follow-up. R, version 4.2.3, was used for statistical analysis.
UNASSIGNED: A total of 4 RCTs and 2848 patients were included, of whom 1580 (55%) received subcutaneous gantenerumab. Concerning clinical scores, the placebo group achieved better rates of change in the Disease Assessment Scale (ADAS-Cog13) (SMD -0.11; 95% CI -0.19- -0.03; p = 0.008569; I2 = 0%). Gantenerumab was strongly associated with the occurrence of ARIA-E and ARIA-H: (19.67% vs. 2.31%; RR 9.46; 95% CI 5.55-16.11; p = <0.000001; I2 = 10%) and (21.95% vs. 12.38%; RR 1.79; 95% CI 1.50-2.13; p = <0.000001; I2 = 0%), respectively.
UNASSIGNED: In this meta-analysis, consistent results suggest that gantenerumab is not safe and efficient for early AD, showing no improvement in clinical scores for AD and being associated with the occurrence of ARIA-E and ARIA-H.