背景:阿尔茨海默病影响着全世界数百万人,很少有药物可用于治疗。单克隆抗体在治疗各种类型的疾病中显示出有希望的效果。Bapineuzumab是人源化单克隆抗体之一,在AD患者中显示出有希望的效果。Bapineuzumab已显示出治疗轻度至中度阿尔茨海默病的疗效。然而,其安全性尚不清楚。
目标:因此,本研究的主要目的是了解bapineuzumab治疗轻中度阿尔茨海默病的确切安全性.
方法:我们使用相关关键词对PubMed和临床试验网站进行了基于网络的文献检索。数据是从符合条件的记录中提取的,并以95%置信区间(CI)计算风险比(RR).使用ReviewManager软件(用于windows的5.3版)进行所有分析。通过卡方检验和I方检验测量异质性。
结果:bapineuzumab与严重治疗引起的不良事件[RR:1.11(0.92,1.35)]的非显着关联,头痛[RR:1.03(0.81,1.32)],谵妄[RR:2.21(0.36,13.53)],呕吐[RR:0.92(0.55,1.55)],高血压[RR:0.49(0.12,2.12)],抽搐[RR:2.23(0.42,11.71)],下降[RR:0.98(0.80,1.21)],致命不良事件[RR:1.18(0.59,2.39)],和肿瘤[RR:1.81(0.07,49.52)]报告;然而,发现与血管源性水肿显著相关[RR:22.58(3.48,146.44)].
结论:根据现有证据,发现bapineuzumab在AD患者的治疗中是安全的。然而,应考虑血管源性水肿。
Alzheimer\'s disease affects millions of people worldwide, and very few drugs are available for its treatment. Monoclonal antibodies have shown promising effects in the treatment of various types of diseases. Bapineuzumab is one of the humanized monoclonal antibodies, which have shown promising effects in AD patients. Bapineuzumab has shown efficacy in the treatment of mild to moderate Alzheimer\'s disease. However, its safety is still unclear.
Thus, the main objective of the current study is to find out the exact safety profile of bapineuzumab in the treatment of mild to moderate Alzheimer\'s disease.
We performed a web-based literature search of PubMed and clinical trial websites using the relevant keywords. Data were extracted from eligible records, and the risk ratio (RR) was calculated with a 95% confidence interval (CI). All the analyses were performed using Review Manager software (version 5.3 for windows). Heterogeneity was measured by Chi-square and I-square tests.
Non-significant association of bapineuzumab with serious treatment-emergent adverse events [RR: 1.11 (0.92, 1.35)], headache [RR: 1.03 (0.81, 1.32)], delirium [RR: 2.21 (0.36, 13.53)], vomiting [RR: 0.92 (0.55, 1.55)], hypertension [RR: 0.49 (0.12, 2.12)], convulsions [RR:2.23 (0.42, 11.71)], falls [RR: 0.98 (0.80, 1.21)], fatal AEs [RR: 1.18 (0.59, 2.39)], and neoplasms [RR:1.81 (0.07, 49.52)] was reported; however, a significant association was found with vasogenic edema [RR: 22.58 (3.48, 146.44)].
Based on available evidence, bapineuzumab is found to be safe in the treatment of AD patients. However, vasogenic edema should be considered.