甘特宁单抗治疗阿尔茨海默病的疗效和安全性:随机对照试验荟萃分析

Milene Vitória Sampaio Sobral , Victor Gonçalves Soares , Ocilio Ribeiro Gonçalves , Victoria Städler de Abreu , Lucas Cael Azevedo Ramos Bendaham , Brenda Leticia Lopes Batista M.D. , Marco Antonnio Rocha dos Santos M.D., MsC
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引用次数: 0

摘要

导言 甘特奈鲁单抗因其改变阿尔茨海默病自然病程的潜力而备受关注。然而,最近的研究显示,使用这种药物治疗阿尔茨海默病的结果好坏参半。因此,本综述比较了甘特宁单抗与安慰剂对阿尔茨海默病患者的治疗效果。方法在 PubMed、Embase 和 Cochrane 数据库中进行文献检索,检索时间从开始至 2023 年 12 月。两位独立作者(MS 和 LV)进行了研究筛选、数据提取和质量评估。本综述的结果如下临床痴呆评级--方框总和(CDR-SB)、阿尔茨海默病评估量表(ADAS-Cog)、迷你精神状态评估(MMSE)以及淀粉样蛋白相关成像异常水肿(ARIA-E)或淀粉样蛋白相关成像异常血沉(ARIA-H)的发生率。使用Review Manager 5.4(Cochrane Collaboration)进行了荟萃分析。结果本综述纳入了四项研究,报告了2848名患者的数据。随访评估时间从 50 周到 104 周不等。与安慰剂相比,Gantenerumab与较低的ADAS-Cog评分(MD -1.05;95 % CI:-1.85至-0.25)和较低的MMSE评分(MD -0.31;95 % CI:-0.55至-0.07)显著相关。CDR-SB 评分没有差异。Gantenerumab 组的 ARIA-E 发生率更高(RR 8.94;95 % CI:6.22 至 12.84)。甘特纳单抗的ARIA-E和ARIA-H发生率较高。需要进行更多高质量的研究,才能对该疗法得出更可靠的结论。
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Efficacy and safety of gantenerumab in the treatment of Alzheimer's disease: A meta-analysis of randomized controlled trials

Introduction

Gantenerumab has garnered considerable attention for its potential to modify the natural course of Alzheimer's disease. However, recent studies have shown mixed results for the use of this medication for the treatment of Alzheimer's Disease. Therefore, this review compared the effects of Gantenerumab with placebo in patients with Alzheimer's disease.

Methods

Literature searches were conducted in PubMed, Embase and Cochrane database from inception to December 2023. Two independent authors (MS and LV) performed the study selection, data extraction and quality assessment. The outcomes of this review were: Clinical Dementia Rating - Sum of Boxes (CDR-SB), the Alzheimer's Disease Assessment Scale (ADAS-Cog), the Mini-Mental State Evaluation (MMSE) and the incidence of Amyloid-Related Imaging Abnormalities with Edema (ARIA-E) or Amyloid-Related Imaging Abnormalities with Hemosiderosis (ARIA-H). Meta-analysis were performed using Review Manager 5.4 (Cochrane Collaboration).

Results

Four studies reporting data for 2,848 patients were included in this review. The lenght of follow-up assessments ranged from 50 to 104 weeks. When compared to placebo, Gantenerumab was significantly associated with a lower ADAS-Cog score (MD -1.05; 95 % CI: -1.85 to -0.25) and lower MMSE score (MD -0.31; 95 % CI: -0.55 to -0.07). There were no differences in the CDR-SB score. Gantenerumab group had a higher incidence of ARIA-E (RR 8.94; 95 % CI: 6.22 to 12.84).

Conclusion

Gantenerumab showed negative effects on cognitive outcomes of people with Alzheimer's Disease. There was a higher incidence of ARIA-E and ARIA-H for gantenerumab. Additional high quality studies are needed to draw more robust conclusions about this treatment.

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