Bai Mengru, Lyv Hanlei, Zhou Xin, Zhang Ye, Han Zhengyi
Second School of Clinical Medicine, Anhui Medical University, Hefei, China.
Department of Anesthesiology, the Second Affiliated Hospital of Anhui Medical University, Hefei, China.
J Alzheimers Dis Rep. 2025 May 21;9:25424823251343789. doi: 10.1177/25424823251343789. eCollection 2025 Jan-Dec.
Alzheimer's disease (AD) manifests as an insidiously progressive neurodegenerative pathology, wherein the current therapeutic armamentarium remains constrained to symptomatic management, highlighting an urgent need for innovative therapies.
This meta-analysis systematically conducts an assessment of the safety and efficacy of focused ultrasound (FUS)-mediated reversible blood-brain barrier opening (BBBO) in AD, while further exploring its potential associations with cognitive function and amyloid-β (Aβ) deposition in patients.
PubMed, Embase, CNKI, Cochrane Library, and Web of Science were searched in this study. The study protocol has been registered with PROSPERO (registration number, CRD42024585286). ROBINS-I tool was used to assess the risk of bias, followed by further data analysis.
Fifty-seven AD patients from eight distinct clinical studies were systematically incorporated into the meta-analytical framework. The time span was from 2018 to 2023. After FUS-mediated BBBO, the analysis demonstrated significant outcomes of FUS for both safety (OR: 0.88; 95% CI: 0.75-0.98, p < 0.01) and efficacy (OR: 0.91; 95% CI: 0.61-1.00, p < 0.01). There was no deterioration of cognitive function after surgery, and the observed adverse events were minor and temporary in nature.
This meta-analysis underscores the potential of FUS as a non-invasive, safe, and effective method for enhancing BBB permeability in AD patients, offering a promising avenue for targeted drug delivery and disease modification. Future multicenter studies with larger sample sizes and standardized methodologies are warranted to confirm these results and explore the integration of FUS with existing and emerging AD therapies.
阿尔茨海默病（AD）表现为一种隐匿性进展的神经退行性病变，目前的治疗手段仍局限于对症治疗，这凸显了对创新疗法的迫切需求。
本荟萃分析系统地评估聚焦超声（FUS）介导的可逆性血脑屏障开放（BBBO）在AD中的安全性和有效性，同时进一步探讨其与患者认知功能和淀粉样β蛋白（Aβ）沉积的潜在关联。
本研究检索了PubMed、Embase、中国知网、Cochrane图书馆和Web of Science。研究方案已在国际前瞻性系统评价注册库（PROSPERO）注册（注册号：CRD42024585286）。使用ROBINS-I工具评估偏倚风险，随后进行进一步的数据分析。
来自8项不同临床研究的57例AD患者被系统纳入荟萃分析框架。时间跨度为2018年至2023年。在FUS介导BBBO后，分析显示FUS在安全性（比值比：0.88；95%置信区间：0.75-0.98，p＜0.01）和有效性（比值比：0.91；95%置信区间：0.61-1.00，p＜0.01）方面均有显著结果。术后认知功能无恶化情况，观察到的不良事件轻微且为暂时性。
本荟萃分析强调了FUS作为一种非侵入性、安全且有效的方法来增强AD患者血脑屏障通透性的潜力，为靶向药物递送和疾病修饰提供了一条有前景的途径。未来有必要开展更大样本量和标准化方法的多中心研究，以证实这些结果，并探索FUS与现有及新兴AD疗法的整合。
