1 Clinical Research and Evidence-Based Medicine Unit, Second Medical Department, Aristotle University of Thessaloniki, Hippokration General Hospital, Thessaloniki, Greece.
2 Laboratory of Neurosciences, Intramural Research Program, National Institute on Aging, Bethesda, MD, USA.
Am J Alzheimers Dis Other Demen. 2019 Aug;34(5):281-289. doi: 10.1177/1533317519843720. Epub 2019 Apr 15.
To assess the efficacy and safety of intravenous immunoglobulin (IVIg) for patients with Alzheimer's disease (AD).
We searched electronic databases and other sources for randomized controlled trials comparing IVIg with placebo or other treatment for adults with AD. Primary outcome was change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog).
Five placebo-controlled trials were included in the meta-analysis. Compared to placebo, IVIg 0.2 and 0.4 g/kg once every two weeks did not change ADAS-Cog score (weighted mean difference: 0.37, 95% confidence interval: -1.46 to 2.20 and 0.77, -1.34 to 2.88, respectively). Furthermore, except for an increase in the incidence of rash, IVIg did not affect the incidence of other adverse events.
IVIg, albeit safe, is inefficacious for treatment of patients with AD. Future trials targeting earlier stages of disease or applying different dosing regimens may be warranted to clarify its therapeutic potential.
评估静脉注射免疫球蛋白(IVIg)治疗阿尔茨海默病(AD)患者的疗效和安全性。
我们检索了电子数据库和其他来源,以寻找比较 IVIg 与安慰剂或其他治疗方法用于 AD 成人患者的随机对照试验。主要结局为从基线开始阿尔茨海默病评估量表-认知子量表(ADAS-Cog)的变化。
荟萃分析纳入了 5 项安慰剂对照试验。与安慰剂相比,每两周 0.2 和 0.4 g/kg 的 IVIg 并未改变 ADAS-Cog 评分(加权均数差:0.37,95%置信区间:-1.46 至 2.20 和 0.77,-1.34 至 2.88)。此外,除皮疹发生率增加外,IVIg 并未影响其他不良事件的发生率。
IVIg 虽然安全,但对 AD 患者的治疗无效。针对疾病早期阶段或应用不同剂量方案的未来试验可能需要进一步阐明其治疗潜力。