背景:后COVID-19状况(PCC),根据世界卫生组织(WHO)的定义,目前缺乏任何监管机构批准的治疗方法,其特征是持续且令人衰弱的认知障碍和情绪症状。此外,代谢功能障碍,已经报道了慢性炎症和体重指数(BMI)升高的相关风险。在这项研究中,我们旨在研究沃替西汀在改善PCC患者认知缺陷方面的疗效,考虑到代谢功能障碍的相互作用,炎症和BMI升高。
方法:这是一项为期8周的随机分析,双盲,安慰剂对照试验是在居住在加拿大的18岁及以上的成年人中进行的,他们正在经历WHO定义的PCC症状。参与者的招募始于2021年11月,并于2023年1月结束。共有200人参加,其中147以1:1的比例随机分配接受沃替西汀(5-20mg,n=73)或安慰剂(n=74),用于双盲条件下的每日治疗。主要结果测量是从基线到终点的数字符号替代测试(DSST)评分的变化。
结果:我们的发现显示了时间的显着影响(χ2=7.771,p=0.005),治疗(χ2=7.583,p=0.006)与治疗时间xCRPxTG-HDLxBMI交互作用(χ2=11.967,p=0.018)对认知功能的影响。此外,组间分析显示,沃替西汀在终点有显著改善(平均差异=0.621,SEM=0.313,p=0.047).
结论:总体而言,沃替西汀在具有代谢功能障碍基线标志物的个体中表现出认知缺陷的显著改善,与安慰剂相比,终点的炎症升高和BMI升高。
背景:NCT05047952(ClinicalTrials.gov;注册日期:2021年9月17日)。
BACKGROUND: Post-COVID-19 Condition (PCC), as defined by the World Health Organization (WHO), currently lacks any regulatory-approved treatments and is characterized by persistent and debilitating cognitive impairment and mood symptoms. Additionally, metabolic dysfunction, chronic inflammation and the associated risks of elevated body mass index (BMI) have been reported. In this study, we aim to investigate the efficacy of vortioxetine in improving cognitive deficits in individuals with PCC, accounting for the interaction of metabolic dysfunction, elevated inflammation and BMI.
METHODS: This is a post-hoc analysis of an 8-week randomized, double-blind, placebo-controlled trial that was conducted among adults aged 18 years and older living in Canada who were experiencing WHO-defined PCC symptoms. The recruitment of participants began in November 2021 and concluded in January 2023. A total of 200 individuals were enrolled, where 147 were randomized in a 1:1 ratio to receive either vortioxetine (5-20 mg, n = 73) or placebo (n = 74) for daily treatment under double-blind conditions. The primary outcome measure was the change in the Digit Symbol Substitution Test (DSST) score from baseline to endpoint.
RESULTS: Our findings showed significant effects for time (χ2 = 7.771, p = 0.005), treatment (χ2 = 7.583, p = 0.006) and the treatment x time x CRP x TG-HDL x BMI interaction (χ2 = 11.967, p = 0.018) on cognitive function. Moreover, the between-group analysis showed a significant improvement with vortioxetine at endpoint (mean difference = 0.621, SEM = 0.313, p = 0.047).
CONCLUSIONS: Overall, vortioxetine demonstrated significant improvements in cognitive deficits among individuals with baseline markers of metabolic dysfunction, elevated inflammation and higher BMI at endpoint as compared to placebo.
BACKGROUND: NCT05047952 (ClinicalTrials.gov; Registration Date: September 17, 2021).