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风险降低型输卵管卵巢切除术(RRSO)后新发认知主诉的治疗:利斯的明的随机对照交叉试验。

Treating new-onset cognitive complaints after risk-reducing salpingo-oophorectomy: A randomized controlled crossover trial of lisdexamfetamine.

机构信息

Department of Psychiatry, Anschutz Medical Campus, University of Colorado, Aurora, CO, United States.

Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.

出版信息

Gynecol Oncol. 2024 Nov;190:62-69. doi: 10.1016/j.ygyno.2024.07.689. Epub 2024 Aug 14.

DOI:10.1016/j.ygyno.2024.07.689
PMID:39146756
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11702344/
Abstract

OBJECTIVE

To determine whether the psychostimulant lisdexamfetamine improves subjective and objective measures of cognitive functioning among women genetically at-risk for cancer who have undergone risk-reducing salpingo-oophorectomy and report new-onset executive functioning difficulties.

METHODS

69 participants were assigned to a randomized controlled crossover trial with 6-week trials of active medication (lisdexamfetamine) and placebo, separated by a minimum 2-week washout in an intent-to-treat framework (clinical trial registration number: NCT03187353). At trial baseline, midpoint, and endpoint, participants completed a self-report measure of executive functioning (Brown Attention Deficit Disorder Scale). At study baseline and trial endpoint, participants completed sustained attention, attention/working memory, and verbal learning/memory cognitive tasks. Side effects were assessed at 2, 3, 4, and 6 weeks for each trial.

RESULTS

From trial baseline to trial endpoint, lisdexamfetamine - relative to placebo - significantly improved total scores on the self-report Brown Attention Deficit Disorder Scale (and scores on four of five subdomains) as well as attention and working memory performance. Significantly more participants endorsed side effects across the lisdexamfetamine trial versus placebo; however, trial completion rates were similar, indicating that lisdexamfetamine was nonetheless well-tolerated.

CONCLUSIONS

Lisdexamfetamine improved both subjective and objective measures of attention and working memory and could offer women experiencing cognitive difficulties post-risk-reducing salpingo-oophorectomy an alternative therapeutic option.

摘要

目的

确定精神兴奋剂 lisdexamfetamine 是否能改善接受预防性输卵管卵巢切除术且新出现执行功能障碍的具有癌症遗传风险的女性的主观和客观认知功能测量。

方法

69 名参与者被分配到一项随机对照交叉试验中,在意向治疗框架中(临床试验注册编号:NCT03187353),每个试验的 6 周试验期分别接受活性药物(lisdexamfetamine)和安慰剂治疗,每个试验之间至少有 2 周的洗脱期。在试验基线、中点和终点,参与者完成了执行功能的自我报告测量(Brown 注意力缺陷障碍量表)。在研究基线和试验终点,参与者完成了持续注意力、注意力/工作记忆和言语学习/记忆认知任务。在每个试验的第 2、3、4 和 6 周评估副作用。

结果

与安慰剂相比,lisdexamfetamine-从试验基线到试验终点-显著改善了自我报告的 Brown 注意力缺陷障碍量表的总分(以及五个子域中的四个)以及注意力和工作记忆表现。与安慰剂相比,更多的参与者报告了 lisdexamfetamine 试验中的副作用;然而,试验完成率相似,表明 lisdexamfetamine 仍然具有良好的耐受性。

结论

Lisdexamfetamine 改善了注意力和工作记忆的主观和客观测量,为经历预防性输卵管卵巢切除术术后认知困难的女性提供了另一种治疗选择。

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