Efficacy and safety of DL-3-N-butylphthalide in the treatment of ischemic poststroke aphasia: A randomized clinical trial.

IF 4.4 2区医学 Q1 CLINICAL NEUROLOGY Annals of Clinical and Translational Neurology Pub Date : 2024-11-22 DOI:10.1002/acn3.52238

Jing Tian, Peng Yang, Jianing Yang, Rui Wang, Biyi Zhou, Kun Zhang, Yanying Zhao, Binbin Wang, Lijuan Liu, Ruomeng Chen, Haoran Wu, Ruihan Miao, Li Guo, Xiaoyun Liu

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Abstract

Objective: Poststroke aphasia (PSA) has a high prevalence and requires a long recovery period, severely impairing life and work. Its existing behavioral interventions, principally speech and language therapy, are limited by numerous factors. The aims of this study are to evaluate the efficacy and safety of DL-3-N-butylphthalein (NBP) and explore its mechanism in the treatment of ischemic PSA.

Methods: Patients hospitalized in the Second Hospital of Hebei Medical University in China were randomly administered NBP soft capsules or placebo orally for 6 months from July 1, 2021, to February 25, 2023. Language skills were assessed using the Western Aphasia Battery-Aphasia Quotient (WAB-AQ). We collected plasma samples and detected neurotransmitters by liquid chromatography-mass spectrometry.

Results: In total, 118 out of 124 patients were included in the outcome analysis. Compared with the control group, AQ values in the NBP group significantly improved at 6 months (U = 1187.5, p = 0.003). After eliminating baseline interference, NBP treatment was independently associated with the 6-month AQ improvement [mean difference (MD) 0.106, 95% confidence interval (CI) 0.018, 0.195, p = 0.019]. We observed no statistically significant difference between the groups in abnormal liver function at 1 month [relative risk (RR) 1.07, 95% CI 0.89, 1.28] and 6 months [RR 0.99, 95% CI 0.86, 1.42]. Statistically significant differences were observed in tyrosine (p = 0.043) and 5-hydroxytryptophan (p = 0.041) between the two groups.

Interpretation: NBP treatment might promote the recovery of WAB-AQ in patients with ischemic PSA by increasing levels of monoamine neurotransmitters.

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DL-3-N-butylphthalide 治疗缺血性卒中后失语症的有效性和安全性：随机临床试验。

目的：脑卒中后失语症（PSA）发病率高，恢复期长，严重影响生活和工作。其现有的行为干预，主要是言语和语言治疗，受到诸多因素的限制。本研究旨在评估DL-3-N-丁基酞（NBP）治疗缺血性PSA的有效性和安全性，并探讨其作用机制：方法：2021年7月1日至2023年2月25日，河北医科大学第二医院住院患者随机口服NBP软胶囊或安慰剂，疗程6个月。语言能力使用西方失语测试-失语商数（WAB-AQ）进行评估。我们收集了血浆样本，并通过液相色谱-质谱法检测了神经递质：结果：124 名患者中共有 118 人被纳入结果分析。与对照组相比，NBP 组的 AQ 值在 6 个月时明显改善（U = 1187.5，p = 0.003）。剔除基线干扰后，NBP 治疗与 6 个月的 AQ 改善有独立相关性[平均差 (MD) 0.106，95% 置信区间 (CI) 0.018，0.195，p = 0.019]。我们观察到，在 1 个月[相对风险 (RR) 1.07，95% CI 0.89，1.28]和 6 个月[RR 0.99，95% CI 0.86，1.42]时，各组间肝功能异常的差异无统计学意义。两组患者的酪氨酸（p = 0.043）和 5-羟色氨酸（p = 0.041）差异具有统计学意义：解释：NBP 治疗可通过提高单胺神经递质水平促进缺血性 PSA 患者的 WAB-AQ 恢复。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of Clinical and Translational Neurology Medicine-Neurology (clinical)

CiteScore

9.10

自引率

1.90%

发文量

218

审稿时长

8 weeks

期刊介绍： Annals of Clinical and Translational Neurology is a peer-reviewed journal for rapid dissemination of high-quality research related to all areas of neurology. The journal publishes original research and scholarly reviews focused on the mechanisms and treatments of diseases of the nervous system; high-impact topics in neurologic education; and other topics of interest to the clinical neuroscience community.