RT Journal Article
SR Electronic
T1 Efficacy of butylphthalide in preventing cognitive decline in ischaemic stroke survivors: a 12-month prospective following-up study
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP svn-2024-003611
DO 10.1136/svn-2024-003611
A1 Han, Qingqing
A1 Zhao, Xiyu
A1 Shao, Yingzhe
A1 Tan, Fengtao
A1 Wen, Haotian
A1 Wang, Di
A1 Li, Xiao
A1 Wang, Yunfan
A1 Tu, Jun
A1 Wang, Lifeng
A1 Ning, Xianjia
A1 Wang, Jinghua
A1 Li, Yan
YR 2025
UL http://svn.bmj.com/content/early/2025/01/24/svn-2024-003611.abstract
AB Background Cognitive decline is a significant concern for stroke survivors, affecting their quality of life and increasing their burden on the healthcare system. DL-3-n-butylphthalide (butylphthalide) has shown efficacy in the short-term treatment of various cognitive impairments. This study evaluated the efficacy of butylphthalide in preventing cognitive decline over a 12-month period in patients with ischaemic stroke.Methods This prospective following-up study involved patients newly diagnosed with ischaemic stroke between 1 month and 6 months after stroke onset and not in the acute phase. Patients were assigned to either the butylphthalide or control group. Cognitive function was assessed using the mini-mental state examination (MMSE) at baseline and at the 12-month follow-up. Statistical analyses included t-tests, χ2 tests and multivariate regression analyses.Results Butylphthalide was negatively associated with the MMSE D-value (β=−0.122; 95% CI −1.932 to −0.298; p=0.003) and the MMSE D-value percentage (β=−0.117; 95% CI −0.057 to −0.011; p=0.004). A multivariate analysis indicated that butylphthalide treatment was negatively associated with both changes in orientation and language score. Additionally, the incidence of cognitive decline was significantly lower in the butylphthalide group (OR, 0.612; p=0.020) than the control group. An age of ≥60 years and lower educational level were identified as risk factors for lower cognitive score and cognitive decline.Conclusion This study demonstrated that butylphthalide is effective in preventing cognitive decline in patients with ischaemic stroke. These findings have significant implications for clinical practice, suggesting that butylphthalide could be incorporated into standard post-stroke care regimens to improve patient outcomes and reduce the healthcare burden. Additional multicentre double-blind trials are recommended to confirm these results in diverse populations.The data supporting the findings of this study are available upon reasonable request. Deidentified participant data, including clinical assessments, neurological outcomes, and other relevant measurements, can be obtained from the corresponding author Jinghua Wang. Data will be made available to qualified researchers upon submission of a request that includes a clear research plan, which outlines how the data will be used in compliance with ethical guidelines and relevant privacy protections. Protocols and statistical analysis plans are also available upon request. The reuse of these data is permitted solely for non-commercial research purposes, and any publications resulting from the use of these data must acknowledge the original study. The authors reserve the right to assess requests and provide data based on applicable institutional and ethical guidelines.