Association of N-butylphthalide treatment with 1-year activities-of-daily-living recovery in convalescent ischemic stroke patients with chronic disease burden: a post-marketing real-world non-randomized controlled study

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• Picked for Internal Medicine (top studies of the week, 23 August 2026): N‑butylphthalide and ADL recovery in ischemic stroke patients

Abstract

BACKGROUND AND OBJECTIVE: ADL recovery is essential for maintaining independence and reducing care burden after IS, particularly in patients with chronic vascular-metabolic disease burden. Although NBP has been studied for acute treatment, recurrence prevention, and cognitive protection, its association with ADL recovery in convalescent IS remains unclear. This study evaluated whether NBP treatment was associated with 1-year ADL recovery in a post-marketing real-world non-randomized controlled study. METHODS: This was a post-marketing, real-world, prospective, non-randomized controlled study conducted in Jizhou District, Tianjin, China. Patients received either NBP plus basic treatment or basic treatment alone and were followed for 12 months. The primary outcome was change in BI score from baseline to 1 year. Secondary outcomes included change in mRS score, mRS >2, BI ≤ 60, and item-level BI changes. Chronic disease burden was defined as the cumulative number of hypertension, diabetes, hyperlipidemia, obesity, and coronary heart disease. Multivariable regression, subgroup analyses, IPTW analysis, and conservative death-imputation analysis were performed. This post-marketing, real-world, prospective, non-randomized controlled study was registered in the Chinese Clinical Trial Registry (ChiCTR2000039118). RESULTS: Among 1,190 enrolled patients, 1,095 completed 1-year functional assessment, including 533 in the NBP group and 562 in the control group. Patients receiving NBP had slightly worse baseline mRS scores and a higher chronic disease burden than controls. At 1 year, the NBP group showed greater BI improvement than the control group (1.31 ± 13.99 vs. -1.11 ± 15.56; P = 0.0067), whereas change in mRS did not differ significantly (-0.18 ± 0.96 vs. -0.17 ± 1.05; P = 0.877). Item-level analyses showed greater improvements in grooming, toilet use, feeding, transfers, mobility on level surfaces, dressing, and stair climbing. In the fully adjusted model, NBP treatment remained associated with greater BI improvement (β = 2.40, 95% CI: 0.77-4.03; P = 0.0038), but not with mRS change. NBP was also associated with lower adjusted odds of ADL dependency at 1 year. The association with BI improvement remained significant in IPTW and conservative death-imputation analyses. CONCLUSION: In this post-marketing real-world non-randomized controlled study, NBP treatment was associated with better 1-year ADL recovery in convalescent IS patients with chronic disease burden, mainly reflected by BI improvement and self-care or mobility-related gains rather than global disability change. These findings support ADL-centered assessment in long-term post-stroke care and suggest that functional recovery should be considered alongside recurrent event prevention and cognitive protection in aging stroke populations. CLINICAL TRIAL REGISTRATION: [ChiCTR2000039118]; http://www.chictr.org.cn.

Abstract as published, via PubMed.