Long-Term Benefits of N-Butylphthalide in Preventing Ischemic Stroke Recurrence: A 12-Month Prospective Study.

Purpose: This study evaluated the effects of 12 months of NBP treatment on stroke recurrence and examined the influence of age and gender on its efficacy.

Methods: A prospective cohort of 1109 patients with non-cardioembolic ischemic stroke (IS) within six months was divided into NBP (n = 538) and control (n = 571) groups. The NBP group received NBP plus standard treatment, while the control group received standard treatment alone. Primary outcomes were recurrent ischemic and hemorrhagic stroke over 12 months. Secondary outcomes included functional status (modified Rankin Scale, m-RS) and all-cause mortality.

Results: NBP reduced recurrent IS by 39% compared to controls (RR:0.61,95% CI:0.40-0.93, P=0.022) and total stroke events by 39.6% (RR:0.60,95% CI:0.40-0.91,P=0.016). Protective effects were more significant in males (RR:0.52,95% CI:0.30-0.91, P=0.021 vs RR:0.53,95% CI:0.40-0.91,P=0.021) and in patients under 70 years (P<0.05). Functional outcomes (modified Rankin Scale and Barthel index) and all-cause mortality did not differ significantly between groups (all P>0.05).

Conclusion: NBP significantly reduces stroke recurrence and overall vascular events, especially in males and younger patients. While it does not improve functional outcomes or mortality, NBP demonstrates substantial preventive value for recurrent strokes.