To evaluate whether additional n-butylphthalide(NBP) therapy can improve the prognosis of acute ischemic stroke (AIS) patients who receive intravenous recombinant tissue plasminogen activator (rt-PA).

150 AIS patients admitted to the Fourth Affiliated Hospital of Guangzhou Medical University from January 2018 to June 2020 were randomly included into two groups: the control group treated with rt-PA, and the NBP group treated with rt-PA plus NBP. Wilcox test was used to compare the scores of the National Institutes of Health stroke scale (NIHSS) in 24 hours, 7 days, and 14 days after the treatment. And χ2-test was used to compare the proportion of the 90 d modified Rankin scale (mRS) score 0-2 (good prognosis) and adverse events after treatment in 12 months between the two groups.

There was no statistical difference in baseline. The NIHSS at 24 h, 7 d, and 14 d in NBP group were lower than that in the control group [4.50(3.00, 7.00) score vs 6.00(5.00, 10.00) score, Z=-2.821, P=0.005; 2.00(0, 4.00) score vs 4.00(2.00, 8.75) score, Z=-3.294, P=0.001; 1.50(0, 2.25) score vs 3.00(1.00, 7.00) score, Z=-3.277, P=0.001). The proportion of mRS score 0-2 was significantly higher in the NBP group (83.8%) than that in the control group (64.5%) after 90 days (χ²=7.266, P=0.007). There was no significant difference in stroke recurrence and death between the two groups at 12 months after treatment.

NBP therapy combined with rt-PA can further improve the neurological function and improve prognosis in patients with acute ischemic stroke.