Human urinary kallidinogenase or edaravone combined with butylphthalide in the treatment of acute ischemic stroke

AIM: The effectiveness of neuroprotective agents is still unclear. Here we analyzed the clinical outcomes of acute ischemic stroke (AIS) patients treated with human urinary kallidinogenase (HUK) or edaravone (Eda) combined with butylphthalide (NBP). METHODS: From January 2016 to December 2017, a total of 165 AIS patients were enrolled in this open‐label, randomized controlled clinical study. Patients were randomly allocated into HUK group and Eda group in a ratio of 2:1. All the patients received basic treatments and NBP (200 mg p.o. qid) while HUK group received 0.15 PNA unit of HUK injection (ivgtt. qd) and Eda group received 30 mg Eda (ivgtt. bid) for 14 consecutive days. Independency rate [12‐month modified Rankin Scale (mRS) score ≤ 1] and related factors were compared between the two groups. RESULTS: Twelve‐month mRS score of the HUK group (1, IQR 0~1) was significantly lower compared with Eda group (2, IQR 1~3, p < .0001). The HUK treatment achieved an independency rate of 79.1% while the Eda treatment only had 45.3% (p < .0001). Further binary logistic regression showed that recurrent stroke (RR: 0.1, 95% CI: 0.0~0.1, p = .038) and HUK treatment (RR: 4.2, 95% CI: 1.1~16.5, p = .041) could significantly affect patients' 12‐month outcomes. CONCLUSION: Human urinary kallidinogenase combined with NBP can enhance AIS patients' long‐term independency rate, and the effectiveness of HUK combined therapy is better than Eda.