The effect of treatment duration with human urinary kallidinogenase on the efficacy and safety of acute ischemic stroke: a subgroup analysis of RESK study
10.3760/cma.j.cn113694-20230921-00180
- VernacularTitle:尤瑞克林用药时长对急性缺血性脑卒中患者疗效和安全性的影响——RESK研究亚组分析
- Author:
Jun NI
1
;
Ming YAO
;
Lihua WANG
;
Ming YU
;
Runhui LI
;
Lihong ZHAO
;
Jiachun WANG
;
Yinzhou WANG
;
Xin WANG
;
Haiqing SONG
;
Benyan LUO
;
Jiawei WANG
;
Yining HUANG
;
Liying CUI
Author Information
1. 中国医学科学院北京协和医学院北京协和医院神经科 疑难重症及罕见病国家重点实验室，北京 100730
- Keywords:
Stroke;
Human urinary kallidinogenase;
Treatment outcome;
Safety;
Treatment duration
- From:
Chinese Journal of Neurology
2024;57(3):225-232
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the impact of treatment duration with human urinary kallidinogenase (HUK) on the efficacy and safety of acute ischemic stroke (AIS).Methods:In this subgroup analysis of RESK study, a total of 990 AIS patients recruited from 65 centers in China between August 2015 and June 2020 were included and divided into short medication group (HUK for 8 days, n=185) or long medication group (HUK for 15 days or 21 days, n=805). The proportions of patients with modified Rankin Scale (mRS) score of 0, 0-1, 0-2 at 90 days, National Institutes of Health Stroke Scale (NIHSS) score change from baseline to 22 days, the proportions of patients with Barthel index (BI)≥95 at 90 days, and the incidences of adverse events were analyzed. Comparisons between groups were conducted using chi-square test, single factor and multivariate Logistic regression analysis, etc. Results:Multivariate regression analysis showed that the proportions of patients with 90-day mRS score of 0-2 [74.1% (137/185) vs 75.0% (604/805); OR=1.047, 95% CI 0.676-1.620, P=0.838] and 22-day NIHSS score change from baseline (4.60±2.00 vs 4.26±2.80; OR=-0.390, 95% CI -1.125-0.344, P=0.297) showed no statistically significant difference between the short medication and long medication groups; the proportions of patients with 90-day mRS score of 0-1 [48.1% (89/185) vs 59.1% (476/805); OR=0.674, 95%CI 0.463-0.983, P=0.041] and 90-day BI≥95 [43.6% (79/181) vs 55.1% (442/802); OR=0.614, 95%CI 0.420-0.897, P=0.012] were significantly lower in the short medication group than in the long medication group. There was no statistically significant difference in the incidences of adverse events between these 2 groups. Conclusions:In AIS patients, consecutive 8-day dosing of HUK improved immediate (22-day NIHSS score) and long-term outcome (90-day mRS score 0-2) and was safely tolerated. When applicable, extended duration of HUK could improve long-term disability-free rate (90-day mRS score 0-1) and quality of life (90-day BI) without increasing the risk of adverse events.
