Cinepazide maleate injection reduced the disability rate for acute ischemic stroke patients: a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase Ⅳ clinical trial
10.3760/cma.j.cn113694-20200616-00444
- VernacularTitle:马来酸桂哌齐特注射液明显促进急性缺血性脑卒中患者的早期功能恢复：一项多中心、随机、双盲、安慰剂对照Ⅳ期临床研究
- Author:
Jun NI
1
;
Huisheng CHEN
;
Guofang CHEN
;
Yong JI
;
Fei YI
;
Zhuobo ZHANG
;
Yi YANG
;
Jin WU
;
Xueli CAI
;
Bei SHAO
;
Jianfeng WANG
;
Yafang LIU
;
Deqin GENG
;
Xinhui QU
;
Xiaohong LI
;
Yan WEI
;
Jianping DING
;
Hua LYU
;
Yining HUANG
;
Yonghua HUANG
;
Bo XIAO
;
Tao GONG
;
Liying CUI
Author Information
1. 中国医学科学院北京协和医院神经内科 100730
- From:
Chinese Journal of Neurology
2020;53(10):790-797
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To assess the efficacy and safety of cinepazide maleate injection in the treatment of patients with acute ischemic stroke.Methods:A multicenter, randomized, double-blind, placebo-controlled phase Ⅳ clinical trial, led by Peking Union Medical College Hospital, was conducted in 65 Hospitals in China. The efficacy of cinepazide maleate injection in patients with acute anterior circulation cerebral infarction with onset time of ≤48 hours, 7≤National Institute of Health stroke scale (NIHSS) score ≤25 was assessed from August 2016 to February 2019, using the proportion of modified Rankin scale (mRS) score≤1 and Barthel index (BI) score≤95 on day 14 as efficacy endpoint. The patients were divided into treatment group who were treated with cinepazide maleate injection and control group who were treated with placebo.Results:A total 937 patients were involved in the final efficacy analysis (466 in treatment group and 471 in control group). The proportion of subjects with mRS score≤1 on day 14 after treatment were higher in the treatment group than that in the control group (102/466(21.89%) vs76/471(16.14%)). Logistic regression analysis showed that patients treated with cinepazide maleate were significantly more likely to have a favorable outcome (mRS score≤1) than patients treated with placebo on day 14 ( OR=0.677, 95% CI 0.484-0.948 , P=0.023), and patients treated with cinepazide maleate were more likely to reach independence in activities of daily living (Barthel Index ≥95) than those treated with placebo on day 14 (125/466(26.82%) vs 91/471(19.32%); OR=0.632, 95% CI0.459-0.869, P=0.005). The rate of adverse events was similar between the treatment and control groups. Conclusion:The 14-day treatment with cinepazide maleate injection could reduce the degree of disability whereas did not increase the risk of adverse events.
