2. Academic Validation
  3. Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial

Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial

  • BMC Neurol. 2020 Jul 14;20(1):282. doi: 10.1186/s12883-020-01844-8.
Jun Ni 1,  Huisheng Chen 2,  Guofang Chen 3,  Yong Ji 4,  Fei Yi 5,  Zhuobo Zhang 6,  Yi Yang 7,  Jin Wu 8,  Xueli Cai 9,  Bei Shao 10,  Jianfeng Wang 11,  Yafang Liu 12,  Deqin Geng 13,  Xinhui Qu 14,  Xiaohong Li 15,  Yan Wei 16,  Jianping Ding 17,  Hua Lü 18,  Yining Huang 19,  Yonghua Huang 20,  Bo Xiao 21,  Tao Gong 22,  Liying Cui 23,  study collaboration group
Affiliations

Affiliations

  • 1 Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.
  • 2 General Hospital of Northern Theater Command, Shenyang, China.
  • 3 Xuzhou Central Hospital, Xuzhou, China.
  • 4 Tianjin Huanhu Hospital, Tianjin, China.
  • 5 Pingxiang People's Hospital, Pingxiang, China.
  • 6 Fourth Affiliated Hospital of Harbin Medical University, Harbin, China.
  • 7 First Bethune Hospital of Jilin University, Changchun, China.
  • 8 Second Affiliated Hospital of Nanjing Medical University, Nanjing, China.
  • 9 Lishui Municipal Central Hospital, Lishui, China.
  • 10 First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
  • 11 Dalian Municipal Central Hospital, Dalian, China.
  • 12 Huangshi Central Hospital, Huangshi, China.
  • 13 Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
  • 14 Jiangxi Provincial People's Hospital affiliated to Nanchang University, Nanchang, China.
  • 15 Jinan Central Hospital, Jinan, China.
  • 16 Hengshui People's Hospital (Harrison International Peace Hospital), Hengshui, China.
  • 17 Xuan Wu Hospital, Capital Medical University, Beijing, China.
  • 18 Shaanxi Provincial People's Hospital, Xi'an, China.
  • 19 Peking University First Hospital, Beijing, China.
  • 20 Seventh Medical Center of the Chinese PLA General Hospital, Beijing, China.
  • 21 Xiangya Hospital Central South University, Changsha, China.
  • 22 Beijing Hospital, Beijing, China.
  • 23 Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China. pumchcuily@sina.com.
PMID: 32664877 DOI: 10.1186/s12883-020-01844-8
Abstract

Background: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 h of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.

Methods: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.

Results: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤ 2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p = 0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p = 0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.

Conclusions: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.

Trial registration: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827 . Retrospectively registered June 13, 2019.

Keywords

Acute cerebral infarction; Cerebrovascular disease; Cinepazide maleate; Stroke.

Figures
Products
嗨！很高兴为您提供帮助！

尊敬的 MCE 客户您好，
请您选择所在区域，我们将转接对应客服为您服务！

热门区域

A

B

C

F

G

H

J

L

N

Q

S

T

X

Y

Z

热 A B C F G H J L N Q S T X Y Z