Efficacy and Safety of Mildronate for Acute Ischemic Stroke: A Randomized, Double-Blind, Active-Controlled Phase II Multicenter Trial

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• 作者：Yi Zhu (1)
  Guangyun Zhang (1)
  Jun Zhao (1)
  Deshuai Li (1)
  Xiaodong Yan (2)
  Juanfang Liu (1)
  Xuedong Liu (1)
  Haibo Zhao (1)
  Jielai Xia (3)
  Xiao Zhang (1)
  Zhengyi Li (4)
  Baorong Zhang (5)
  Zongcheng Guo (6)
  Lianyuan Feng (7)
  Zhaodong Zhang (8)
  Fang Qu (9)
  Gang Zhao (1)
  
• 刊名：Clinical Drug Investigation
• 出版年：2013
• 出版时间：October 2013
• 年：2013
• 卷：33
• 期：10
• 页码：755-760
• 全文大小：298 KB
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• 作者单位：Yi Zhu (1)
  Guangyun Zhang (1)
  Jun Zhao (1)
  Deshuai Li (1)
  Xiaodong Yan (2)
  Juanfang Liu (1)
  Xuedong Liu (1)
  Haibo Zhao (1)
  Jielai Xia (3)
  Xiao Zhang (1)
  Zhengyi Li (4)
  Baorong Zhang (5)
  Zongcheng Guo (6)
  Lianyuan Feng (7)
  Zhaodong Zhang (8)
  Fang Qu (9)
  Gang Zhao (1)
  
  1. Department of Neurology, Xijing Hospital, The Fourth Military Medical University, Xi’an, Shaanxi, China
  2. Department of Orthopaedics, Tangdu Hospital, Fourth Military Medical University, Xi’an, Shaanxi, China
  3. Department of Health Statistics, Fourth Military Medical University, Xi’an, Shaanxi, China
  4. First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi, China
  5. Second Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang, China
  6. People’s Hospital of Hebei Province, Hebei, China
  7. Bethune International Peace Hospital of People’s Liberation Army, Hebei, China
  8. First Hospital of China Medical University, Beijing, China
  9. General Hospital of Shenyang Military Region, Shenyang, China
  
• ISSN：1179-1918

文摘

Background and Objective Mildronate, an inhibitor of carnitine-dependent metabolism, is considered to be an anti-ischemic drug. This study is designed to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke. Methods We performed a randomized, double-blind, multicenter clinical study of mildronate injection for treating acute cerebral infarction. 113 patients in the experimental group received mildronate injection, and 114 patients in the active-control group received cinepazide injection. In addition, both groups were given aspirin as a basic treatment. Modified Rankin Scale (mRS) score was performed at 2?weeks and 3?months after treatment. National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index (BI) score were performed at 2?weeks after treatment, and then vital signs and adverse events were evaluated. Results A total of 227 patients were randomized to treatment (n?=?113, mildronate; n?=?114, active-control). After 3?months, there was no significant difference for the primary endpoint between groups categorized in terms of mRS scores of 0- and 0- (p?=?0.52 and p?=?0.07, respectively). There were also no significant differences for the secondary endpoint between groups categorized in terms of NIHSS scores of >5 and >8 (p?=?0.98 and p?=?0.97, respectively) or BI scores of >75 and >95 (p?=?0.49 and p?=?0.47, respectively) at 15?days. The incidence of serious adverse events was similar between the two groups. Conclusion Mildronate injection is as effective and safe as cinepazide injection in treating acute cerebral infarction.