Department of Neurology, Xijing Hospital, The Fourth Military Medical University, Xi'an, Shaanxi, China.
Clin Drug Investig. 2013 Oct;33(10):755-60. doi: 10.1007/s40261-013-0121-x.
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.
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.
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 0-1 and 0-2 (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.
Mildronate injection is as effective and safe as cinepazide injection in treating acute cerebral infarction.
米力农是一种肉碱依赖性代谢抑制剂，被认为是一种抗缺血药物。本研究旨在评估米力农注射液治疗急性缺血性脑卒中的疗效和安全性。
我们进行了一项米力农注射液治疗急性脑梗死的随机、双盲、多中心临床研究。实验组 113 例患者接受米力农注射液治疗，阳性对照组 114 例患者接受桂哌齐特注射液治疗。此外，两组均给予阿司匹林作为基础治疗。治疗后 2 周和 3 个月进行改良 Rankin 量表（mRS）评分。治疗后 2 周进行美国国立卫生研究院卒中量表（NIHSS）评分和巴氏指数（BI）评分，然后评估生命体征和不良事件。
共有 227 例患者被随机分配至治疗组（米力农组，n = 113；阳性对照组，n = 114）。治疗 3 个月后，mRS 评分 0-1 分和 0-2 分组间主要终点无显著差异（p = 0.52 和 p = 0.07）。NIHSS 评分＞5 分和＞8 分组间（p = 0.98 和 p = 0.97）及 BI 评分＞75 分和＞95 分组间（p = 0.49 和 p = 0.47）的次要终点也无显著差异。两组严重不良事件发生率相似。
米力农注射液治疗急性脑梗死的疗效和安全性与桂哌齐特注射液相当。
