Chinese Journal of Stroke ›› 2021, Vol. 16 ›› Issue (04): 343-347.DOI: 10.3969/j.issn.1673-5765.2021.04.005

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Hydroxy Safflower Yellow in Acute Cerebral Infarction with Myocardial Ischemia: A Randomized, Open Label and Controlled Study

  

  • Received:2020-06-12 Online:2021-04-20 Published:2021-04-20

红花黄色素治疗急性脑梗死合并心肌缺血的随机、开放、对照研究

魏微,张翔建,肖保国,台立稳,马星光,黄勇华,王海霞,杨倩,张微微   

  1. 1北京 100700解放军总医院第七医学中心神经内科
    2河北医科大学附属第二医院神经内科
    3复旦大学神经病学研究所
    4北京中医药大学管理学院
  • 通讯作者: 张微微 zhangvivian@vip.sina.com

Abstract:

Objective To observe the efficacy of hydroxy safflower yellow in acute cerebral infarction with myocardial ischemia. Methods This prospective multicenter study enrolled the hospitalized patients with acute cerebral infarction and myocardial ischemia who were admitted to Department of Neurology of Chinese PLA General Hospital No.7 Medical Center and the Second Hospital of Hebei Medical University from April 2016 to December 2017. All the patients were randomizely divided into the observation group (conventional treatment and hydroxy safflower yellow) and control group (conventional treatment). The primary outcomes included mRS score at 14 and 90 days and electrocardiogram (ECG) myocardial ischemia improvement. Secondary outcomes included NIHSS score at 14, 28 and 90 days after enrollment. Results A total of 144 cases were enrolled, and 122 cases were included in the final analysis, including 62 cases in observation group and 60 cases in control group. The mRS at 14 days (P <0.0001) and 90 days (P <0.0001) in observation group was better than that in control group. The improvement rate of ECG at 14 days (92.7% vs 75.0%, P =0.0113) and 90 days (90.3% vs 58.3%, P <0.001) in observation group was higher than that in control group. There was no statistical difference in the NIHSS score at 14 days between the two groups (P =0.0001) , while the NIHSS at 28 and 90 days in observation group were lower than that in control group. Conclusions Hydroxy safflower yellow injection combined with conventional treatment had a definite clinical effect on acute cerebral infarction with myocardial ischemia.

Key words: Cerebral infarction; Myocardial ischemia; Hydroxide safflor yellow;Electrocardiogram

摘要:

目的 观察注射用红花黄色素治疗急性脑梗死合并心肌缺血的临床疗效。 方法 选取2016年4月-2017年12月解放军总医院第七医学中心神经内科和河北医科大学附属第二 医院神经内科收治的急性脑梗死合并心肌缺血的住院患者,随机接受注射用红花黄色素(160 mg/d, 连续10 d)联合标准内科治疗(治疗组)和标准内科治疗(对照组)。主要终点为14 d和90 d的mRS评分、 心电图心肌缺血改善状况;次要观察指标为入组14 d、28 d及90 d NIHSS评分。 结果 研究共入组144例,完成随访并纳入分析共122例,其中治疗组62例,对照组60例。治疗组14 d (P<0.0001)和90 d(P<0.0001)的mRS评分均优于对照组;治疗组14 d(92.7% vs 75.0%,P =0.0113) 和90 d(90.3% vs 58.3%,P <0.0001)的心电图心肌缺血有效改善率均高于对照组;14 d时两组NIHSS 评分差异无统计学意义,但28 d和90 d时,治疗组的NI HSS评分均低于对照组。 结论 注射用红花黄色素联合基础治疗对急性脑梗死合并心肌缺血有较好的临床疗效。

关键词: 脑梗死; 心肌缺血; 红花黄色素; 心电图