Chen H S, Yang Y, Ni J, Chen G F, Ji Y, Yi F, Zhang Z B, Wu J, Cai X L, Shao B, Wang J F, Liu Y F, Geng D Q, Qu X H, Li X H, Wei Y, Han S G, Zhu R X, Ding J P, Lyu H, Huang Y N, Huang Y H, Xiao B, Gong T, Yu X F, Cui L Y
Department of Neurology, General Hospital of Northern Theater Command, Shenyang 110016, China.
Department of Neurology, the First Bethune Hospital of Jilin University, Changchun 130021, China.
Zhonghua Nei Ke Za Zhi. 2022 Aug 1;61(8):916-920. doi: 10.3760/cma.j.cn112138-20210822-00574.
To investigate the blood pressure change in patients with acute ischemic stroke (AIS) and hypertension treated with cinepazide maleate injection. This was a subgroup analysis of post-marketing clinical confirmation study of cinepazide maleate injection for acute ischemic stroke: a randomized, double-blinded, multicenter, placebo-parallel controlled trial, which conducted in China from August 2016 to February 2019. Eligible patients fulfilled the inclusive criteria of acute anterior circulation ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores of 7-25. The primary endpoints were mean blood pressure of AIS patients treated with cinepazide maleate or control, which were assessed during the treatment period (14 days), and the proportion of the patients with normal blood pressure was analyzed after the treatment period. Furthermore, a subgroup analysis was performed to investigate a possible effect of the history of hypertension on outcomes. This analysis included 809 patients with hypertension. There was no significant difference in patients blood pressure and the proportion of patients with normal blood pressure (60.5% vs. 59.0%,>0.05) between cinepazide maleate group and control group. Administration of cinepazide maleate injection does not affect the management of clinical blood pressure in patients with AIS.
探讨马来酸桂哌齐特注射液治疗急性缺血性脑卒中(AIS)合并高血压患者的血压变化情况。这是一项关于马来酸桂哌齐特注射液治疗急性缺血性脑卒中的上市后临床验证研究的亚组分析:一项随机、双盲、多中心、安慰剂平行对照试验,于2016年8月至2019年2月在中国开展。符合条件的患者满足急性前循环缺血性脑卒中的纳入标准,美国国立卫生研究院卒中量表(NIHSS)评分7 - 25分。主要终点为接受马来酸桂哌齐特或对照治疗的AIS患者在治疗期间(14天)的平均血压,并在治疗期后分析血压正常患者的比例。此外,进行亚组分析以研究高血压病史对结局的可能影响。该分析纳入了809例高血压患者。马来酸桂哌齐特组与对照组患者的血压及血压正常患者的比例(60.5%对59.0%,>0.05)无显著差异。马来酸桂哌齐特注射液的使用不影响AIS患者临床血压的管理。