依那普利叶酸对伴有H型高血压的急性缺血性卒中患者转归的影响

Effect of enalaprilat folic acid on the outcomes in acute ischemic stroke patients with H-type hypertension

目的探讨依那普利叶酸片对伴有H型高血压的急性缺血性卒中患者转归的影响。方法前瞻性连续纳入伴有H型高血压的急性缺血性卒中患者，随机分为依那普利叶酸治疗组和依那普利治疗组。依那普利叶酸治疗组给予马来酸依那普利叶酸片（10mg／0．8mg，1次／d）；依那普利治疗组给予马来酸依那普利片（10mg，1次／d）。收集所有患者的人121学特征以及基线临床资料。应用改良Rankin量表（modified RankinSacle，mRS）评估患者出院和90d时的转归情况，转归良好定义为mRS评分0～2分，转归不良定义为mRS评分〉2分。结果共纳入248例患者，其中男性占66．5％，平均高半胱氨酸（homocysteine，Hey）水平为（18．513±9．700）μmol／L。依那普利叶酸组和依那普利组分别为123例和125例，2组人口统计学、基线临床资料均无显著差异，转归不良的患者比例亦无显著差异（16．3％对18．4％x2=0．198，P=0．738）。将2组所有病例分为转归良好组和转归不良组，其中转归良好组205例（82．7％），转归不良组43例（17．3％）。转归良好组平均年龄显著小于转归不良组[（69．22±11．12）岁对（75．88±9．26）岁；t=-4．826，P〈0．001]，基线收缩压[（139．88±19．23）mmHg对（144．28±17．92）mmHg，1mmHg=0．133kPa；t=2．138，P=0．033]和美国国立卫生研究院卒中量表（NationalInstitutes of Health Stroke Scale，NIHSS）评分[（2．454±2．340）分对（13．605±6．415）分；t=-27．081，P〈0．001]以及大动脉粥样硬化性卒中的患者构成比（58．50％对74．4％；X2=5．901，P=0．015）均显著低于转归不良组，但Hcy水平[（18．524±10．339）μmol／L对（18．298±6．105）μmol／L；t=0．013，P=0．989]和接受依那普利叶酸治疗的患者比例（50．2％对46．5％；X2=0．198，P=O．738）无显著差异。多变量logistic回归分析显示，大动脉粥样硬化性卒中（优势比1．025，95％可信区间1．002～1．049；P=0．006）和基线NIHSS评分（优势比2．4，95％可信区间1．734～3．322；P〈0．001）是转归不良的独立危险因素。结论 Hey水平不是伴有H型高血压的急性缺血性卒中患者转归不良的独立危险因素。与依那普利比较，依那普利叶酸不能显著改善伴有H型高血压的急性缺血性卒中患者的转归。

Objective To investigate the effect of enalaprilat folic acid on the outcomes of acute ischemic stroke patients with H-type hypertension. Methods The consecutive acute ischemic stroke patients with H-type hypertension were enrolled prospectively. They were randomly divided into either an enalaprilat folic acid treatment group or an enalaprilat treatment group. The enalaprilat folio acid group was treated with enalapril maleate and folio acid tablets （10 mg/0. 8 mg daily）; the enalaprilat treatment group was treated with enalapril maleate tablets （10 mg daily）. Demographic characteristics and baseline clinical data of all the patients were collected. The modified Rankin scale （mRS） was used to evaluate the outcome at discharge and at day 90. The good outcome was defined as mRS score 0-2 and poor outcome was defined as mRS score 〉2. Results A total of 248 patients were enrolled, and the males accounted for 66. 5%. The mean homoeysteine （Hey） level was 18. 513±9. 700μmol/L. There were 123 and 125 patients respectively in the enalaprilat folie acid treatment group and the enalaprilat treatment group. There were no significant differences in demography and baseline clinical data between the two groups. There was also no significant difference in the proportion of patients with poor outcome between the 2 groups （16. 3% vs. 18.4% ;X2 = 0. 198, P = 0. 738）. All the cases in both groups were divided into a good outcome group and a poor outcome group. There were 205 patients （82. 7%） ha the good outcome group and 43 （17.3%） in the poor outcome group. The mean age in the good outcome group was significantly lower than that in the poor outcome group （69.22 ± 11.12 years vs. 75.88 ± 9.26 years; t= -4. 826, P〈 0.001）. The baseline systolic blood pressure （139. 88 ± 19. 23 mmHg vs. 144. 28 ±17. 92）mmHg, 1 mmHg = 0. 133 kPa; t = 2. 138, P =0. 033）, National Institutes of Health Stroke Scale （NIHSS） score （2. 454 ±2. 340 vs. 13.605 ±6. 415; t = - 27. 081, P 〈 0. 001 ）, and proportions of the patients with large artery atherosclerotic stroke （58.50% vs. 74.4%;X2 =5. 901, P=0.015） in the good outcome group were significantly lower than those in the poor outcome group, however, there were no significant differences in the Hey level （18. 524 ±10. 339 μmol/L vs. 18.298 ± 6. 105 μmol/L; t = 0. 013, P = 0. 989） and the proportion of patients who were treated with enalaprilat folic acid （50.2% vs. 46. 5% ; X2 = 0. 198, P = 0. 738）. Multivariate logistic regression analysis showed that large atherosclerotic stroke （odds ratio [ OR] 1. 025, 95% confidence interval [ CI] 1. 002-0. 049; P =0. 006） and the baseline NIHSS score （OR 2.4, 95% CI 1.734-3.322; P 〈 0. 001） were independent risk factors for poor outcome. Conclusions Hey level is not an independent risk factor for poor outcome in acute ischemic stroke patients with H-type hypertension. Compared with enalaprilat, enalaprilat folio acid can not significantly improve the outcome of acute ischemic stroke patients with H-type hypertension.