早期强化药物治疗对合并吞咽障碍大动脉粥样硬化性脑梗死的影响
Effect of Early Intensive Drug Therapy on Atherosclerotic Cerebral Infarction with Dysphagia

目的：本研究探索早期(24小时内)启动经胃管强化药物治疗较延迟(第7天)治疗对合并吞咽障碍大动脉粥样硬化性急性脑梗死患者的影响。方法：选择2018年6月至2020年9月于神经内科确诊且住院治疗的合并吞咽障碍的大动脉粥样硬化性急性脑梗死患者84例，随机区组法1:1分为研究组和对照组。研究组24 h内安置胃管并启动强化药物治疗，对照组7天后开始置入胃管并强化药物治疗。主要终点事件为90天的良好功能(mRS评分为0，1，2，mRS评分范围为0~6，分数越高提示残疾程度越重)比例、神经功能改善程度(NIHSS评分下降程度)；次要功效指标：联合血管事件(症状性卒中，心肌梗死及血管源性死亡等)；主要安全目标为主要出血事件发生率，包括致命/危及生命的主要出血和其他主要出血。结果：90天mRS ≤ 2的比例，研究组50%，对照组为26.19%，差异有统计学意义(P = 0.042)；90天NIHSS评分降幅，研究组为6.57 ± 2.31，而对照组为4.45 ± 2.10，两组差异有统计学意义(P < 0.01)。两组在联合血管事件及主要出血、不良事件等方面，无显著性差异。结论：24小时内安置胃管并强化药物治疗可以显著改善合并吞咽障碍的大动脉粥样硬化性脑梗死的功能预后，而不增加出血的风险。
Objective: This study explored the effect of early (within 24 h) initiation of intensive medical thera-py via gastric tube on delayed (day 7) treatment in patients with acute cerebral infarction caused by large atherosclerosis with dysphagia. Methods: A total of 84 patients with atherosclerotic acute cerebral infarction complicated with dysphagia, who were diagnosed and hospitalized in the De-partment of Neurology from June 2018 to September 2020, were divided into study group and con-trol group by 1:1 used randomized block design. In the study group, gastric tube placement and in-tensive medical therapy were initiated within 24 h, and in the control group, gastric tube placement and intensive drug therapy were initiated 7 days later. The primary end points were the proportion of good function (a score of 0, 1, or 2 on the modified Rankin scale, which ranges from 0 to 6, with higher scores indicating more severe disability) at 90 days and the degree of improvement in neu-rological function (NIHSS score decreased). Secondary efficacy outcomes were combined vascular events (symptomatic stroke, myocardial infarction, or death from ischemic vascular causes). The primary safety outcomes were the incidence of major bleeding events, including fa-tal/life-threatening major bleeding and other major bleeding. Results: The proportion of 90 days mRS ≤ 2 was 50% in the study group and 26.19% in the control group, the difference was statisti-cally significant (P = 0.042). NIHSS score decreased by 6.57 ± 2.31 in the study group and 4.45 ± 2.10 in the control group at 90 days, and the difference between the two groups was statistically significant (P < 0.01). There was no significant difference in vascular events, major bleeding and adverse events between the two groups. Conclusions: Gastric tube placement within 24 hours and intensive medication may significantly improve the functional outcome of large atherosclerotic cerebral infarction with dysphagia, without increasing the risk of bleeding.