丁苯酞预防脑梗死后早期神经功能恶化的真实世界研究  

A real-world study of DL-3-n-butylphthalide in preventing early neurological deterioration after cerebral infarction

作　　者：张萍[1] 李洁[1] 易兴阳[1] 卿婷 陈洪[1] 朱亚兰[3] 刘姗 段勇[5] 谢娟 ZHANG Ping;LI Jie;Yi Xingyang;QING Ting;CHEN Hong;ZHU Yalan;LIU Shan;DUAN Yong;XIE Juan(Department of Neurology,Deyang People’s Hospital,Deyang,Sichuan 618000,P.R.China;Department of Neurology,the Second People’s Hospital of Deyang,Deyang,Sichuan 618000,P.R.China;Department of Neurology,Guanghan People’s Hospital,Guanghan,Sichuan 618300,P.R.China;Department of Neurology,Deyang Jingyang Hospital of T.C.M,Deyang,Sichuan 618000,P.R.China;Department of Neurology,People’s Hospital of Zhongjiang County,Zhongjiang,Sichuan 618100,P.R.China;Department of Neurology,Deyang Integrated Traditional Chinese and Western Medicine Hospital,Deyang,Sichuan 618000,P.R.China)

机构地区：[1]德阳市人民医院神经内科,四川德阳618000 [2]德阳市第二人民医院神经内科,四川德阳618000 [3]广汉市人民医院神经内科,四川广汉618300 [4]德阳市旌阳区中医院神经内科,四川德阳618000 [5]中江县人民医院神经内科,四川中江618100 [6]德阳市中西医结合医院神经内科,四川德阳618000

出　　处：《华西医学》2023年第5期680-687,共8页West China Medical Journal

基　　金：德阳市科学技术局科技计划项目(2020SZZ069)。

摘　　要：目的探讨真实世界中丁苯酞与脑梗死后早期神经功能恶化(early neurological deterioration,END)发生的相关性。方法采用多中心注册登记研究,纳入德阳地区5家医院2019年3月31日-2021年7月31日发病72 h内入院的脑梗死患者,根据真实世界中用药情况分为标准治疗组(基于指南的标准治疗)和丁苯酞治疗组(标准治疗+丁苯酞),主要终点指标为脑梗死后END,次要终点指标为发病后90 d的神经功能预后不良(定义为改良Rankin量表评分3~6分)。结果共纳入314例脑梗死患者,其中126例接受标准治疗,188例接受在标准治疗基础上联用丁苯酞治疗。共有69例患者在10 d内发生END,其中丁苯酞治疗组32例(发生率17.0%),标准治疗组37例(发生率29.4%),两组比较差异有统计学意义(P=0.010)。logistic回归分析显示,入院血清神经丝轻链蛋白水平[比值比(odds ratio,OR)=1.020,95%置信区间(confidence interval,CI)(1.004,1.035),P=0.013]、丁苯酞治疗[OR=0.449,95%CI(0.253,0.797),P=0.006]、双联抗血小板治疗[OR=0.373,95%CI(0.196,0.710),P=0.003]是脑梗死后END发生的独立影响因素;年龄[OR=1.063,95%CI(1.024,1.103),P=0.002]、入院时美国国立卫生研究院卒中量表评分[OR=1.532,95%CI(1.313,1.787),P<0.001]、丁苯酞治疗[OR=0.375,95%CI(0.177,0.794),P=0.010]、END[OR=7.450,95%CI(3.294,16.852),P<0.001]与脑梗死患者90 d时神经功能预后不良独立相关。结论在真实世界中,丁苯酞可以预防脑梗死后END发生风险,改善患者90 d时的神经功能结局。Objective To explore the correlation between DL-3-n-butylphthalide(NBP)and early neurological deterioration(END)after cerebral infarction in real-world study.Methods A multicenter registry observational study was conducted,enrolling patients with acute cerebral infarction within 72 h of onset from five hospitals in Deyang from March 31st,2019,to July 31st,2021.The patients were divided into two groups based on the treatment regimen,whether they received NBP in addition to standard therapy or not.The primary endpoint was END after cerebral infarction,and the secondary endpoint was unfavorable outcome(defined as modified Rankin Scale score of 3 to 6)90 d after onset.Results A total of 314 patients with cerebral infarction were included in the study,among whom,126 received standard therapy without NBP treatment(standard treatment group)and 188 received NBP in addition to standard therapy(NBP treatment group).A total of 69 cases occurred END within 10 d after admission.In the NBP treatment group,32 cases(17.0%)had END within 10 d after admission,while in the standard treatment group,37 cases(29.4%)occurred END,and the difference between the two groups was statistically significant(P=0.010).Logistic regression analyses showed that the influencing factors related to END included the serum neurofilament light chain level on admission[odds ratio(OR)=1.020,95%confidence interval(CI)(1.004,1.035),P=0.013],NBP treatment[OR=0.449,95%CI(0.253,0.797),P=0.006],and dual antiplatelet therapy[OR=0.373,95%CI(0.196,0.710),P=0.003],and the influencing factors for poor neurological functional prognosis in patients with cerebral infarction included age[OR=1.063,95%CI(1.024,1.103),P=0.002],National Institute of Health Stroke Scale score on admission[OR=1.532,95%CI(1.313,1.787),P<0.001],NBP treatment[OR=0.375,95%CI(0.177,0.794),P=0.010],and END[OR=7.450,95%CI(3.294,16.852),P<0.001].Conclusion The results of our study provide the initial evidence that NBP treatment reduces the occurrence of END,and improves the neurological functional pro

关 键 词：丁苯酞 脑梗死 早期神经功能恶化 

分 类 号：R743.33[医药卫生—神经病学与精神病学]