急性基底动脉闭塞患者早期血管内治疗联用丁苯酞的多中心、前瞻性队列研究

Safety and efficacy of early endovascular therapy combined with butylphthalide for acute basilar artery occlusion:a multicenter,prospective cohort study

目的探讨急性基底动脉闭塞患者早期血管内治疗联用丁苯酞的有效性及安全性。方法连续性纳入2014年1月至2019年5月在陆军军医大学第二附属医院及46家分中心的急性基底动脉闭塞早期接受血管内治疗患者,依据是否使用丁苯酞药物治疗,将其分为丁苯酞组和对照组,比较90 d良好功能预后发生率[定义为改良Rankin量表(mRS)评分≤3分]、48 h内症状性颅内出血(symptomatic intracranial hemorrhage, sICH)和90 d病死率。采用二元Logistic回归探讨丁苯酞与90 d功能预后、sICH发生率及90 d病死率的相关性,校正因素包括年龄、血压、发病到穿刺时间、mTICI血流分级、糖尿病、基线NIHSS评分、后循环Alberta卒中项目早期CT评分、闭塞部位等混杂因素。结果最终共纳入患者645例,丁苯酞组232例,对照组413例。丁苯酞组90 d良好功能预后比例显著高于对照组[39.2%(91/232)vs28.1%(116/413);χ^2=8.454,P=0.005];丁苯酞组患者sICH发生率明显低于对照组[1.7%(4/232)vs10.2%(41/403),χ^2=15.965,P<0.001];丁苯酞组90 d病死率显著低于对照组[34.1%(79/232)vs 52.8%(218/413),χ2=20.983,P<0.001]。使用丁苯酞治疗是90 d良好功能预后(OR:1.646,95%CI 1.091~2.483,P=0.018)、降低sICH发生率(OR:0.164,95%CI:0.056~0.475,P=0.001)及90 d病死率(OR:0.424,95%CI:0.278~0.647,P<0.001)的独立保护因素。结论早期血管内治疗联用丁苯酞可显著改善急性基底动脉闭塞患者的90 d功能预后,降低sICH风险及病死率。

Objective To investigate the efficacy and safety of early endovascular therapy(EVT)combined with butylphthalide(NBP)in the patients with acute basilar artery occlusion(BAO).Methods From January 2014 to May 2019,645 acute BAO patients(from the Second Affiliated Hospital of Army Medical University and other 46 comprehensive stroke centers in China)who underwent EVT were enrolled into this study.According to receiving NBP treatment or not,the patients were divided into simple EVT group(control group,n=413)and EVT+NBP group(NBP group,n=232).Safety and efficacy were evaluated and compared between the 2 groups,with symptomatic intracerebral hemorrhage(sICH)within 48 h and 90-day all cause mortality as evaluation criteria for safety,and the modified Rankin Scale(mRS)score and the modified Thrombolysis in Cerebral Infarction(mTICI)for efficacy.Binary Logistic regression was used for multi-factor analysis,with calibration factors of age,blood pressure,time from onset to puncture,mTICI grade,diabetes mellitus,baseline NIHSS score,pc-ASPECTS score,ASITN/SIR grade and occlusion sites,etc.Results At 90 d after treatment,the NBP group had a higher rate of mRS low score(≤3)than the control group[39.2%(91/232)vs 28.1%(116/413),Chi-square=8.454,P=0.005],indicating better functional prognosis.The incidence of sICH[1.7%(4/232)vs 10.2%(41/403),Chi-square=15.965,P<0.001]and 90-day mortality[34.1%(79/232)vs 52.8%(218/413),Chi-square=20.983,P<0.001]were both significantly lower in the NBP group when compared to the control group.Logistic regression analysis indicated that NBP was an independent protective factor for good functional prognosis at 90 d(OR=1.646,95%CI:1.091~2.483,P=0.018),reduced incidence of sICH(OR=0.164,95%CI:0.056~0.475,P=0.001)and lower mortality at 90 d(OR=0.424,95%CI:0.278~0.647,P<0.001).Conclusion Early EVT combined with NBP can significantly improve the 90-day functional prognosis,and reduce the sICH risk and mortality in the acute BAO patients.