摘要
目的探索中国老年非瓣膜性房颤患者使用利伐沙班预防卒中的合适剂量,提高抗凝治疗的有效性及安全性。方法连续入选中国人民解放军总医院第一医学中心心血管内科2016年12月至2018年12月老年非瓣膜性房颤患者152例,采用随机数表法分为利伐沙班A组及利伐沙班B组。A组采用国际推荐剂量的利伐沙班(15 mg),B组采用低剂量利伐沙班(10 mg)。随访12个月后,最后入组患者A组73例,B组67例。检测应用利伐沙班前后患者的血常规、凝血功能、血浆抗Ⅹa因子活性浓度及血栓弹力图等指标,记录随访期间的出血、缺血事件及全因死亡情况。采用SPSS 26.0统计软件进行数据分析。根据数据类型,分别采用t检验、方差分析或秩和检验进行组间比较;采用Kaplan-Meier进行生存分析。结果服用利伐沙班治疗前后2组患者的丙氨酸氨基转移酶、天冬氨酸氨基转移酶、血肌酐、血尿素氮、尿酸、血红蛋白、血小板、血小板聚集功能均无明显变化,差异无统计学意义(P>0.05)。A组患者的活化部分凝血活酶时间峰值、血浆凝血酶原时间峰值、凝血酶原活动度峰值、国际标准化比值峰值及抗Xa因子谷浓度值均明显高于B组,差异意义有统计学(P<0.05)。2组其余凝血指标比较差异均无统计学意义(P>0.05)。2组血栓弹力图各项主要指标均无统计学差异(P>0.05)。除血尿外,2组患者的其他出血性事件、缺血性事件及全因死亡均无明显统计学差异(P>0.05)。A组的累积生存率为93.5%,B组为84.6%,差异无统计学意义(P>0.05)。结论我国老年非瓣膜性房颤患者卒中防治前需个体化评估缺血/出血风险,抗凝治疗推荐选用偏低剂量的利伐沙班,可取得明显且相对安全的临床获益。
Objective To explore the appropriate dose of rivaroxaban to prevent stroke in elderly Chinese patients with non-valvular atrial fibrillation in order to improve the effectiveness and safety of anticoagulation therapy.Methods From December 2016 to December 2018,152 consecutive elderly patients with nonvalvular atrial fibrillation admitted in the First Medical Center of Chinese PLA General Hospital were randomly divided into rivaroxaban A group and rivaroxaban B group.Group A received the international recommended dose of rivaroxaban(15 mg)and group B a low dose(10 mg).After 12-month follow-up,the clinical data of 73 patients in group A and 67 patients in group B got analyzed.The blood routine,coagulation function,plasma anti-Xa factor activity concentration were tested and thromboelastography was performed before and after the treatment of rivaroxaban.The bleeding events,ischemic events and all-cause deaths were recorded during 12 months of follow-up.SPSS statistics 26.0 was used to perform the statistical analysis.Student′s t test,Chi-square test,or Rank sum test was employed for intergroup comparison depending on different data types.Kaplan-Meier survival curve is plotted for survival analysis.Results There were no significant changes in the levels of alanine aminotransferase(ALT),aspartate aminotransferase(AST),serum creatinine(SCr),blood urea nitrogen(BUN),uric acid(UA)and hemoglobin(Hb),blood platelet(PLT)count,or platelet aggregation before and after rivaroxaban treatment in both groups(P>0.05).The peak activated partial thromboplastin time(APTT),peak plasma prothrombin time(PT),peak prothrombin activity(PTA),peak international normalized ratio(INR)and trough concentration of anti-Xa factor were significantly higher in group A than group B(P<0.05).But there were neither obvious differences in the other coagulation indexes between the 2 groups(P>0.05),nor in the main indicators of the thromboelastogram between them(P>0.05).Except for hematuria,no significant differences were found in the incidences of ischemic events,major hemorrhagic events and all-cause deaths between the 2 groups(P>0.05).The results of Kaplan-Meier survival analysis showed that the cumulative survival rate of group A was 93.5%and that of group B was 84.6%,but there was also no statistical difference(P>0.05).Conclusion The risk of ischemia and hemorrhage in elderly patients with non-valvular atrial fibrillation in China needs to be individually assessed before the initiatively prevention and treatment of stroke.A low dose of rivaroxaban is recommended for anticoagulation therapy,which can achieve obvious and relatively safe clinical benefits.
作者
王海明
赵芸漳
刘子凡
高一凡
孙哲
林莹
张然
徐勇
郭新红
WANG Hai-Ming;ZHAO Yun-Zhang;LIU Zi-Fan;GAO Yi-Fan;SUN Zhe;LIN Ying;ZHANG Ran;XU Yong;GUO Xin-Hong(Department of Cardiovascular Medicine,First Medical Center,Chinese PLA General Hospital,Beijing 100853,China)
出处
《中华老年多器官疾病杂志》
2021年第7期481-487,共7页
Chinese Journal of Multiple Organ Diseases in the Elderly
基金
解放军总医院临床扶持基金(2016FC-TSYS-2003)。
关键词
老年人
利伐沙班
非瓣膜性房颤
aged
rivaroxaban
non-valvular atrial fibrillation
