不同剂量利伐沙班用于左心室心尖部血栓治疗的临床效果及安全性比较

Comparison of the efficacy and safety of the different doses of rivaroxaban in treatment of left ventricular apical thrombus

目的：探讨不同剂量利伐沙班用于左心室心尖部血栓治疗的临床效果及安全性。方法87例左心室心尖部血栓患者按数字表法随机分为华法林组（n ＝21）、利伐沙班1组（n ＝22）、利伐沙班2组（n ＝21）和利伐沙班3组（n ＝23），华法林组患者初始给予华法林2．5 mg，1次／d，根据国际标准化比值（INR）对华法林剂量进行调整；利伐沙班1组患者给予利伐沙班10 mg 口服，1次／d；利伐沙班2组给予利伐沙班20 mg口服，1次／d；利伐沙班3组初始给予利伐沙班15 mg 口服，2次／d，持续服用21 d，后改为20 mg 口服，1次／d。四组患者连续随访观察3个月，记录四组患者服药3 d 时 D-二聚体下降百分比、D-二聚体正常时间、左心室心尖部血栓消失时间、消失例数、INR 达标情况，记录四组患者血栓栓塞事件和出血事件发生情况。结果利伐沙班1组、利伐沙班2组和利伐沙班3组患者服药3 d 时 D-二聚体下降百分比均高于华法林组，且利伐沙班3组均高于利伐沙班1组和利伐沙班2组，利伐沙班1组、利伐沙班2组和利伐沙班3组患者 D-二聚体正常时间和血栓消失时间均低于华法林组，且利伐沙班3组均低于利伐沙班1组和利伐沙班2组，差异均有统计学意义（F ＝8．443、19．319、35．475，均 P ＜0．05）；利伐沙班3组患者 INR 达标例数高于华法林组，差异有统计学意义[18例（78．3％）比9例（42．9％），χ2＝5．803，P ＜0．05]；利伐沙班1组和利伐沙班3组各出现1例轻微出血，利伐沙班1组、利伐沙班2组和利伐沙班3组患者血栓栓塞事件和出血事件发生率均低于华法林组，但差异均无统计学意义（χ2＝0．732、2．357，均 P ＞0．05）。结论利伐沙班用于左室心尖部血栓治疗安全有效，且不增加栓塞和出血事件发生，且初始给予利伐沙班15 mg 口服（2次／d），持续服用21 d，后改为20 mg口服（1次／d）的治疗方案效果更佳。

Objective To investigate the clinical efficacy and safety analysis on the different doses of rivaroxaban in treatment of left ventricular apical thrombus.Methods 87 patients with left ventricular apical thrombus were randomly divided into warfarin group （n =21 ）,rivaroxaban 1 group （n =22）,rivaroxaban 2 group （n =21 ）and rivaroxaban 3 group（n =23）.Patients in the warfarin group were given the doses of warfarin 2.5mg once daily,and the doses were adjusted according to INR.Patients in the rivaroxaban 1 group were given the doses of rivaroxaban 10mg once daily.Patients in the rivaroxaban 2 group were given the doses of rivaroxaban 20mg once daily.Patients in the rivaroxaban 3 group were given the doses of rivaroxaban 15mg twice daily for 21d,then followed by 20mg once daily. Patients in the four groups were followed up for 3 months.The percent reduction of D -dimmer at taking drug 3d,D -dimmer normal time,left ventricular apical thrombus disappearing time,the number of disappearance and INR compliance rate were recorded.The occurrences of thromboembolic events and bleeding events in the four groups were recorded. Results The percent reduction of D -dimmer at taking drug 3d in the rivaroxaban 1 group,rivaroxaban 2 group and rivaroxaban 3 group were higher than the warfarin group,and the rivaroxaban 3 group were higher than the rivaroxaban 1 group and rivaroxaban 2 group,the D -dimmer normal time and thrombus disappearing time in the rivaroxaban 1 group,rivaroxaban 2 group and rivaroxaban 3 group were lower than the warfarin group,and the rivaroxaban 3 group were lower than the rivaroxaban 1 group and rivaroxaban 2 group,the differences were statistically significant（F =8.443,19.319,35.475,all P 〈0.05）.The numbers of INR compliance in the rivaroxaban 3 group were higher than those in the warfarin group,the differences were statistically significant[18cases（78.3%）vs.9cases（42.9%）,χ2 =5.803,P 〈0.05].There was 1 case of patient appeared minor bleeding in each rivaroxaban 1 group and rivaroxaban 3 group.The occurrence rates of thromboembolic events and bleeding events in the rivaroxaban 1 group,rivaroxaban 2 group and rivaroxaban 3 group were lower than those in the warfarin group,but the differences were not statistically significant（χ2 =0.732,2.357,all P 〉0.05）.Conclusion Rivaroxaban applied to treatment of left ventricular apical thrombus was safe and effective,and without increasing embolism and bleeding events.And treatment plan of the doses of rivaroxaban 15mg twice daily for 21d,then followed by 20mg once daily was superior.