马睿,任静,王者香,门剑龙.用凝血酶原时间监测利伐沙班安全性[J].临床检验杂志,2019,(9):666-670
用凝血酶原时间监测利伐沙班安全性
Study on safety monitoring of rivaroxaban by prothrombin time
投稿时间:2019-07-05  
DOI:
中文关键词:  凝血酶原时间  利伐沙班  出血
英文关键词:prothrombin time  rivaroxaban  bleeding
基金项目:国家重点研发计划,精准医学研究专项(2016YFC0905600-2016YFC0905601);天津市自然科学基金(16JCYBJC17800)
作者单位
马睿 天津医科大学总医院精准医学中心天津300052 
任静 天津医科大学总医院精准医学中心天津300052 
王者香 天津医科大学检验学院天津 300203 
门剑龙 天津医科大学总医院精准医学中心天津300052 
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中文摘要:
      摘要:目的:研究凝血酶原时间(PT)在监测利伐沙班安全性中的作用。方法:选择2018年5月至2019年2月天津医科大学总医院血栓疾病患者105例并随访,23例发生出血患者为出血组,其他82例为无出血组。用IL ACL TOP 700型血液凝固仪及其配套试剂检测PT,数据以M(P25,P75)表示,两组间数据比对采用Mann-Whitney U检验,多组间数据比对采用Kruskal-Wallis H检验。用ROC曲线评价PT的诊断性能。结果:出血组患者用药后第1、3天,峰值PT均高于当天谷值水平;第3天无论峰值PT还是谷值均高于第1天。无出血组患者与出血组患者第1天峰值PT差异无统计学意义(P>0.05),而出血组谷值PT高于无出血组(P<0.001);第3天出血组峰值和谷值PT水平均高于无出血组(P<0.001)。用药后第1、3天谷值PT预测出血风险的诊断性能均优于峰值PT,而第1天和第3天谷值PT预测出血事件的效果相近。就评估出血风险而言,谷值PT优于峰值PT,第3天优于第1天。结论:PT在进行充分性能验证后,可有效评估利伐沙班的出血风险,为临床合理用药提供可靠依据。
英文摘要:
      Abstract: Objective: To investigate the safety of rivaroxaban by detecting prothrombin time (PT). Methods: 105 patients with thrombosis from May 2018 to February 2019 in Tianjin Medical University General Hospital were selected and followed up. 23 patients with hemorrhage were in the bleeding group and 82 others were in the non-bleeding group. PT was detected by IL ACL TOP 700 blood coagulation instrument and its supporting reagents. Data were expressed as M(P25,P75). Mann-Whitney U test was used for data comparison between the bleeding and non-bleeding groups. Kruskal-Wallis H test was used for age data comparison among multiple groups. The diagnostic performance of PT was evaluated by a receiver operating characteristic curve (ROC). Results: In the bleeding group, PT changed significantly between before and after treatment of rivaroxaban. On the 1st and 3rd days after treatment, PT peak was significantly higher than the day′s trough level, and on the 3rd day, both the peak value and the trough value were all significantly higher than the levels on the 1st day. There was no significant difference in peak PT between the patients in the non-bleeding group and the bleeding group on the 1st day (P>0.05), while the trough PT level in the bleeding group was significantly higher than that in the non-bleeding group (P<0.001). On the 3rd day, the levels of peak and trough PT in the bleeding group were significantly higher than those in non-bleeding (P<0.001). The diagnostic performance of the trough PT predicting bleeding risk on the day 1 and 3 after treatment was superior to the peak PT level, while the effects of the trough PT predicted on the 1st was similar to the 3rd days. In terms of assessing the risk of bleeding, the trough PT level should be superior to the peak PT, and the 3rd day should be better than the 1st day. Conclusion: PT could effectively evaluate the bleeding risk of rivaroxaban after sufficient performance verification, and provide a reliable basis for clinical rational use for drug.
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