马睿,任静,王者香,门剑龙.利用凝血酶原时间监测利伐沙班安全性的研究[J].临床检验杂志,2019,(9):666-670
利用凝血酶原时间监测利伐沙班安全性的研究
Study on the monitoring with safety of rivaroxaban by prothrombin time
投稿时间:2019-07-05  修订日期:2019-10-03
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E-mail
马睿 天津医科大学总医院 13820777370@163.com 
任静 天津医科大学总医院  
王者香 天津医科大学  
门剑龙 天津医科大学总医院 thromhaemo@126.com 
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中文摘要:
      目的 研究凝血酶原时间(PT)监测利伐沙班安全性。方法 用IL ACL TOP 700型血液凝固仪及其配套试剂进行PT检测。数据以M(P25~P75)表示,两组间数据比对采用Mann-Whitney U检验,多组间年龄数据比对采用Kruskal-Wallis H检验,P<0.05为差异有统计学意义。采用受试者工作特征曲线(ROC)评价PT的诊断性能。结果 出血组患者在用药前后PT变化显著,在给药后的第1、3天,峰值PT均显著高于当天的谷值水平;而且到第3天时,无论峰值还是谷值均显著高于第1天的水平。无出血组患者与出血组患者在第1天的峰值PT无显著差异(P>0.05),而出血组的谷值PT显著高于无出血组(P<0.001);在第3天时,出血组的峰值和谷值PT水平均显著高于无出血组(P<0.001)。用药后第1、3天的谷值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天的谷值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:
      Objective To investigate the safety of rivaroxaban by using prothrombin time (PT). Methods 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 two groups. Kruskal-Wallis H test was used for age data comparison between multiple groups. P<0.05 was considered statistically significant. The diagnostic performance of PT was evaluated by a receiver operating characteristic curve (ROC). Results In the bleeding group, the PT changes significantly between before and after treatment groups. On the 1st and 3rd days after treatment, the peak PT was significantly higher than the day"s trough level; and on the 3rd day, the peak value and the trough value were significantly higher than the 1st day’s level. 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 in the bleeding group was significantly higher than that in the non-bleeding group (P<0.001). On the 3rd day, the bleeding group the peak and trough PT levels were significantly higher than those without bleeding (P < 0.001). The diagnostic performance of the trough PT predicting bleeding risk on days 1 and 3 after treatment was superior to the peak PT, while the effect of the trough PT predicted on the 1st and 3rd days was similar. In terms of assessing the risk of bleeding, the trough PT is superior to the peak PT, and the 3rd day is better than the 1st day. Conclusion PT can effectively evaluate the bleeding risk of rivaroxaban after sufficient performance verification, and provide a reliable basis for clinical rational drug use.
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