【作者】 王国栋；

【导师】 孔俭；

【作者基本信息】 吉林大学 ， 临床医学硕士（专业学位）， 2018， 硕士

【摘要】 目的:利伐沙班作为新一代的抗凝药物,因使用方便、疗效确切、安全性高、适应症不断增多,使得在各级基层医院中的应用越来越广泛。目前关于利伐沙班的国内外研究多聚焦正常年龄段人群,针对于老年患者使用利伐沙班的相关研究少见。老年患者生理功能较为特殊,以及目前有部分研究表明老年患者使用抗凝药物出血风险增加,为明确老年患者使用利伐沙班安全性,了解真实调研结果,进行此项研究。研究方法:本研究为回顾性研究。本文对吉林大学第一医院老年干部科2015年9月至2017年12月使用利伐沙班,年龄大于等于65岁的老年患者进行回顾性研究。分别采集患者的年龄,性别,每日用药剂量,利伐沙班治疗目的,首次出血发生时间,出血类型。分析患者不同年龄,不同性别,不同用药剂量,不同利伐沙班治疗目的与出血发生率之间的关系。收集出血患者口服利伐沙班期间首次出血时间。将数据与国内外利伐沙班临床试验结果进行对比。数据资料采用统计软件SPSS22.0进行统计学分析,P<0.05有统计学意义。研究结果:本回顾性研究共统计使用利伐沙班的老年患者608例,排除其中在抗凝过程中使用其他抗凝药物、不规律使用利伐沙班、病史资料不全117例患者,共入组患者491例。其中男性患者有183例,占总人数的37.3%,女性患者308例,占总人数的62.7%。平均年龄为76.01±5.54岁。最大年龄为89岁,最小年龄65岁。在所有使用利伐沙班治疗的老年患者中,出血人数63人,总出血发生率为12.83%。患者不同每日口服剂量出血率情况:每日口服利伐沙班剂量5mg出血率为0%;每日剂量10mg,出血率为11.60%;每日剂量为15mg,出血率为14.11%;每日剂量20mg,出血率为75.0%,差异有统计学意义,P值小于0.01。患者不同年龄段出血发生率情况:65-70岁出血率为6.82%,71-75岁出血率为13.95%,76-80岁出血率为15.15%,81-85岁出血率为15.31%,86岁及以上出血率为15.38%。但各组出血率差异无统计学意义,P值大于0.05。在所有出血类型中,皮肤出血发生率为5.07%,占所有出血类型的44.44%;黏膜出血发生率为4.07%,占所有出血类型的31.75%;消化道出血发生率为3.05%,占所有出血类型的23.81%;未见致死性和导致需要输血纠正的大出血发生。在所有口服利伐沙班出血的老年患者中,53.97%的患者首次出血发生在口服利伐沙班的1个月以内,26.98%患者首次出血发生在1-2个月,12.70%的患者首次出血发生在2-3个月,仅有6.35%的患者发生在口服利伐沙班3个月以后。不同利伐沙班适应征出血发生率不同:AF血栓预防组出血率为16.22%;PE治疗组出血率为14.29%;DVT治疗组出血率为6.94%;VTE预防组组出血率为15.87%,不同组别出血发生率差异有统计学意义,P值小于0.05。本回顾性研究中,男性老年患者口服利伐沙班后出血率为10.93%,女性老年患者口服利伐沙班后出血率为13.96%,男女患者出血发生率差异无统计学意义,P值大于0.05。结论:本次回顾性分析表明:1.随着每日用药量的增加,老年患者的出血发生率明显增加,10mg每日剂量对老年患者可能比较安全。2.所有利伐沙班使用患者中,女性所占的比例高于男性。3.老年患者服用利伐沙班的第1个月可能是出血高风险期。4.不同利伐沙班治疗组,出血风险不同。AF血栓预防组出血发生率可能最高。更多还原

【Abstract】 Objective:As a new generation of anticoagulant,rivaroxaban has been widely used in basic hospital for its convient,curative effect,increased indications.Current studies on rivaroxaban at home and abroad are more focused on the population of all age groups less on elderly patients.For the special physiological structure of elderly patients and some current studies have shown that the risk of bleeding for elderly patients after oral anticoagulant therapy is increased.So we carry out this study to investigate the real clinical results and safety for elderly patients after oral anticoagulant therapy.Method:This study is a retrospective research.This article is a retrospective study for the elderly patients in the No.1 Hospital of Jilin University cadre ward from September2015 to December 2017 using rivaroxaban,whose age is equal or more than 65 years old.The age,sex,daily dose,the purpose of rivaroxaban treatment,the first time of bleeding and the type of bleeding were collected.The relationship between age,sex,dosage,different purpose of rivaroxaban treatment and the rate bleeding are analysed.What’s more,the data are compared with the results of the domestic and foreign rivaroxaban clinical trials and analysed by statistical software SPSS22.0.P <0.05 means statistical sense.Result:608 cases of elderly patients with rivaroxaban were retrospective analysed.117 patients were excluded because of irregular use of rivaroxaban,incomplete medical history and usage of other anticoagulant besides of rivaroxaban.Among the 491 recruited patient,183 cases of male patients account for 37.3% of the total and 308 cases of male patients account for 62.7%.The average age is 76.01± 5.54 years old.The maximum age is 89 years,the minimum age is 65.Among all patients treated with rivaroxaban,the number of hemorrhage patients is 63 and the total hemorrhage rate is 12.83%.The bleeding rate of Patients who take daily dose of 5mg is 0%,while10 mg is 11.60%,15 mg is 14.11%,20 mg is 75.0%.The difference have statistical sense.(P<0.01).The incidence of bleeding in different age groups:the rate of 65-70 year old group is 6.82% as well as 71-75 group is 13.95%,76-80 group is15.15%,81-85 group is 15.31% and more than 86 group is 15.38%.The difference have no statistical sense(P>0.05).In all types of bleeding,The incidence of dermorrhagia is 5.07%,accounting for 44.44% of all types of bleeding in the meanwhile the rate of mucosa bleeding is 4.07%,accounting for 31.75% and the rate of hemorrhage of digestive tract is 3.05%,accounting for 23.81%.There is no massive haemorrhage which cause the death of patients or require blood transfusions in our survey.The first bleeding of 53.97% of the bleeding patients occured within 1 months during period of taking rivaroxaban as well first bleeding of 26.98% of the patients occured within 1-2 months 12.70%of first bleeding happened within 2-3 months and only 6.35% of first bleeding occured more than 3 months.The bleeding rates of different treatment group are different: the rate of AF group is 16.22%,the rate of PE group is 14.29%,the rate of DVT group is 6.94%,the rate of VTE group is 15.87%.The difference have statistical sense.(P<0.05).In this retrospective study,the bleeding rate of male elderly patients is 10.93%,and the rate of female elderly patients is13.96%.There was no difference in bleeding risk between male and female patients(P>0.05).Conclusion :The following is found in the larger series of investigation: 1.With the increase of daily dose,the risk of bleeding in patients taking rivaroxaban increased significantly.10 mg per day may be safety.2.The proportion of women is higher than that of men among people who take rivaroxaban.3.The first months for elderlypatients who taking rivaroxaban may be a high risk period for bleeding.4.Different purpose of rivaroxaban treatment may have different bleeding rates: the incidence of hemorrhage for AF group is the highest.更多还原