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一种预测接受直接口服抗凝剂(达比加群和利伐沙班)治疗的患者发生重大胃肠道出血风险的新模型。

A new model to predict the risk of major gastrointestinal bleeding in patients on direct oral anticoagulants (dabigatran and rivaroxaban).

作者信息

Lv Meina, Jiang Shaojun, Wu Tingting, Huang Nianxu, Chen Xia, Chen Chunmei, Zhang Jinhua

机构信息

Department of Pharmacy, Fujian Provincial Maternity and Children's Hospital, Affiliated Hospital of Fujian Medical University, Fujian, China.

Department of Pharmacy, Taikang Tongji (Wuhan) Hospital, Wuhan, China.

出版信息

Br J Clin Pharmacol. 2023 Jan;89(1):253-260. doi: 10.1111/bcp.15491. Epub 2022 Aug 22.

Abstract

AIMS

The aim of this study was to identify factors associated with gastrointestinal bleeding (GIB) in patients on direct oral anticoagulants (DOACs) and develop a risk score that would provide an effective tool for the clinical assessment of GIB.

METHODS

This was a multicentre retrospective analysis of clinical and follow-up data of patients treated with DOACs. The score was developed through logistic regression. The performance of score was evaluated using the area under the receiver operating characteristic curve (AUC), sensitivity, specificity and Hosmer-Lemeshow test.

RESULTS

The 11 903 patients had a mean age of 65.1 years. In multivariate analysis, age ≥65 years, alcohol use, history of peptic ulcer, history of major bleeding, abnormal liver function or renal function, cancer, platelet count <100 × 10 /L, anaemia, and concurrent antiplatelet agent or non-steroidal anti-inflammatory drug treatment were independent risk factors for GIB, and concurrent treatment with gastrointestinal protective agents were a protective factor. The Alfalfa-DOAC-GIB score was constructed using these 12 factors. The AUC of the Alfalfa-DOAC-GIB score was 0.77 (95% CI 0.74-0.81), which was higher than that of the HAS-BLED score (0.69; 95% CI 0.65-0.72) and the New score (0.65; 95% CI 0.61-0.68).

CONCLUSIONS

Based on 12 factors, we developed a gastrointestinal bleeding risk score. The newly developed Alfalfa-DOAC-GIB score has better predictive value than the HAS-BLED score and the New score, and might be an effective tool to help reduce the occurrence of GIB in patients using DOACs.

摘要

目的

本研究旨在确定接受直接口服抗凝剂(DOACs)治疗的患者发生胃肠道出血(GIB)的相关因素,并制定一个风险评分,为GIB的临床评估提供有效工具。

方法

这是一项对接受DOACs治疗患者的临床和随访数据进行的多中心回顾性分析。通过逻辑回归制定评分。使用受试者操作特征曲线下面积(AUC)、敏感性、特异性和Hosmer-Lemeshow检验评估评分的性能。

结果

11903例患者的平均年龄为65.1岁。多因素分析显示,年龄≥65岁、饮酒、消化性溃疡病史、大出血病史、肝功能或肾功能异常、癌症、血小板计数<100×10⁹/L、贫血以及同时使用抗血小板药物或非甾体抗炎药治疗是GIB的独立危险因素,而同时使用胃肠道保护剂是一个保护因素。利用这12个因素构建了苜蓿-DOAC-GIB评分。苜蓿-DOAC-GIB评分的AUC为0.77(95%CI 0.74-0.81),高于HAS-BLED评分(0.69;95%CI 0.65-0.72)和New评分(0.65;95%CI 0.61-0.68)。

结论

基于12个因素,我们制定了一个胃肠道出血风险评分。新制定的苜蓿-DOAC-GIB评分比HAS-BLED评分和New评分具有更好的预测价值,可能是帮助减少使用DOACs患者发生GIB的有效工具。

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