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低分子量肝素在合并肾功能不全的急性肺栓塞中的剂量及预后:一项大型真实世界研究的分析

LMWHs dosage and outcomes in acute pulmonary embolism with renal insufficiency, an analysis from a large real-world study.

作者信息

Wang Dingyi, Fan Guohui, Lei Jieping, Yang Yuanhua, Xu Xiaomao, Ji Yingqun, Yi Qun, Chen Hong, Hu Xiaoyun, Liu Zhihong, Mao Yimin, Zhang Jie, Shi Juhong, Zhang Zhu, Wu Sinan, Tao Xincao, Xie Wanmu, Wan Jun, Zhang Yunxia, Zhang Shuai, Zhen Kaiyuan, Zhang Zhonghe, Fang Baomin, Wang Chen, Zhai Zhenguo

机构信息

Institute of Clinical Medical Sciences, National Center for Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China.

Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Beijing, China.

出版信息

Thromb J. 2022 May 5;20(1):26. doi: 10.1186/s12959-022-00385-z.

Abstract

BACKGROUND

Renal function is associated with prognoses for acute pulmonary embolism (PE).

OBJECTIVE

To investigate the application of anticoagulants and dosage of LMWH among patients with renal insufficiency (RI), and the association between LWMH dosage and the patients' in-hospital outcomes.

METHODS

Adult patients diagnosed with non-high risk acute PE from 2009 to 2015, with available data of creatinine clearance (CCr) were enrolled from a multicenter registry in China. Renal insufficiency (RI) was defined as CCr < 60 ml/min. LMWH dosage was converted into IU/kg daily dose and presented as adjusted dose (≤ 100 IU/kg/day) and conventional dose (> 100 IU/kg/day). All-cause death, PE-related death and bleeding events during hospitalization were analyzed as endpoints.

RESULTS

Among the enrolled 5870 patients, RI occurred in 1311 (22.3%). 30 ≤ CCr < 60 ml/min was associated with higher rate of bleeding events and CCr < 30 ml/min was associated with all-cause death, PE-related death and major bleeding. Adjusted-dose LMWH was applied in 26.1% of patients with 30 ≤ CCr < 60 ml/min and in 26.2% of CCr < 30 ml/min patients. Among patients with RI, in-hospital bleeding occurred more frequently in those who were administered conventional dose of LMWH, compared with adjusted dose (9.2% vs 5.0%, p = 0.047). Adjusted dose of LMWH presented as protective factor for in-hospital bleeding (OR 0.62, 95%CI 0.27-1.00, p = 0.0496) and the risk of bleeding increased as length of hospital stay prolonged (OR 1.03, 95%CI 1.01-1.06, p = 0.0014).

CONCLUSIONS

The proportion of adjusted usage of LMWH was low. The application of adjusted-dose LMWH was associated with lower risk of in-hospital bleeding for RI patients, in real-world setting of PE treatment. Anticoagulation strategy for RI patients should be paid more attention and requires evidence of high quality.

TRIAL REGISTRATION

The CURES was registered in ClinicalTrias.gov, identifier number: NCT02943343 .

摘要

背景

肾功能与急性肺栓塞(PE)的预后相关。

目的

探讨抗凝剂在肾功能不全(RI)患者中的应用及低分子肝素(LMWH)的剂量,以及LMWH剂量与患者住院结局之间的关联。

方法

从中国一个多中心登记处纳入2009年至2015年诊断为非高危急性PE且有肌酐清除率(CCr)可用数据的成年患者。肾功能不全(RI)定义为CCr<60 ml/分钟。LMWH剂量换算为每日国际单位/千克剂量,并表示为调整剂量(≤100国际单位/千克/天)和常规剂量(>100国际单位/千克/天)。将住院期间的全因死亡、PE相关死亡和出血事件作为终点进行分析。

结果

在纳入的5870例患者中,1311例(22.3%)发生RI。30≤CCr<60 ml/分钟与出血事件发生率较高相关,CCr<30 ml/分钟与全因死亡、PE相关死亡和大出血相关。38.1%的30≤CCr<60 ml/分钟患者和38.2%的CCr<30 ml/分钟患者应用了调整剂量的LMWH。在RI患者中,与调整剂量相比,接受常规剂量LMWH治疗的患者住院期间出血更频繁(9.2%对5.0%,p = 0.047)。调整剂量的LMWH是住院出血的保护因素(OR 0.62,95%CI 0.27 - 1.00,p = 0.04),且出血风险随着住院时间延长而增加(OR 1.03,95%CI 1.01 - 1.06,p = 0.0014)。

结论

LMWH调整使用的比例较低。在PE治疗的实际临床环境中,调整剂量的LMWH应用与RI患者较低的住院出血风险相关。RI患者的抗凝策略应得到更多关注,且需要高质量的证据。

试验注册

CURES在ClinicalTrials.gov注册,标识符编号:NCT02943343 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5bd/9074331/de896f715731/12959_2022_385_Fig1_HTML.jpg

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