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利伐沙班与低分子量肝素在中国非高危肺栓塞肺癌患者中的疗效与安全性比较。

Comparison of the efficacy and safety of rivaroxaban and low-molecular-weight heparin in Chinese lung cancer patients with nonhigh-risk pulmonary embolism.

作者信息

Song Yijun, Yang Dawei, Hou Dongni, She Jun, Song Yuanlin

机构信息

Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, China.

Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, China.

出版信息

Thromb J. 2023 Feb 2;21(1):16. doi: 10.1186/s12959-023-00453-y.

Abstract

BACKGROUND

Data that guide selection of differing anticoagulant regimens for specific cancer-associated venous thromboembolism (VTE) are lacking. We aimed to compare the efficacy and safety of rivaroxaban and low-molecular-weight heparin (LMWH) against nonhigh-risk pulmonary embolism (PE) in Chinese lung cancer patients.

METHODS

Four hundred forty-six Chinese lung cancer patients with nonhigh-risk PE who initiated treatment with rivaroxaban or LMWH were identified from Zhongshan Hospital database from 2016 to 2020. The primary outcomes were the composite event of VTE recurrence or major bleeding, and all-cause mortality. The secondary outcomes were VTE recurrence, major bleeding and clinically relevant non-major bleeding (CRNMB). Propensity score matching was used to balance baseline covariates. We conducted sensitivity analysis by stabilized inverse probability of treatment weighting and competing risk analysis by a Fine and Gray subdistribution hazard model.

RESULTS

In propensity score-matched cohorts, rivaroxaban was similar to LMWH in the risks of the composite outcome (hazard ratio (HR), 0.73; 95% confidence interval (CI), 0.45-1.21; P = 0.22), VTE recurrence (HR, 0.69; 95% CI, 0.36-1.34; P = 0.28), major bleeding (HR, 0.79; 95% CI, 0.37-1.68; P = 0.54) and CRNMB (HR, 1.13; 95% CI, 0.62-2.09; P = 0.69). All-cause mortality was significantly lower in rivaroxaban group than LMWH group (HR, 0.52; 95% CI, 0.36-0.75; P < 0.001). The primary and secondary outcomes favored rivaroxaban over LMWH in all the subgroups expect for central PE and intermediate-risk PE. The sensitivity analysis yielded similar results, and competing risk analysis was in accordance with the primary findings.

CONCLUSIONS

Rivaroxaban might be a promising alternative to LMWH as initial treatment for nonhigh-risk PE in lung cancer patients.

摘要

背景

缺乏指导为特定癌症相关静脉血栓栓塞症(VTE)选择不同抗凝方案的数据。我们旨在比较利伐沙班与低分子肝素(LMWH)在中国肺癌患者中治疗非高危肺栓塞(PE)的疗效和安全性。

方法

从中山医院2016年至2020年的数据库中,确定446例开始使用利伐沙班或LMWH治疗的中国非高危PE肺癌患者。主要结局为VTE复发或大出血及全因死亡的复合事件。次要结局为VTE复发、大出血和临床相关非大出血(CRNMB)。采用倾向评分匹配法平衡基线协变量。我们通过稳定的逆概率治疗加权进行敏感性分析,并通过Fine和Gray亚分布风险模型进行竞争风险分析。

结果

在倾向评分匹配队列中,利伐沙班在复合结局风险(风险比(HR),0.73;95%置信区间(CI),0.45 - 1.21;P = 0.22)、VTE复发(HR,0.69;95% CI,0.36 - 1.34;P = 0.28)、大出血(HR,0.79;95% CI,0.37 - 1.68;P = 0.54)和CRNMB(HR,1.13;95% CI,0.62 - 2.09;P = 0.69)方面与LMWH相似。利伐沙班组的全因死亡率显著低于LMWH组(HR,0.52;95% CI,0.36 - 0.75;P < 0.001)。除中心型PE和中危PE外,在所有亚组中,主要和次要结局均显示利伐沙班优于LMWH。敏感性分析得出相似结果,竞争风险分析与主要发现一致。

结论

利伐沙班可能是LMWH的一种有前景的替代药物,可作为肺癌患者非高危PE的初始治疗药物。

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