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癌症相关静脉血栓栓塞症患者继续低分子肝素治疗:一项日常临床实践中的前瞻性队列研究。

Continuation of low-molecular-weight heparin treatment for cancer-related venous thromboembolism: a prospective cohort study in daily clinical practice.

机构信息

Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.

Respiratory Department, Ramon y Cajal Hospital IRYCIS, Seville, Spain.

出版信息

J Thromb Haemost. 2017 Jan;15(1):74-79. doi: 10.1111/jth.13563. Epub 2016 Dec 24.

Abstract

UNLABELLED

Essentials Low-molecular-weight heparin (LMWH) injections for venous thromboembolism (VTE) may be burdensome. Patients with active cancer and confirmed VTE were included to evaluate LMWH continuation. The cumulative incidence of discontinuation was 21% after a median period of 90 days. One out of five patients discontinued LMWH injections because of side effects.

SUMMARY

Background Current guidelines recommend low-molecular-weight heparin (LMWH) monotherapy for 3-6 months as the first-line treatment for cancer-associated venous thromboembolism (VTE). However, although daily administration of LMWH injections over a course of several months may be burdensome, the number of patients who stop treatment because of LMWH side-effects is unknown. Objectives To evaluate the continuation rate and complications of daily LMWH injections in patients with cancer-associated VTE. Methods Consecutive patients with active cancer and objectively confirmed symptomatic proximal deep vein thrombosis and/or pulmonary embolism, treated at three Dutch hospitals and one Spanish hospital, were included to evaluate continuation LMWH therapy during LMWH treatment. Patients were excluded when they received other anticoagulants, were lost to follow-up, or experienced a venous catheter-associated thrombosis. Results A total of 372 patients were analyzed during LMWH treatment for a maximum of 180 days. The cumulative incidence of discontinuation was 21% (95% confidence interval [CI] 17-25) after a median period of 90 days (interquartile range 60-120 days). Only female sex was found to be significantly associated with premature LMWH discontinuation (odds ratio 1.6; 95% CI 1.03-2.5). Thirty patients (8.1%) developed recurrent VTE, 30 patients (8.3%) suffered a major bleed, and 106 patients (28%) died. Conclusion Our study reveals that one of five patients with cancer-associated VTE stopped LMWH injections because of side-effects. This finding provides relevant background information for current clinical trials investigating the efficacy and safety of direct oral anticoagulants as compared with LMWH.

摘要

目的

目前指南建议低分子肝素(LMWH)单药治疗 3-6 个月作为癌症相关静脉血栓栓塞症(VTE)的一线治疗方法。然而,尽管在几个月的时间内每天给予 LMWH 注射可能会带来负担,但因 LMWH 副作用而停止治疗的患者人数尚不清楚。

方法

连续纳入在荷兰的 3 家医院和西班牙的 1 家医院治疗的活动性癌症且客观证实有症状的近端深静脉血栓形成和/或肺栓塞的患者,以评估在 LMWH 治疗期间继续 LMWH 治疗的患者。当患者接受其他抗凝剂、失访或发生静脉导管相关血栓形成时,则排除这些患者。

结果

在 LMWH 治疗期间,最多有 180 天的时间内对 372 例患者进行了分析。在中位数为 90 天(四分位距 60-120 天)后,停药的累积发生率为 21%(95%置信区间 [CI] 17-25)。仅发现女性性别与 LMWH 过早停药显著相关(优势比 1.6;95%CI 1.03-2.5)。30 例(8.1%)患者发生复发性 VTE,30 例(8.3%)患者发生大出血,106 例(28%)患者死亡。

结论

我们的研究表明,五分之一的癌症相关 VTE 患者因副作用而停止 LMWH 注射。这一发现为目前正在进行的比较直接口服抗凝剂与 LMWH 的疗效和安全性的临床试验提供了相关的背景信息。

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