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癌症门诊患者化疗相关血栓栓塞风险及那屈肝素预防性治疗的效果:PROTECHT 研究的回顾性分析结果。

Chemotherapy-associated thromboembolic risk in cancer outpatients and effect of nadroparin thromboprophylaxis: results of a retrospective analysis of the PROTECHT study.

机构信息

Oncology Department, San Filippo Neri Hospital, via Martinotti 20, Rome, 00135, Italy.

出版信息

J Transl Med. 2011 Oct 20;9:179. doi: 10.1186/1479-5876-9-179.

DOI:10.1186/1479-5876-9-179
PMID:22013950
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3220644/
Abstract

BACKGROUND

Cancer patients receiving chemotherapy are at increased risk of thrombosis. Nadroparin has been demonstrated to reduce the incidence of venous and arterial thrombotic events (TEs) by about 50% in cancer outpatients receiving chemotherapy. The aims of this retrospective analysis were to evaluate the thromboembolic risk and the benefit of thromboprophylaxis according to type of chemotherapy.

METHODS

Cancer outpatients were randomly assigned to receive subcutaneous injections of nadroparin or placebo. The incidence of symptomatic TEs was assessed according to the type of chemotherapy. Results were reported as risk ratios with associated 95% CI and two-tailed probability values.

RESULTS

769 and 381 patients have been evaluated in the nadroparin and placebo group, respectively. In the absence of thromboprophylaxis, the highest rate of TEs was found in patients receiving gemcitabine- (8.1%) or cisplatin-based chemotherapy (7.0%). The combination of gemcitabine and cisplatin or carboplatin increased the risk to 10.2%. Thromboprophylaxis reduced TE risk by 68% in patients receiving gemcitabine; with a further decrease to 78% in those receiving a combination of gemcitabine and platinum.

CONCLUSIONS

This retrospective analysis confirms that patients undergoing chemotherapy including gemcitabine, platinum analogues or their combination are at higher risk of TEs. Our results also suggest that outpatients receiving chemotherapy regimens including these agents might achieve an increased benefit from thromboprophylaxis with nadroparin.

CLINICAL TRIAL REGISTRATION NUMBER

NCT 00951574.

摘要

背景

接受化疗的癌症患者发生血栓的风险增加。那屈肝素已被证明可使接受化疗的门诊癌症患者静脉和动脉血栓事件(TE)的发生率降低约 50%。本回顾性分析的目的是评估根据化疗类型血栓栓塞风险和血栓预防的获益。

方法

癌症门诊患者随机接受那屈肝素或安慰剂皮下注射。根据化疗类型评估症状性 TE 的发生率。结果以风险比(RR)及相关 95%置信区间(CI)和双侧概率值报告。

结果

分别有 769 例和 381 例患者纳入那屈肝素组和安慰剂组。未进行血栓预防时,接受吉西他滨-(8.1%)或顺铂为基础的化疗患者(7.0%)TE 发生率最高。吉西他滨联合顺铂或卡铂增加至 10.2%。接受吉西他滨治疗的患者中,血栓预防可降低 TE 风险 68%;而接受吉西他滨联合铂类治疗的患者中,该风险进一步降低至 78%。

结论

本回顾性分析证实,接受包含吉西他滨、铂类类似物或其联合化疗的患者发生 TE 的风险更高。我们的结果还提示,接受包含这些药物的化疗方案的门诊患者可能会从那屈肝素预防血栓中获得更大获益。

临床试验注册号

NCT 00951574。

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本文引用的文献

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High incidence of thromboembolic events in patients treated with cisplatin-based chemotherapy: a large retrospective analysis.顺铂类化疗治疗患者血栓栓塞事件发生率高:一项大型回顾性分析。
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A step in the right direction, but one size might not fit all.朝着正确方向迈出了一步,但一刀切可能并不适用于所有人。
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Lancet Oncol. 2009 Oct;10(10):943-9. doi: 10.1016/S1470-2045(09)70232-3. Epub 2009 Aug 31.
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Thrombotic events in patients with cancer receiving antiangiogenesis agents.接受抗血管生成药物治疗的癌症患者中的血栓形成事件。
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Thromboembolism in patients with advanced gastroesophageal cancer treated with anthracycline, platinum, and fluoropyrimidine combination chemotherapy: a report from the UK National Cancer Research Institute Upper Gastrointestinal Clinical Studies Group.蒽环类药物、铂类和氟嘧啶联合化疗治疗晚期食管癌患者的血栓栓塞:英国国家癌症研究所上消化道临床研究组的报告
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Gemcitabine: vascular toxicity and prothrombotic potential.吉西他滨:血管毒性和促血栓形成潜力。
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Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656.