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一项关于使用芦曲泊帕预防血小板计数低的肝细胞癌患者行射频消融术时出血并发症的研究:前瞻性观察研究。

A study on prevention of bleeding complications using lusutrombopag for safe RFA in patients with hepatocellular carcinoma with low platelet counts: prospective observational study.

机构信息

Dept. of Gastroenterology and Hepatology, Japanese Red Cross Medical Center, Tokyo, Japan.

Division of Gastroenterological Medicine, Mitsui Memorial Hospital, Tokyo, Japan.

出版信息

BMC Gastroenterol. 2023 Jul 24;23(1):250. doi: 10.1186/s12876-023-02879-0.

DOI:10.1186/s12876-023-02879-0
PMID:37488476
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10364390/
Abstract

BACKGROUND

Platelet (PLT) transfusion was the most practical way to increase patients' PLT counts before invasive hepatic procedures such as radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC). A novel drug that raises the PLT count by acting on the thrombopoietin receptor has recently become available.

METHODS

Lusutrombopag 3 mg was administered daily for 7 days to patients who underwent RFA for liver tumors with low PLT counts (< 50,000 PLT µL). We collected demographic data concerning the patients' liver function and PLT counts.

RESULTS

Lusutrombopag was administered to 91 patients, with a median age of 71 years (range 51-86). Forty-two patients had hepatitis C, 12 had hepatitis B, 21 had alcoholic liver disease, 11 had nonalcoholic steatohepatitis, and five had other diseases. The median Child-Pugh score was 7 (range 5-11). Thirty-seven patients had stage I tumors, 41 had Stage II, 12 had stage III, and one had stage IV. PLT count was elevated from 4.4 × 10 ± 1.4 × 10 to 8.6 × 10 ± 2.5 × 10 PLT µL. Lusutrombopag administration prevented PLT transfusions in 84/91 patients (92%). No patient had bleeding complications after RFA. One had portal thrombosis after lusutrombopag administration. Patients who achieved PLT counts of > 50,000 PLT µL had higher PLT counts before lusutrombopag administration. The degree of splenomegaly did not affect the rate of PLT count elevation. There was no specific adverse effect by administrating lusutrombopag for patients with PLT counts of around 50,000 µL but > 50,000 µL.

CONCLUSIONS

Lusutrombopag administration before RFA was effective and seemed to be relatively safe for hepatocellular carcinoma patients with low PLT counts.

TRIAL REGISTRATION

This study was approved by Japanese Red Cross Medical Center Institutional Reseach Comittie (#862, 07/03/2016), and was registered in a publically accessible primary register (#UMIN000046629, registered date: 14/01/2022).

摘要

背景

在进行侵入性肝脏手术(如肝癌的射频消融术)之前,血小板(PLT)输注是增加患者 PLT 计数的最实用方法。一种通过作用于血小板生成素受体来提高 PLT 计数的新型药物最近已上市。

方法

对 PLT 计数较低(<50,000 PLT/μL)的肝癌患者,在进行射频消融术(RFA)前,每日给予芦曲泊帕 3mg,连续 7 天。我们收集了有关患者肝功能和 PLT 计数的人口统计学数据。

结果

共对 91 例患者给予了芦曲泊帕治疗,中位年龄为 71 岁(范围 51-86)。42 例患者患有丙型肝炎,12 例患者患有乙型肝炎,21 例患者患有酒精性肝病,11 例患者患有非酒精性脂肪性肝炎,5 例患者患有其他疾病。中位 Child-Pugh 评分为 7 分(范围 5-11)。37 例患者为Ⅰ期肿瘤,41 例患者为Ⅱ期,12 例患者为Ⅲ期,1 例患者为Ⅳ期。PLT 计数从 4.4×10±1.4×10至 8.6×10±2.5×10 PLT/μL升高。芦曲泊帕治疗预防了 91 例患者中的 84 例(92%)需要 PLT 输注。RFA 后无患者发生出血并发症。1 例患者在芦曲泊帕治疗后发生门静脉血栓形成。PLT 计数>50,000 PLT/μL 的患者在给予芦曲泊帕治疗前 PLT 计数更高。脾肿大程度不影响 PLT 计数升高的发生率。对于 PLT 计数在 50,000μL 左右但>50,000μL 的患者,给予芦曲泊帕治疗没有特定的不良反应。

结论

在进行 RFA 前给予芦曲泊帕治疗对于 PLT 计数较低的肝癌患者是有效且似乎相对安全的。

临床试验注册

本研究经日本红十字会医疗中心机构研究委员会批准(#862,2016 年 3 月 7 日),并在一个公共可访问的初级注册处进行了注册(#UMIN000046629,注册日期:2022 年 1 月 14 日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46c0/10364390/2e3c30e9fc1a/12876_2023_2879_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46c0/10364390/6735ecca9ccd/12876_2023_2879_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46c0/10364390/2e3c30e9fc1a/12876_2023_2879_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46c0/10364390/6735ecca9ccd/12876_2023_2879_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46c0/10364390/2e3c30e9fc1a/12876_2023_2879_Fig2_HTML.jpg

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本文引用的文献

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Lusutrombopag is effective and safe in patients with chronic liver disease and severe thrombocytopenia: a multicenter retrospective study.芦曲泊帕治疗慢性肝病伴严重血小板减少症患者的有效性和安全性:一项多中心回顾性研究。
BMC Gastroenterol. 2020 Dec 14;20(1):427. doi: 10.1186/s12876-020-01573-9.
2
Real-life experience of lusutrombopag for cirrhotic patients with low platelet counts being prepared for invasive procedures.卢苏替尼在准备接受侵入性操作的低血小板计数肝硬化患者中的真实世界经验。
PLoS One. 2019 Feb 15;14(2):e0211122. doi: 10.1371/journal.pone.0211122. eCollection 2019.
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Lusutrombopag for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Invasive Procedures (L-PLUS 2).
芦曲泊帕治疗接受有创操作的慢性肝病患者血小板减少症(L-PLUS 2)。
Hepatology. 2019 Oct;70(4):1336-1348. doi: 10.1002/hep.30561. Epub 2019 Mar 15.
4
Efficacy and safety of repeated use of lusutrombopag prior to radiofrequency ablation in patients with recurrent hepatocellular carcinoma and thrombocytopenia.复发肝细胞癌合并血小板减少症患者在射频消融术前重复使用芦曲泊帕的疗效和安全性。
Hepatol Res. 2019 May;49(5):590-593. doi: 10.1111/hepr.13305. Epub 2019 Feb 6.
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Relationship between response to lusutrombopag and splenic volume.芦曲泊帕治疗应答与脾脏体积的关系。
World J Gastroenterol. 2018 Dec 14;24(46):5271-5279. doi: 10.3748/wjg.v24.i46.5271.
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Lusutrombopag Reduces Need for Platelet Transfusion in Patients With Thrombocytopenia Undergoing Invasive Procedures.芦曲泊帕可减少接受有创操作的血小板减少症患者的血小板输注需求。
Clin Gastroenterol Hepatol. 2019 May;17(6):1192-1200. doi: 10.1016/j.cgh.2018.11.047. Epub 2018 Nov 28.
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