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一项前瞻性随机对照试验,旨在确定体外冲击波疗法对接受多柔比星治疗且无心血管风险的乳腺癌患者亚临床心脏毒性一级预防的安全性和有效性。

A prospective randomized controlled trial to determine the safety and efficacy of extracorporeal shock waves therapy for primary prevention of subclinical cardiotoxicity in breast cancer patients without a cardiovascular risk treated with doxorubicin.

作者信息

Song Shinjeong, Woo Joohyun, Kim HyunGoo, Lee Jun Woo, Lim Woosung, Moon Byung-In, Kwon Kihwan

机构信息

Division of Cardiology, Department of Internal Medicine, Ewha Womans University College of Medicine, Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea.

Department of Surgery, Ewha Womans University College of Medicine, Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea.

出版信息

Front Cardiovasc Med. 2024 Feb 7;11:1324203. doi: 10.3389/fcvm.2024.1324203. eCollection 2024.

DOI:10.3389/fcvm.2024.1324203
PMID:38385137
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10879594/
Abstract

BACKGROUND

Doxorubicin is a highly effective anti-cancer drug that causes left ventricular (LV) dysfunction and induces late-onset cardiomyopathy. However, an effective and clinically applicable preventive treatment is yet to be discovered.

OBJECTIVE

Cardiac-Extracorporeal shockwave therapy (C-ESWT) has been suggested to treat inflammatory and ischemic diseases and protect cardiomyocytes from doxorubicin-induced cardiomyopathy. This study aims to assess the safety and efficacy of C-ESWT in the prevention of subclinical cardiotoxicity.

METHODS

We enrolled 64 breast cancer patients. C-ESWT group 33 patients were treated with our C-ESWT (200 shots/spot at 0.09 mJ/mm for 20 spots, 3 times every six weeks). The efficacy endpoints were the difference in left ventricular global longitudinal strain (LVGLS) change by 2D speckle tracking echocardiography and chemotherapy-related cardiac dysfunction (CTRCD). Echocardiography was performed on the baseline line and every 4 cycles of chemotherapy, followed by a follow-up 3,6 months after chemotherapy to compare the incidence of cardiomyopathy of subclinical LV dysfunction due to chemotherapy between the two groups.

RESULTS

Participants averaged 50 ± 9 years in age, 100% female. In the results of follow-up 6 months after the end of chemotherapy, there was a significant difference in delta LVGLS between the C-ESWT group and the control group (LVGLS; -1.1 ± 10.9% vs. -11.5 ± 11.6% -value; <0.001). A total of 23% (15 patients) of patients developed CTRCD (Control group; 13 vs. C-ESWT group; (2). C-ESWT was performed safely without any serious adverse events.

CONCLUSION

In this prospective study, C-ESWT established efficacy in preventing subclinical cardiotoxicity, especially in breast cancer patients using doxorubicin chemotherapy, and the safety of C-ESWT.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, identifier (NCT05584163).

摘要

背景

阿霉素是一种高效抗癌药物,可导致左心室功能障碍并引发迟发性心肌病。然而,尚未发现一种有效且可临床应用的预防性治疗方法。

目的

心脏体外冲击波疗法(C-ESWT)已被建议用于治疗炎症性和缺血性疾病,并保护心肌细胞免受阿霉素诱导的心肌病影响。本研究旨在评估C-ESWT预防亚临床心脏毒性的安全性和有效性。

方法

我们招募了64名乳腺癌患者。C-ESWT组33例患者接受了我们的C-ESWT治疗(每点200次冲击,能量密度0.09 mJ/mm,共20个点,每六周3次)。疗效终点为二维斑点追踪超声心动图测量的左心室整体纵向应变(LVGLS)变化差异以及化疗相关心脏功能障碍(CTRCD)。在基线和每4个化疗周期时进行超声心动图检查,化疗结束后3、6个月进行随访,比较两组因化疗导致的亚临床左心室功能障碍性心肌病的发生率。

结果

参与者平均年龄50±9岁,均为女性。化疗结束后6个月的随访结果显示,C-ESWT组和对照组之间的LVGLS差值有显著差异(LVGLS;-1.1±10.9%对-11.5±11.6%,P值;<0.001)。共有23%(15例患者)发生CTRCD(对照组13例对C-ESWT组2例)。C-ESWT治疗安全,未发生任何严重不良事件。

结论

在本前瞻性研究中,C-ESWT在预防亚临床心脏毒性方面显示出疗效,尤其在使用阿霉素化疗的乳腺癌患者中,且C-ESWT具有安全性。

临床试验注册

ClinicalTrials.gov,标识符(NCT05584163)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66c8/10879594/23aa1a7c590a/fcvm-11-1324203-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66c8/10879594/a2fecff6e25a/fcvm-11-1324203-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66c8/10879594/c9046645d05b/fcvm-11-1324203-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66c8/10879594/23aa1a7c590a/fcvm-11-1324203-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66c8/10879594/a2fecff6e25a/fcvm-11-1324203-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66c8/10879594/c9046645d05b/fcvm-11-1324203-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66c8/10879594/23aa1a7c590a/fcvm-11-1324203-g003.jpg

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