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可能的保护作用的瑞舒伐他汀在化疗诱导的心脏毒性在 HER2 阳性乳腺癌患者:一项随机对照试验。

Possible protective effect of rosuvastatin in chemotherapy-induced cardiotoxicity in HER2 positive breast cancer patients: a randomized controlled trial.

机构信息

Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, Egypt.

Clinical Oncology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

出版信息

Med Oncol. 2024 Jul 8;41(8):196. doi: 10.1007/s12032-024-02426-1.

DOI:10.1007/s12032-024-02426-1
PMID:38977536
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11230999/
Abstract

Cardiotoxicity is a side effect of chemotherapy in human epidermal growth factor receptor 2 (HER2) positive breast cancer patients receiving both anthracyclines and trastuzumab. We looked for a possible protective effect of rosuvastatin against chemotherapy-induced cardiotoxicity. Methods: 50 newly diagnosed HER2 positive breast cancer patients were randomly allocated into two groups: 25patients in each. Group 1(control group) received doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy. Group 2 (treatment group) received doxorubicin for 4 cycles (3 months) followed by trastuzumab adjuvant therapy and 20 mg of oral rosuvastatin 24 h before the first cycle of chemotherapy and once daily for the rest of the follow-up period (6 months). Transthoracic echocardiography was done, and blood samples were collected for patients 24 h before the initiation of therapy, after 3 months and after 6 months to assess serum levels of high sensitivity cardiac troponin I (hs-cTnI), Myeloperoxidase (MPO), Interleukin-6 (IL-6) and Alanine aminotransferase (ALT). The study was retrospectively registered in Clinical Trials.gov in April 2022. Its ID is NCT05338723. Compared to control group, Rosuvastatin-treated group had a significantly lower decline in LVEF after 3 months and after 6 months. They had significantly lower Hs-cTnI and IL-6 after 3 months and after 6 months, and significantly lower MPO after 6 months. Four patients in control group experienced cardiotoxicity while no one in rosuvastatin-treated group. Rosuvastatin attenuated cardiotoxicity, so it is a promising protective agent against chemotherapy-induced cardiotoxicity.

摘要

心脏毒性是接受蒽环类和曲妥珠单抗化疗的人表皮生长因子受体 2 (HER2) 阳性乳腺癌患者的一种副作用。我们寻找瑞舒伐他汀对化疗引起的心脏毒性的可能保护作用。

方法

50 例新诊断的 HER2 阳性乳腺癌患者随机分为两组:每组 25 例。组 1(对照组)接受多柔比星 4 个周期(3 个月),然后接受曲妥珠单抗辅助治疗。组 2(治疗组)接受多柔比星 4 个周期(3 个月),然后接受曲妥珠单抗辅助治疗,在第 1 个化疗周期前 24 小时口服瑞舒伐他汀 20mg,在其余随访期间每天一次。治疗前 24 小时、治疗 3 个月和 6 个月时进行经胸超声心动图检查,并采集血样,以评估血清高敏肌钙蛋白 I (hs-cTnI)、髓过氧化物酶 (MPO)、白细胞介素-6 (IL-6)和丙氨酸氨基转移酶 (ALT)水平。该研究于 2022 年 4 月在 ClinicalTrials.gov 上进行了回顾性注册,其 ID 号为 NCT05338723。与对照组相比,瑞舒伐他汀治疗组在 3 个月和 6 个月后左心室射血分数下降明显减少。他们在 3 个月和 6 个月后 hs-cTnI 和 IL-6 显著降低,6 个月后 MPO 显著降低。对照组 4 例患者发生心脏毒性,而瑞舒伐他汀治疗组无 1 例发生心脏毒性。瑞舒伐他汀减轻了心脏毒性,因此它是一种有前途的对抗化疗引起的心脏毒性的保护剂。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b01/11230999/b73d9d42f2ad/12032_2024_2426_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b01/11230999/2b81b0ac4783/12032_2024_2426_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b01/11230999/b73d9d42f2ad/12032_2024_2426_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b01/11230999/2b81b0ac4783/12032_2024_2426_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b01/11230999/b73d9d42f2ad/12032_2024_2426_Fig2_HTML.jpg

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