【摘要】 目的：观察注射用盐酸美法仑应用于血液恶性肿瘤患者自体造血干细胞移植(auto-HSCT)及其序贯嵌合抗原受体T细胞(CART)治疗前预处理的近期疗效及毒副作用。方法：回顾性分析2019年8月-2021年5月在华中科技大学同济医学院附属同济医院接受含注射用盐酸美法仑(迈维宁，Evomela,用量120～200 mg/m~2)的预处理方案进行auto-HSCT及auto-HSCT序贯CART细胞治疗的45例恶性血液肿瘤患者的临床资料。结果：45例恶性血液肿瘤患者中，无植入失败病例；42例患者粒细胞植入良好，中位植活时间为12.6(7～23) d, 2例患者粒细胞植入不良；42例患者血小板植入良好，中位植活时间为12.4(5～26) d, 2例患者血小板植入不良；另1例血小板和白细胞均植入不良。37例(82.2%)患者发生口腔黏膜炎，25例(45.4%)为Ⅰ～Ⅱ级，12例(26.6%)为Ⅲ～Ⅳ级；32例(71.1%)患者发生恶心呕吐，26例(57.8%)为Ⅰ～Ⅱ级，6例(13.3%)为Ⅲ～Ⅳ级；37例(82.2%)患者出现胃肠炎，28例(62.3%)为Ⅰ～Ⅱ级，9例(20.0%)为Ⅲ级；7例(15.5%)患者出现肝脏毒性损害，6例(13.3%)为Ⅱ级，1例(2.2%)为Ⅲ级；5例(1.1%)患者出现心脏毒性损伤，4例(8.9%)为Ⅰ～Ⅱ级，1例(2.2%)为Ⅲ级；1例(2.2%)患者出现Ⅱ级中枢神经系统症状；45例患者中未出现肾脏毒性损伤。结论：注射用盐酸美法仑作为预处理用药应用于恶性血液肿瘤患者auto-HSCT及auto-HSCT序贯CART细胞治疗，疗效确切，毒副作用可控。更多还原

【Abstract】 Objective: To study the recent efficacy and toxicity of Melphalan hydrochloride for injection in autologous hematopoietic stem cell transplantation(auto-HSCT) and auto-HSCT sequential chimeric antigen receptor T cell(CART) therapy of patients with hematologic malignancies. Methods: The clinical data of 45 hematologic malignancies patients who underwent auto-HSCT or auto-HSCT sequential CART cell therapy with Evomela(Melphalan hydrochloride for injection, dose of 120 to 200 mg/m~2) in Tongji Hospital of Tongji Medical College in Huazhong University of Science and Technology between August, 2019 and May, 2021 were retrospectively analyzed. Results: There was no implantation failure among 45 patients with hematologic malignancies. A total of 42 cases had good granulocyte function with a median implantation day of 12.6 days(7-23) and 2 cases had poor granulocyte function. Forty-two cases had good platelet function with a median implantation time of 12.4 days(5-26) and 2 cases had poor platelet function. One case had poor granulocyte function and poor platelet function both. Thirty-seven cases(82.2%) had oral mucositis, including 25 cases(45.4%) of grade Ⅰ-Ⅱ and 12 cases(26.6%) of grade Ⅲ-Ⅳ. Thirty-two cases(71.1%) had nausea and vomiting, including 26 cases(57.8%) of grade Ⅰ-Ⅱ and 6 cases(13.3%) of grade Ⅲ-Ⅳ. Thirty-seven cases(82.2%) had gastroenteritis, including 28 cases(62.3%) of grade Ⅰ-Ⅱ and 9 cases(20.0%) of grade Ⅲ. Seven cases(15.5%) had hepatotoxic damage, including 6 cases(13.3%) of grade Ⅱ and 1 case(2.2%) of grade Ⅲ. Five cases(1.1%) had cardiotoxic damage, including 4 cases(8.9%) of grade I-Ⅱ and 1 case(2.2%) of grade Ⅲ. One case(2.2%) had grade Ⅱ central nervous system symptoms.No nephrotoxic injury occurred in 45 cases. Conclusion: Evomela, as a conditioning regimen drug, is of precise therapeutic effects and controllable toxic side effects in auto-HSCT and auto-HSCT sequential CART cell therapy for hematologic malignancies.更多还原