中国药物警戒 ›› 2025, Vol. 22 ›› Issue (6): 664-668.
DOI: 10.19803/j.1672-8629.20240864

• 安全与合理用药 • 上一篇    下一篇

塞替派预处理方案联合自体造血干细胞移植治疗原发中枢神经系统

傅蔚然, 邹东梅, 倪婧, 孙婉玲, 郭轶先*   

  1. 首都医科大学宣武医院血液科,北京 100053
  • 收稿日期:2024-11-08 发布日期:2025-06-18
  • 通讯作者: *郭轶先,女,博士,副主任医师,血液系统恶性疾病诊治。E-mail: bjxwgyx@163.com
  • 作者简介:傅蔚然,女,本科,血液系统恶性疾病诊治。
  • 基金资助:
    首都医科大学宣武医院教育改革课题（2023XWJXGG-04）

Short-Term Efficacy and Safety of Thiotepia-based Conditioning Regimen Combined with Autologous Hematopoietic Stem Cell Transplantation in the Treatment of Primary Central Nervous System Lymphoma

FU Weiran, ZOU Dongmei, NI Jing, SUN Wanling, GUO Yixian*   

  1. Department of Hematology, Xuanwu Hospital, Capital Medical University, Beijing 1000053, China
  • Received:2024-11-08 Published:2025-06-18

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摘要： 目的 评估含塞替派预处理方案在符合自体干细胞移植（auto-HSCT）适应证的原发中枢神经系统淋巴瘤（PCNSL）患者中的近期疗效及安全性。方法 回顾性分析本院2021年至2023年接受含有塞替派的BCNU-TT（卡莫司汀、塞替派）预处理方案[卡莫司汀400 mg·m-2 静脉滴注（ivgtt）,给药时间为移植第-6天;塞替派5 mg·kg-1 ivgtt 每12 h给药1次（q12h）给药时间为移植第-5、-4天]和TBC（塞替派、白消安、环磷酰胺）预处理方案（塞替派6.4 mg·kg-1 ivgtt给药时间为移植第-1、-2、-3天;白消安30 mg·m-2 ivgtt q6h,给药时间为移植第-3、-4、-5天;环磷酰胺60 mg·kg-1ivgtt给药时间为移植第-4、-5天）的 auto-HSCT的PCNSL患者,总结病例特点和共性并对比分析预后及不良反应。结果 8例PCNSL患者中,1例接受TBC方案,其余7例接受BCNU-TT方案预处理。移植后3个月评估显示,完全缓解率为100%;在中位观察时间466.5 d的观察期内,周期性评估的完全缓解率为100%。主要不良反应及其评级为：发热性中性粒细胞减少（3级,100%）、恶心/呕吐（1级,100%）、腹泻（1~2级,75%）、水肿（1级,37.5%）、皮疹包块（1级,50%）、乏力（1级,62.5%）、头晕（1级,37.5%）、感染（1~2级,50%）、咳嗽（1级,37.5%）及肝功能异常（转氨酶升高1级和3级,37.5%）。结论 含塞替派的预处理方案用于 auto-HSCT治疗PCNSL患者,能提高近期疗效和改善预后,在不良反应管理方面也表现出较好的耐受性。

关键词: 塞替派, 卡莫司汀、塞替派预处理方案, 塞替派、白消安、环磷酰胺预处理方案, 中枢神经系统淋巴瘤, 自体干细胞移植, 药品不良反应, 临床疗效

Abstract: Objective To evaluate the short-term efficacy and safety of a conditioning regimen involving cetiapib in patients with primary central nervous system lymphoma (PCNSL) who meet the indications for autologous stem cell transplantation (auto-HSCT). Methods The clinical data of PCNSL patients was analyzed who underwent auto-HSCT with a thiotepia-based BCNU-TT conditioning regimen (carmustine 400 mg·m-2, administered via intravenous infusion 6 days before transplantation, thiotepia at 5 mg·kg-1, administered via intravenous infusion every 12 hours 4 and 5 days before transplantation) and a TBC conditioning regimen (thiotepia at 6.4 mg·kg-1, administered via intravenous infusion 1, 2 and 3 days before transplantation, busulfan at 30 mg·m-2, administered via intravenous infusion every 6 hours 3, 4 and 5 days before transplantation, cyclophosphamide at 60 mg·kg-1, administered via intravenous infusion 4 and 5 days before transplantation) between 2019 and 2023. The clinical characteristics of these cases were summarized before the outcomes and adverse reactions were compared. Results Among the eight PCNSL patients, one received the TBC regimen while the rest were treated with the BCNU-TT regimen. Three months after transplant, the CR rate was 100%. During a median follow-up of 466.5 days, regular assessments showed a CR rate of 100%. The primary adverse reactions and their severity ratings were febrile neutropenia (grade 3, 100%), nausea/vomiting (grade 1, 100%), diarrhea (grades 1-2, 75%), edema (grade 1, 37.5%), rash or lumps (grade 1, 50%), fatigue (grade 1, 62.5%), dizziness (grade 1, 37.5%), infections (grades 1-2, 50%), cough (grade 1, 37.5%), and liver function abnormalities (elevated transaminases grade 1 and grade 3, 37.5%). Conclusion The thiotepia-based conditioning regimen can effectively improve the short-term therapeutic efficacy and prognosis in auto-HSCT for PCNSL patients while demonstrating good tolerability in adverse reaction management.

Key words: Thiotepia, BCNU-TT Conditioning Regimen, TBC Conditioning Regimen, Primary Central Nervous System Lymphoma, Autologous Stem Cell Transplantation, Adverse Drug Reactions, Clinical Outcomes

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