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投稿时间:2025-05-16 网络发布日期:2026-04-02
投稿时间:2025-05-16 网络发布日期:2026-04-02
中文摘要: 目的探讨达雷妥尤单抗联合方案治疗多发性骨髓瘤患者的疗效和安全性,比较不同方案和疗程长短对患者无进展生存期(PFS)的影响。方法回顾性分析南通大学附属医院2020年6月至2023年12月用达雷妥尤单抗治疗的81例多发性骨髓瘤患者的临床资料(77例可评估疗效)。根据使用疗程,分为短疗程组(≤3个月,n=30)、中疗程组(4~8个月,n=22)和长疗程组(≥9个月,n=25)。依照不同的化疗方案分为Dd组(达雷妥尤单抗联合地塞米松,n=7)和多联用药组(达雷妥尤单抗联合蛋白酶体抑制剂和/或免疫调节剂,n=70),分析其疗效、生存情况及不良反应。结果随访截止日期为2023年12月31日。77例患者的总有效率(ORR)达87.0%,其中严格意义的完全缓解9例,完全缓解11例,非常好的部分缓解15例,部分缓解16例,微小缓解16例,疾病稳定6例,疾病进展4例。多药联合组ORR显著高于Dd组[90.0%(63/70)vs 57.1%(4/7),P=0.043]。与短疗程组患者相比,长疗程组患者有更优的ORR[100.0%(25/25)vs 76.7%(23/30),χ2=6.684,P=0.010]及中位PFS(2.99年vs2.02年,P=0.005)。不良反应主要为血液系统不良事件,多为1~2级。结论达雷妥尤单抗联合方案治疗多发性骨髓瘤疗效肯定,且治疗期间严重不良事件发生率较低,可有效提高缓解程度和PFS。
Abstract:Objective To investigate the efficacy and safety of daratumumab-based regimens in the treatment of patients with multiple myeloma, and to compare the impact of different regimens and treatment durations on patients’ progression -free survival (PFS). Methods A retrospective analysis was conducted on the clinical data of 81 patients with multiple myeloma treated with daratumumab at the Affiliated Hospital of Nantong University between June 2020 and December 2023 (77 cases can be evaluated for efficacy). Based on treatment duration, patients were divided into short-course group (≤3 months, n=30), medium-course group (4-8 months, n=22), and long-course group (≥9 months, n=25) groups. According to different chemotherapy regimens, patients were categorized into the Dd group (daratumumab combined with dexamethasone, n=7) and the multidrug combination group (daratumumab combined with a proteasome inhibitor and/or an immunomodulatory agent, n=70). Their efficacy, survival outcomes, and adverse reactions were analyzed. Results The deadline of follow-up was December 31, 2023. The overall response rate (ORR) of 77 patients was 87.0%, including 9 cases of stringent complete response, 11 cases of complete response, 15 cases of very good partial response, 16 cases of partial response, 16 cases of minimal response, 6 cases of stable disease, and 4 cases of progressive disease. The ORR in the multidrug combination group was significantly higher than that in the Dd group [90.0% (63/70) vs 57.1% (4/7), P=0.043]. Compared with the short-course group, the long-course group showed superior ORR [100.0% (25/25) vs 76.7% (23/30), χ2=6.684, P=0.010]and median PFS (2.99 years vs 2.02 years, P= 0.005). Adverse reactions were primarily hematological toxicities, with most being grade 1-2. Conclusion Daratumumab -based regimens demonstrate confirmed efficacy in treating patients with multiple myeloma, with a low incidence of severe adverse reactions during treatment, and can effectively improve the depth of response and PFS.
文章编号: 中图分类号:R733.3 文献标志码:A
基金项目:国家自然科学基金青年科学基金项目(82200219);江苏省研究生科研与实践创新计划项目(SJCX24_2051);南通大学附属医院研究型医院建设经费“揭榜挂帅”——研究型医师发展基金(YJXYY202204-YSB61)
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引用文本:
许锦涛,高紫婷,苏文峰,等.达雷妥尤单抗联合方案治疗多发性骨髓瘤的疗效及安全性[J].中国临床研究,2026,39(3):449-452.
许锦涛,高紫婷,苏文峰,等.达雷妥尤单抗联合方案治疗多发性骨髓瘤的疗效及安全性[J].中国临床研究,2026,39(3):449-452.
