国产硼替佐米(昕泰■)治疗多发性骨髓瘤的临床疗效及安全性

Clinical efficacy of domestic Bortezomib(Xintai■)in the treatment of multiple myeloma and its safety

目的评价以国产硼替佐米(昕泰■)为基础的方案治疗多发性骨髓瘤的临床疗效和安全性。方法选择在首都医科大学附属北京朝阳医院接受以国产硼替佐米(昕泰■)为基础方案治疗的多发性骨髓瘤患者为研究对象,分析患者的临床疗效及不良反应发生情况。结果本研究共纳入117例多发性骨髓瘤患者,其中新诊断80例,复发/难治37例。中位治疗4个疗程(范围:1~11个),总有效率(ORR)为72.6%(85/117),其中新诊断多发性骨髓瘤患者ORR为91.3%(73/80),复发/难治多发性骨髓瘤患者的ORR为32.4%(12/37)。不良反应均以1~2级为主,其中血液学不良反应主要为白细胞减少和血小板减少,发生率分别为35.0%(41/117)和32.5%(38/117);非血液学不良反应主要为周围神经病变和胃肠道反应,发生率分别为32.5%(38/117)和53.0%(62/117)。结论国产硼替佐米(昕泰■)适宜用于新诊断多发性骨髓瘤患者一线治疗,疗效和耐受性良好,长期疗效尚需进一步随访,但复发/难治多发性骨髓瘤患者的临床疗效欠佳。

Objective To evaluate the clinical efficacy and safety of domestic Bortezomib(Xintai■)based regimen in the treatment of multiple myeloma.MethodsPatients with multiple myeloma who received the domestic Bortezomib(Xintai■)based treatment in Beijing Chao-Yang Hospital,Capital Medical University were selected as the study subjects to analyze the clinical efficacy and adverse reactions.ResultsA total of 117 patients with multiple myeloma were included,80 newly diagnosed patients and 37 relapsed/refractory patients.After 4 cycles of median therapy(range 1-11 cycles),the overall response rate(ORR)was 72.6%(85/117),91.3%(73/80)for newly diagnosed multiple myeloma and 32.4%(12/37)for relapsed/refractory multiple myeloma.The adverse reactions were mainly in grade 1-2,among which hematologic adverse reactions were mainly leukopenia and thrombocytopenia,with the incidence of 35.0%(41/117)and 32.5%(38/117),respectively;while the non-hematological adverse reactions were mainly neuropathy(32.5%,38/117)and gastrointestinal reactions(53.0%,62/117),respectively.ConclusionsDomestic Bortezomib(Xintai■)is suitable for the first-line treatment of newly diagnosed multiple myeloma patients,with good efficacy and tolerance,but the long-term efficacy require a further follow-up;the clinical efficacy of patients with relapsed and refractory multiple myeloma is poor.