国产与原研伊马替尼治疗初发慢性髓性白血病慢性期患者有效性和安全性比较的单中心、前瞻性队列研究

A comparison of efficacy and safety between Chinese generic imatinib versus branded imatinib in patients with newly-diagnosed chronic myeloid leukemia in the chronic phase： a single-center prospective cohort study

目的评价原研甲磺酸伊马替尼和国产仿制品治疗新诊断慢性髓性白血病慢性期（CML—CP）患者的有效性和安全性。方法新诊断的CML．CP患者根据经济承担能力分别接受原研甲磺酸伊马替尼（格列卫）或国产仿制品（听维）治疗，药物起始剂量均为400mg／d，定期评价有效性和安全性。结果从2014年1月至2015年9月，共纳入145例患者，其中国产药组89例，原研药组56例，疗程均1〉3个月。3个月时，国产药组和原研药组的完全血液学反应率分别为95．5％（85／89）和100％（56／56），主要细胞遗传学反应率分别为74．2％（66／89）和80．4％（45／56），国际标准化BCR—ABL融合基因转录本水平（BCR—ABL^IS）≤10％的比例分别为76．1％（67／88）和82．1％（46／56），两组间差异均无统计学意义（P值均〉0．05）。在6、12和18个月时可评估病例中，两组治疗反应率相似（P值均〉0．1）。中位追踪随访期约为1年，国产药组和原研药组各有2例患者疾病进展至加速期或急变期。两组血液学和非血液学不良反应发生率相似。结论初发CML—CP患者采用原研伊马替尼或国产仿制品昕维治疗的早期治疗反应、疾病进展及不良反应无明显差异。

Objective To compare the efficacy and safety between Chinese generic imatinib （Xinwei, Jiansu Hansoh Pharmaceutical Group Co. , Ltd. ） versus branded imatinib （Glivec, Novartis） in patients with newly-diagnosed chronic myeloid leukemia in chronic phase （CML-CP）. Methods Patients with newly diagnosed CML-CP were enrolled and assigned to receive either Xinwei or Glivec at an initial dose of 400 mg/d according to patients＇ financial capability. The efficacy and adverse effects were evaluated. Results From January 2014 to September 2015, 145 eligible patients were assigned to Xinwei （ n = 89 ） or Glivee （ n = 56 ） group. All patients were treated and followed up at least 3 months. At 3 months, the complete response rates were 95.5% （85/89） and 100% （56/56）, major cytogenetic response rates were 74. 2% （66/89） and 80.4% （45/56）, and the proportions of achieving BCR-ALB^IS≤ 10% were 76. 1% （67/88） and 82. 1% （46/56） in Xinwei and Glivee groups respectively （all P 〉0.05）. With a median follow-up of 12 months, 2 patients in each group progressed to accelerate or blast phase. Hematologic and non-hematologic side effects were similar between the 2 groups. Conclusions Early hematological, cytogenetic and molecular responses between Xinwei and Glivec are comparable in newly- diagnosed CML-CP patients. The progression rate and side effects are also similar between the 2 groups.