曲妥珠单抗生物类似药对比原研药疗效及不良反应的回顾性分析

Retrospective analysis of the efficacy and adverse reactions of trastuzumabbiosimilar versus original drug

目的 比较HER-2阳性乳腺癌患者接受原研药赫赛汀(注射用曲妥珠单抗)治疗、国产生物类似药汉曲优(注射用曲妥珠单抗)治疗,以及两种药物更替治疗后的疗效和不良反应。方法 通过患者全视窗系统查找某院使用赫赛汀和汉曲优的患者资料,将患者分为赫赛汀组、汉曲优组和更替用药组。收集各组患者的影像学诊断资料和中性粒细胞减少、白细胞降低、血小板减少和碱性磷酸酶升高等不良反应的记录。采用卡方检验对收集的数据进行统计分析,以评估各组间是否具有显著性差异。结果 赫赛汀组、汉曲优组和更替用药组临床疗效(67.7%、76.1%、69.6%)差异无统计学意义(P> 0.05)。三组患者的中性粒细胞减少、白细胞降低、血小板减少和碱性磷酸酶升高等不良反应的发生率没有显著性差异(P> 0.05)。结论 HER-2阳性乳腺癌患者接受赫赛汀治疗、汉曲优治疗,以及两药更替治疗,疗效和不良反应均相当。

Objective To compare the therapeutic efficacy and adverse reactions of HER-2 positive breast cancer patients treated with the original drug Herceptin(trastuzumab for injection),the domestic biosimilar Zercepac(trastuzumab for injection),and alternating treatment with both drugs.Methods The data of patients using Herceptin or Zercepac were searched through the patient full-window system in a hospital.The patients were divided into Herceptin group,Zercepac group and alternate drug group.Imaging diagnosis data and adverse reactions such as neutropenia,leukopenia,thrombocytopenia and elevated alkaline phosphatase were collected.Chi-square test was used to analyze the collected data to evaluate whether there were significant differences between the groups.Results There was no difference in clinical efficacy between the Herceptin group,Zercepac group and the alternate drug group(67.7%、76.1%、69.6%)(P>0.05).There was no significant differencein the incidence of adverse reactions such as neutropenia,leukopenia,thrombocytopenia and elevated alkaline phosphatase among the three groups(P>0.05).Conclusion HER-2 positive breast cancer patients received Herceptin treatment,Zercepac treatment,and alternating treatment with both drugs,the therapeutic effect and adverse reactions were comparable.