曲妥珠单抗生物类似药与原研药治疗HER-2阳性乳腺癌的疗效与成本—效果比比较  

Comparison of the efficacy and cost-effectiveness ratio between trastuzumab biosimilar and the original drug in the treatment of HER-2 positive breast cancer

作　　者：张云[1] 孙磊[1] ZHANG Yun;SUN Lei(Outpatient Pharmacy,Jingjiang People′s Hospital,Jiangsu Province,Jingjiang 214500,China)

机构地区：[1]江苏省靖江市人民医院门诊药房,214500

出　　处：《临床合理用药杂志》2024年第22期13-15,20,共4页Chinese Journal of Clinical Rational Drug Use

摘　　要：目的 比较曲妥珠单抗生物类似药与原研药治疗人表皮生长因子受体2(HER-2)阳性乳腺癌的疗效与成本—效果比。方法 选取2020年1月—2022年12月靖江市人民医院收治的HER-2阳性乳腺癌患者74例,遵循1∶1原则随机分为生物类似药组和原研药组,各37例。生物类似药组采用曲妥珠单抗生物类似药治疗,原研药组采用曲妥珠单抗原研药治疗,3周为1个疗程,2组均持续治疗6个疗程。比较2组疗效,治疗前后肿瘤标志物[癌胚抗原(CEA)、糖类抗原125(CA125)、糖类抗原153(CA153)]水平、肿瘤长径、卡氏(KPS)评分及成本—效果比。结果 生物类似药组与原研药组客观缓解率比较差异不显著(59.46%vs.62.16%,χ^(2)=0.057,P=0.812)。治疗6个疗程后,2组CEA、CA125、CA153水平低于治疗前(P均<0.01),但生物类似药组与原研药组组间比较差异不显著(P>0.05);2组肿瘤长径较治疗前缩短,KPS评分较治疗前提高(P均<0.01),但生物类似药组与原研药组组间比较差异不显著(P>0.05);生物类似药组成本/疗效优于原研药组,经济效益更高。结论 曲妥珠单抗原研药与生物类似药均可改善患者病情,促使肿瘤长径缩短,降低肿瘤标志物水平,且二者疗效相当,但曲妥珠单抗生物类似药的成本—效果比更优,其经济效益更显著。Objective To compare the efficacy and cost-effectiveness ratio of trastuzumab biosimilar and the original drug in the treatment of human epidermal growth factor receptor 2(HER-2) positive breast cancer.Methods A total of 74 patients with HER-2 positive breast cancer admitted to Jingjiang People′s Hospital from January 2020 to December 2022 were selected and randomly divided into biological analog group and original research drug group according to the principle of 1∶1,37 cases in each group.The biosimilar analog group was treated with trastuzumab biosimilar drug,and the original research drug group was treated with trastuzumab monoantigen research drug.Three weeks was a course of treatment,and both groups were treated for 6 courses.The curative effect,tumor markers(CEA,CA125,CA153) levels,tumor length and diameter,Karnofsky(KPS) scores and cost-effectiveness ratio before and after treatment were compared between the two groups.Results There was no significant difference in the objective response rate between the biosimilar analog group and the original research drug group(59.46% vs.62.16%,χ~2=0.057,P=0.812).After 6 courses of treatment,the levels of CEA,CA125 and CA153 in the two groups were lower than those before treatment(P<0.01),but there was no significant difference between the biosimilar analog group and the original research drug group(P>0.05).The tumor length and diameter of the two groups were shorter than those before treatment,and the KPS scores were higher than those before treatment(P<0.01),but there was no significant difference between the biosimilar analog group and the original research drug group(P>0.05).The C/E ratio of the biosimilar analog group was better than that of the original research drug group,and the economic benefit was higher.Conclusion Both trastuzumab antigen and biosimilar drugs can improve the patient's condition,shorten the tumor length and diameter,and reduce the level of tumor markers,and the curative effects of the two drugs are equivalent,but the cost-effectiveness r

关 键 词：乳腺癌 人表皮生长因子受体2阳性 曲妥珠单抗生物类似药 曲妥珠单抗生物原研药 疗效 成本—效果比 

分 类 号：R737.9[医药卫生—肿瘤] R956[医药卫生—临床医学]