利妥昔单抗原研药与生物类似药在CHOP联用方案中疗效及不良反应的回顾性分析

Retrospective comparison of efficacy and adverse reactions of rituximab and its biosimilar in CHOP chemotherapy

目的:回顾分析比较利妥昔单抗原研药美罗华与国产生物类似药汉利康在与CHOP联用治疗方案中的疗效和不良反应是否具有显著性差异,探讨2种药物更替使用对疗效和不良反应是否产生影响。方法:收集接受利妥昔单抗与环磷酰胺、多柔比星、长春新碱、泼尼松联用方案(R+CHOP)治疗弥漫性大B细胞淋巴瘤(DLBCL)患者的资料,按不同的药品厂家将患者设为3组,只使用美罗华的为M+CHOP组、只使用汉利康的为H+CHOP组、先用美罗华后改用汉利康的为M/H+CHOP组。收集各组患者的影像学诊断、细胞学检查、血常规检测、心肌生化指标、发生感染和发热症状的记录,以卡方检验分析各组患者中肿瘤学指标出现异常和出现不良反应的发生率是否具有显著性差异。结果:在M+CHOP组、H+CHOP组和M/H+CHOP组中,肿瘤学指标出现异常的发生率均没有显著性差异(P>0.05)。在不良反应比较中,M+CHOP组血小板减少的发生率(17.58%)低于H+CHOP组(31.76%)和M/H+CHOP组(33.96%),差异具有统计学意义(P<0.017)。结论:在R+CHOP治疗方案中,使用美罗华或汉利康对DLBCL疗效相当,两药更替使用对疗效和不良反应影响不大。相对于单用汉利康和更替用药,单用美罗华血小板减少的发生率较低。

Objective:To compare the efficacy and adverse reactions of rituximab original drug(Mabthera)and its biosimilar(Hanlikang)in CHOP chemotherapy and to study the efficacy and adverse reactions in the alternative use of the two drugs retrospectively.Methods:Patients with diffuse large B-cell lymphomas(DLBCL)who received rituximab combined with cyclophosphamide,doxorubicin,vincristine and prednisone(R+CHOP)were collected.According to rituximab of different manufacturers used,the patients were divided into three groups:M+CHOP group was treated with Mabthera,H+CHOP group was treated with Hanlikang,and M/H+CHOP group was treated with both drugs.The imaging diagnosis results,cytological examination,hematological examination,myocardial biochemical examination,infection and fever symptoms of patients in each group were observed.Chi square test was used to analyze whether there were significant differences in the frequency of abnormal oncological examination and adverse reaction events in each group.Results:There was no significant difference of abnormal oncological items among M+CHOP group,H+CHOP group and M/H+CHOP group(P>0.05).Regarding adverse reactions,the incidence of thrombocytopenia in M+CHOP group(17.58%)was lower than that in H+CHOP group(31.76%)and M/H+CHOP group(33.96%)significantly(P<0.017).Conclusion:There is no significant difference in efficacy between Mabthera+CHOP and Hanlikang+CHOP,reflecting that the efficacy of rituximab from the two manufacturers is equivalent,and the alternative use showed little influence on the efficacy.In the treatment of rituximab combined with CHOP,Mabthera showed lower probability of thrombocytopenia.