注射用核糖核酸Ⅱ联合化疗治疗晚期非小细胞肺癌效果及安全性的多中心回顾性对照研究

Efficacy and safety of ribonucleic acid for injectionⅡcombined with chemotherapy in treatment of advanced non-small cell lung cancer:a multicenter,retrospective and controlled study

目的:评价注射用核糖核酸Ⅱ联合化疗治疗晚期非小细胞肺癌(NSCLC)的效果和安全性。方法:基于LinkDoc数据库纳入2014年1月至2017年12月就诊于华中科技大学同济医学院附属同济医院等8家研究中心且确诊为ⅢB、Ⅳ期NSCLC患者2111例。依据化疗过程中使用和未使用注射用核糖核酸Ⅱ,将患者分为观察组(1039例)和对照组(1072例)。采用逆处理概率加权法对患者混杂因素进行校正,其中对照组1078例,观察组1033例;比较两组患者的总生存(OS)、无进展生存(PFS)及不良事件和化疗相关不良反应的发生情况。结果:观察组和对照组的中位OS时间分别为18.51个月和15.65个月,中位PFS时间分别为7.00个月和5.49个月,差异均有统计学意义(P值分别为0.001、0.003)。观察组不良事件发生率略高于对照组[75.6%(781/1033)比74.1%(799/1078)],观察组化疗相关不良反应发生率略高于对照组[43.9%(453/1033)比40.7%(439/1078)],但差异均无统计学意义(均P>0.05)。结论:注射用核糖核酸Ⅱ能够延长接受化疗的ⅢB、Ⅳ期NSCLC患者OS时间和PFS时间,安全性良好,在一定程度上增加患者的临床获益。

Objective To evaluate the efficacy and safety of ribonucleic acid for injectionⅡcombined with chemotherapy in the treatment of advanced non-small cell lung cancer(NSCLC).Methods Based on the LinkDoc database,2111 patients who were diagnosed with stageⅢB andⅣNSCLC in 8 research centers such as Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology from January 2014 to December 2017 were included.Patients were divided into observation group(1039 cases)and control group(1072 cases)according to whether or not they had used ribonucleic acid for injectionⅡduring chemotherapy.Inverse probability of treatment weighting was used to correct the confounding factors of patients,and there were 1078 cases in the control group and 1033 cases in the observation group;the overall survival(OS),progression-free survival(PFS)and the occurrence of adverse events and chemotherapy-related adverse reactions were compared between the two groups.Results The median OS time of the observation group and the control group was 18.51 months and 15.65 months,and the median PFS time was 7.00 months and 5.49 months,and the differences were statistically significant(P values​​were 0.001 and 0.003).The incidence of adverse events in the observation group was slightly higher than that in the control group[75.6%(781/1033)vs.74.1%(799/1078)],and the incidence of chemotherapy-related adverse reactions in the observation group was slightly higher than that in the control group[43.9%(453/1033)vs.40.7%(439/1078)],but the differences were not statistically significant(both P>0.05).Conclusions Ribonucleic acid for injectionⅡcan prolong the OS and PFS time of patients with stageⅢB andⅣNSCLC receiving chemotherapy.It is safe and can increase the clinical benefit of patients to a certain extent.