消癌平注射液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研究  

Xiaoaiping injection combined with chemotherapy in treatment of patients with advanced non⁃small cell lung cancer:a multicenter,retrospective study of therapeutic efficacy and safety

作　　者：孙旭 刘怀民[1] 杨永丽 张鑫硕 Sun Xu;Liu Huaimin;Yang Yongli;Zhang Xinshuo(Department of Integrated Traditional Chinese and Western Medicine,Henan Cancer Hospital,Zhengzhou 450008,China;Department of Clinical Research,LinkDoc Technology(Beijing)Co.,Ltd,Beijing 100080,China)

机构地区：[1]河南省肿瘤医院中西医结合科,郑州450008 [2]零氪科技(北京)有限公司临床研究事业部,北京100080

出　　处：《肿瘤研究与临床》2022年第1期33-38,共6页Cancer Research and Clinic

摘　　要：目的探讨消癌平注射液联合化疗治疗晚期非小细胞肺癌(NSCLC)患者的临床效果和安全性。方法基于LinkDoc数据库,纳入2014年至2018年就诊于河南省肿瘤医院等4所医疗中心的首诊为ⅢB~Ⅳ期NSCLC的患者1144例。对入组患者基线资料进行倾向性评分匹配,将患者分为试验组(572例)和对照组(572例),试验组采用消癌平注射液联合化疗,对照组为单纯化疗。观察比较两组患者的客观缓解率(ORR)、疾病控制率(DCR)、总生存(OS)、无进展生存(PFS)、疾病进展时间(TTP)以及不良反应的发生情况。结果基于对有疗效评价记录的患者进行统计,试验组和对照组ORR分别为26.54%(86/324)、26.07%(79/303),差异无统计学意义(χ^(2)=0.02,P=0.894);DCR分别为61.42%(199/324)、62.38%(189/303),差异无统计学意义(χ^(2)=0.06,P=0.805)。试验组和对照组中位OS时间分别为21.2个月和16.5个月,差异有统计学意义(χ^(2)=7.53,P=0.006);中位PFS时间分别为9.3个月和8.9个月,差异无统计学意义(χ^(2)=2.25,P=0.134);中位TTP分别为1.8个月(1.2个月,5.1个月)和1.7个月(1.2个月,5.8个月),差异有统计学意义(Z=3.89,P=0.049)。试验组和对照组骨髓抑制发生率分别为75.52%(432/572)、64.51%(369/572),差异有统计学意义(χ^(2)=16.53,P<0.001);肝功能异常发生率分别为39.86%(228/572)、29.55%(169/572),差异有统计学意义(χ^(2)=13.43,P<0.001);肾功能异常发生率分别为2.45%(14/572)、3.15%(18/572),差异无统计学意义(χ^(2)=0.51,P=0.473)。结论消癌平注射液联合化疗治疗晚期NSCLC可以延长患者生存期,但需要注意潜在的骨髓抑制及肝损伤风险。Objective To investigate the clinical efficacy and safety of Xiaoaiping injection combined with chemotherapy in treatment of non‑small cell lung cancer(NSCLC)patients.Methods Based on LinkDoc database,a total of 1144 patients first diagnosed as stageⅢB-ⅣNSCLC in 4 medical centers including Henan Cancer Hospital from 2014 to 2018 were enrolled.The baseline data of included patients was used to make propensity score matching.The patients were divided into the experimental group(Xiaoaiping injection combined with chemotherapy)and the control group(chemotherapy alone),572 cases in each group.The objective response rate(ORR),disease control rate(DCR),overall survival(OS),progression‑free survival(PFS),time to progression(TTP)and adverse reactions of the two groups were observed and compared.Results Based on the statistical results of patients with records of efficacy evaluation,the ORR of the experimental group and the control group was 26.54%(86/324)and 26.07%(79/303),respectively,and there was no statistically significant difference(χ^(2)=0.02,P=0.894);the DCR of both groups was 61.42%(199/324)and 62.38%(189/303),respectively,and there was no statistically significant difference(χ^(2)=0.06,P=0.805).The median OS time of the experimental group and the control group was 21.2 months and 16.5 months,respectively,and there was a statistically significant difference(χ^(2)=7.53,P=0.006).The median PFS time was 9.3 months and 8.9 months,respectively,and there was no statistically significant difference(χ^(2)=2.25,P=0.134).The median TTP was 1.8 months(1.2 months,5.1 months)and 1.7 months(1.2 months,5.8 months),respectively,and there was a statistically significant difference(Z=3.89,P=0.049).The incidence of bone marrow suppression was 75.52%(432/572)and 64.51%(369/572),respectively in the experimental group and the control group,and there was a statistically significant difference(χ^(2)=16.53,P<0.001);the incidence of liver dysfunction was 39.86%(228/572)and 29.55%(169/572),respectively,and there was a statisti

关 键 词：癌 非小细胞肺 药物疗法 联合 治疗结果 不良反应 

分 类 号：R734.2[医药卫生—肿瘤]