7种常用口服中成药辅助治疗晚期非小细胞肺癌患者的回顾性研究  

A retrospective study of seven commonly used oral Chinese patent medicines in adjuvant treatment of patients with advanced non-small cell lung cancer

作　　者：赵林林[1] 王艳亭[2] 孔凡铭[1] 李小江[1] 刘宏根[1] 王晓群[1] 贾英杰[1] ZHAO Lin-lin;WANG Yan-ting;KONG Fan-ming;LI Xiao-jiang;LIU Hong-gen;WANG Xiao-qun;JIAYing-jie(National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Department of Oncology,The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China;The Fourth People’s Hospital of Jinan,Jinan 250031,China)

机构地区：[1]天津中医药大学第一附属医院肿瘤科,国家中医针灸临床医学研究中心,天津300381 [2]济南市第四人民医院,山东济南250031

出　　处：《中草药》2022年第16期5119-5127,共9页Chinese Traditional and Herbal Drugs

基　　金：国家重点研发计划(2018YFC1707400);天津市教委科研计划项目(2021KJ143)。

摘　　要：目的 评估7种常用口服中成药在辅助治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)中的疗效及预后相关因素。方法 采用回顾性队列研究,收集2019年1月1日-2020年12月31日于天津中医药大学第一附属医院肿瘤科门诊及住院治疗的晚期NSCLC患者150例,以7种常用中成药(紫龙金片、回生口服液、康莱特软胶囊、参一胶囊、威麦宁胶囊、复方菝葜颗粒、槐耳颗粒)暴露情况作为分组因素,分为暴露组(73例)与非暴露组(77例)。主要研究指标为无进展生存期(progression free survival,PFS),次要研究指标为总生存期(overall survival,OS)。对150例患者进行单因素Kaplan-Meier分析,明确各单因素对Ⅲb~Ⅳ期NSCLC患者PFS的影响。并比较7种常用中成药辅助治疗晚期NSCLC的疗效分析其预后相关因素。结果 暴露组患者中位无进展生存期(median progression free survival,m PFS)较非暴露组长(5.8个月vs 4.9个月),差异有统计学意义(P<0.05)。单因素分析表明,与非暴露组比较,女性、腺癌、Ⅲb~Ⅳ期、既往接受靶向治疗、伴随化疗5个因素显著延长暴露组m PFS(P<0.05);进一步比较7种中成药对暴露组PFS的影响,结果显示与回生口服液、威麦宁胶囊、槐耳颗粒相比,紫龙金片能显著延长暴露组患者的m PFS(P<0.05),与威麦宁胶囊相比,康莱特软胶囊、复方菝葜颗粒能显著延长暴露组患者的m PFS(P<0.05);除暴露因素外,卡氏行为状态(Karnofsky performance status,KPS)评分、临床分期、既往是否接受过靶向治疗3个因素与Ⅲb~Ⅳ期NSCLC患者m PFS显著相关。结论 7种常用抗肿瘤中成药在辅助治疗晚期NSCLC中的疗效确切,其中紫龙金片m PFS最长。女性、腺癌、Ⅲb~Ⅳ期、既往接受靶向治疗、伴随化疗的患者中成药获益更加明显。Objective To evaluate the efficacy and prognostic factors of seven commonly used Chinese patent medicines in the adjuvant treatment of advanced non-small cell lung cancer(NSCLC).Methods The retrospective cohort study was conducted to collect 150 patients with advanced NSCLC who were treated in the outpatient and inpatient department of oncology of the First Affiliated Hospital of Tianjin University of Traditional Chinese medicine from January 1,2019 to December 31,2020.The exposure of seven commonly used Chinese patent medicines[Zilongjin Tablet(紫龙金片),Huisheng Oral Liquid(回生口服液),Kanglaite Soft Capsule(康莱特软胶囊),Shenyi Capsule(参一胶囊),Weimaining Capsule(威麦宁胶囊),Compound Baqia Granule(复方菝葜颗粒)and Huaier Granule(槐耳颗粒)]were used as grouping factors,they were divided into exposure group(73 cases)and non-exposure group(77 cases).The main study index was progression free survival(PFS),and the secondary study index was overall survival(OS).Univariate Kaplan-Meier analysis was performed on 150 patients to clarify the impact of each univariate on PFS in patients with stageⅡIb—IV NSCLC.The efficacy of seven commonly used Chinese patent medicines in the adjuvant treatment of advanced NSCLC was compared,and the prognostic factors were analyzed.Results The median progression free survival(mPFS)in the exposed group was significantly higher than that in the non-exposed group(5.8 months vs 4.9 months)(P<0.05).Univariate analysis showed that female,adenocarcinoma,stageⅡIb—IV,previous targeted therapy and concomitant chemotherapy were significantly correlated with the prolongation of mPFS in exposed group compared with non-exposed group(P<0.05);The results showed that compared with Huisheng Oral Liquid,Weimaining Capsule and Huaier Granule,Zilongjin Tablet could significantly prolong the mPFS of patients in the exposure group(P<0.05),Kanglaite Soft Capsule and Compound Baqia Granule could significantly prolong the mPFS of patients in the exposure group(P<0.05)com

关 键 词：中成药 晚期非小细胞肺癌 疗效 预后相关因素 紫龙金片 回生口服液 康莱特软胶囊 参一胶囊 威麦宁胶囊 复方菝葜颗粒 槐耳颗粒 

分 类 号：R285.64[医药卫生—中药学]