金复康口服液联合辅助化学疗法治疗气阴两虚型早中期非小细胞肺癌术后患者的临床观察  

Clinical observation of Jinfukang Oral Liquid combined with adjuvant chemotherapy in treating postoperative patients with early to mid‑stage non‑small cell lung cancer and qi‑yin deficiency syndrome

作　　者：张任 朱丽华[1] 陈智伟[2] 范瑞 张学林[4] 周蕾[1] 陆恩昊[1] 管懋莹 李和根[1] ZHANG Ren;ZHU Lihua;CHEN Zhiwei;FAN Rui;ZHANG Xuelin;ZHOU Lei;LU Enhao;GUAN Maoyin;LI Hegen(Department of Oncology,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Department of Oncology,Shanghai Chest Hospital,Shanghai 200030,China;Department of Integrated Chinese and Western Medicine,Shanghai Pulmonary Hospital,Shanghai 200433,China;Department of Thoracic Surgery,Huadong Hospital Affiliated to Fudan University,Shanghai 200040,China)

机构地区：[1]上海中医药大学附属龙华医院肿瘤科,上海200032 [2]上海市胸科医院肿瘤科,上海200030 [3]上海市肺科医院中西医结合科,上海200433 [4]上海市华东医院胸外科,上海200040

出　　处：《上海中医药杂志》2025年第2期55-59,共5页Shanghai Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金项目(82205214,82374532);国家中医药管理局高水平中医药重点学科建设项目(ZYZK007-002);上海市科委中医肿瘤临床医学研究中心项目(21MC1930500);上海市卫健委李和根名老中医学术经验研究工作室建设项目(SHGZS-202215)。

摘　　要：目的观察金复康口服液联合辅助化学疗法(以下简称“化疗”)对早中期非小细胞肺癌(NSCLC)术后患者生活质量及无病生存期(DFS)的影响。方法将204例气阴两虚型早中期术后NSCLC患者随机分为试验组、对照组,每组102例。两组患者均行4周期辅助化疗,试验组在此基础上加用金复康口服液。比较两组患者治疗前后生活质量的变化情况;完成化疗周期后进行随访,记录所有患者的DFS,计算6个月、12个月、24个月、36个月的无病生存率。结果①最终完成试验者198例,其中试验组100例、对照组98例。②治疗前后组内比较,试验组角色功能、情绪功能及总体健康状况评分升高(P<0.05),疲乏、疼痛、呼吸困难评分降低(P<0.05);对照组认知功能、呼吸困难及总体健康状况评分降低(P<0.05),食欲下降评分升高(P<0.05)。组间治疗后比较,躯体功能、疲乏、呼吸困难、睡眠障碍、食欲下降及总体健康状况评分差异有统计学意义(P<0.05)。③截至末次随访,试验组预期DFS为52.1个月,对照组预期DFS为49.2个月,差异无统计学意义(P>0.05)。④完成4周期治疗后有98例患者接受金复康后续治疗,100例患者仅单纯随访。对照组中接受后续治疗患者的预期DFS为55.2个月,单纯随访患者的预期DFS为43.6个月,差异有统计学意义(P<0.05)。⑤后续金复康治疗干预时间分层,干预>3年的预期DFS显著延长(P<0.05)。结论与辅助化疗相比,加用金复康口服液能更好地改善气阴两虚型早中期NSCLC术后患者的生活质量,DFS情况仍待长期随访。Objective To observe the effect of Jinfukang Oral Liquid combined with adjuvant chemotherapy on the quality of life and disease-free survival(DFS)in early to mid-stage non-small cell lung cancer(NSCLC)patients after surgery.Methods A total of 204 early to mid-stage NSCLC postoperative patients with qi-yin deficiency syndrome were randomly divided into the experimental group(n=102)and the control group(n=102).Both groups underwent four cycles of postoperative adjuvant chemotherapy(hereinafter referred to as‘chemotherapy’),with the experimental group additionally receiving Jinfukang Oral Liquid.The study compared changes in quality of life.After the completion of the chemotherapy cycles,follow-up visits were conducted to record the DFS of all patients,and the DFS rates at 6,12,24,and 36 months were calculated.Results①There were 198 finalized trial participants,with 100 in the experimental group and 98 in the control group.②Intra-group comparisons before and after treatment showed that the experimental group showed an increase in role function,emotional function,and general health status(P<0.05),while scores for fatigue,pain,and dyspnea decreased(P<0.05).The cognitive function,dyspnea,and general health status scores of the control group decreased(P<0.05),while the anorexia score increased(P<0.05).Post-treatment comparisons between the groups showed that differences in physical function,fatigue,dyspnea,sleep disturbances,anorexia,and general health status scores were statistically significant(P<0.05).③By the last follow-up,the expected DFS was 52.1 months for the experimental group and 49.2 months for the control group,with no significant difference(P>0.05).④After 4 cycles of treatment,98 patients received JinFukang subsequent therapy,100 patients received follow-up only.The expected DFS was 55.2 months in the control group and 43.6 months in the follow-up group,the difference was statistically significant(P<0.05).⑤Stratified by the follow-up treatment intervention time,the expected DFS was significant

关 键 词：非小细胞肺癌 金复康口服液 辅助化学疗法 中西医结合疗法 无病生存期 临床试验 

分 类 号：R73[医药卫生—肿瘤]