目的 探讨艾愈胶囊(山慈菇、白英、当归等)或复方斑蝥胶囊(斑蝥、人参、黄芪等)联合盐酸埃克替尼治疗晚期非小细胞肺癌(NSCLC)疗效、副作用、对免疫功能影响及成本-效果.方法 160例晚期NSCLC患者随机分为3组,盐酸埃克替尼组(80例,盐酸埃克替尼125 mg/次,每日3次)、盐酸埃克替尼+艾愈胶囊组(40例,盐酸埃克替尼125 mg/次,每日3次;艾愈胶囊,3粒/次,每日3次)、盐酸埃克替尼+复方斑蝥胶囊组(40例,盐酸埃克替尼125 mg/次,每日3次;复方斑蝥胶囊,1粒/次,每日3次).比较3组患者疗效、副作用、血清肿瘤标志物、淋巴细胞亚群、成本-效果.结果 治疗后8周,盐酸埃克替尼组患者有效率73.75％,盐酸埃克替尼+艾愈胶囊组、盐酸埃克替尼+复方斑蝥胶囊组有效率分别为82.50％、92.50％,盐酸埃克替尼+艾愈胶囊组、盐酸埃克替尼+复方斑蝥胶囊组有效率明显高于盐酸埃克替尼组(P＜0.05);盐酸埃克替尼组、盐酸埃克替尼+艾愈胶囊组、盐酸埃克替尼+复方斑蝥胶囊组患者6个月生存率分别93.7％、97.5％、97.5％,1年生存率生存率分别为53.7％、72.5％、75.0％,2年生存率生存率分别为20.0％、37.5％、40.0％.盐酸埃克替尼+艾愈胶囊组和盐酸埃克替尼+复方斑蝥胶囊组的1年、2年生存率显著高于盐酸埃克替尼组(P＜0.05).盐酸埃克替尼+艾愈胶囊组、盐酸埃克替尼+复方斑蝥胶囊组患者髓样树突状细胞(mDC)亚群增长值(d8周-d1)显著高于盐酸埃克替尼组(P＜0.05).3组患者浆细胞样树突状细胞(pDC)亚群无显著变化(P＞0.05).盐酸埃克替尼+艾愈胶囊组、盐酸埃克替尼+复方斑蝥胶囊组癌胚抗原(CEA)、细胞角蛋白19片段(CYFRA21-1)、神经元特异性烯醇化酶(NSE)变化显著高于盐酸埃克替尼组(P＜0.05).盐酸埃克替尼+艾愈胶囊组、盐酸埃克替尼+复方斑蝥胶囊组治疗成本显著低于盐酸埃克替尼组(P＜0.05).3组患者副反应无显著性差异(P＞0.05).结论 艾愈胶囊或复方斑蝥胶囊联合盐酸埃克替尼在治疗晚期NSCLC过程中的疗效及成本-效果优于单用盐酸埃克替尼.%AIM To explore the curative effects,adverse events,effects on immunity function and cost-effectiveness of Aiyu Capsules (Cremastrae pseudobulbus,Solanum lyratum,Angelicae sinensis Radix,etc.) or Fufang Banmao Capsules (Mylabris,Ginseng Radix et Rhizoma,Astragali Radix,etc.) combined with icotinib hydrochloride in the treatment of advanced non-small cell lung carcinoma (NSCLC).METHODS One hundred and sixty patients with advanced NSCLC were randomly divided into three groups.The patients in icotinib hydrochloride group (n =80) took icotinib hydrochloride,125 mg each time,three times a day;the patients in Aiyu Capsules + icotinib hydrochloride group or Fufang Banmao Capsules + icotinib hydrochloride group were treated with Aiyu Capsules (40 cases,three pills each time,three times a day) or Fufang Banmao Capsules (40 cases,one pill each time,three times a day) combined with icotinib hydrochloride (125 mg each time,three times a day),respectively.Curative effects,adverse events,serum tumor markers,dendritic cell subsets and cost-effectiveness among the three groups were compared.RESULTS Eight weeks after the treatment,effective rates in the Aiyu Capsules + icotinib hydrochloride group (82.50％) and Fufang Banmao Capsules + icotinib hydrochloride group (97.5％) were significantly higher than that in the icotinib hydrochloride group (73.5％) (P ＜ 0.05).Six-month survival rates in the icotinib hydrochloride group,Aiyu Capsules + icotinib hydrochloride group and Fufang Banmao Capsules + icotinib hydrochloride group were 93.7％,97.5％ and 97.5％,respectively;one-year survival rates in the three groups were 53.7％,72.5％ and 75.0％,respectively;two-year survival rates in the three groups were 20.0％,37.5％ and 40.0％,respectively.One-year,two-year survival rates in the Aiyu Capsules + icotinib hydrochloride group and Fufang Banmao Capsules + icotinib hydrochloride group were significantly higher than those in the icotinib hydrochloride group (P ＜ 0.05).Myeloid dendritic cell (mDC) subsets' increases (d8week-d1) in the Aiyu Capsules + icotinib hydrochloride group and Fufang Banmao Capsules + icotinib hydrochloride group were significantly higher than that in the icotinib hydrochloride group (P ＜ 0.05).There was no statistical significance in plasmacytoid dendritic cell (pDC) subsets' change among the three groups (P ＞ 0.05).Changes of carcinoembryonic antigen (CEA),cytokeratin-19-fragment (CYFRA21-1),neuron-specific enolase (NSE) in the Aiyu Capsules + icotinib hydrochloride group and Fufang Banmao Capsules + icotinib hydrochloride group were higher than those in the icotinib hydrochloride group (P ＜ 0.05).Treatment costs in the Aiyu Capsules + icotinib hydrochloride group and Fufang Banmao Capsules + icotinib hydrochloride group were significantly lower than that in the icotinib hydrochloride group (P ＜ 0.05).No obvious statistical difference in adverse events was found among the three groups (P ＞ 0.05).CONCLUSION The curative effects and cost-effectiveness of Aiyu Capsules or Fufang Banmao Capsules combined with icotinib hydrochloride are better than those of icotinib hydrochloride alone in the treatment of advanced NSCLC.
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