艾愈胶囊或复方斑蝥胶囊联合盐酸埃克替尼治疗晚期NSCLC

Aiyu Capsules or Fufang Banmao Capsules combined with icotinib hydrochloride in the treatment of advanced NSCLC

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(m DC)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(p DC)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 were20. 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（m DC） subsets’ increases（d8 week-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（p DC） 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.