扶正抗癌方联合吉非替尼治疗PS≤2分晚期NSCLC的疗效与安全性研究  

Study on the effect and safety of Fuzheng Kangai Decoction combined with gefitinib in the treatment of advanced NSCLC with PS≤2

作　　者：柴小姝[1] 吴万垠[2] 李柳宁[1] 何春霞[1] 李福瑞[3] 

机构地区：[1]广东省中医院大学城分院,广东广州510006 [2]广东省中医院,广东广州510120 [3]广州中医药大学第二临床医学院,广东广州510120

出　　处：《现代中西医结合杂志》2014年第3期229-231,250,共4页Modern Journal of Integrated Traditional Chinese and Western Medicine

基　　金：广东省中医药局建设中医药强省科研课题(20111213)

摘　　要：目的探讨扶正抗癌方联合吉非替尼治疗体力状况评分（Ps）≤2分且EGFR基因突变型晚期非小细胞肺癌（NSCLC）的疗效与安全性。方法连续入组51例PS≤2分的ⅢB／Ⅳ期病理组织学确诊且EGFR基因突变型NSCLC患者，随机分为治疗组25例及对照组26例。分别接受挟正抗癌方汤剂1次／d联合吉非替尼250mg1次／d和单药吉非替尼250mg1次／d治疗，比较2组患者治疗后无进展生存时间（PFS）、总生存时间（OS）、客观缓解率（ORR）、疾病控制率（DCR）及毒性反应。结果治疗组PFS与OS较对照组显著延长（P均〈0．05），2组ORR及DCR比较均无显著性差异（P均〉0．05）。2组均出现I～Ⅱ度皮疹、腹泻或I：／腔溃疡，治疗组少于对照组，但无显著性差异（P〉0．05）。结论扶正抗癌方联合吉非替尼治疗PS≤2分且EGFR基因突变型晚期NSCLC，可延长患者PFS及OS，且两药联合使用毒副反应有减少趋势，提示扶正抗癌方对吉非替尼有增效减毒的作用。Objective It is to approach the effect and toxicity of Fuzheng Kangai Decoction （FZKAD） combined with ge- fitinib in the treatment of advanced non-small cell lung cancer （ NSCLC ） with PS ≤ 2. Methods 51 cases of histologically diag- nosed advanced NSCLC patients with epidermal growth factor receptor （EGFR） mutation and PS ≤ 2 were randomly divided in- to two groups, 25 patients in the treatment group were received FZKAD （1 dose per day） combined with gefitinib 250 mg/d, and the other 26 patients in the control group with gefitinib 250 mg/d alone. Progression-free survival （PFS） , overall survival （OS） , overall response rate （ORR） , disease control rate （DCR） and toxicity were evaluated between two groups. Results There were significant differences in PFS and OS between both groups （ all P 〈 0.05 ） but were no significant differences in ORR or DCR （all P 〉 0. 05 ）. Mild diarrhea, rash and oral ulcers were occured in two groups, but there was no significant difference between both grOups （ ail P 〉 0. 05 ）. ConciSe/ibM Regimen of FZKAD combined with gefitinib in the treatment of advanced NSCLC with PS≤2 can prolong the p.FS and OS, reduce the toxicity of gefitinib.

关 键 词：扶正抗癌方 吉非替尼 非小细胞肺癌 EGFR基因突变型 

分 类 号：R734.2[医药卫生—肿瘤]