榄香烯联合吉非替尼治疗晚期非小细胞肺癌疗效与安全性研究

Study on the Effect and Safety of Elemene Combined with Gefitinib in the Treatment of Advanced NSCLC

目的：探讨榄香烯联合吉非替尼一线治疗晚期EGFR敏感突变型非小细胞肺癌的疗效与安全性。方法：研究纳入54例ⅢB/Ⅳ期经组织学确诊为非小细胞肺癌（NSCLC）且EGFR基因检测为敏感突变型的患者,随机分为观察组及对照组各27例。分别接受单药吉非替尼250 mg/d和榄香烯联合吉非替尼250 mg/d治疗。观察比较两组患者临床疗效、临床症候变化、免疫功能及安全性。结果：联合治疗组PFS（P=0.045）与OS（P=0.016）较对照组显著延长,两组ORR（P=0.272）及DCR（P=0.305）均无显著性差异;同时,联合治疗组在改善气短、乏力及免疫功能方面均优于对照组（P〈0.05）;两组患者在毒副反应方面无显著性差异（P〉0.05）。结论：榄香烯联合吉非替尼治疗晚期EGFR敏感突变型NSCLC疗效较好,并能有效改善临床症状及免疫功能,安全性好,依从性较高。

Objective：To observe elemene combined with gefitinib in treatment of non-small cell lung cancer（NSCLC）.Methods：54 cases of histologically diagnosed advanced NSCLC patients with epidermal growth factor receptor（EGFR）mutation were randomly divided into two groups.27 patients in the treatment group received gefitinib 250 mg/d combined with elemene,and the other 27 patients in the control group with gefitinib 250 mg/d alone.The effect,the clinical symptoms,the immune function and adverse reactions of both groups were evaluated between two groups.Results：There were significant differences in PFS（P=0.045） and OS（P=0.016） between both groups,but were no significant differences in ORR（P=0.272）or DCR（P=0.305）.The improvements of clinical symptoms and immune function were seen in treatment group（P0.05）,while there were no significant differences in adverse reactions between the two groups（P0.05）.Conclusion：Elemene in combination with gefitinib in treatment of non-small cell lung cancer have better efficacy.The clinical symptoms and immune function were also improved by the combined treatment,which was safe enough to be popularized.