替吉奥单药治疗晚期非小细胞肺癌近期疗效及安全性的观察

Short-Term Efficacy and Safety of S-1 in Treatment of Advanced Non-Small-Cell Lung Cancer

目的观察替吉奥单药治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的近期疗效及不良反应。方法 45例经病理组织学确诊的晚期NSCLC患者,按简单随机方法分为观察组22例和对照组23例。观察组采用替吉奥胶囊单药化疗,80 mg·m-2·d-1,分早晚2次服用,连用28 d,休息2周,6周为一周期,同时行常规支持治疗;对照组接受中成药(艾迪注射液)抗肿瘤及最佳支持治疗。2周期后评价近期疗效和不良反应。结果观察组疾病控制率为54.55%(12/22),明显高于对照组的21.74%(5/23)(P<0.05)。观察组主要不良反应有白细胞减少、血小板减少、贫血、恶心呕吐、口腔黏膜炎、腹泻,无Ⅳ级不良反应;对照组仅1例出现轻度恶心反应。结论替吉奥胶囊单药治疗晚期NSCLC有一定的疗效,不良反应可以耐受,安全性良好。

Objective To observe the short-term efficacy and adverse reactions of S-1 in the treatment of advanced non-small-cell lung cancer（NSCLC）.Methods Forty-five patients with advanced NSCLC confirmed by histopathology were randomly divided into two groups. The observation group （n=22） was treated with S^-1 80 mg·d^-1 twice daily （morning and evening） for consecutive 28 days and was simultaneously given routine supportive treatment. Then the drug was discontinued for 2 weeks. Each treatment cycle was 6 weeks. The control group （n=23） was treated with Chinese patent medicine （Aidi-injection） and best supportive care. The short-term efficacy and adverse reactions were evaluated after 2 weeks. Results The disease control rate in observation group （54.55%,12/22） was significantly higher than that in control group （21.74%,5/23）.The main adverse reactions included leucopenia, thrombocytopenia, anemia, nausea, vomiting, oral mucositis and diarrhea in observation group. No grade Ⅳ adverse reactions were found in observation group.Only 1 patient had mild nausea in control group. Conclusion The S-1 is an effective and safe treatment with acceptable toxicity in patients with advanced NSCLC.