【摘要】 目的 本研究致力于评价盐酸安罗替尼胶囊针对接受了常规二级化疗但仍未获得有效控制的广泛期小细胞肺癌（SCLC）的治疗，研究该药物在常规二级化疗但仍未获得有效控制的广泛期SCLC中的有效性和安全性。方法 选取2018年5月—2018年10月福建省立医院肿瘤内科收治的广泛期SCLC二线化疗后进展或不良反应不能耐受的病例13例，PS 0～2分，予以标准剂量安罗替尼治疗，若患者出现安罗替尼不可耐受不良反应可予以安罗替尼减量，观察分析安罗替尼对二线治疗后的广泛期SCLC疗效及安全性。主要观察指标为无疾病进展时间（PFS）和总生存期（OS）。次要观察指标为神经元特异性烯醇化酶（NSE）水平及安罗替尼的安全性。从而为安罗替尼的应用提供相应的临床依据。结果 经过2～6个周期的治疗，发现安罗替尼的mPFS为5.2个月（95%CI 5.0～5.4）;mOS为7.0个月。安罗替尼的NSE有所降低。虽然总体不良反应比例达到75%，其中3/4级不良反应的比例仅有5%。结论 安罗替尼是一种治疗SCLC的药物，它能够控制疾病的发展，并且有一定的疗效；使用安罗替尼进行SCLC的三线治疗能够显著改善患者的PFS和OS，并且具有较强的安全性和耐受性。更多还原

【Abstract】 Objective This study aims to evaluate the e fficacy and safety of anlotinib hydrochloride capsules in broad-stage small cell lung cancer(SCLC) patients that have received conventional secondary chemotherapy but still received no ef fective control, to study the efficacy and safety of this drug in broad-stage SCLC with conventional secondary chemotherapy but still no effective control. The primary outcome measures were time to no disease progression(PFS) and overall survival(OS). Methods A total of 13 extensive stage SCLC patients were selected who were reated at Fujian provincial hospital medical oncology from May 2018 to October 2018. Among these patients,progression or advers reactions after chemotherapy happened, with PS 0-2 points. the standard dose anlotinib treatment were given to them,and if patients suffered from intolerance advers reactions,the dose of anlotinib can be reduced.The observation and analysis of anlotinib for second-line treatment of extensive SCLC were done for evaluation of drug e fficacy and safety. The primary study endpoints were PFS and OS, and the secondary study endpoints were NSE level and safety of anlotinib,so as to provide the corresponding clinical basis for the promotion and application of anlotinib. Results After two to six cycles of treatment, we found that the mPFS of anlotinib was 5.2 months(95%CI 5.0～5.4); mOS 7.0 months. NSE decreased with anlotinib. Although the overall proportion of side ef fects reached 75%, only the proportion of grade 3/4 side ef fects was 5%. Conclusion Anlotinib is a treatment for SCLC that controls the development of the disease and has some e fficacy; Third-line treatment of SCLC with anlotinib can significantly improve PFS and OS and has strong safety and good tolerability.更多还原