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目的比较国产培美曲塞二钠或多西他赛单药用于治疗一线化疗失败的晚期非小细胞肺癌(NSCLC)患者的疗效与安全性。方法 86例既往一线化疗失败或不能耐受的ⅢB或Ⅳ期NSCLC患者分别入培美曲塞二钠组(A组)或多西他赛组(B组),28例患者接受培美曲塞二钠500 mg.m-2治疗,58例患者接受多西他赛75 mg.m-2治疗。入组患者至少接受2个周期以上化疗。结果入组的86例患者均可评价疗效,治疗1年后随访83例,A组27例,B组56例,失访3例。A组和B组的总有效率分别是7.14%和10.34%,疾病控制率分别是67.86%和70.69%,1年的生存率分别为44.44%和55.36%,中位生存期为11.2个月和12.2个月,两组的不良反应主要表现在骨髓控制、肝损伤、恶心/呕吐、乏力及皮疹。A组骨髓抑制的发生率明显低于B组,但皮疹的发生率却明显高于B组。结论对于既往一线化疗失败或不能耐受的晚期NSCLC患者,单药使用培美曲塞二钠或多西他赛进行化疗疗效相似;不良反应各有特点,患者都可以耐受,值得临床推广。
Objective To compare the efficacy and safety of domestic pemetrexed disodium or docetaxel monotherapy in the treatment of patients with advanced non-small cell lung cancer (NSCLC) who failed first-line chemotherapy. Methods A total of 86 patients with stage ⅢB or Ⅳ NSCLC who were previously failed or intolerant to chemotherapy were enrolled in the study. Patients in the group receiving pemetrexed disodium (group A) or docetaxel (group B), and 28 patients receiving pemetrexed Disodium 500mg.m-2 treatment, 58 patients received docetaxel 75mg.m-2 treatment. Patients in the group received at least 2 cycles of chemotherapy. Results All the 86 patients were enrolled in the study. The follow-up of 83 cases after 1 year of treatment was as follow: group A, 27 cases, group B, 56 cases, and no-visit. The total effective rates in group A and group B were 7.14% and 10.34%, respectively. The disease control rates were 67.86% and 70.69% respectively. The 1-year survival rates were 44.44% and 55.36% respectively. The median survival time was 11.2 months. At 12.2 months, adverse reactions in both groups were mainly manifested in bone marrow control, liver injury, nausea / vomiting, fatigue and rash. The incidence of bone marrow suppression in group A was significantly lower than that in group B, but the incidence of rash was significantly higher than that in group B. Conclusion For patients with advanced NSCLC who have failed or can not tolerate first-line chemotherapy, the efficacy of single-agent chemotherapy with pemetrexed disodium or docetaxel is similar. Adverse reactions have their own characteristics and are tolerable and worthy of clinical promotion.