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目的观察评价新一代铂类抗癌药物洛铂(labaplatin,LBP)联合吉西他滨(gemicitabine,GEM)组成的GP方案治疗晚期肺腺癌和晚期小细胞肺癌(SCLC)的安全性。方法开放性、单试验组、Ⅰ期临床研究,共入组2例,均为常规放化疗效果差的患者,男性1例,女性1例,年龄分别为79岁、53岁。病理类型分别为小细胞肺癌(广泛期)、肺腺癌(Ⅳ期)。应用GP方案,即LBP 30 mg/m2,静滴,d1;GEM1 000 mg/m2,静滴,d1,8,21 d为1个周期。其中男性SCLC患者接受1个周期化疗、女性NSCLC患者接受1.5个周期化疗,按照WHO和NCI标准评价客观疗效和毒副反应,定期随访。结果2例毒副反应主要表现为可逆性的骨髓抑制、胃肠道反应、一过性肝损害、脱发,未见明显心肾毒性。结论LBP联合GEM组成GP方案治疗晚期NSCLC和SCLC的毒副反应可以耐受,可进一步研究观察。
Objective To evaluate the safety and safety of a GP regimen consisting of a new generation of platinum anticancer drugs (LBP) and gemicitabine (GEM) in the treatment of advanced lung adenocarcinoma and advanced small cell lung cancer (SCLC). Methods Open, single test group, phase Ⅰ clinical study, 2 cases were enrolled in the study. All of them were patients with poor radiotherapy and chemotherapy. There were 1 males and 1 females, aged 79 and 53 respectively. Pathological types were small cell lung cancer (extensive), lung adenocarcinoma (Ⅳ). Application GP regimen, LBP 30 mg / m2, intravenous infusion, d1; GEM1 000 mg / m2, intravenous infusion, d1, 8, 21 d for a cycle. One male SCLC patients received one cycle of chemotherapy, female NSCLC patients received 1.5 cycles of chemotherapy, according to WHO and NCI criteria to evaluate the objective efficacy and toxicity, regular follow-up. Results The two cases of side effects mainly manifested as reversible myelosuppression, gastrointestinal reaction, transient hepatic injury, hair loss and no obvious cardio-renal toxicity. Conclusion LBP plus GEM GP regimen in the treatment of advanced NSCLC and SCLC toxicity can be tolerated, further study.