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目的:探讨低剂量延时静脉滴入吉西他滨联合顺铂方案治疗晚期非小细胞肺癌(NSCLC)的临床疗效和安全性。方法:60例ⅢB～Ⅳ期NSCLC患者随机分为治疗组(30例)和对照组(30例)。治疗组采用吉西他滨低剂量延时静脉滴入联合顺铂方案治疗:吉西他滨250mg/m2加入500mL生理盐水,6h持续静脉滴入,d1、d8;顺铂75mg/m2加入500mL生理盐水,d1、d3,每21d重复。对照组治疗方案:吉西他滨1000mg/m2加入100mL生理盐水,30min静脉滴入,d1、d8;顺铂75mg/m2加入500mL生理盐水,d1、d3,每21d重复。治疗周期结束后评价近期疗效、观察毒副反应,随访1年评价客观疗效和生存率。结果:治疗组近期临床疗效有效率为40.0%,高于对照组(36.7%),但两组比较差异无统计学意义,P>0.05;治疗组1年生存率、平均随访时间和中位疾病进展时间显著高于对照组,差异均有统计学意义,P<0.05;两组白细胞、血红蛋白、血小板毒性与非血液系统毒性之间差异无统计学意义(P<0.05),但治疗组Ⅲ～Ⅳ度的白细胞、血小板毒性和恶心、呕吐发生率低于对照组,差异有统计学意义,P<0.05。结论:低剂量延时静脉滴入吉西他滨联合顺铂方案治疗晚期NSCLC临床疗效肯定,毒副反应小,值得临床推广。
Objective: To investigate the clinical efficacy and safety of low-dose delayed intravenous infusion of gemcitabine combined with cisplatin in the treatment of advanced non-small cell lung cancer (NSCLC). Methods: Sixty patients with stage ⅢB-Ⅳ NSCLC were randomly divided into treatment group (30 cases) and control group (30 cases). The treatment group was treated with low-dose delayed intravenous infusion of gemcitabine combined with cisplatin: Gemcitabine 250mg / m2 added 500mL saline, continuous intravenous infusion 6h, d1, d8; cisplatin 75mg / m2 added 500mL saline, d1, d3, Repeat every 21d. Control group treatment: gemcitabine 1000mg / m2 added 100mL saline, intravenous infusion 30min, d1, d8; cisplatin 75mg / m2 added 500mL saline, d1, d3, repeated every 21d. After the end of the treatment period, the curative effect was evaluated and the side effects were observed. The follow-up of 1 year was used to evaluate the objective curative effect and survival rate. Results: The effective rate of clinical treatment in the treatment group was 40.0%, higher than that in the control group (36.7%), but there was no significant difference between the two groups (P> 0.05). The 1-year survival rate, mean follow-up time and median disease The progress time was significantly higher than the control group, the difference was statistically significant, P <0.05; two groups of leukocytes, hemoglobin, platelet toxicity and non-hematological toxicity was no significant difference (P <0.05), but the treatment group Ⅲ ~ Ⅳ degree of white blood cells, platelet toxicity and nausea, vomiting incidence lower than the control group, the difference was statistically significant, P <0.05. Conclusion: The low dose delayed intravenous injection of gemcitabine combined with cisplatin regimen in the treatment of advanced NSCLC clinical efficacy of certain side effects, worthy of clinical promotion.