摘要
目的 :评价国产注射用盐酸拓扑替康 (TPT)治疗小细胞肺癌的疗效和不良反应 ,并与卡铂加依托泊苷进行比较。方法 :入组小细胞肺癌 47例 ,随机分为TPT单药组 32例和对照组 15例 (卡铂加依托泊苷 )。单药组用TPT 1.2 5mg·m-2 ·d-1,静滴 >30min ,d1～d5 ;每 3周重复 1次。对照组用卡铂 30 0mg·m-2 ,静滴 ,d1;依托泊苷6 0mg·m-2 ·d-1,静滴 >6 0min ,d1～d5 ;每 3周重复 1次。治疗 2周期后评价疗效 ,有效病例 4周后确认疗效。结果 :单药组有效率 37.9% ,对照组有效率 6 6 .7% ,对照组高于单药组 ,但无显著性差异 (P >0 .0 5 )。主要不良反应为中性粒细胞减少 ,二者Ⅲ /Ⅳ度毒性单药组为 43.8% ,对照组为 2 0 .0 % ,无显著性差异 (P >0 .0 5 )。 2组非血液学毒性均轻微。结论 :国产注射用TPT单用和卡铂加依托泊苷比较治疗小细胞肺癌疗效相似 ,特别对复发小细胞肺癌疗效较好 ,耐受性良好 ,值得进一步深入临床研究。
Objective:To evaluate the efficacy and safety of d omestic TPT in treatment of SCLC (small cell lung cancer).Methods:47 patients with SCLC were randomly divided to receive TPT( n =32) or CBP(carboplatin)plus etoposide( n =15).In the active group,patients were treated with 1.25 mg·m -2 ·d -1 TPT given by infusion during 30 minutes in d1～d5 and repeated every 3 weeks.In the control group,they were trea ted with 300 mg·m -2 CBP given by infusion at day 1 plus 60 mg·m -2 ·d -1 etoposide given by infusion during>60 minutes in d1～d5 and repeated every 3 weeks.The efficacy was evaluated after 2 cycles of treatment and confir med after 4 cycles.Results:The response rate was 37.9% in active group and 66.7% in contr ol group.The figure in control group was superior to that of active group,howeve r,there was no significant difference( P >0.05).The main toxicity was neutrope nia of degree Ⅲ/Ⅳ with an incidence rate of 43.8% in active group vs 20.0% in control group.There was no significan t difference( P >0.05) among groups in toxicity.Mild non hematological toxici ty was also observed.Conclusion:The efficacy of domestic TPT is similar to that of CBP plus etoposide in treatment of SCLC,especially of recurrent SCLC.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2001年第10期760-763,共4页
Chinese Journal of New Drugs
关键词
盐酸拓扑替康
小细胞肺癌
化学治疗
topotecan hydrochloride
small cell lung cancer
che motherapy
