NP方案时辰化疗治疗非小细胞肺癌的临床研究

Clinical study of NP regimen chronochemotherapy in non-smallcell lung cancer

目的:比较长春瑞滨(Vinorelbine,NVB)和顺铂(Cisplatin,DDP)组成的NP方案时辰化疗与常规化疗治疗非小细胞肺癌(NSCLC)的疗效和不良反应。方法:80例非小细胞肺癌患者随机分两组,时辰化疗组38例予NP方案时辰化疗,NVB25mg/m2静脉滴注第1、8天,DDP总量80mg/m2静脉滴注第1～3天,0∶00AM～4∶00AM;常规化疗组42例予NP方案常规化疗,9∶00AM～1∶00PM。每例至少完成2周期化疗方可评价疗效。结果:时辰化疗组有效率(CR+PR)为57.9%(22/38),常规化疗组有效率为35.7%(15/42),两组总有效率比较,差异有统计学意义(P=0.047)。主要不良反应是血液毒性、消化道反应、脱发以及静脉炎,而心脏、肝脏、神经毒性及其他毒性发生率较小;时辰化疗组食欲下降、恶心、呕吐较常规化疗组低(P<0.01),脱发和肝损害也较对照组低(P<0.05)。两组患者治疗后KPS评分升高率在时辰化疗组为74.1%,常规化疗组为60.5%,时辰化疗组KPS评分升高率及升高幅度均高于常规化疗组(P=0.024,P=0.002)。两组疾病进展时间(timetoprogress,TTP)及生存期比较,差异均无统计学意义(P>0.05)。结论:采用NP方案时辰化疗治疗非小细胞肺癌疗效高于常规化疗,毒副反应明显小于常规化疗,且在改善患者生活质量方面更具有优势,值得临床进一步研究。

Objective：To compare the efficacy and toxicity of vinorelbine （NVB） and cisplatin （DDP） combined NP regimen using chrono or conventional chemotherapy in advanced non-small cell lung cancer. Methods：Eighty cases of NSCLC patients were randomly grouped. Thirty-eight cases were treated with NP regimen as chronochemotherapy group： NVB 25mg/m^2 iv gtt d1, d8 ; Total dose of DDP 80mg/m^2 iv gtt d1-3 and chemotherapy proceeded from 0 AM to 4 AM while 42 cases were treated with conventional chemotherapy proceeded from 9 AM to 1 PM as control. Both regimens were repeated every 21-28 days. For needs of evaluation, all patients must complete at least two cycles. Results：The total response rate （PR ＋ CR） in chronochemotherapy and conventional chemotherapy groups were 57.9% （22/38） and 35.7% （15/42） respectively. The difference between two groups had statistical significance （P =0. 047）. The main adverse events of chemotherapy were leucopenia, gastrointestinal discomfort, alopecia and phlebitis. The heart toxicity, liver toxicity, neurotoxicity and other toxicity were mild. The chronochemotherapy group acheived lower rate of decreased appetite, nausea and vomiting （P 〈 0. 01 ） and lower rate of alopecia and liver function disorder than conventional chemotherapy group （P 〈 0. 05 ）. The post-therapy KPS score increased rate in chronochemotherapy and conventional chemotherapy group were 57.9% and 35.7% respectively and the former seemed achieved both higher score increased rate and score grade （ P = 0. 024, P = 0. 002 ）. No difference were found between two groups in time to progress （TIP） and survival time （P 〉 0. 05 ）. Conclusion：The NP regimen chronochemotherapy was more effective than conventional chemotherapy in NSCLC and had lower adverse reactions as well. The chronochemotherapy had more predominance in improving quality of life（QOL） of NSCLC patients and more clinical research and application should be taken.