CAJ | 학술논문

目的观察单硝酸异山梨酯对长春瑞滨和顺铂治疗ⅢB～Ⅳ期初治非小细胞肺癌(NSCLC)的化疗增敏作用.方法 110例ⅢB～Ⅳ期初治的NSCLC患者采用随机数字表方法随机分为试验组(A组,57例,长春瑞滨+顺铂+单硝酸异山梨酯缓释片)和对照组(B组,53例,长春瑞滨+顺铂),2周期化疗后,按实体瘤疗效评价标准(RECIST) 1.1评价近期疗效,按美国国立癌症研究所抗癌药物不良反应评定标准(NCI-CTC) 3.0评价不良反应,并随访至疾病进展.结果 A、B两组有效率分别为58.2％(32/55)和30.8％(16/52),两组间比较,差异有统计学意义(x2=8.120,P=0.004)；中位疾病进展时间分别为8.2个月和5.8个月(x2=10.684,P=0.001)；中位生存期分别为11.6个月和9.0个月(x2=11.231,P=0.001)；鳞状细胞癌的化疗效果更好(RR=2.438,95％ CI为1.136～5.231,P=0.022).A组头痛发生率显著高于B组(P＜0.001),血液学毒性及胃肠道反应两组差异无统计学意义.结论单硝酸异山梨酯可以增加长春瑞滨联合顺铂方案治疗ⅢB～Ⅳ期NSCLC患者化疗的敏感性.
목적 관찰단초산이산리지대장춘서빈화순박치료ⅢB～Ⅳ기초치비소세포폐암(NSCLC)적화료증민작용.방법 110례ⅢB～Ⅳ기초치적NSCLC환자채용수궤수자표방법수궤분위시험조(A조,57례,장춘서빈+순박+단초산이산리지완석편)화대조조(B조,53례,장춘서빈+순박),2주기화료후,안실체류료효평개표준(RECIST) 1.1평개근기료효,안미국국립암증연구소항암약물불량반응평정표준(NCI-CTC) 3.0평개불량반응,병수방지질병진전.결과 A、B량조유효솔분별위58.2％(32/55)화30.8％(16/52),량조간비교,차이유통계학의의(x2=8.120,P=0.004)；중위질병진전시간분별위8.2개월화5.8개월(x2=10.684,P=0.001)；중위생존기분별위11.6개월화9.0개월(x2=11.231,P=0.001)；린상세포암적화료효과경호(RR=2.438,95％ CI위1.136～5.231,P=0.022).A조두통발생솔현저고우B조(P＜0.001),혈액학독성급위장도반응량조차이무통계학의의.결론 단초산이산리지가이증가장춘서빈연합순박방안치료ⅢB～Ⅳ기NSCLC환자화료적민감성.
Objective To investigate the efficacy and safety of isosorbide mononitrate sustained release tables plus vinorelbine and cisplatin in patients with previously untreated advanced non-small-cell lung cancer (NSCLC).Methods One hundred and ten patients with stage ⅢB-Ⅳ NSCLC were randomly assigned to group A (57 cases) and group B (53 cases) by random mumber table.Patients in group A were treated with vinorelbine 25 mg/m2 on the first and eighth day and cisplatin 25 mg/m2 on day 2-4,with transdermally applied isosorbide mononitrate sustained release tables (40 mg,daily for 8 days),and patients in group B were treated with vinorelbine and cisplatin.Response to treatment was assessed by RECIST1.1 and adverse effect was assessed by NCI-CTC(3.0).Results The response rate in group A (58.2％,32/55 patients) was significandy higher than that for patients in group B (30.8％,16/52 patients; x2 =8.120,P =0.004).Median TTP and median OS in group A were longer than those in group B (8.2 vs 5.8 months,x2 =10.684,P =0.001 ; 11.6 vs 9.0 months,x2 =11.231,P =0.001).While,patients with squamous carcinoma showed better response to chemotherapy (RR =2.438,95％ CI:1.136-5.231,P =0.022).Adverse effect difference was not significant between group A and group B,except headache.The rate of grade 1 to 2 headache in group A (34.5％ ; 19 of 55 patients) was significantly higher than that in group B (3.8％ ; 2 of 52 patients; P ＜0.001).Conclusion Use of isosorbide mononitrate sustained release tables combined with vinorelbine and cisplatin may improve overall response,TTP and OS in patients with advanced stage NSCLC.