CAJ | 학술논문

目的：比较奥沙利铂联合多西他赛(TOMOX)与奥沙利铂联合5-氟尿嘧啶和亚叶酸（FOLFOX4）两种方案作为原发性肝癌一线化疗药物的疗效。方法采用奇偶数随机分组方法，将183例患者随机分为FOLFOX4组91例，TOMOX组92例。FOLFOX4组在治疗的第1~2天用亚叶酸200 mg/m2、5-FU片剂400 mg/m2联合静脉持续注射600 mg/m25-FU ，以后每天85 mg/m2奥沙利铂，每2周为一个疗程。TOMOX组每天注射3 mg/m2多西他赛15 min，45 min后注射130 mg/m2奥沙利铂，3周为一个疗程。本研究治疗终止时间为出现进展性疾病(PD)，患者死亡或不可耐受的毒性。主要观察指标为肿瘤反应率(ORR)、完全缓解(CR)、部分缓解(PR)、稳定(SD)和进展(PD)。次要目标有生存期(OS)、无时进展生存期(PFS)和药物毒性反应等。结果 FOLFOX4组的ORR为36.3%，TOMOX组为45.6%，两组比较差异有统计学意义(χ2=3.046，P=0.032)。药物毒性发生率方面，FOLFOX4组发生白细胞减少和中性粒细胞减少的比例明显高于TOMOX组，差异均有统计学意义(χ2=6.397，P=0.028；χ2=8.906，P=0.032)。结论 TOMOX疗法具有安全稳定等特点，可以作为氟尿嘧啶一种很好的替代方案。
목적：비교오사리박연합다서타새(TOMOX)여오사리박연합5-불뇨밀정화아협산（FOLFOX4）량충방안작위원발성간암일선화료약물적료효。방법채용기우수수궤분조방법，장183례환자수궤분위FOLFOX4조91례，TOMOX조92례。FOLFOX4조재치료적제1~2천용아협산200 mg/m2、5-FU편제400 mg/m2연합정맥지속주사600 mg/m25-FU ，이후매천85 mg/m2오사리박，매2주위일개료정。TOMOX조매천주사3 mg/m2다서타새15 min，45 min후주사130 mg/m2오사리박，3주위일개료정。본연구치료종지시간위출현진전성질병(PD)，환자사망혹불가내수적독성。주요관찰지표위종류반응솔(ORR)、완전완해(CR)、부분완해(PR)、은정(SD)화진전(PD)。차요목표유생존기(OS)、무시진전생존기(PFS)화약물독성반응등。결과 FOLFOX4조적ORR위36.3%，TOMOX조위45.6%，량조비교차이유통계학의의(χ2=3.046，P=0.032)。약물독성발생솔방면，FOLFOX4조발생백세포감소화중성립세포감소적비례명현고우TOMOX조，차이균유통계학의의(χ2=6.397，P=0.028；χ2=8.906，P=0.032)。결론 TOMOX요법구유안전은정등특점，가이작위불뇨밀정일충흔호적체대방안。
Objective To compare the clinical efficacy of docetaxel combined with oxaliplatin (TOMOX), docetaxel combined with 5-fluorouracil and folinic acid (FOLFOX4) as first-line chemotherapy drugs for primary liv-er cancer. Methods Based on odd/even randomized method, 183 patients were divided into FOLFOX4 group of 91 cases and TOMOX group of 92 cases. FOLFOX4 group was treated with 200 mg/m2 folinic acid, 400 mg/m2 5-FU tablets combined with continuous intravenous injection of 600 mg/m2 5-FU on day 1~2, followed by 85 mg/m2 oxalipl-atin every day, with 2 weeks as a course of treatment. TOMOX group applied daily injections of 3 mg/m2 docetaxel for 15 min, followed by injection of 130 mg/m2 oxaliplatin 45 min later, with 3 weeks as a course of treatment. Time for termination was progressive disease (PD), death or intolerable toxicity. Main indicators observed were tumor response rate (ORR), complete remission (CR), partial remission (PR), stable disease (SD) and progressive disease (PD). The secondary indicators include overall survival (OS), progression free survival (PFS) and drug toxicity reactions. Results ORR was 36.3% in FOLFOX4 group and 45.6% TOMOX group, with statistically significant difference between the two groups (χ2=3.046, P=0.032). For drug toxicity reactions, the incidence of leukopenia and neutropenia in the FOLFOX4 group were significantly higher than TOMOX group (χ2=6.397, P=0.028;χ2=8.906, P=0.032). Conclusion TOMOX therapy has good security and stability, which can be used as an alternative to fluorouracil.