国产与进口卡培他滨片用于晚期结直肠癌联合化疗后维持治疗的对照研究
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摘要
目的比较晚期结直肠癌联合化疗后使用国产和进口卡培他滨维持治疗的临床效果及安全性。方法将47例晚期结直肠癌患者随机分为进口组(26例)和国产组(21例),两组分别使用进口和国产卡培他滨片,每天2.5 g/m2,连用14 d,服用14 d后停药7 d,21 d为1个周期。观察两组维持治疗无进展生存期、生活质量及不良反应。结果两组无进展生存期、生活质量改善情况、不良反应发生率比较,差异均无统计学意义(P>0.05)。结论晚期结直肠癌联合化疗后使用国产卡培他滨片维持治疗与进口卡培他滨片相比同样安全有效。
Objective To compare the clinical efficacy and safety of maintenance therapy with imported and domestic capecitabine after chemotherapy in patients with incurable colorectal cancer. Methods Forty-seven patients with incurable colorectal cancer were divided into imported group( 26 cases) and domestic group( 21 cases). The two groups were treated with imported and domestic capecitabine respectively,2. 5 g/m2 daily,d1~ d14,21 days were one cycle. The progression-free-survival( PFS),the changes on quality of life( QOL),and the adverse reactions were observed after maintenance therapy.Results The median PFS,the ratio of improvement and stability in the changes on quality of life( QOL) and the main adverse reactions between the two groups had no significant difference( P < 0. 05). Conclusion It is safe and effective for domestic capecitabine equally compared with imported capecitabine in the treatment of incurable colorectal cancer.
Objective To compare the clinical efficacy and safety of maintenance therapy with imported and domestic capecitabine after chemotherapy in patients with incurable colorectal cancer. Methods Forty-seven patients with incurable colorectal cancer were divided into imported group( 26 cases) and domestic group( 21 cases). The two groups were treated with imported and domestic capecitabine respectively,2. 5 g/m2 daily,d1~ d14,21 days were one cycle. The progression-free-survival( PFS),the changes on quality of life( QOL),and the adverse reactions were observed after maintenance therapy.Results The median PFS,the ratio of improvement and stability in the changes on quality of life( QOL) and the main adverse reactions between the two groups had no significant difference( P < 0. 05). Conclusion It is safe and effective for domestic capecitabine equally compared with imported capecitabine in the treatment of incurable colorectal cancer.
引文
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[6]郭海艳,刘爽,汪晓东,等.卡培他滨在结直肠癌中单用与连用的应用现状[J].华西医学,2012,27(4):613-616.
[7]Hisch B R,Zafar S Y.Capecitabine in the management of colorectal cancer[J].Cancer Manag Res,2011,3:79-89.
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[9]冯娜欣,袁彩君,于兴旭,等.卡培他滨维持治疗老年晚期转移性结直肠癌的生存分析[J].肿瘤防治研究,2014,41(1):65-68.
[10]吴志海,吴大英,郭予武,等.卡培他滨维持治疗转移性结肠、直肠癌的疗效及安全性观察[J].实用临床医药杂志,2012,16(7):85-87.
[2]徐瑞华,邱妙珍.晚期结直肠癌化疗的研究进展[J].癌症,2008,27(6):661-666.
[3]杨冬阳,黎莹,刘建化,等.晚期结直肠癌联合化疗后卡培他滨维持治疗的临床评价[J].南方医科大学学报,2013,3(12):1815-1818.
[4]Aapro M S,Kohne C H,Cohen H J,et al.Never too old?Age should not be a barrier to enrollment in cancer clinical trials[J].Oncologist,2005,10(3):198-204.
[5]方伟达,陈昌南,张呈,等.低剂量替吉奥口服治疗放弃静脉化疗的晚期结直肠癌[J].现代肿瘤医学,2011,19(9):1823-1825.
[6]郭海艳,刘爽,汪晓东,等.卡培他滨在结直肠癌中单用与连用的应用现状[J].华西医学,2012,27(4):613-616.
[7]Hisch B R,Zafar S Y.Capecitabine in the management of colorectal cancer[J].Cancer Manag Res,2011,3:79-89.
[8]Hoff P M.Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer:results of a randomized phaseⅢstudy[J].J Clin Oncol,2001,19(8):2282-2292.
[9]冯娜欣,袁彩君,于兴旭,等.卡培他滨维持治疗老年晚期转移性结直肠癌的生存分析[J].肿瘤防治研究,2014,41(1):65-68.
[10]吴志海,吴大英,郭予武,等.卡培他滨维持治疗转移性结肠、直肠癌的疗效及安全性观察[J].实用临床医药杂志,2012,16(7):85-87.