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出 处:《中国新药杂志》2010年第17期1589-1592,共4页Chinese Journal of New Drugs
摘 要:目的:评价复方苦参注射液联合FOLFIRI方案(亚叶酸钙+氟尿嘧啶+伊立替康)与单纯FOLFIRI方案治疗转移性或复发性晚期大肠癌的疗效及不良反应。方法:将转移性或复发性晚期大肠癌患者100例随机分为试验组和对照组,每组各50例。试验组接受复方苦参注射液联合FOLFIRI方案,对照组单用FOLFIRI方案,至少治疗4个周期以上进行疗效评价。结果:试验组可评价疗效50例:部分缓解(PR)21例,稳定(SD)20例,总有效率为42.00%;对照组可评价疗效48例:PR 19例,SD 18例,总有效率为39.58%;两组疗效比较差异无显著性(P>0.05)。试验组中32例癌痛患者治疗后癌痛缓解率为81.25%;对照组中29例癌痛患者治疗后癌痛缓解率为51.72%,两组有显著性差异(P<0.05)。试验组生活质量Karnofsky评分提高率58.00%;对照组提高率28.00%,两组有显著性差异(P<0.05)。试验组白细胞减少的发生率,消化道反应(恶心呕吐、腹泻)发生率和肝肾毒性显著少于对照组(P<0.05)。结论:复方苦参注射液能够减少FOLFIRI方案化疗不良反应,增加患者化疗耐受性,提高生活质量。Objective: To observe and compare the efficacy and toxicity of compound matrine injection combined with FOLFIRI regimen(CPT-11 plus 5-Fu/Lv) or FOLFIRI regime alone in the treatment of patients with advanced colorectal cancer.Methods: Patients with advanced colorectal cancer diagnosed pathologically and imageologically(n=100) were randomly divided into 2 groups.They were treated with compound matrine injection combined with FOLFIRI regimen(matrine group,n=50),or FOLFIRI regimen alone(control group,n=50).Each patient received at least 4 cycles;the efficacy and toxicity were then evaluated.Results: In 50 patients of matrine group and 48 patients in control group,the efficacy could be evaluated.The overall response rate was 42.0% in matrine group and 39.58% in control group(P0.05).The pain remission rate was 81.25% in matrine group and 51.72% in control group(P0.05).The increase rate of Karnofsky score for the quality of life was 58.0% in matrine group and 28.0% in control group(P0.05).The incidence rates of leucopenia,gastrointestinal reactions,hepatotoxicity and renal toxicity were significantly lower in matrine group than in control group.Conclusion: Compound matrine injection can reduce toxic effects of FOLFIRI chemotherapy,enhance patients' tolerance to chemotherapy and improve patients' quality of life.
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