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机构地区:[1]天津医科大学总医院普外科,天津300052 [2]天津医科大学静海临床学院 [3]静海县医院外二科,天津301600
出 处:《中国临床药理学杂志》2014年第10期904-906,共3页The Chinese Journal of Clinical Pharmacology
摘 要:目的评价沙利度胺联合奥沙利铂(L-OHP)与卡培他滨(CAP)(XELOX)化疗方案与单纯XELOX方案治疗晚期转移性结直肠癌(amCRC)的疗效及安全性。方法 103例晚期转移性结直肠癌患者分为沙利度胺联合XELOX方案化疗(试验组)46例和单纯用XELOX方案化疗(对照组)57例。对照组:静脉滴注L-OHP 130 mg·m-2,持续4 h;口服CAP 1000 mg·m-2,bid,l^14 d;试验组:在对照组基础上口服沙利度胺200 mg,qn,1~14 d;21 d为1周期,化疗3周期后进行疗效评价。结果试验组客观有效率(ORR)为34.8%,显著高于对照组的14.0%(P<0.05);试验组中位疾病进展时间为8.1个月,显著高于对照组6.2个月(P<0.05);2组患者胃肠道反应及血液学毒性差别无统计学意义(P>0.05)。结论沙利度胺联合XELOX化疗方案可提高晚期转移性结直肠癌的临床疗效,延长患者无病生存时间,且不增加患者不良反应。Objective To evaluate clinical efficacy and safety of thalido-mide plus oxaliplatin ( L -OHP) and capecitabine ( CAP) regimen (XELOX) and single XELOX chemotherapy regimen in the treatment of advanced metastatic colorectal cancer ( amCRC ) . Methods One hundred and three subjects with amCRC were recruited and randomly divided into the XELOX (control group, n =57) and XELOX plus tha-lidomide(treatment group, n =46) group.Control group: L -OHP 130 mg·m^-2 through intravenous infusion, lasting for 4 h, CAP 1000 mg· m^-2 , bid, po, l to 14 days. Treatment group: L - OHP 130 mg· m^-2 through intravenous infusion , lasting for 4 h, CAP 1000 mg· m^-2 , bid, po, l to 14 days, as well as thalidomide 200 mg, qn, po, 1 to 14 days.21 days as a cycle.Results The objective response rate (ORR) in treatment group was 34.8%, significantly higher than that of control group (14.0%) (P 〈0.05); the median time to progression in the treatment group was 8.1 months, much longer than that in the control group (6.2 months) (P 〈0.05).No statistical differences of gastrointesti -nal reactions and hematologic toxicity were found between the two groups (P 〉0.05 ) .Conclusion Thalidomide plus XELOX chemotherapy regimen can significantly increase the clinical efficacy on patients with amCRC without increasing adverse reactions .
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