摘要
目的:比较标准剂量和小剂量吉西他滨对根治术后胰腺癌辅助化疗的疗效及安全性。方法:采用随机双盲平行对照的临床试验方法,以疾病相关症状改善、生存分析及毒副反应为结局终点指标,比较标准剂量(1000mg/m2)和小剂量(500mg/m2)吉西他滨辅助化疗根治术后胰腺癌的疗效及安全性。结果:2005年1月至2007年3月间符合标准的患者共83例,随机分组后患者性别、年龄等具有基线可比性(P>0.05)。意向性治疗分析和方案分析均显示标准剂量组和小剂量组疾病相关症状改善及术后生存均相当(P>0.05),而毒副反应,尤其是血液系统毒性在标准剂量组高于小剂量组(P<0.05)。结论:小剂量吉西他滨对根治术后胰腺癌辅助化疗的疗效和标准剂量相当,而毒副反应减少。
Objective：To compare standard-dose and low-dose gemcitabine adjuvant chemotherapy for pancreatic cancer after radical operation,assessing its efficacy and safety.Methods：A randomized double-blind,parallel-controlled clinical trial was used in this study,disease-related symptoms improved,survival analysis and toxicity as the end point for the outcome indicators to compare standard-dose（1 000 mg/m2） and low-dose（500 mg/m2） gemcitabine adjuvant chemotherapy after radical resection of pancreatic cancer.Results：From January 2005 to March 2007,83 patients who meet the criteria were enrolled in the study.The baseline in two groups was the same（P 0.05）.Intention to treat analysis and per-protocol analysis have shown that disease-related symptom improvement and survival were the same in two groups（P0.05）,but toxicity,especially hematologic toxicity in standard-dose group was higher than that in the low-dose group（P0.05）.Conclusion：Low-dose gemcitabine was efficacy for pancreatic cancer after radical resection,but the toxicity reduced compared with standard-dose chemotherapy.
出处
《重庆医科大学学报》
CAS
CSCD
北大核心
2010年第3期436-439,共4页
Journal of Chongqing Medical University
关键词
胰腺癌
根治术
化疗
吉西他滨
随机对照临床研究
Pancreatic cancer
Radical resection of pancreatic cancer
Chemotherapy
Gemcitabine
Randomized controlled clinical study
