摘要
目的探索中大剂量的抗血管药物沙利度胺(Thalidomide)和TACE对中晚期原发性肝癌的协同治疗作用以及相关不良反应。方法以肿瘤标记物、影像学改变、生存期、无病进展生存期(PFS)生活状况为观察指标;采用前瞻性随机对照、双盲研究,对符合入组的中晚期原发性肝癌47例病例随机分为治疗组和对照组,治疗组给予沙利度胺200～1 000 mg/d(中位剂量500mg/d,95%的可信区间300～750 mg)口服2个月以上同时联合TACE治疗;对照组给予纤维素片口服2个月以上同时联合TACE治疗。TACE化疗药物的选择:羟基喜树碱(Hydroxycamptothecine,HCPT)HCPT20 mg/m2,表柔比星(Epirubicin,E-ADM,EPI)EPI 60mg/m2,5-氟尿嘧啶(Fluorouracil,5-Fu)5-Fu 600 mg/m2;栓塞剂采用超液态碘油、明胶海绵,治疗前及治疗后4周作影像学检查、血标记物检查及KPS评分随访生存期且作预后分析。结果研究结果提示对照组与治疗组的中位生存期分别是12.5周(95%的可信区间8.5～16.5周),16周(95%的可信区间8.5～23.5周)两者差异无统计学意义(P>0.05);其无病进展生存期(Progres-sion-Free Survival,PFS)的中位时间分别为96 d(95%的可信区间61～131 d)和152 d(95%的可信区间83～221 d)两者差异有统计学意义(P<0.05);不良反应方面:治疗组与对照组在嗜睡、纳差、乏力的发生率差异有统计学意义(P<0.05)。结论中大剂量沙利度胺联合TACE较单纯TACE能延长无病进展生存期,并适当延长中位生存期,其不良反应为大多数患者耐受。
Objective This study aimed to explore middle-high doses of anti-angiogenic drug thalidomide and TACE for advanced primary liver cancer synergistic therapeutic effect as well as related adverse reactions.Methods The tumor markers,imaging changes,survival,progression-free survival(PFS) were used to observe the conditions of life indicators;using prospective randomized controlled,double-blind study,in our hospital from October 2005 to June 2007,47 cases of liver cancer patients were randomly divided into treatment group and control group,treatment group were given thalidomide 200-1 000 mg/d [median dose 500 mg/d,95% confidence interval(CI),300-750 mg]orally two months over the same time,combined TACE treatment;the control group were given cellulose tablet two months over the same time,combined TACE treatment.TACE chemotherapy options: Hydroxycamptothecine(HCPT):20 mg/m2;Epirubicin(EPI) :60 mg/m2;5-Fluorouracil(5-Fu): 600 mg/m2,super-liquid embolic agent lipiodol,gelatin sponge,treatment for four weeks before and after treatment imaging examination,blood markers inspection and follow-up KPS score and for prognosis of survival.Results For the control group and treatment group,the median survival time was 12.5 months(95%CI 8.5-16.5 months),and 16 months(95%CI 8.5-23.5 months) respectively,the difference was not statistically significant(P>0.05);regarding their PFS,the median time was 96 days(95%CI 61-131 days),and 152 days(95%CI 83-221 days) respectively,the difference was statistically significant(P<0.05).Adverse reactions: lethargy,anorexia,fatigue and the incidence had significant differences(P<0.05) between the treatment group and control group.Conclusion Compared with TACE alone,High-dose thalidomide combined TACE can prolong PFS,and an appropriate extension of median survival time,adverse reactions were tolerated in most patients.
出处
《安徽医学》
2009年第12期1419-1422,共4页
Anhui Medical Journal
关键词
原发性肝癌
肝动脉栓塞化疗
血管内皮生长因子
沙利度胺
无病进展生存期
Primary liver cancer
Transcatheter arterial chemoembolization
Vascular endothelial growth factor
Thalidomide
Progression-free survival
