中大剂量沙利度胺联合TACE治疗原发性肝癌临床研究

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。

Clinical research on middle-high dose Thalidomide Combined TACE treatment of primary liver cancer

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 treat...