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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 To explore the synergistic therapeutic effect and related adverse reactions of medium-to-late primary hepatocellular carcinoma (HCC) treated with medium- and large-dose anti-angiogenic agents Thalidomide and TACE. Methods Tumor markers, imaging changes, survival, disease-free survival (PFS) life status as the observation index; prospective randomized controlled, double-blind study, in line with the group of 47 cases of advanced primary liver cancer The patients were randomly divided into treatment group and control group. Patients in the treatment group were given thalidomide 200-1 000 mg / d (median dose 500 mg / d, 95% confidence interval 300-750 mg) orally for more than 2 months TACE treatment; control group given oral administration of cellulose tablets more than 2 months combined with TACE treatment. TACE Chemotherapy Options: HCPT Hydroxycamptothecine (HCPT) 20 mg / m2 Epirubicin EPI EPI 60 mg / m2 Fluorouracil (5-Fu) 5- Fu 600 mg / m2; embolization agent using ultra-liquid lipiodol, gelatin sponge, before and after treatment for 4 weeks for imaging studies, blood markers and KPS score follow-up survival and prognostic analysis. Results The results suggest that the median survival of the control and treatment groups was 12.5 weeks (95% confidence interval 8.5 to 16.5 weeks) and 16 weeks (95% confidence interval 8.5 to 23.5 weeks) (P> 0.05). The median time to progression-free survival (Progres-sion-Free Survival, PFS) was 96 d (95% confidence interval 61-131 d) and 152 d (P <0.05); adverse reactions: the incidence of lethargy, anorexia and fatigue in the treatment group and the control group was statistically significant (P <0.05), the difference between the two groups was statistically significant ). Conclusion High-dose of thalidomide combined with TACE than TACE alone can prolong the progression-free survival and extend the median survival time appropriately. The adverse reactions are tolerated in most patients.