经肝动脉化疗栓塞术联合沙利度胺或索拉非尼治疗不可切除原发性肝癌的效果比较

Therapeutic effect of transcatheter arterial chemoembolization combined with thalidomide or sorafenib in treatment of unresectable primary liver cancer: a comparative analysis

目的探讨经肝动脉化疗栓塞术(TACE)联合沙利度胺及TACE联合索拉非尼两种化疗方式对不可切除性原发性肝癌患者的治疗效果。方法收集2012年1月-2013年8月在陕西省核工业215医院进行两种方式治疗的原发性肝癌患者102例作为研究对象,随机分为TACE联合沙利度胺组(49例)和TACE联合索拉非尼组(53例),对其近期疗效、远期疗效、治疗前后相关化验指标变化及不良反应进行评价。计量资料组间比较采用成组t检验,组内比较采用配对t检验,计数资料组间比较采用χ2检验,采用生存曲线对生存数据进行分析,并采用Log-Rank检验进行比较。结果两组在客观缓解率、疾病控制率等近期疗效方面差异均无统计学意义(P值均>0.05)。两组患者的2年生存率差异有统计学意义(χ2=4.692,P=0.03)。两组患者总生存时间及中位无疾病进展生存时间差异均有统计学意义(χ2值分别为8.267、6.896,P值分别为0.004、0.009)。两组患者甲胎蛋白及GGT治疗后组间比较差异均有统计学意义(t值分别为2.035、2.843,P值分别为0.038、0.025)。两组患者在恶心呕吐、头晕头痛、皮疹脱屑及血压升高4个不良反应方面的差异均具有统计学意义(P值均<0.05)。结论 TACE联合沙利度胺在与TACE联合索拉非尼具有相同近期疗效的同时可提高患者的远期疗效,还可更显著降低甲胎蛋白及GGT水平,然而也具有恶心呕吐及头晕头痛等不良反应发生率高的不足。

Objective To investigate the therapeutic effect and adverse effects of transcatheter arterial chemoembolization（ TACE） combined with thalidomide or sorafenib in the treatment of unresectable primary liver cancer. Methods A total of 102 patients who underwent TACE combined with thalidomide or sorafenib in 215 Hospital of Nuclear Industry of Shaanxi Province from January 2012 to August 2013 were enrolled and divided into TACE- thalidomide group（ 49 patients） and TACE- sorafenib group（ 53 patients）. The short- term outcome,long- term outcome,changes in related indices,and adverse events were evaluated. The independent- samples t- test was applied for comparison of continuous data between groups,and the paired t- test was applied for comparison of continuous data within one group; the chi- square test was applied for comparison of categorical data between groups; the survival curve was used for survival analysis,and the log-rank test was applied for survival comparison. Results The indices of short- term outcome,objective response rate and disease control rate,showed no significant differences between the two groups. The 2- year survival showed a significant difference between the two groups（ χ2=4. 692,P = 0. 03）. The log- rank test showed that overall survival time and median progression- free survival time showed significant differences between the two groups（ χ2= 8. 267 and 6. 896,P = 0. 004 and 0. 009）. After treatment,alpha- fetoprotein（ AFP） and gamma- glutamyl transpeptidase（ GGT） showed significant differences between the two groups（ t = 2. 035 and 2. 843,P = 0. 038 and 0. 025）. The incidence rates of nausea / vomiting,dizziness / headache,rash / desquamation,and increased blood pressure showed significant differences between the two groups（ all P〈0. 05）. Conclusion TACE combined with thalidomide has the same short- term therapeutic effect as TACE combined with sorafenib and can improve the patient＇s long- term outcome and significantly reduce the levels of AFP and GGT,but it has high incidence of nausea / vomiting and dizziness / headache.