华蟾素注射液经肝动脉灌注联合碘油栓塞治疗巴塞罗那C期原发性肝癌的效果和安全性

Clinical effect and safety of hepatic arterial infusion of cinobufotalin injection combined with lipiodol chemoembolization in treatment of Barcelona Clinic Liver Cancer stage C primary liver cancer

目的观察华蟾素注射液经肝动脉灌注联合碘油栓塞治疗巴塞罗那C期原发性肝癌的疗效和安全性。方法回顾性分析2010年12月-2014年10月长海医院中医肿瘤科收治的巴塞罗那C期原发性肝癌患者共82例,根据术中用药不同分为2组,其中华蟾素组40例,采用华蟾素肝动脉灌注及碘油栓塞;对照组42例,采用表阿霉素行经肝动脉化疗栓塞术(TACE)治疗。行单次治疗后,比较2组患者的客观缓解率、疾病进展时间、中位生存期和急性不良反应。计量资料组间比较采用t检验,计数资料组间比较采用χ~2检验,累计生存率采用Kaplan-Meier法。结果术后1.5个月时,华蟾素组客观缓解率为27.5%,优于对照组的9.52%(χ~2=4.429,P=0.035);华蟾素组疾病进展时间为2.4个月[95%可信区间(95%CI):1.978~2.822],对照组为3.0个月(95%CI:2.260~3.740),2组比较差异无统计学意义(P=0.344);华蟾素组中位生存期为6.6个月(95%CI:4.131~9.069),对照组为10.3个月(95%CI:0.089~20.511),2组比较差异无统计学意义(P=0.132)。华蟾素组术后第5天ALT、WBC、PLT水平异常以及肝区疼痛、腹胀、恶心呕吐等不良事件的发生率明显低于对照组(χ~2值分别为6.193、5.311、6.096、5.909、4.761、4.173,P值均<0.05)。结论华蟾素注射液经肝动脉灌注联合碘油栓塞治疗巴塞罗那C期原发性肝癌患者,近期疗效优于常规化疗药物TACE,不良反应较轻,远期疗效相仿。

Objective To investigate the clinical effect and safety of hepatic arterial infusion of cinobufotalin injection combined with lipiodol chemoembolization（ TACE） in the treatment of Barcelona Clinic Liver Cancer（ BCLC） stage C primary liver cancer.Methods A retrospective analysis was performed for the clinical data of 82 patients with BCLC stage C primary liver cancer who were admitted to Department of TCM Oncology in Changhai Hospital from December 2010 to October 2014.According to intraoperative medication,the patients were divided into two groups.The 40 patients in the cinobufotalin group were treated with hepatic arterial infusion with cinobufotalin combined with lipiodol embolism,and the 42 patients in the control group underwent TACE with epirubicin.The objective response rate,time to progression,median survival time,and acute adverse events were compared between the two groups after a single treatment.The t- test was used for comparison of continuous data between groups,the chi- square test was used for comparison of categorical data between groups,and the Kaplan- Meier method was used for the analysis of cumulative survival rate.Results At 1.5 months after surgery,the cinobufotalin group had a significantly higher objective response rate than the control group（ 27.5% vs 9.52%,χ~2= 4.429,P = 0.035）.The time to progression was 2.4 months（ 95% CI：1.978- 2.822） in the cinobufotalin group and 3.0 months（ 95% CI：2.260- 3.740） in the control group,and there was no significant difference between the two groups（ P = 0.344）.The median survival time was 6.6 months（ 95% CI：4.131-9.069） in the cinobufotalin group and 10.3 months（ 95% CI：0.089- 20.511） in the control group,and there was no significant difference between the two groups（ P = 0.132）.At 5 days after surgery,the cinobufotalin group had significantly lower incidence rates of abnormal alanine aminotransferase level,white blood cell count,and platelet count,as well as adverse events including hepatalgia,abdominal distension,and nausea / vomiting than the control group（ χ~2= 6.193,5.311,6.096,5.909,4.761,and 4.173,all P〈0.05）.Conclusion As for patients with BCLC stage C primary liver cancer,hepatic arterial infusion of cinobufotalin injection combined with lipiodol chemoembolization has a better short- term therapeutic effect,milder adverse effects,and a similar long- term therapeutic effect compared with TACE with conventional chemotherapeutic agents.