八宝丹胶囊联合肝动脉栓塞化疗治疗原发性肝癌的临床疗效

Clinical effect of Babaodan capsules combined with transcatheter arterial chemoembolization therapy in patients with primary hepatocellular carcinoma

目的 观察八宝丹胶囊联合肝动脉栓塞化疗（TACE）治疗巴塞罗那分期（BCLC分期）B期原发性肝癌的临床疗效.方法 收集2010年5月至2013年3月就诊于福建省肿瘤医院介入科的BCLC分期B期且不能手术的原发性肝癌患者32例作为治疗组,按照配对研究方法选取同期行单纯TACE治疗的BCLC分期B期原发性肝癌患者64例作为对照组.治疗组采用TACE联合八宝丹胶囊进行治疗;对照组采用单纯TACE治疗.比较两组肿瘤客观缓解率（ORR）、疾病进展时间（TTP）、总生存（OS）时间、TACE后1周肝功能变化及栓塞后综合征的差异.计量资料比较采用t检验,计数资料比较采用χ2检验.采用Kaplan-Meier法进行生存分析,Log-rank法进行检验.结果 治疗组和对照组TACE术后1.5个月的ORR分别为75.0%、81.3%（P=0.477）;中位TTP分别为8.9个月（95% CI 3.1-14.7个月）、5.5个月（95% CI 4.3-6.7个月）（P=0.048）;中位OS时间分别为16.0个月（95% CI 8.0-24.0个月）、12.0个月（95% CI 11.0-13.0个月）（P=0.159）.对照组TACE术后血清丙氨酸氨基转移酶升高明显,与治疗组比较,差异有统计学意义（P=0.018）.治疗组第1次TACE术后,美国国家癌症研究所常见不良事件评价标准2级以上疼痛的发生率低于对照组,两组差异有统计学意义（P=0.019）.结论 八宝丹胶囊联合TACE治疗中晚期肝癌,可在一定程度上减少TACE术后疼痛的发生,改善术后肝损害,延长术后疾病进展时间.

Objective To evaluate the effect of Babaodan capsules combined with transcatheter arterial chemoembolization （TACE） therapy in patients with BCLC stage B primary hepatocellular carcinoma （HCC）. Methods A total of 32 patients with BCLC B primary hepatocellular carcinoma who cannot be treated with operation in the Department of Oncology in Fujian Province Cancer Hospital from May 2010 to March 2013 were enrolled in the experimental group. According to paired design, 64 patients with BCLC B primary liver cancer who were treated with only TACE were as control. The patients of experimental group were treated with Babaodan capsules combined with TACE, and the patients of control group were treated with only TACE. Overall response rate （ORR）, time to progression （TTP）, overall survival （OS）, liver function change 1 week after TACE, and post-embolization syndromes were analyzed. Measurement data were compared using t test, count data were compared with χ^2test. Kaplan-Meier method was used for survival analysis, and Log-rank method for testing. Results The ORR 1.5 month after TACE was 75.0%in experimental group and 81.3%in control group（P=0.477）. The median TTP was 8.9 months（95%CI 3.1-14.7 months） in experimental group, and 5.5 months （95%CI 4.3-6.7 months） in control group （P=0.048）. The median OS time was 16 months（95%CI 8.0-24.0 months） in experimental group, and 12 months（95%CI 11.0-13.0 months） in control group （P=0.159）. Compared with the experimental group, the alanine transaminase 1 week after TACE in control group increased obviously （P=0.018）. The incidence rate of ≥CTCAE grade 2 pain after the first time TACE in experimental group was lower than that in control group（P=0.019）. Conclusion Babaodan capsules could reduce pain of HCC patients after TACE, improve liver damage after TACE,and prolong the TTP of patients with BCLC stage B HCC.