目的 评价重组人P53腺病毒灌注栓塞联合中医药治疗伴门静脉癌栓(PVTT)的原发性肝细胞癌(HCC)的疗效.方法 随访本院2007年1月至2010年8月伴PVTT的HCC共78例,分为治疗组(n=43)和对照组(n=35),选用不同药物经肝动脉灌注栓塞治疗.对照组采用吡柔比星(THP,20~40 mg)、丝裂霉素(MMC,10 mg)、卡铂(CBP,100~300 mg)混合碘油(10~20 ml),治疗组在此基础上加用重组人P53腺病毒注射液(1×1012~4×1012病毒颗粒)灌注栓塞,并于围手术期联合中医药方法治疗.两组疗程每月1次,连续3次,比较栓塞术前后瘤体及门静脉癌栓大小变化情况、血常规、肝功能、甲胎蛋白(AFP)水平及应用Karnofsky评分评定生活质量的变化.结果 治疗组和对照组术后瘤体及PVTT均缩小,有效率分别为79.1%、76.7%和42.9%、40.0%,两组间差异有统计学意义(均P<0.05).治疗组术后白细胞下降率为25.6%,其中Ⅰ级18.6%,Ⅱ级4.7%,Ⅲ级2.3%,Ⅳ级0%,对照组下降率为80.0%,其中Ⅰ级11.4%,Ⅱ级28.6%,Ⅲ级34.3%,Ⅳ级5.7%,两组间下降率及下降程度差异均有统计学意义(均P<0.05).治疗组术后肝功能Child-Pugh A级79.1%,B级16.3%,C级4.7%,而对照组分别为37.1%,31.4%,31.4%,治疗组肝功能好于对照组(P=0.000).治疗组术后AFP下降率和Karnofsky评分提高率均高于对照组(74.4%比40.0%,72.1%比42.9%).但前者差异无统计学意义(P=0.912),后者有统计学意义(P=0.009).结论 重组人P53腺病毒注射液灌注栓塞联合中医药治疗伴PVTT的HCC,能增强抗癌疗效,减轻不良反应,提高患者的生存质量.
Objective To evaluate the efficacy of recombinant adenovirus- P53 (rAd- P53) transcatheter hepatic arterial chemoembolization (TACE) plus traditional Chinese medicine in treatment of primary hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT). Methods Between January 2007 and August 2010, 78 patients with HCC and PVTT registered to our hospital were recruited in this study. The patients were divided into a control group (n=35) to receive TACE using pirarubicin (THP,20~40 mg), mitomycin (MMC, 10 mg), carboplatin (CBP, 100~300 mg) and mixed lipiodol ( 10~20 ml),and a treatment group (n=43) to receive TACE using the same agents as in control group combined with rAdP53 injection ( 1 × 1012~4× 1012 virus particle). During the perioperative period, traditional Chinese medicine were given to the treatment group. The treatments for all patients were delivered monthly for consecutively three months. Changes from baseline in size of primary tumor and PVTT, complete blood counts, liver function, level of alpha fetoprotein (AFP) , and quality of life as measured by Karnofsky score were compared between the two groups. Results Reduction in sizes of the primary tumor and PVTT was found in the control and treatment groups after operation. The effective rates were respectively in 79.1% and 76.7% of patients in treatment vs 42.9% and 40.0% in the control group, with significant differences (all P〈0.05).Leucopenia occurred in 25.6% (including 18.6% with grade Ⅰ , 4.7% with grade Ⅱ , 2.3% with grade Ⅲ and 0% with grade Ⅳ leucopenia) of the patients in the treatment group, compared significantly with 80.0%(including 11.4% with grade Ⅰ , 28.6% with grade Ⅱ , 34.3% with grade Ⅲ and 5.7% with grade Ⅳleucopenia) of patients in control group. There were statistical significance in rate and degree of decline between two groups (all P〈0.05 ). Compared with control group, the patients in treatment group showed better liver functio