Azab Mohamed, Zaki Samy, El-Shetey Anwar G, Abdel-Moty Mohamed F, Alnoomani Nabil M G, Gomaa Ahmad A, Abdel-Fatah Sabry, Mohiy Sayed, Atia Faried
Department of Tropical Medicine, Al-Azhar University, Cairo, Egypt.
Arab J Gastroenterol. 2011 Sep;12(3):113-8. doi: 10.1016/j.ajg.2011.07.005. Epub 2011 Sep 7.
Hepatocellular carcinoma (HCC) is a major burden on health-care systems worldwide. Although radiofrequency ablation (RFA) is currently considered the best technique for coagulative necrosis, the superiority of concomitant use of RFA and percutaneous ethanol injection (PEI) needs to be determined. The study was designed to compare efficacy, safety and rate of survival of patients with HCC assigned to receive combined PEI-RFA versus RFA alone and versus PEI alone.
This 3-year study enrolled 90 cirrhotic patients with HCC (Child's class A or B, but not class C). They were randomly assigned for either PEI-RFA (group I), RFA alone (group II) or PEI alone (group III). The primary end point was ablation of the tumour. The secondary end point was rate of survival and recurrence.
After the first session, complete ablation was significantly higher in the combination group (87.9%) compared with the RFA group (54.54%). After the second session, complete ablation was achieved in 97.0% of the combination group and in 84.8% of the RFA group. Regarding the PEI group, 75% had complete ablation, whereas 25% had partial ablation after multiple sessions. The survival rate, 1.5 years later, was significantly higher in group I (86.7%) compared with group III (63.3%). The overall incidence of serious adverse events was nil.
Combined treatment is superior to RFA alone and to PEI alone, in safety and efficacy in patients with HCC.
肝细胞癌(HCC)是全球医疗保健系统的一项重大负担。尽管射频消融(RFA)目前被认为是实现凝固性坏死的最佳技术,但RFA与经皮乙醇注射(PEI)联合使用的优势仍有待确定。本研究旨在比较接受PEI-RFA联合治疗、单纯RFA治疗和单纯PEI治疗的HCC患者的疗效、安全性和生存率。
这项为期3年的研究纳入了90例HCC肝硬化患者(Child's A或B级,但非C级)。他们被随机分配接受PEI-RFA治疗(第一组)、单纯RFA治疗(第二组)或单纯PEI治疗(第三组)。主要终点是肿瘤消融。次要终点是生存率和复发率。
在第一次治疗后,联合治疗组的完全消融率(87.9%)显著高于RFA组(54.54%)。在第二次治疗后,联合治疗组97.0%的患者实现了完全消融,RFA组为84.8%。对于PEI组,75%的患者实现了完全消融,而25%的患者在多次治疗后实现了部分消融。1.5年后,第一组的生存率(86.7%)显著高于第三组(63.3%)。严重不良事件的总体发生率为零。
在HCC患者的安全性和疗效方面,联合治疗优于单纯RFA治疗和单纯PEI治疗。