肝恶性肿瘤不可逆电穿孔消融的安全性和近期疗效

Safety and short-term effect of irreversible electroporation ablation of hepatic neoplasms

目的：探讨应用不可逆电穿孔（IRE）技术，消融不可手术切除肝恶性肿瘤的安全性及短期疗效。方法2015年7月17日至12月24日前瞻性收集经病理学确诊为原发性肝癌或肝恶性转移瘤患者，且不适合外科手术、术前功能状态（PS）评分≤2，排除不能耐受气管全身麻醉、严重肝肾功能不全、安装心脏起搏器的患者，共16例纳入研究，男12例、女4例，年龄40～86岁，平均（60＆#177;10）岁。在B超和CT引导下经皮IRE消融治疗。观察术中血流动力学的改变；采用双侧t检验比较手术前后7 d内肝、肾功能变化；记录术后30 d内治疗的不良反应。术后1个月复查CT或MR，应用改良实体瘤疗效评价标准（RECIST）评价其短期疗效。结果所有患者IRE手术均顺利完成。术后30 d内不良反应腹痛7例次、腹腔积液5例次、胸腔积液4例次、发热3例次、咳嗽及恶心呕吐各2例次、胆道感染及血小板减少各1例次，均经对症治疗后好转；未发生治疗相关大出血、胆漏等严重并发症。术后24 h肝功谷氨酸转移酶（ALT）、天冬氨酸转移酶（AST）一过性升高至（637＆#177;597）U/L、（510＆#177;396）U/L，予以保肝处理后7 d恢复正常。术后1个月疗效评价：完全缓解1例、部分缓解12例、稳定2例、进展1例，肿瘤缓解率81.3%。结论 IRE消融不可手术切除肝恶性肿瘤，安全性高、不良反应轻微、近期疗效较好，长期疗效有待长时间随访观察。

Objective To explore the safety and short？term efficacy of irreversible electroporation （IRE）ablation which is a novel ablation technology in unresectable hepatic neoplasms. Methods Patients with pathologically diagnosed as liver cancer or liver metastases were prospectively enrolled. The patients were not suitable for surgery with PS score ≤ 2. Exclusion criteria included who was not tolerate general anesthesia, severe liver and kidney dysfunction, and with cardiac pacemaker. A total of 16 patients were included in this study. There was 12 males and 4 females, aged 40 to 86 years with mean age （60 ＆#177; 10）y. Ultrasound and CT guided percutaneous IRE ablation was performed. Perioperative hemodynamic changes were reviewed. Liver and kindey function before and 7 d after ablation was compare by t test. The adverse reactions within 30 d after ablation treatment were recorded. CT and MR scans within 1 month were performed and the 30 d curative effect was evaluated by the modified RECIST criteria. Results All patients received IRE treatment successfully, and some patients experienced adverse reactions within 30 days after ablation, including abdominal pain in 7 cases, peritoneal effusion in 5 cases, hydrothorax in 4 cases, fever in 3 cases, cough, nausea and vomiting in 2 cases, biliary tract infection and thrombocytopenia in 1 case. After symptomatic treatment, these symptoms were improved. Severe complications, such as massive haemorrhage and bile leakage didn＆#39;t occur. At 30 days after ablation, the curative effects were evaluated. Complete response （CR） was achieved in 1 patient , partial response （PR） was achieved in 12 patients, stable disease （SD） was in 2 patients , and progressive disease（PD） was 1 patients . The tumor relief rate （complete response＋partial response） was 81.3%. Conclusions IRE ablation in the treatment of unresectable hepatic malignant tumor could have many advantages, including high safety, mild adverse reactions, and short？term efficacy. However, its long？term effect still need further observation.