碘化油联合或不联合无水乙醇灌注化疗栓塞治疗中晚期肝细胞癌的安全性和有效性分析

The Safety and Efficacy of Lipiodol with or without Ethanol Chemoembolization in the Treatment of Advanced Hepatocellular

摘要: 目的：验证碘化油加无水乙醇行肝动脉灌注化疗栓塞治疗中晚期肝细胞癌的安全性以及效果是否优于单用碘化油。方法：收集随访资料完整的中晚期肝细胞癌患者45例。根据碘化油是否混合无水乙醇进行栓塞分为观察组(碘化油乙醇混合液，23例)和对照组(碘化油，22例)。比较两组患者的毒副反应以及疗效。结果：观察组平均无进展生存时间(PFS)为6.44 ± 0.65月，对照组为4.68 ± 0.56月，差异有统计学意义(P < 0.05)；观察组与对照组疾病进展风险比(HR)为0.59，观察组疾病进展风险更小，但无统计学差异(P > 0.05)。术后一周内观察组患者肝区肿瘤性疼痛症状减轻较对照组明显，有统计学差异(P < 0.05)。此外，不良反应发生率、术后一周ECOG改善情况、术后1个月碘化油沉积情况、3个月mRECIST疗效评价及第二次介入治疗间隔时间均未观察到统计学差异(P > 0.05)。采用无水乙醇加碘化油栓塞对碘化油栓塞的临床净获益为53.4。结论：碘化油加无水乙醇行肝动脉灌注化疗栓塞治疗中晚期肝细胞癌可延长患者无疾病进展生存时间，显著地改善肿瘤相关疼痛，经济负担小并且安全、简便、实用，值得推广。但是否有总生存的获益还需要长期、大样本的随机对照研究证实。

Abstract: Objective: To evaluate the safety and efficacy of ethanol-Lipiodol in the treatment of advanced hepatocellular carcinoma (HCC). Methods: 45 HCC patients who received TACE and were followed up at least once were enrolled. 23 in the treatment group were administered with ethanol-lipiodol (mixture 1:10 of Ethanol and Lipiodol) based transarterial chemo-embolization (TACE), while 22 patients in the control group were treated with lipiodol based TACE. Adverse and curative effects of two groups were compared. Results: In the treatment group, cancerous pain of one week post-operation was alleviated significantly (P < 0.05). The mean progression-free survival time (PFS) of the treatment group was significantly longer (6.44 ± 0.65 vs. 4.68 ± 0.56 months P < 0.05). The PFS hazard ratio (HR) was 0.59. Although the risk of disease progression in the observation group was smaller, there was no statistical significance (P > 0.05). There were no significant differences detected between the two groups in the incidence of adverse reactions (P > 0.05), the improvement of ECOG one week post-operation (P > 0.05), the deposition of iodized oil 1 - 3 months post-operation (P ≥ 0.05), the mRECIST of 1 - 3 months (P > 0.05) and the interval between the first to the second TACE (P > 0.05). Ethanol-lipiodol group had a net health benefit of 53.4. Conclusion: Compared to lipiodol TACE, ethanol-Lipiodol TACE was superior in cancerous pain lessening and PFS. Ethanol-Lipiodol TACE is safe, feasible and prolongs PFS. Large-scale randomized controlled trials were needed to identify whether the ethanol-Lipiodol TACE can prolong overall survival of HCCs.