CAJ | 학술논문

目的：探讨索拉非尼治疗中晚期原发性肝癌的临床疗效、安全性及其预后影响因素。方法回顾性研究我院54例应用索拉非尼治疗3个月以上的中晚期肝癌患者，分析其客观疗效、肿瘤进展时间（TTP）、总生存期（OS）及不良反应的发生情况。结果54例患者服药1.5月后疾病控制率（DCR）为88.9％，服药3月后DCR为72.2％，患者的中位TTP为6.0个月（1.5~11.5个月），中位OS为11.0个月（3.0~40.0个月）。单用索拉非尼和联合索拉非尼治疗的患者，中位TTP和OS比较均无显著性差异（P>0.05），索拉非尼治疗时间<4.5月的患者，中位TTP和OS均较索拉非尼治疗时间≥4.5月的患者显著缩短（P<0.01），治疗前血清AFP水平≥400 ng·mL-1患者TTP和OS均较治疗前血清AFP水平<400 ng·mL-1患者显著缩短（P<0.05）。手足皮肤反应、腹泻、高血压是索拉非尼治疗所致的主要不良反应。结论索拉非尼可有效治疗中晚期肝癌，不良反应可耐受。单用或联合应用索拉非尼治疗中晚期肝癌的预后相当，索拉非尼治疗时间及患者治疗前血清AFP水平与索拉非尼治疗中晚期肝癌的预后有关。
목적：탐토색랍비니치료중만기원발성간암적림상료효、안전성급기예후영향인소。방법회고성연구아원54례응용색랍비니치료3개월이상적중만기간암환자，분석기객관료효、종류진전시간（TTP）、총생존기（OS）급불량반응적발생정황。결과54례환자복약1.5월후질병공제솔（DCR）위88.9％，복약3월후DCR위72.2％，환자적중위TTP위6.0개월（1.5~11.5개월），중위OS위11.0개월（3.0~40.0개월）。단용색랍비니화연합색랍비니치료적환자，중위TTP화OS비교균무현저성차이（P>0.05），색랍비니치료시간<4.5월적환자，중위TTP화OS균교색랍비니치료시간≥4.5월적환자현저축단（P<0.01），치료전혈청AFP수평≥400 ng·mL-1환자TTP화OS균교치료전혈청AFP수평<400 ng·mL-1환자현저축단（P<0.05）。수족피부반응、복사、고혈압시색랍비니치료소치적주요불량반응。결론색랍비니가유효치료중만기간암，불량반응가내수。단용혹연합응용색랍비니치료중만기간암적예후상당，색랍비니치료시간급환자치료전혈청AFP수평여색랍비니치료중만기간암적예후유관。
Objective To study the clinical efficacy and safety as well as the influencing factors of prognosis of Sorafenib in the treatment of middle and advanced primary hepatocellular carcinoma (PHC). Methods Fifty-four patients with middle and advanced primary hepatocellular carcinoma treated in our hospital by sorafenib for at least three months were retro-spectively analyzed, and the objective efficacy, time to progression (TTP), overall survival (OS) and incidence of adverse ef-fects were observed during the treatment. Results After treatment for 1.5 months, the disease control rate (DCR) was 88.9%, but was 72.2%after 3 months’treatment. The median TTP was 6.0 months (1.5~11.5 months), and median OS was 11.0 months (3.0~40.0 months). No significant differences were found in the median TTP and OS between patients treated by Sorafenib alone and those by combination with Sorafenib. The median TTP and OS of patients who were treated by Sorafenib for<4.5 months were significantly shorter than those of patients who were treated by Sorafenib for≥4.5 months (P<0.01). The median TTP and OS of patients whose serum AFP level≥400 ng·mL-1 before treatment were obviously shorter than those of patients whose serum AFP level<400 ng·mL-1 before treatment (P<0.05). Moreover, the main adverse events lead-ing to discontinuation of sorafenib treatment included hand-foot skin reaction, diarrhea, and hypertension. Conclusion This study showed that Sorafenib was safe and effective in the treatment of middle and advanced PHC. The prognosis of PHC pa-tients treated by Sorafenib alone was equal to that of patients treated by combination with Sorafenib. The treatment duration of Sorafenib and the serum AFP level before treatment were significantly related to the prognosis of PHC patients.