摘要
目的评价索拉非尼预防和治疗肝细胞肝癌（HCC）肝移植术后肿瘤复发的有效性和安全性。方法采用回顾性队列研究方法，将广东省器官移植中心2007年7月至2010年5月22例超出米兰标准的HCC行肝移植并在术后口服索拉非尼的患者作为治疗组，选取同期22例原发病和免疫抑制方案相似但未服用索拉非尼治疗的患者作为对照组。分析移植术后1年的无瘤生存率（DFS）、总生存率（OS）、急性排斥反应率和移植物存活率，同时评估索拉非尼治疗的安全性。结果44例患者全部具有完整的随访资料。治疗组病例较对照组1年的DFS[81．8％（18例）比63．6％（14例）]和OS[90．9％（20例）比72．7％（16例）]均得到明显改善（均P〈0．05）。两组的术后急性排斥反应率[13．6％（3例）比18．2％（4例），P=0．524]和移植物存活率[86．4％（19例）比72．7％（16例），P=0．086]差异无统计学意义。治疗组总的药物不良反应率明显高于对照组[68．1％（15例）比31．8％（7例），P〈0．01]，治疗组索拉非尼的主要不良反应为腹泻（45．5％，10例），肝功能异常（40．9％，9例），手足皮肤反应（31．8％，7例）和头部及四肢疼痛（22．7％，5例）。其中3级不良反应2例，经停药治疗无效后退出治疗，其余不良反应均在1～2级，3例完全耐受索拉非尼口服400mg每天2次至观察终点，其余17例经药物调整后服用至观察终点。结论索拉非尼可以明显延缓超出米兰标准的HCC肝移植术后肿瘤复发并延长复发后患者总的生存期，并不增加急性排斥反应率和减少移植物存活率，尽管其药物不良反应发生率较高，但多在停药1周后减轻或消失，大多数患者可改为减量或间断性用药继续治疗。
Objective To evaluate the efficacy and safety of sorafenib in the prevention and treatment of hepatocellular carcinoma （HCC） relapse after liver transplantation. Methods A retrospective cohort study was performed to assess the efficacy and safety of sorafenib for HCC. Forty-four patients who underwent liver transplant for HCC beyond Milan criteria form July 2007 to May 2010 were included study group （ sorafenib, n = 22） and control group （ without sorafenib, n = 22）. The primary endpoints of the study were disease-free survival （DFS）, overall survival （OS）. Secondary outcomes included the rates of acute rejection and graft survival. Results The clinical data of 44 patients were completely collected. There were significantly differences between sorafeinb group and control group in 1-year DFS （81.8 % （n = 18） vs 63.6% （n = 14）, P 〈0. 05） and OS （90. 9% （n =20） vs 72.7% （n = 16）, P 〈0. 05） respectively. The acute rejection rates in Sorafenib were 13.6% （3/22）, compared with 18. 2% （4/22） in control group （P = 0. 524） and l-year graft survival in Sorafenib group were 86.4% （ 19/22）, compared with 72.7% （16/22） in control group （P = 0. 086）. The overall incidence of treatment-related adverse events was 68. 1% （ n = 15） in sorafenib group and 31.8% （n = 7） in the control group （P 〈 0. 01 ）. Adverse events that were reported for patients receiving sorafenib were predominantly grade 1 or 2 in severity including diarrhea （45.5%, rt = 10）, liver dysfunction （40.9%, n =9）, hand-foot skin reaction （31.8%, n =7） and pains of head and four limbs （22. 7%, n =5）. Two patients with grade 3 adverse events in study group were stopped continuing to use the sorafenib. Three patients with the dose of 400 mg twice daily and 17 patients with the dose reduction of sorafenib continued to the study endpoint. Conclusion Patients with HCC undergoing liver transplantation could get the benefits of Sorafenib in reducing the incidence of tumor
出处
《中华医学杂志》
CAS
CSCD
北大核心
2012年第18期1264-1267,共4页
National Medical Journal of China
关键词
肝移植
肝肿瘤
复发
索拉非尼
Liver transplantation
Liver neoplasms
Recurrence
Sorafenib
