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目的探讨索拉非尼在预防肝细胞癌(肝癌)肝移植患者术后肿瘤复发中的临床价值。方法本前瞻性研究对象为2010年3月至2012年7月在郑州人民医院肝胆胰腺外科行肝移植术,且超出加州大学旧金山分校(UCSF)标准的41例肝癌患者。所有患者均签署知情同意书,符合医学伦理学规定。其中男35例,女6例;年龄34~61岁,中位年龄49岁。按照患者自主选择是否术后应用索拉非尼,将患者分为索拉非尼组(9例)和对照组(32例)。索拉非尼组患者服用索拉非尼,400 mg口服,每日2次;患者不能耐受不良反应时,调整为半量服用(200 mg口服,每日2次)。对照组患者术后未服用索拉非尼或肿瘤复发后改索拉非尼治疗。术后患者接受随访,随访期间记录患者肿瘤复发和存活情况。两组患者术后肿瘤复发率比较采用χ2检验,术后1、2年无瘤生存率和累积生存率比较采用Kaplan-Meier法和Log-rank检验。结果索拉非尼组患者术后肿瘤复发率3/9,其中2例为索拉非尼半量服用者。对照组患者术后肿瘤复发率47%(15/32),其中3例肝转移瘤行射频消融,2例肺转移瘤行放射治疗(放疗),2例肺转移瘤口服索拉非尼,其他8例多发转移未行治疗。两组患者肿瘤复发率比较差异无统计学意义(χ2=0.523,P>0.05)。索拉非尼组患者无发生死亡,对照组12例死于肿瘤复发、转移。索拉非尼组和对照组患者术后2年无瘤生存率分别为67%、53%,差异无统计学意义(χ2=2.226,P>0.05);术后2年累积生存率分别为100%、63%,差异有统计学意义(χ2=5.126,P<0.05)。结论索拉非尼能提高超出UCSF标准肝癌肝移植患者的2年累积生存率,对预防术后肿瘤复发有一定价值。
Objective To investigate the clinical value of sorafenib in preventing postoperative tumor recurrence in hepatocellular carcinoma (HCC) patients with liver transplantation. Methods The prospective study was performed on 41 hepatocellular carcinoma patients who underwent liver transplantation in hepatobiliary and pancreatic surgery at Zhengzhou People’s Hospital from March 2010 to July 2012 and who surpassed the UCSF criteria. All patients signed informed consent, in line with medical ethics rules. Including 35 males and 6 females; aged 34 to 61 years, the median age of 49 years. Patients were randomly divided into sorafenib group (n = 9) and control group (n = 32) according to whether patients chose Sorafenib after operation. Sorafenib patients taking sorafenib, 400 mg orally twice daily; patients can not tolerate adverse reactions, adjusted to half the dose (200 mg orally twice daily). Patients in the control group were treated with sorafenib after operation or after treatment with esophageal varnish. Postoperative patients were followed up, during the follow-up of patients with tumor recurrence and survival records. Two groups of patients with postoperative tumor recurrence rate compared with χ2 test, 1 year and 2 years after the tumor-free survival rate and cumulative survival rate using Kaplan-Meier method and Log-rank test. Results The postoperative tumor recurrence rate in Sorafenib group was 3/9, of which 2 were sorafenib. In the control group, postoperative tumor recurrence rate was 47% (15/32). Among them, 3 cases of liver metastases underwent radiofrequency ablation, 2 cases of lung metastases underwent radiotherapy (radiation therapy), 2 cases of lung metastases received sorafenib, while others 8 cases of multiple metastasis was not treated. There was no significant difference in tumor recurrence between the two groups (χ2 = 0.523, P> 0.05). No patients died in the sorafenib group, and 12 in the control group died of tumor recurrence and metastasis. The 2-year disease-free survival rates of patients in sorafenib group and control group were 67% and 53% respectively, with no significant difference (χ2 = 2.226, P> 0.05). The 2-year postoperative cumulative survival rates were 100 %, 63%, the difference was statistically significant (χ2 = 5.126, P <0.05). Conclusion Sorafenib can improve the 2-year cumulative survival rate of patients with liver transplantation beyond UCSF standard, which is of certain value in preventing the recurrence of postoperative tumor.