探讨索拉非尼预防原发性肝癌（肝癌）患者根治性治疗术后复发的临床效果。

本前瞻性研究对象为2009年6月至2012年6月在中山大学附属第三医院行肝癌根治性治疗术的70例患者。所有患者均签署知情同意书，符合医学伦理学规定。根据术后治疗方案的不同，将患者分为索拉非尼组和对照组。索拉非尼组24例，男22例，女2例；平均年龄（48±10）岁；给予索拉非尼400 mg口服，一日两次，连续服用6个月。对照组46例，男40例，女6例；平均年龄（48±11）岁；给予安慰剂口服。患者术后均接受随访。观察患者术后肿瘤复发率、生存率及药物不良反应。两组患者术后肿瘤复发率、不良反应发生率比较采用χ²检验或Fisher确切概率法，术后生存率的比较采用Kaplan-Meier法和Log-rank检验。

索拉非尼组的1、2、3年复发率分别为25%（6/24）、42%（10/24）、50%（12/24），对照组相应为28%（13/46）、46%（21/46）、53%（25/46），两组比较差异无统计学意义（χ²=0.020，0.102，0.120；P>0.05）。索拉非尼组的1、2、3年累积生存率分别为95.83%、87.50%、70.83%，对照组相应为91.30%、82.61%、63.04%，两组总体生存率比较差异无统计学意义（χ²=0.078，P>0.05）。索拉非尼组手足皮肤反应、腹泻、高血压、红斑的不良反应发生率为42% （10/24）、29% （7/24）、21%（5/24）、25%（6/24），明显高于对照组的7%（3/46）、7%（3/46）、2%（1/46）、4%（2/46） （χ²=10.663，4.885，4.828，4.762；P<0.05）。

索拉非尼既不能减少肝癌患者根治性治疗术后肿瘤复发，也不能提高总体生存率。

To evaluate the clinical efficacy of sorafenib in preventing the recurrence of primary liver cancer after radical surgery.

Seventy patients with primary liver cancer undergoing radical surgery in the Third Affiliated Hospital of Sun Yat-sen University between June 2009 and June 2012 were enrolled in this prospective study. The informed consents of all patients were obtained and the local ethical committee approval had been received. According to different postoperative therapies, the patients were divided into the sorafenib group (n=24) and control group (n=46). In the sorafenib group, there were 22 males and 2 females with a mean age of (48±10) years. A dose of 400 mg sorafenib was orally administered twice daily for consecutive 6 months. In the control group, there were 40 males and 6 females with a mean age of (48±11) years. The patients were orally administered with placebo. All patients received postoperative follow-up. Postoperative recurrence rate, survival rate and drug-induced adverse reactions were observed. Postoperative recurrence rate and incidence of adverse reactions of two groups were compared using Chi-square test or Fisher exact probability test. Postoperative survival rate was analyzed by Kaplan-Meier plot and Log-rank test.

In the sorafenib group, the 1-, 2- and 3-year recurrence rates were 25% (6/24), 42% (10/24), 50% (12/24) respectively, and 28% (13/46), 46% (21/46), 53% (25/46) respectively in the control group. No significant difference was observed between two groups (χ²=0.020, 0.102, 0.120; P>0.05). The 1-, 2- and 3-year cumulative survival rates in the sorafenib group were 95.83%, 87.50% and 70.83%, and no significant difference was observed compared with 91.30%, 82.61% and 63.04% in the control group (χ²=0.078, P>0.05). In the sorafenib group, the incidence of hand-foot skin reaction, diarrhea, hypertension and erythema were 42% (10/24), 29% (7/24), 21% (5/24) and 25% (6/24), which were significantly higher compared with 7% (3/46), 7% (3/46), 2% (1/46) and 4% (2/46) in the control group (χ²=10.663, 4.885, 4.828, 4.762; P<0.05).

Sorafenib can neither decrease postoperative recurrence of peimary liver cancer after radical surgery nor enhance the overall survival rate.