目的 探讨槐耳颗粒与索拉非尼联合治疗晚期肝癌患者的临床效果。方法 选择上海中医药大学附属曙光医院2016年1月-2017年1月收治的晚期肝癌患者113例，随机分成对照组（56例）和治疗组（57例）。对照组患者口服甲苯磺酸索拉非尼片，2片/次，2次/d。治疗组患者在对照组基础上口服槐耳颗粒，1袋/次，3次/d。两组患者均连续治疗2个月。观察两组患者临床疗效，同时比较治疗前后两组患者血管内皮生长因子（VEGF）、甲胎蛋白（AFP）和白蛋白（ALB）水平，KPS和IBI评分及不良反应情况。结果 治疗后，对照组临床有效率为46.43%，临床控制率为64.28%，1年生存率为57.14%，治疗组临床有效率为68.42%，临床控制率为87.72%，1年生存率为77.19%，两组分别比较差异均具有统计学意义（P<0.05）。治疗后，两组患者VEGF、AFP和ALB水平均显著降低（P<0.05），且治疗组患者VEGF、AFP和ALB水平明显低于对照组患者（P<0.05）。治疗后，两组患者KPS评分显著升高（P<0.05），IBI评分显著降低（P<0.05），同时治疗后治疗组患者的KPS评分和IBI评分均显著优于对照组患者（P<0.05）。治疗期间，对照组患者不良反应发生率为19.64%，显著高于治疗组患者的5.26%，两组比较差异具有统计学意义（P<0.05）。结论 槐耳颗粒联合索拉非尼治疗晚期肝癌临床疗效显著，不良反应发生率低，具有一定的临床推广应用价值。

Objective To explore the clinical effect of Huaier Granules combined with sorafenib in treatment of advanced liver cancer. Methods Patients (113 cases) with advanced liver cancer in Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from January 2016 to January 2017 were randomly divided into control (56 cases) and treatment (57 cases) groups. Patients in the control group were po administered with Sorafenib Tosylate Tablets, 2 tablets/time, twice daily. Patients in the treatment group were po administered with Huaier Granules on the basis of the control group, 1 bag/time, three times daily. Patients in two groups were treated for 2 months. After treatment, the clinical efficacy was evaluated, and the VEGF, AFP and ALB levels, KPS and IBI scores, and adverse reactions in two groups before and after treatment were compared. Results After treatment, the clinical curative effect in the control group was 46.43%, and the clinical control rate was 87.72%, 1 year survival rate was 77.19%, and the clinical curative effect, the clinical control rate, 1 year survival rate in the treatment group respectively were 68.42%, 64.28%, and 57.14%, and there were differences between two groups (P<0.05). After treatment, the VEGF, AFP, and ALB levels in two groups were significantly decreased (P<0.05), and these indexes in the treatment group after treatment were significantly lower than those in the control group (P<0.05). After treatment, the KPS scores in two groups were significantly increased (P < 0.05), the IBI scores in two groups were significantly decreased (P<0.05). After treatment, the KPS and IBI scores in the treatment group after treatment were significantly better than those in the control group (P<0.05). During the treatment, the adverse reactions rate in the control group was 19.64%, which was significantly higher than 5.26% in the treatment group, with significant difference between two groups (P<0.05). Conclusion Huaier Granules combined with sorafenib in treatment of advanced liver cancer has good clinical efficacy with lower adverse reactions incidence, which has a certain clinical application value.

国家自然科学基金资助项目（81603589、81403351、81774256）；上海市青年科技启明星计划项目（13QA1403500）