复方苦参注射液联合索拉非尼治疗晚期原发性肝癌的临床研究

Clinical study on Compound Kushen Injection combined with sorafenib in treatment of advanced primary hepatocellular carcinoma

目的探讨复方苦参注射液联合索拉非尼治疗晚期原发性肝癌的临床效果。方法选取2013年10月—2015年10月惠州市中心人民医院收治的原发性肝癌患者128例,按照治疗方案的不同分为对照组和治疗组,每组各64例。对照组患者于1~14 d口服甲苯磺酸索拉非尼片,0.4 g/次,2次/d。治疗组患者在对照组的基础上静脉滴注复方苦参注射液,20 m L加入250 m L生理盐水中,1次/d,14 d为1个疗程,休息14 d进入下1个疗程,连续治疗3个疗程。观察两组患者的临床效果、疼痛缓解情况和生存质量改善情况,同时比较两组患者治疗前后血液中抗肿瘤因子变化情况。结果治疗后,对照组和治疗组的有效率分别为20.31%、32.81%,临床获益率分别为59.38%、79.69%,两组比较差异具有统计学意义(P<0.05、0.01)。治疗后,对照组的疼痛缓解率为48.44%,显著低于治疗组的65.63%(P<0.01)。对照组和治疗组患者生活质量改善率分别为56.25%和78.13%,两组患者生存质量改善率比较差异具有显著统计学意义(P<0.01)。治疗后,对照组肿瘤坏死因子-α(TNF-α)水平显著升高,治疗组γ-干扰素(IFN-γ)和TNF-α水平均显著升高,同组治疗前后比较差异具有统计学意义(P<0.05);且治疗组患者IFN-γ和TNF-α水平高于对照组,两组比较差异具有统计学意义(P<0.05)。治疗过程中,对照组的不良反应发生率为60.94%,显著高于治疗组的46.88%,两组不良反应发生率比较差异具有显著统计学意义(P<0.01)。结论复方苦参注射液联合索拉非尼片对晚期原发性肝癌患者具有较显著的治疗效果,可显著缓解患者疼痛、提高生活质量、增强免疫功能,具有一定的临床推广应用价值。

Objective To explore the clinical efficacy of Compound Kushen Injection combined with sorafenib in treatment of advanced primary hepatocellular carcinoma. Methods Patients（128 cases） with advanced primary hepatocellular carcinoma in Huizhou Center People＇s Hospital from October 2013 to October 2015 were divided into control and treatment groups based on different treatments, and each group had 64 cases. Patients in the control group were po administered with Sorafenib Tosylate Tablets from the first day to the 14 th day, 0.4 g/time, twice daily. Patients in the treatment group were iv administered with Compound Kushen Injection on the basis of the control group, 20 m L added into 250 m L normal saline, once daily, and 14 d for a course of treatment. They were repeated the next course of treatment after rest for 14 d, and they were treated for three courses of treatment. After treatment, the clinical efficacy, pain relief rate, and the improvement of survival quality were evaluated, and the change of cytokines in two groups before and after treatment were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 20.31% and 32.81%, respectively, and there was difference between two groups（P〈 0.05）. At the same time the clinical benefit rate in two groups were 59.38% and 79.69%, respectively, with significant difference between two groups（P〈 0.01）. After treatment, the pain relief rate in the control was 48.44%, which was significantly lower than 65.63% in the treatment group（P〈 0.01）. After treatment, TNF-α in the control group was significantly increased, IFN-γ and TNF-α in the treatment group was significantly increased, and the difference was statistically significant in the same group（P〈 0.05）. And these indicators in the treatment group were significantly better than those in the control group, with significant difference between two groups（P〈 0.05）. In the process of treatment, incidence of adverse reactions in the control was 60.94%, which was significantly higher than 46.88% in the treatment group（P〈 0.01）. Conclusion Compound Kushen Injection combined with sorafenib has a significant efficacy in treatment of advanced primary hepatocellular carcinoma, which can relief the pain, improve life quality, immune function, and has a certain clinical application value.