榄香烯注射液联合索拉非尼治疗肝癌的临床研究

目的探讨榄香烯注射液联合甲苯磺酸索拉非尼片治疗肝癌的临床疗效。方法选取2014年1月—2016年1月武警后勤学院附属医院收治的晚期原发性肝癌患者78例为研究对象,根据随机区组设计法将患者分为对照组和治疗组,每组各39例。对照组口服甲苯磺酸索拉非尼片,0.4 g/次,2次/d。治疗组在对照组治疗的基础上静脉滴注榄香烯注射液,0.6 g加入到5%葡萄糖溶液500 m L中,1次/d,连续使用21 d。以1个月为1个疗程,两组患者治疗2个疗程。观察两组的临床疗效,比较两组的生活质量改善情况、肝功能指标、血清细胞因子、生存情况。结果治疗后,对照组和治疗组的客观缓解率(ORR)分别为38.5%、61.5%,临床获益率(DCR)分别为61.5%、82.1%,两组比较差异均有统计学意义(P0.05)。治疗后,两组KPS评分、美国东部肿瘤协作组(ECOG)评分均显著升高,同组治疗前后比较差异有统计学意义(P0.05);且治疗组卡氏评分(KPS评分)高于对照组,ECOG评分低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转氨酶(AST)、总胆红素(TBIL)水平均显著下降,白蛋白(ALB)水平显著升高,同组治疗前后比较差异有统计学意义(P0.05);且治疗组肝功能指标明显优于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组血清甲胎蛋白(AFP)、血管内皮生长因子(VEGF)水平均显著下降,同组治疗前后比较差异有统计学意义(P0.05);且治疗组血清细胞因子水平明显低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,治疗组中位生存期、1年生存率、2年生存率均显著高于对照组,两组比较差异具有统计学意义(P0.05)。结论榄香烯注射液联合甲苯磺酸索拉非尼片治疗肝癌具有较好的临床疗效,可改善患者肝功能,延长生存期,提高生存质量,安全较好,具有一定的临床推广应用价值。

Clinical study on Elemene Injection combined with sorafenib in treatment of liver cancer

Objective To investigate the clinical effect of Elemene Injection combined with Sorafenib Tosylate Tablets in treatment of liver cancer. Methods Patients (78 cases) with liver cancer in the Affiliated Hospital of Armed Police Logistics College from January 2014 to January 2016 were randomly divided into control and treatment groups, and each group had 39 cases. Patients in the control group were po administered with Sorafenib Tosylate Tablets, 0.4 mg/time, twice daily. Patients in the treatment group were iv administered with Elemene Injection on the basis of the control group, 0.6 g added into 5% glucose solution 500 mL, once daily, treated for 21 d. Patients in two groups were treated for 2 courses with 1 month as 1 course of treatment. After treatment, the clinical efficacies were evaluated, and the improvement of quality of life, liver function indexes, serum cytokines, and living condition in two groups were compared. Results After treatment, the ORR in the control and treatment groups were 38.5% and 61.5%, respectively, and there was difference between two groups (P<0.05). After treatment, the DCR in the control and treatment groups were 61.5% and 82.1%, respectively, and there was difference between two groups (P<0.05). After treatment, KPS scores and ECOG scores in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the KPS score in the treatment group was significantly higher than those in the control group, but the ECOG score in the treatment group was significantly lower than those in the control group, with significant difference between two groups (P<0.05). After treatment, the levels of ALT, AST, and TBIT in two groups were significantly decreased, but the levels of ALB in two groups were significantly increased, and the difference was statistically significant in the same group (P<0.05). And the liver function indexes in the treatment group were significantly better than those in the control group, with significant difference between two groups (P<0.05). After treatment, the levels of AFP and VEGF in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the serum cytokines levels in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). After treatment, median survival, 1 year survival rate, and 2 year survival rate in the treatment group were higher than those in the control group, and there was difference between two groups (P<0.05). Conclusion Elemene Injection combined with Sorafenib Tosylate Tablets has clinical curative effect in treatment of liver cancer, can improve the liver function, prolong the survival time, and improve the quality of life, with good safety, which has a certain clinical application value.