榄香烯口服乳联合甲磺酸阿帕替尼治疗晚期胃癌的临床观察

Clinical study of elemene oral emulusion combined with apatinib mesylate in the treatment of advanced gastric cancer

目的:研究榄香烯口服乳联合甲磺酸阿帕替尼治疗晚期胃癌的疗效性及安全性,探讨适合晚期胃癌三线治疗的方案。方法:选取南通大学附属如皋医院2020年1月—2021年6月二线化疗失败的晚期胃癌患者50例,按随机数字表法分为观察组和对照组,各25例。对照组予单药甲磺酸阿帕替尼500 mg/d口服,8周为1个疗程,同时予最佳支持治疗。观察组在对照组的基础上予榄香烯口服乳饭前空腹口服,20 mL/次,tid,6周为1个疗程,停用2周后重复下1个疗程。比较两组患者临床疗效、客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)、无进展生存时间(progression-free-survival,PFS)、生存质量(quality of life,QOL)及不良反应发生情况。结果:观察组的ORR、DCR优于对照组,但差异无统计学意义(P>0.05);观察组中位PFS、QOL改善情况优于对照组(P<0.05);两组的不良反应发生比较差异无统计学意义(P>0.05)。结论:榄香烯口服乳联合甲磺酸阿帕替尼能提高晚期胃癌的临床疗效,且耐受性好,不良反应轻微,具有一定的临床价值。

Objective:To study the clinical efficacy and safety of elemene oral emulsion combined with apartinib mesylate in the treatment of advanced gastric cancer,and to explore the scheme suitable for the third line treatment of advanced gastric cancer.Methods:Fifty patients who failed second-line chemotherapy for advanced gastric cancer in Nantong University Affiliated Rugao Hospital from January 2020 to June 2021 were selected and randomly divided into the observation group and the control group,25 cases in each group.The control group was given a single oral administration of apartinib mesylate at 500 mg/d,for consecutive 8 weeks,while the best supportive treatment was given.On the basis of the control group,the observation group was orally administrated with 20 mL of elemene orally in the fasting state before meals,three times a day,for consecutive 6 weeks.One course of treatment was defined as continuous oral administration.After the patients were stopped for 2 weeks,the next course of treatment was repeated.The clinical effects of the two groups were observed,and the objective response rate(ORR),disease control rate(DCR),progression-free survival(PFS),quality of life(QOL)and incidence of adverse reactions in the two groups were compared.Results:The ORR and DCR of the observation group were better than those of the control group,but the differences were not statistically significant(P>0.05).The improvement of median PFS and QOL in the observation group were superior to that in the control group,and the differences were statistically significant(P<0.05).There was no significant difference in adverse reactions between the two groups(P>0.05).Conclusion:Elemene oral emulsion combined with apatinib mesylate can improve the clinical efficacy of advanced gastric cancer,and it is well tolerated with mild toxicity,thus having certain clinical value.