HAIC联合动脉灌注榄香烯注射液治疗进展期肝癌临床研究

Clinical study of hepatic arterial infusion chemotherapy combined with arterial infusion of elemene injection in the treatment of advanced liver cancer

目的探讨肝动脉灌注化疗术(HAIC)联合动脉灌注榄香烯注射液治疗进展期肝癌患者的临床疗效。方法选取2021年4月至2022年1月江门市五邑中医院收治的80例进展期肝癌患者展开研究,按随机数表法分为观察组和对照组各40例。两组患者均接受HAIC治疗,对照组患者药物为奥沙利铂、氟尿嘧啶,观察组患者则在对照组治疗的基础上联合榄香烯注射液动脉灌注,两组患者均以3周为一个治疗周期,连续治疗6周。比较两组患者治疗6周后的临床疗效,比较两组患者随访2年的总生存期(OS)、无进展生存期(PFS),同时比较两组患者治疗期间的不良反应发生率。结果观察组患者的客观缓解率(ORR)为47.50%,明显高于对照组的25.00%,差异有统计学意义(P<0.05),但观察组和对照组患者的疾病控制率(DCR)分别为75.00%、60.00%,差异无统计学意义(P>0.05);随访2年显示,观察组患者的OS、PFS分别为(16.12±3.69)个月、(14.60±3.30)个月,明显长于对照组的(13.44±3.71)个月、(11.27±3.08)个月,差异均有统计学意义(P<0.05);观察组患者转氨酶升高、骨髓抑制、发热、恶心呕吐、腹泻、血液系统毒性、疼痛的发生率分别为50.00%、20.00%、17.50%、75.00%、35.00%、40.00%、37.50%,对照组分别为40.00%、25.00%、17.50%、67.50%、40.00%、42.50%、35.00%,差异均无统计学意义(P>0.05)。结论HAIC联合动脉灌注榄香烯注射液治疗进展期肝癌可提高患者的ORR,延长OS、PFS,具有临床应用价值。

Objective To investigate the clinical effect of hepatic arterial infusion chemotherapy(HAIC)combined with arterial infusion of elemene injection in the treatment of advanced liver cancer.Methods A total of 80 patients with advanced liver cancer admitted to Jiangmen Wuyi Hospital of Traditional Chinese Medicine from April 2021 to January 2022 were selected and divided into an observation group and a control group according to random number table,with 40 patients in each group.Based on HAIC,patients in the control group were treated with oxaliplatin and fluorouracil,and those in the observation group were treated with arterial infusion of elemene injection on the basis of the treatment in the control group.The two groups of patients were treated continuously for 6 weeks,with 3 weeks as one cycle of treatment.The clinical efficacy after 6 weeks of treatment were compared between the two groups,as well as the overall survival(OS)and progression-free survival(PFS)after 2 years of follow-up.The incidence of adverse reactions was also compared.Results The objective response rate(ORR)in the observation group was 47.50%,which was significantly higher than 25.00%in the control group(P<0.05).The disease control rate(DCR)was 75.00%in the observation group and 60.00%in the control group,with no statistically significant differences between the two groups(P>0.05).After 2 years of follow-up,the OS and PFS in the observation group were(16.12±3.69)months and(14.60±3.30)months,which were significantly longer than(13.44±3.71)months and(11.27±3.08)months in the control group(P<0.05).The incidence of aminotransferase elevation,bone marrow suppression,fever,nausea and vomiting,diarrhea,blood system toxicity,and pain were 50.00%,20.00%,17.50%,75.00%,35.00%,40.00%,and 37.50%in the observation group versus 40.00%,25.00%,17.50%,67.50%,40.00%,42.50%,and 35.00%in the control group,respectively(P>0.05).Conclusion HAIC combined with arterial infusion of elemene injection can improve ORR,prolong OS and PFS in the treatment of patients with advanced liver cancer,which thus has significant clinical application value.