榄香注射液及华蟾素注射液分别联合TACE治疗中晚期原发性肝癌临床研究

目的:观察比较榄香注射液及华蟾素注射液分别联合肝动脉导管化疗栓塞治疗中晚期原发性肝癌的临床疗效及不良反应发生率的差异。方法:纳入104例2018年8月—2020年1月于肿瘤科治疗的中晚期原发性肝癌患者作为研究对象,按照治疗方案的不同随机分成2组各52例。2组患者均给予肝动脉导管化疗栓塞(TACE)治疗1次,华蟾素注射液组予华蟾素注射液10 mL加入到5%葡萄糖注射液500 mL中静脉滴注,每天1次。榄香注射液组加用榄香注射液静脉滴注,每次0.4 g,每天1次,2组连续治疗15 d后休息15 d,连续治疗2个疗程。观察比较2组临床疗效、肝功能指标(谷丙转氨酶(ALT)、谷草转氨酶(AST)及总胆红素(TBil)]的变化及甲胎蛋白(AFP)、卡氏评分(KPS)和肿瘤体积的变化,以及不良反应发生率的差异。结果:临床疗效总有效率榄香注射液组88.46%,华蟾素注射液组71.15%,2组比较,差异有统计学意义(P<0.05)。治疗后,2组血清ALT、AST和TBil水平较治疗前均显著降低,差异均有统计学意义(P<0.05);2组间血清ALT、AST和TBil水平相比较,差异无统计学意义(P>0.05)。治疗后,与华蟾素注射液组比较,榄香注射液组AFP降低值、肿瘤体积缩小值及KPS评分升高值均多于华蟾素注射液组,差异均有统计学意义(P<0.01)。治疗期间,2组不良反应总发生率比较,差异无统计学意义(P>0.05);华蟾素注射液组发生的不良反应以恶心呕吐为主,发生率高于榄香注射液组,差异有统计学意义(P<0.05);榄香注射液组发生的不良反应以注射部位疼痛为主,发生率高于华蟾素注射液组,差异有统计学意义(P<0.05)。结论:榄香注射液联合TACE治疗中晚期原发性肝癌的临床疗效优于华蟾素注射液,2种中药制剂治疗期间仍需要注意不良反应的发生情况。

Clinical Study on TACE Combined with Elemene Injection and Cinobufagin Injection Respectively for Middle and Advanced Primary Hepatic Carcinoma

Objective:To observe and compare the differences in the clinical effect and the incidences of adverse reactions of transcatheter arterial chemoembolization(TACE)combined with elemene injection and cinobufagin injection respectively for middle and advanced primary hepatic carcinoma.Methods:A total of 104 cases of patients with middle and advanced primary hepatic carcinoma who were treated in the oncology department from August 2018 to January 2020 were included as the study objects,and were randomly divided into two groups according to different treatment regimens,52 cases in each group.Both groups were treated with TACE once;the cinobufagin injection group was given intravenous infusion with 500 mL of 5%glucose injection and 10 mL of cinobufagin injection once a day;the elemene injection group was given intravenous infusion with elemene injection of 0.4 g each time and once a day.Both groups were treated for two courses,15 days of continuous treatment with a rest of 15 days being one course.The clinical effect,the changes in the indexes of liver function including alanine amino transferase(ALT),aspartate transaminase(AST)and total bilirubin(TBil),the scores of alpha-fetoprotein(AFP)and Karnofsky(KPS)and tumor volumes as well as the difference in the incidences of adverse reactions between the two groups were observed and compared.Results:The total clinical effective rate was 88.46%in the elemene injection group and 71.15%in the cinobufagin injection group,the difference being significant(P<0.05).After treatment,the levels of ALT,AST and TBil in serum in the two groups were significantly decreased when compared with those before treatment,differences being significant(P<0.05).There was no significant difference being found in the comparison of the levels of ALT,AST and TBil in serum between the two groups(P>0.05).After treatment,the decrease of AFP,tumor volume and the increase of KPS scores in the elemene injection group were significantly more than those in the cinobufagin injection group,differences being significant(P<0.01).During treatment,there was no significant difference being found in the comparison of the total incidences of adverse reactions between the two groups(P>0.05).The adverse reactions in the cinobufagin injection group were mainly nausea and vomiting,with higher incidence than that in the elemene injection group,the difference being significant(P<0.05).The adverse reactions in the elemene injection group were mainly pain at the injection site,with higher incidence than that in the cinobufagin injection group,the difference being significant(P<0.05).Conclusion:The therapy of elemene injection combined with TACE for middle and advanced primary hepatic carcinoma has better clinical effect than that of cinobufagin injection,but the occurrence of adverse reactions should still be paid attention to during the treatment with the two Chinese herbal medicines.