艾迪注射液联合肝动脉化疗栓塞术治疗原发性肝癌临床研究

Aidi Injection Combined with Transcatheter Arterial Chemoembolization in Treatment of Primary Hepatocellular Carcinoma

目的:探讨艾迪注射液联合肝动脉化疗栓塞术治疗原发性肝癌(hepatocellular carcinoma,HCC)的临床疗效。方法:将128例HCC患者按随机数字表法分为对照组和观察组,每组各64例。对照组给予肝动脉化疗栓塞术及对症支持治疗,观察组在对照组的基础给予艾迪注射液静脉滴注,28 d为1个周期,共治疗4个月。观察治疗后两组患者无进展生存期和生存率,评价患者生存质量,同时检测T淋巴细胞亚群(CD_3^+、CD_4^+、CD_8^+、CD_4^+/CD_8^+)、自然杀伤细胞(natural killer cell,NK)及甲胎蛋白、谷丙转氨酶、谷草转氨酶水平,评价临床疗效。结果:观察组有效率为95.31%,对照组有效率为84.38%,两组比较,差异有统计学意义(P<0.05);观察组PFS长于对照组,且生存率高于对照组,两组比较,差异有统计学意义(P<0.05);治疗后观察组生存质量评分优于对照组(P<0.05),且治疗后观察组CD_3^+、CD_4^+、CD_4^+/CD_8^+和NK水平高于对照组,CD_8^+、甲胎蛋白、谷丙转氨酶、谷草转氨酶水平低于对照组(P<0.01)。结论:艾迪注射液联合肝动脉化疗栓塞术治疗原发性肝癌,能延长PFS和生存期,提高患者的生存率,改善患者的生存质量,并具有提高免疫功能,保护肝功能的作用。

Objective：To investigate the clinical efficacy of Aidi injection combined with transcatheter arterial chemoembolization in treatment of hepatocellular carcinoma（HCC）.Methods：128 cases of HCC patients were randomly divided into control group and observation group,with 64 cases in each group.The control group was given hepatic arterial chemoembolization as symptomatic supporting treatment.The observation group was given intravenous infusion of Aidi injection in addition to that of the control group.Each treatment period was 28 days and the treatment lasted for 4 months.The progression-free survival and survival rate of the two groups were observed after treatment.The quality of life of the patients was evaluated and the T lymphocyte subsets（CD3^＋,CD4^＋,CD8^＋,CD4^＋/CD8^＋）,natural killer cell（NK）,Alpha-fetoprotein,alanine aminotransferase and aspartate aminotransferase levels in the two groups of patients were detected and the clinical efficacy was evaluated.Results：The effective rate in the observation group was 95.31%and that in the control group was 84.38%.The difference was statistically significant（P〈0.05）.The survival rate of the observation group was significantly higher than that of the control group（P〈0.05）.The quality of life of the observation group was significantly better than that of the control group（P〈0.05）.The levels of CD3^＋,CD4^＋,CD8^＋and NK in the observation group were significantly higher than those in the control group,CD8^＋,while the alpha-fetoprotein,alanine aminotransferase and aspartate aminotransferase were significantly lower than those in the control group（P〈0.01）.Conclusion：Aidi injection combined with transcatheter arterial chemoembolization in treatment of primary liver cancer can prolong PFS time,improve the survival rate,improve the quality of life,and improve immune function and protect liver function of patients.