参莲胶囊联合ECF方案治疗晚期胃癌的临床研究

Clinical study on Shenlian Capsules combined with ECF chemotherapy regimen in treatment of advanced gastric cancer

目的研究参莲胶囊联合ECF方案(注射用盐酸表柔比星、顺铂注射液和氟尿嘧啶注射液)治疗晚期胃癌的临床疗效。方法选取2017年5月—2019年5月在河南科技大学第一附属医院治疗的80例晚期胃癌患者,将所有患者随机分为对照组和治疗组,每组各40例。对照组患者给予ECF方案,第1天静脉滴注顺铂注射液60 mg/m^2;第1天静脉滴注注射用盐酸表柔比星50 mg/m^2;静脉滴注氟尿嘧啶注射液200 mg/m^2,1次/d。治疗组在对照组基础上口服参莲胶囊,6粒/次,3次/d。21d为1个治疗周期,两组患者持续治疗3个治疗周期。观察两组患者客观缓解率(ORR)和疾病控制率(CBR)、Karnofsky(KPS)评分、血清肿瘤标志物水平和不良反应。结果治疗后,对照组ORR和CBR分别为37.50%、52.50%;治疗组ORR和CBR分别为55.00%、65.00%;治疗组显著高于对照组(P<0.05)。治疗后,两组患者KPS评分均明显升高(P<0.05);且治疗组KPS评分升高较明显(P<0.05)。治疗后,两组血清癌胚抗原(CEA)、糖链抗原199(CA199)、胃癌抗原(CA724)水平显著降低(P<0.05);并且治疗组血清CEA、CA199、CA724水平降低较明显(P<0.05)。治疗后,治疗组中性粒细胞减少、血小板减少、肝损伤、恶心呕吐等不良反应明显较低(P<0.05)。结论参莲胶囊联合ECF方案治疗晚期胃癌具有较好的临床疗效,能够提高生活质量,降低肿瘤标志物水平,安全性较好。

Objective To study efficacy of Shenlian Capsules combined with ECF chemotherapy regimen(Epirubicin Hydrochloride for injection,Cisplatin Injection and Fluorouracil Injection)in treatment of advanced gastric cancer.Methods Patients(80 cases)with advanced gastric cancer in the First Affiliated Hospital of Henan University of Science and Technology from May 2017 to May 2019 were randomly divided into control and treatment groups,and each group had 40 cases.Patients in the control group were given ECF chemotherapy regimen:Cisplatin Injection was intravenously injected with 60 mg/m^2 at the first day,Epirubicin Hydrochloride for injection was intravenously injected with 50 mg/m^2 at the first day,and Fluorouracil Injection was intravenously injected with 200 mg/m^2,once daily.Patients in the treatment group were po administered with Shenlian Capsules on the basis of the control group,6 grains/time,three times daily.A treatment cycle had 21 d,and patients in two groups were treated for 3 cycles.After treatment,the clinical efficacies were evaluated,and ORR,CBR,KPS score,serum tumor markers and adverse reactions in two groups were compared.Results After treatment,ORR and CBR of the control group were 37.50%and 52.50%,respectively;ORR and CBR of the treatment group were 55.00%and 65.00%,respectively;and the indexes of the treatment group were significantly higher than those of the control group(P<0.05).After treatment,the KPS scores of two groups were significantly increased(P<0.05),and the KPS score of the treatment group was significantly higher than that of the control group(P<0.05).After treatment,the serum levels of CEA,CA199,and CA724 in two groups were significantly decreased(P<0.05),and the serum levels of CEA,CA199,and CA724 in the treatment group were significantly lower than those in the control group(P<0.05).After treatment,the adverse reactions of neutrophilia,thrombocytopenia,liver injury,nausea,and vomiting in the treatment group were significantly lower than those in the control group(P<0.05).Conclusion Shenlian Capsules combined with ECF chemotherapy regimen has clinical curative effect in treatment of advanced gastric cancer,can improve the quality of life,and reduce the level of tumor markers,with good safety.