参莲胶囊联合替吉奥治疗晚期胃癌的临床研究

目的探讨参莲胶囊联合替吉奥胶囊治疗晚期胃癌的临床疗效。方法选取2016年1月—2018年1月海安市人民医院收治的60例晚期胃癌患者作为研究对象,将所有患者随机分为对照组和治疗组,每组各30例。对照组患者餐后服用替吉奥胶囊,体表面积1.25 m~2,40 mg/次;1.25～1.50 m~2,50 mg/次;体表面积1.50 m~2,60 mg/次,2次/d,早晚各一次,连续使用14 d后停药7 d为1个周期。治疗组在对照组基础上口服参莲胶囊,6粒/次,3次/d。3周为一个周期,两组患者连续治疗2个周期。比较两组患者的近期疗效,同时比较两组的生命质量测定量表(QLQ-C30)评分、血清细胞因子水平、毒副作用和生存情况。结果治疗后,对照组的客观缓解率(ORR)和疾病控制率(DCR)分别为23.3%、50.0%,分别显著低于治疗组的36.7%、76.7%,两组比较差异具有统计学意义(P0.05)。治疗后,两组躯体功能、认知功能、情绪功能、角色功能、社会功能评分和总评分均显著提高,同组治疗前后比较差异具有统计学意义(P0.05);且治疗组QLQ-C30评分各维度均显著高于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组血清基质金属蛋白溶解酶-9(MMP-9)、胃泌素17(G17)、癌胚抗原(CEA)、肿瘤相关巨噬细胞(TAM)水平均明显下降,同组治疗前后比较差异具有统计学意义(P0.05);且治疗组治疗后血清细胞因子水平均显著低于对照组,两组比较差异具有统计学意义(P0.05)。治疗期间,治疗组各毒副作用发生例数均显著低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,治疗组进展生存期(PFS)、中位总生存时间(mOS)、1年生存率均显著高于对照组,两组比较差异具有统计学意义(P0.05)。结论参莲胶囊联合替吉奥胶囊治疗晚期胃癌可有效缓解病情的发展,减轻毒副作用,具有一定的临床推广应用价值。

Clinical study on Shenlian Capsules combined with tegafur, gimeracil and oteracil potassium in treatment of advanced gastric cancer

Objective To investigate the clinical effect of Shenlian Capsules combined with Tegafur, Gimeracil and Oteracil Potassium Capsules in treatment of advanced gastric cancer. Methods Patients (60 cases) with advanced gastric cancer in Haian People''s Hospital from January 2016 to January 2018 were randomly divided into control and treatment groups, each group had 30 cases. Patients in the control group were po administered with Tegafur, Gimeracil and Oteracil Potassium Capsules after meals, 40 mg/time for the patients of body surface area less than 1.25 m², and 50 mg/time for the patients of body surface area in the range of 1.25 -1.50 m², and 60 mg/time for the patients of body surface area more than 1.50 m², twice daily. A cycle was treatment time of 14 d and 7 d of withdrawal. 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 cycle had 3 weeks, and patients in two groups were treated for 2 cycles. After treatment, the short-term efficacy were compared, and the QLQ-C30 scores, serum cytokine levels, incidence of toxic and side effects, and living conditions in two groups were compared. Results After treatment, the ORR and DCR in the control group were 23.3% and 50.0%, which were significantly lower than 36.7% and 76.7% in the treatment group, respectively, and there were differences between two groups (P < 0.05). After treatment, the scores of physical, cognitive, emotional, role and social function, and the total score in two groups were significantly increased, and the difference was statistically significant in the same group (P< 0.05). And the QLQ-C30 scores in the treatment group were significantly higher than those in the control group, with significant difference between two groups (P< 0.05). After treatment, the serum MMP-9, G17, CEA, and TAM levels in two groups were significantly decreased, and the difference was statistically significant in the same group (P< 0.05). And the serum cytokine levels in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P< 0.05). During the treatment, the cases of side effects in the treatment group were significantly lower than that in the control group, and there was difference between two groups (P < 0.05). After treatment, PFS, mOS and 1-year survival rate in the treatment group were significantly higher than those in the control group, and there was difference between two groups (P < 0.05). Conclusion Shenlian Capsules combined with Tegafur, Gimeracil and Oteracil Potassium Capsules in treatment of advanced gastric cancer can effectively alleviate the development of the disease, reduce toxicity and side effects, which has a certain clinical application value.