金龙胶囊在老年中晚期胃癌FOLFOX4方案化疗中的疗效观察

Efficacy of Jinlong capsule on elderly patients with advanced gastric cancer underdoing chemotherapy with FOLFOX4 regimen

目的评价金龙胶囊联合FOLFOX4（奥沙利铂＋氟尿嘧啶＋亚叶酸钙）方案治疗中晚期胃癌的临床效果。方法将57例中晚期胃癌患者应用随机数字表法随机分入治疗组和对照组。治疗组28例,给予FOLFOX4方案化疗4-6个周期,化疗开始时给予金龙胶囊口服,每次4粒,1天3次,连用6周。对照组29例,给予FOLFOX4方案化疗4-6个周期。观察两组患者的客观疗效、免疫功能变化及不良反应。结果治疗组的客观有效率为39.3%,对照组为34.5%,两组比较无显著统计学差异（P=0.145）。治疗组应用金龙胶囊后NK细胞及T细胞亚群中的CD3＋、CD4＋及CD4＋/CD8＋分别由（30.78±3.56）、（45.36±9.52）、（32.74±7.65）、（1.04±0.36）升高至（35.45±6.23）、（48.54±7.36）、（34.29±9.25）、（1.30±0.54）,治疗前后有统计学差异（P=0.029,P=0.032,P=0.016,P=0.023）,对照组治疗前后无显著统计学差异。治疗组骨髓抑制、恶心、呕吐及腹泻等不良发生率略低于对照组。结论金龙胶囊联合FOLFOX4方案治疗晚期胃癌可显著改善患者免疫功能,在一定程度上可减轻化疗相关不良反应。

Objective： To evaluate the clinical efficacy of Jirdong capsule combined with FOLFOX4 （oxaliplatin ＋ flu- orouracil ＋ leucovorin） regimen in the treatment of advanced gastric cancer. Methods ： A total of 57 patients with advanced gastric cancer were randomly divided into the treatment group and the control group using random number table. In the treat- ment group, 28 patients received 4-6 cycles of chemotherapy with FOLFOX4 regimen, and at the start of chemotherapy, Jin- long capsule 4 pills once orally and 3 times per day lasted for six weeks. In the control group, 29 patients received 4 -6 cy- cles of chemotherapy with FOLFOX4 regimen. Objective response, immune function and adverse reactions were observed in both groups. Results： In the treatment group and the control group, the objective response rate （RR） was 39. 3% and 34. 5%, respectively, and there was no statistically significant difference between the two groups （P = 0. 145 ）. The NK cells andCD3＋, CD4＋and CD4＋ CD8＋were raised to （35.45 ±6.23）, （48.54±7.36）, （34.29 ±9.25）, （1.30±0.54） from （ 30.78 ± 3.56 ）, （45.36 ± 9. 52 ）, （ 32. 74 ±7. 65 ）, （ 1.04 ± 0. 36 ） , respectively, and there was statistically signifi- cant difference in the treatment group before and after treatment （ P = 0. 029, P = 0. 032, P = 0. 016, P = 0. 023 ）, but there was no statistically significant difference in the control group before and after treatment. The incidence rates of bone marrow suppression, nausea, vomiting and diarrhea in the treatment group were slightly lower than those of the control group. Conclu- sion： Jinlong capsule combined with FOLFOX4 regimen in the treatment of advanced gastric cancer can significantly improve the immune function of patients, and reduce chemotherapy-related adverse reactions to a certain extent.