乌苯美司胶囊对晚期胃癌化疗患者影响的临床研究

Effects of ubenimex capsule in patients with advanced gastric cancer receiving chemotherapy

目的评价乌苯美司胶囊对晚期胃癌化疗患者生活质量、不良反应及免疫功能的影响。方法 63例晚期胃癌患者随机分为治疗组(32例)和对照组(31例),所有患者均给予DCF方案化疗2个周期:多西他赛40mg/m^2静脉滴注,d1、8;顺铂15mg/m^2静脉滴注,d1～5天;替加氟600mg/m^2静脉滴注,d1～5天。治疗组在化疗开始时给予乌苯美司胶囊30mg每日清晨顿服,连用8周。观察治疗前、后患者KPS评分,体重变化,血白细胞、血红蛋白、血小板变化及淋巴细胞免疫功能变化。结果治疗组化疗后KPS评分及体重与化疗前相比稳定率达65.6%和68.8%;对照组均为35.5%(P<0.05)。治疗组化疗后血白细胞、血红蛋白、血小板降低程度小于对照组(P<0.05)。两组T抑制、杀伤淋巴细胞(CD3^+、CD8^+)变化无统计学意义。治疗组T淋巴细胞(CD3^+),T辅助、诱导淋巴细胞(CD3^+、CD4^+),NK细胞(CD16^+、CD56^+)水平均较用药前有所提高,而对照组均较化疗前下降,两组相比有统计学意义(P<0.05)。结论乌苯美司胶囊有提高肿瘤患者免疫功能的作用,同时还能减轻化疗不良反应,改善化疗患者的生活质量。

Objective To evaluate the efficacy of ubenimex in treating patients with advanced gastric cancer receiving chemotherapy. Methods Totally 63 patients with advanced gastric cancer were randomly divided into ubenimex group （ n = 32） and control group （ n = 31 ）. All patients were treated with DCF regimen for 2 cycles： docetaxel 40mg/m2 intravenous infusion on day 1 and day 8, and cisplatin 15mg/m2 and tegafur 600mg/m2 intravenous infusion from day 1 to days. The ubenimex group additionally received oral ubenimex 30mg/d in the morning, which continued 8 weeks from the begin- ning of the chemotherapy. The KPS score, body weight, leukoeytes, hemoglobin, platelet and lymphocyte immune func- tion were measured or deternlined before and after treatment. Results The stable rates of KPS score and body weight after chemotherapy were 65.6% and 68.8% in treatment group and were 35.5% and 35.5% in control group （both P 〈 0. 05 ）. The reductions of leukoeytes, hemoglobin and platelet after chemotherapy was significantly less in treatment group than that in control gwup （all P 〈 0. 05）. The T lymphocytes （CD3 ＋ ） ,T assisted, induced lymphoeytes （CD3＋ and CD4 ＋ ） , T suppressor, and NK cells （CDI6 ＋ and CD56 ＋ ） were increased after treatment in ubenimix group. While in control group they were decreased （ P 〈 0. 05 ）. Conclusion Ubenimex can enhance immune function, reduce chemo- therapy toxicity, and improve the quality of life in patients with cancer.