替吉奥联合华蟾素片治疗老年晚期胃癌的疗效及安全性

Efficacy and safety of S1 combined with cinobufacin in treating the elderly patients with advanced gastric cancer

目的观察胃癌晚期不可切除或复发患者使用替吉奥单药化疗联合华蟾素的疗效及安全性。方法晚期胃癌老年患者60例随机分为治疗组和对照组，各30例，治疗组给予替吉奥胶囊联合华蟾素片，对照组给予5-氟尿嘧啶（5-Fu）静脉滴注。结果治疗组和对照组总有效率分别为33．3％（10／30）和20％（6／30），差异无统计学意义（P〉0．05）；治疗组疾病控制率73．0％（22／30），高于对照组的43．3％（13／30），差异有统计学意义（P〈0．05）。治疗组免疫状态（NK细胞活性）较对照组改善明显，不良反应发生（121腔黏膜、皮疹）情况低于对照组，差异均有统计学意义（P〈0．05）。结论替吉奥联合华蟾素片对于老年晚期胃癌患者疗效确切，能改善患者免疫状态，并发症相对较少，能减轻患者黏膜及皮肤反应，但仍需大样本、长期随机对照试验进一步验证。

Objective To observe the clinical efficacy and adverse effects of S1 combined with cinobufacin in treating the elderly patients with advanced gastric cancer. Methods A total of 60 elderly patients with metastatic or recurrent un-resectable gastric cancer were randomized to either control group or treatment group. Treatment group was treated with S-1 plus cinobufacin and control group was treated with intravenous injection of 5-Fu. Results The overall response rate was 33.3% （10/30） in treatment group and 20% （6/30） in control group, with no significant difference （P 〉0.05）. Disease control rate was 73.3% （22/30） in treatment group and was 43.3% （13/30）, with a significant difference （P 〈 0. 05）. compared with the control group , the treatment group received a better outcome of immunity function and less adverse reaction （P 〈 0.05）. Conclusion S1 combined with cinobufacin is an poten- tially effective and safe treatment for elderly patients with metastatic or recurrent un-resectable gastric cancer. More evidence will be required from further studies with larger population and longer follow-up.