复方谷氨酰胺肠溶胶囊用于同步放化疗晚期胃癌的疗效及安全性评价

Evaluation on Effect and Safety of Compound Glutamin Enterosoluble Capsules Used in Advanced Gastric Cancer Treated by Concurrent Radiochemotherapy

目的观察并探讨复方谷氨酰胺肠溶胶囊对采用三维适形放疗同步化疗老年晚期胃癌患者的临床疗效及不良反应。方法选择2009年7月至2011年12月收治的85例晚期胃癌患者,随机分为观察组(43例)和对照组(42例)。对照组给予XELOX(奥沙利铂+卡培他滨)3周期化疗,同步3DCRT放疗,观察组在此基础上加用复方谷氨酰胺肠溶胶囊。治疗后2个月,比较两组患者治疗前后卡氏生活质量(KPS)评分,观察近期疗效和不良反应;随访24个月,对比两组患者的生存率。结果治疗结束后2个月,观察组KPS评分为(75.3±5.4)分,明显高于对照组的(72.5±4.9)分(P<0.05),但两组总体有效率、临床获益率差异无统计学意义(P>0.05);观察组胃肠道不良反应发生率为46.51%,明显低于对照组的76.19%(P<0.05),两组其他类型的不良反应发生率相当(P>0.05);观察组平均生存时间、中位生存时间均显著高于对照组(P<0.05),但1年生存率和2年生存率相当(P>0.05)。结论 3DCRT放疗同步XELOX方案化疗治疗老年晚期胃癌时加用复方谷氨酰胺肠溶胶囊,虽未显著提高近期和远期疗效,但能大大改善患者生活质量,减少胃肠道不良反应,提高治疗的依从性。

Objective To observe and explore the clinical efficacy of Compound Glutamin Enterosoluble Capsules used in elderly patients with advanced gastric cancer treated by the three dimensional conformal radiotherapy（3DCRT） concurrent chemotherapy. Methods 85 patients with advanced gastric cancer in our hospital from July 2009 to December 2011 were selected and randomly divided into the observation group（43 cases） and the control group（42 cases）. The control group was given 3 cycles of XELOX chemotherapy（oxaliplatin plus capecitabine） and concurrent 3DCRT,while on this basis the observation group was added with Compound Glutamin Enterosoluble Capsules. The karnofsky performance scale（KPS） scores after 2- month treatment were compared between the two groups.The short term efficacy and adverse reactions were observed. The 24- month follow- up was conducted for comparing the survival rates between the two groups. Results The KPS score at 2 months after treatment in the observation group was（75. 3 ± 5. 4） points,which was significantly higher than（72. 5 ± 4. 9） points in the control group score（P〈0. 05）; but the total effective rate and the clinical benefit rate had no statistically significant difference between the two groups（P〈0. 05）. The occurrence rate of gastrointestinal tract adverse reaction in the observation group was 46. 51%,which was significantly lower than 76. 19% in the control group（P 〉0. 05）;the occurrence rates of other adverse reactions in the two groups were similar（P 〉0. 05）; the mean survival time and median survival time in the observation group were significantly higher than those in the control group（P〈0. 05）,but the 1- year survival rate and2- year survival rate in the two groups were similar（P〉 0. 05）. Conclusion Although adding Compound Glutamin Enterosoluble Capsules in elderly advanced gastric cancer treated by 3DCRT concurrent XELOX chemotherapy could not significantly increase the short term and long term efficacy,but can greatly improve the living quality of the patients,reduces the gastrointestinal adverse reactions and increases the therapeutic compliance.