甘氨双唑钠对食管癌放射增敏作用的生存分析

Metronidazole-amino-acidum-natrium(CMNa)as a radiosensitizer for radiotherapy of esophageal carcinoma:analysis of survival rates

目的通过多中心随机对照临床研究,对甘氨双唑钠(CMNa)的食管癌放射增敏作用进行生存分析。方法各期食管癌患者152例随机分为试验组(A组)和对照组(B组)。A组放疗同时使用CMNa,B组为单纯放疗组。进行疗效和安全性评价并定期随访。结果完成试验者150例,A组101例,B组49例。A组Ⅰ～Ⅲa期患者(69例)1、2、3年生存率分别为77%、54%和28%,中位生存时间27个月；B组Ⅰ～Ⅲa期患者(38例)的分别为71%、25%、19%、16个月(x^2=4．23,P=0．040)。两组总不良反应发生率分别为37%和39%(x^2=0．03,P=0．859),未观察到神经系统毒性。结论CMNa对食管癌有良好放射增敏作用且对提高生存率有一定意义,毒副作用小。

Objective To verify the role of metronidazole--amino-acidum-natrium （CMNa） in enhancing radiosensitivity through analysis of survival rates from a multieenter prospective randomized controlled trial. Methods 152 patients with esophagus carcinoma were randomly divided into two groups（test group A and control group B）. The patients in group A were given intravenous drip CMNa 800 mg/m^2 three times weekly during the whole period of radiotherapy. Patients in group B were treated by radiotherapy alone with the effects and safety evaluated and survival follow-up were carried out. Results 150 （98.7%） patients completed their designed treatment in which 101（67.3% ） patients were allotted to group A and 49 patients to group B. Among the 69 stage Ⅰ-Ⅲa patients in Group A, the 1-, 2- and 3-year survival rates were 77% ,54% and 28%,with a median of 27 months. Among the 38 stage Ⅰ- Ⅲ a patients in Group B, they were 71%, 25 %, 19 % and 16 months （x^2 = 4.23, P =0.040）. The rate of adverse reactions was 37% and 39% in group A and group B （x^2 = 0.03, P = 0.859）, without any neurotoxicity observed. Conclusions CMNa, being an effective radiosensitizer, can improve survival rates of stage Ⅰ-Ⅲ a esophageal carcinoma patients to certain extent, with safety proved as shown in this study.