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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 conduct a survival analysis of radiosensitization of esophageal carcinoma of glycopyrrolate sodium (CMNa) through a multicenter randomized controlled clinical study. Methods 152 cases of esophageal cancer patients were randomly divided into experimental group (A group) and control group (B group). Group A radiotherapy with CMNa, B group was a radiotherapy group. Efficacy and safety evaluation and regular follow-up. Results 150 patients completed the trial, A group of 101 cases, B group 49 cases. The 1-, 2- and 3-year survival rates were 77%, 54%, and 28% in group A to IIIa (n = 69), and the median survival time was 27 months in group A. The patients in group B Respectively, 71%, 25%, 19%, 16 months (x ~ 2 = 4.23, P = 0.040). The overall incidence of adverse reactions in both groups was 37% and 39%, respectively (x 2 = 0.03, P = 0.859), and no neurotoxicity was observed. Conclusion CMNa has a good radiosensitizing effect on esophageal cancer and has certain significance to improve the survival rate, with small toxic and side effects.