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目的观察甘氨双唑钠对接受化疗的局部晚期喉癌放疗增敏作用的远期效果。方法选择局部晚期喉癌60例,分为甘氨双唑钠加放疗组(观察组)30例和单纯放疗组(对照组)30例。观察组采用甘氨双唑钠700 mg/m2溶于0.9%氯化钠注射液100 ml中,20 min内滴完,每周3次,共21次,药物滴完后30 min内进行常规放疗;对照组采用安慰剂加0.9%氯化钠注射液,方法同观察组。观察终点为无进展生存期、总生存期和远期毒性及不良反应。结果观察组与对照组分别有27例、24例完成治疗,观察组和对照组中位无进展生存期分别为1.9、1.6年,差异有统计学意义(P=0.026);观察组和对照组中位总生存期分别为2.7、2.2年,差异无统计学意义(P=0.727)。两组均未出现远期严重毒性及不良反应。多因素分析提示N分期及肿瘤位置是无进展生存的预后影响因素,风险比(HR)分别为1.86、3.33;T分期和N分期是总生存期的预后影响因素,HR分别为3.08、1.95。结论甘氨双唑钠对局部晚期喉癌有明显的放疗增敏作用,可以延长患者的无进展生存期,且患者耐受性良好。
Objective To observe the long-term effect of glycidrazole sodium on radiosensitization of locally advanced laryngeal carcinoma undergoing chemotherapy. Methods Sixty patients with locally advanced laryngeal carcinoma were selected and divided into 30 cases of glycopyrrolate plus radiotherapy group (observation group) and 30 cases of radiotherapy alone group (control group). The observation group with glycopyrrolate sodium 700 mg / m2 dissolved in 0.9% sodium chloride injection 100 ml, drip finished within 20 min, 3 times a week for a total of 21 times, 30 minutes after dropping the drug for conventional radiotherapy The control group received placebo plus 0.9% sodium chloride injection, the same way as the observation group. Endpoints for the observation of progression-free survival, overall survival and long-term toxicity and adverse reactions. Results The observation group and the control group were 27 cases, 24 cases completed treatment, the median progression-free survival of the observation group and the control group were 1. 9, 1.6 years, the difference was statistically significant (P = 0.026); the observation group and the control group The median overall survival was 2.7 and 2.2 years, respectively, with no significant difference (P = 0.727). Long-term serious toxicity and adverse reactions did not appear in either group. Multivariate analysis showed that N stage and tumor location were the prognostic factors for progression-free survival. The risk ratios (HR) were 1.86 and 3.33, respectively. T stage and N stage were the prognostic factors of overall survival, with HRs of 3.08 and 1.95 respectively. Conclusion Sodium glycididazole has obvious radiosensitization effect on locally advanced laryngeal carcinoma, which can prolong the progression-free survival of patients with advanced laryngeal carcinoma and the patients are well tolerated.