甘氨双唑钠(CMNa)对食管癌放射治疗增敏作用的研究

The study of radiosensitizer metronidazole amino acidum natrium(CMNa)in patients with esophagus carcinma.

目的 通过前瞻性研究探讨甘氨双唑钠对食管癌的放射增敏作用及其安全性。方法 各期食管癌患者 15 0例 ,均符合入组条件并有病理证实 ,按随机对照原则 ,分为试验组 (A组 )和对照组 (B组 )。A组病人放疗同时使用CMNa80 0mg/m2 ,每周 3次 ,连续用药至放疗结束 ;B组为单纯放疗组。放射治疗方法两组均采用目前标准放疗方案。放疗前 2周内、放疗后 3周和 7周 ,分别行CT或X线拍片以观察疗效。放疗中每周测血常规并观察各种不良反应 ,每 3周查肝肾功能及心电图。结果 完成放疗者 14 1例 ,A组 93例 ,B组 4 8例。A组的CR率高于B组 ,两组差异有统计学意义 (P =0 0 0 2 )。A组肿瘤抑制率高于B组 ,两组差异有统计学意义 (P =0 0 0 9)。A组病人治疗达CR时的中位剂量较B组降低 ,但由于疗效观察方法的限制 ,两组差异无统计学意 (P =0 0 5 6 6 )。两组病人不良反应发生率比较无统计学意义 (P =0 85 9) ,未观察到神经系统毒性。结论 CMNa较明显的提高了食管癌的放射治疗的近期疗效 ,在使用过程中未发现明显不良反应 ,是一种低毒有效的放射增敏剂 。

Objective To verify the role of CMNa in enhancing radiosensitivity and its safety.Methods 150 patients with esophagus carcinoma were randomly divided into two groups(test group A and control group B).Diagnosis in all cases was confirmed by pathology.The patients in group A were intravenous dripped CMNa 800mg/m^2 three times weekly duing whole treatment period by radiotherapy .Patients in group B were treated by radiotherapy alone .The standard protocols of radiotherapy were adopted in two groups.The effects were assessed by CT scan or X-ray.Various adversereactions and blood routine test were observed weekly while the liver function、renal function and EKG were examed every three weeks.Results All 141 patients were completed their designed treatment in which 93 patients were in group A and 48 patients were in group B.The CR rate of group A was higher than that of group B(P=0.002)and the tumor inhibition rate in group A was much better than that in group B(P=0.009).The median dose by which the effects had reached CR was lower in group A than that in group B,but there was no strong correlation because of the limit of the methods assessing the therapeutic effects. There were no significant difference between two groups in the rate of adverse reacion(P=0.859).No neurotoxicity was observed.Conclusion CMNa is an effective radiosensitzer with low toxicity and high safety,which obviously enhanced the early responses of esophagus carcinoma and had no specific toxicity in our study.Remote results await further follow-up.