放疗增敏剂甘氨双唑钠的Ⅱ期临床研究

Primary clinical study of Radiosensitizer CMNa

目的 :按二期临床研究要求观察注射用甘氨双唑钠 (简称CMNa)的有效性和安全性。方法 :采用平行对照、随机分组的设计方法 ,将 2 8例经病理组织学确诊的需接受放射治疗的头颈部、食管和肺部肿瘤患者 ,按 2∶1的比例分设实验组(CMNa +常规放疗 )和对照组 (单纯常规放疗 ) ,观察其有效性和安全性的相关指标。结果 :治疗前后血常规、肝肾功能的实验室检查 ,治疗中和治疗后不良反应、严重程度的观察比较及不良反应率的结果比较。两组均无显著性差异。肿瘤原发灶和转移灶的CR率和CR +PR率两组未见显著性差异。但转移灶达PR时所需的照射剂量明显低于对照组 (P <0 0 5 )。结论 :安全性与前期研究结果相符 ,在临床推荐剂量内未观察到明显消化道和神经系统等的不良反应 ,有效率未见显著性差异可能与样本数较少有关。据后期汇总的大样本统计显示两组的显著性差异表现在CMNa可提高CR率和总有效率 。

Objective:To ob serve the safety and effectiveness of the radiosensitizer CMNa for injection according to the standard of the clinical study (11 stage).Methods:The 28 cases are all diagnosed by pathology and needed radiot herapy. These patients suffered from the c ancers of lung, esophagus and head and neck were randomly divided into two groups according to the ratio of 2∶1. CM Na+irradiation for testing group and irra diation only for control group. Then the relevant index in effectiveness and safety was observed. Results:On the kinds, the sev ere degree and the rate of side effect. There is no obviously difference between two groups when doing and finishing treatment by the laboratary test of blood routine, liver and kidney functions and observing the clinical symptoms. On the rate of CR and CR+PR, there is also no significant difference in primary and matastasis lesions of two groups, but the irradiation dose needed when making matastasis lesions to CR is obviously lower than control group( P <0.05).Conclusion:No obviously side effect was found in digestive tract and ne rvous system under the recommended clinical dose. This result match with the study (1 stage).The small sample may be the reason for no significant difference i n effective rate between two groups. Beca use CR and total effective rate were incr eased and the irradiation dose was come down using CMNa being found in big sample sumed up later.