3种用药频次较高的抗肿瘤靶向药物临床使用调研

Investigation of Three Antineoplastic Targeted Drugs with High-frequency Clinic Application

目的从临床使用安全性角度出发,调研3种抗肿瘤靶向治疗药物利妥昔单抗(Rituximab)、曲妥珠单抗(Trastuzumab)及尼妥珠单抗(Nimotuzumab)按药品说明书界定的适应证范围进行临床应用的状况。方法依据药品说明书和文献资料,确定临床应用适应证范围;同时利用医院信息系统(HIS),查阅本院2008年7～12月份临床上分别应用过上述3种药物的病例,逐一核查分析患者的出院诊断与适应证的相符性。结果使用过以上3种药物的病例分别为149、28和18例,与药品说明书界定的适应证范围的相符率分别是80.54%、50%和55.56%;依照国内外指南推荐用法及文献资料提供的参考适应证的相符率则分别是99.33%、89.29%和55.56%。结论3种靶向治疗药物临床使用与药品说明书界定的适应证范围不能完全相符,究其原因是药品说明书较国内外开展的临床试验和出台的治疗指南有一定的滞后性,不一定能全面地代表该类药物目前的全部治疗信息,而且抗肿瘤靶向治疗药物上?时间一般不长,临床应用经验有限。抗肿瘤靶向药物的使用亟待进一步规范化。

Objective To investigate the clinical application of 3 kinds of antineoplastie target therapy drugs： Rituximab, Trastuzumab, and Nimotuzumab. Methods The indications of those 3 drugs were determined according to dispensatories and other usages referred to literatures. Meanwhile, the cases administrated with the 3 drugs in the latter half of 2008 were indexed by Hospital Information System （HIS）. Then the conformities between discharge diagnosis of cases and indications of drugs were analyzed. Results There were 149, 28, and 18 cases which had taken Rituximab, Trastuzumab, and Nimotuzumab, respectively. The conformity ratio of 3 drugs were 80.54%, 50%, and 55.56% according to dispensatories, respectively, versus 99.33% ,89.29%, and 55.56% on the basis of dispensatories and references, respectively. Conclusion The results showed that the off - label usage of the 3 antineoplastic drugs were due to the limitations of clinical usage experiences and the stagnant property of dispensatories. But at the same time, the application of drugs must be according to the standard in order to efficiently improve the level of rational drug use.