论文部分内容阅读
目的:了解3种新型抗肿瘤靶向治疗药物西妥昔单抗、厄洛替尼和索拉非尼的临床应用状况。方法:参考药品说明书和文献资料,确定3种药物临床应用适应证范围;同时利用医院信息系统,查阅中山大学附属肿瘤医院2008年1-6月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:使用过西妥西单抗、厄洛替尼和索拉非尼的病例分别为78例、41例和48例,出院诊断与国家食品药品监督管理局审批的国内药品说明书界定适应证的相符率分别是49%、73%和13%,与国内外指南推荐用法适应证的相符率则分别是40%、10%和54%,其他用法则分别为12%、17%、33%。结论:3种抗肿瘤靶向治疗药物的临床应用存在“药品说明书之外的用法”或“超适应证使用”的情况,该类药物的使用亟待进一步规范化。
Objective: To investigate the clinical application of three novel anti-tumor targeted therapies cetuximab, erlotinib and sorafenib. Methods: Reference drug instructions and literature to determine the scope of clinical indications for three drugs; at the same time using the hospital information system, access to Cancer Hospital Affiliated Sun Yat-sen from January to June 2008, respectively, the clinical application of the above three kinds of drug cases, one by one Check the consistency of the patient’s discharge diagnosis and indications. Results: The cases of cetuximab, erlotinib and sorafenib were 78 cases, 41 cases and 48 cases respectively. The diagnosis of discharge matched the definition of the indications in the national drug manuals approved by the State Food and Drug Administration The rates were 49%, 73% and 13% respectively. The corresponding rates were 40%, 10% and 54% respectively. The other usage rates were 12%, 17% and 33% respectively. Conclusion: The clinical application of three anti-tumor targeted therapies has the situation of “usage other than drug instruction” or “use of hyper-indications”. The use of these drugs needs to be further standardized.