论文部分内容阅读
目的了解本院常用抗肿瘤药说明书中老年人用药标注的情况,为完善和修订抗肿瘤药说明书提供参考。方法收集常用的98种抗肿瘤药说明书,根据《药品说明书和标签管理规定》和《化学药品和治疗用生物制品说明书规范细则》,结合临床实际需要,重点对“用法用量”和“药代动力学”中有关老年人的表述,以及“药物过量”、“药物相互作用”和“禁忌”进行统计分析。结果 “药物相互作用”和“禁忌”的标注率较高,但其他3项标注率较低,尤其是国产药品。结论建议生产厂家对药品说明书进行完善,明确用药时间及剂量,推进老年人药代动力学试验,确保用药安全、有效。
Objective To understand the indications of drug use in the elderly in the commonly used antineoplastic agents in our hospital and provide references for improving and revising the instructions of antineoplastic agents. Methods A total of 98 kinds of commonly used antineoplastic agents were collected. According to the Regulation of Drug Instructions and Labeling and the Rules and Regulations for Biological Drugs and Therapy Biological Instructions, combined with the actual clinical needs, Pharmacokinetics “for the elderly, as well as statistical analysis of” overdose “,” drug interactions “and” taboo “. Results ”drug interactions “ and ”taboo " labeling rate is higher, but the other three items labeled rate is low, especially domestic drugs. Conclusion It is suggested that the manufacturer should improve the drug specification, determine the time and dosage of drug, promote the pharmacokinetics test in elderly to ensure the drug is safe and effective.