摘要
目的:为抗肿瘤药类注射剂的药品说明书完善与合理使用提供参考。方法:以《化学药品和治疗用生物制品说明书规范细则》为标准,结合临床实际需要,对临床常用的33份抗肿瘤药类注射剂药品说明书进行调查分析。结果:33份说明书中,多数项目齐全,但用法用量、特殊人群用药、药物相互作用、药物过量、贮藏项目内容不完整;其中,用法用量的完整率仅60.6%,临床试验的完整率仅12.1%。33份说明书中,含有静脉输液配制指导内容的有20份(约占60.6%),无静脉输液配制指导的有13份(约占39.4%)。结论:国内抗肿瘤药类注射剂药品说明书的规范性有待提高,建议补充完善说明书的不足之处。
OBJECTIVE： To provide reference for the improvement of package inserts of antitumor drug injection and rational use of it. METHODS： According to Regulations for Package Inserts of Chemical Drugs and Biological Products, 33 package in- serts of antitumor drug injection were investigated and analyzed on the basis of clinical practice. RESULTS： Of total 33 package in- serts, most projects were described completely, but the contents, including dosage and usage, special populations, drug interac- tions, drug overdose and storage, were incomplete, especially the 60.6% of dosage and usage were described, and only 12.1% of clinical trials were complete in contents. Among 33 package inserts, there were 20 package inserts containing intravenous infusion preparation （about 60.6% ）, 13 package inserts didn＇t contain it （about 39.4% ）. CONCLUSIONS： The package inserts of antitu- mor drug injection need to be improved in China. It is suggested to supplement the content of package inserts.
出处
《中国药房》
CAS
CSCD
2014年第1期91-93,共3页
China Pharmacy
