铜绿假单胞菌注射液超说明书用药的合理性探讨及案例分析

Rationality Discussion of Off-label Drug Use in Pseudomonas Aeruginosa Preparation and Cases Analysis

关键词:  铜绿假单胞菌注射液  超说明书用药  合理性

Key words:  pseudomonas aeruginosa preparation  off-label drug use  rationality

摘要:

目的 统计昆明医科大学第一附属医院住院患者超说明书使用铜绿假单胞菌注射液情况并进行分析。方法 以说明书为依据，查阅国内外指南及文献等相关资料，结合典型病例进行分析。结果 共纳入病例1 349份，超说明书用药情况有848份，占62.86%。其中适应证超说明书用药有237份，给药剂量、给药途径超说明书用药有848份。结论 恶性肿瘤术中创面喷洒大剂量铜绿假单胞菌注射液的用法有一定科学理论、临床试验证据的支持；而鼻窦炎术中使用铜绿假单胞菌注射液无循证医学证据，临床应谨慎使用。

Abstract:

OBJECTIVE To collect and analyze the rationality of off-label drug use in hospitalized patients who used the pseudomonas aeruginosa preparation in First Affiliated Hospital of Kunming Medical University. METHODS Based on the drug specification, analyzed the rationality of the typical cases by searching relevant data at home and abroad, such as guidelines and literature. RESULTS A total of 1 349 cases were summarized, 848 cases of which were off-label, accounting for 62.86%, including 237 cases for indications beyond the instructions and 848 cases for dosage or drug delivery route beyond the instructions. CONCLUSION Spraying the high-dose pseudomonas aeruginosa preparation on the operative wound during the cancer surgery depended on scientific theories and clinical trials, and the use of pseudomonas aeruginosa injection in rhinosinusitis surgery without evidence medical evidence shall be used cautiously.