目的 以临床常用抗菌药物盐酸克林霉素棕榈酸酯分散片为例,探索抗菌药物综合评价的内容和方法,为抗菌药的临床合理使用以及药品相关决策提供依据,推动安全有效合理用药。方法 基于系统检索文献和权威出版物,利用循证医学等基本方法,从成分结构、药物代谢、相互作用和抗菌药物的抗菌谱、药敏和耐药等药学特性对盐酸克林霉素棕榈酸酯分散片进行评价。结果 盐酸克林霉素棕榈酸酯分散片有效成分和在说明书适应证上的药理作用明确,抗菌谱广,酯化结构的前药设计相比克林霉素具有更好的依从性;其在欧美国家与在我国的耐药现状并不一致。结论 盐酸克林霉素棕榈酸酯分散片是克林霉素的前体药物,在体内一步代谢生成克林霉素。盐酸克林霉素棕榈酸酯分散片酯化前药设计克服了克林霉素的口味缺陷,提高了儿童等特殊患者的应用依从性,但在临床应用中也应注意结合药敏结果精确临床定位。

Objective Taking clindamycin palmitate dispersible tablets as an example, to explore the contents and methods of comprehensive evaluation of antibacterial drugs, provide basis for rational clinical use of antibacterial drugs and drug-related decision-making, and promote safe, effective and rational drug use. Methods Based on systematic retrieval of literature and authoritative publication, using evidence-based medicine and other basic methods, the pharmaceutical characteristics of clindamycin palmitate were evaluated from the aspects of composition structure, drug metabolism, interaction, antibacterial spectrum, drug sensitivity and resistance of antibacterial drugs. Results Clindamycin palmitate has clear active composition and pharmacological action on indication, wide antibacterial spectrum, prodrug design with esterification structure has better compliance than clindamycin. The status of drug resistance in Europe and America is not consistent with that in China. Conclusion Clindamycin palmitate dispersible tablets is the palmitate prodrug that is metabolized into clindamycin in one step in vivo. Esterification prodrug design in clindamycin palmitate dispersible tablets overcomes clindamycin taste defects and improves compliance for children and other special patients. However, precise clinical positioning should be combined with drug sensitivity results.

R978.1