目的 以臨床常用抗菌藥物鹽酸克林霉素棕櫚酸酯分散片為例,探索抗菌藥物綜合評價的內(nèi)容和方法,為抗菌藥的臨床合理使用以及藥品相關(guān)決策提供依據(jù),推動安全有效合理用藥。方法 基于系統(tǒng)檢索文獻和權(quán)威出版物,利用循證醫(yī)學等基本方法,從成分結(jié)構(gòu)、藥物代謝、相互作用和抗菌藥物的抗菌譜、藥敏和耐藥等藥學特性對鹽酸克林霉素棕櫚酸酯分散片進行評價。結(jié)果 鹽酸克林霉素棕櫚酸酯分散片有效成分和在說明書適應(yīng)證上的藥理作用明確,抗菌譜廣,酯化結(jié)構(gòu)的前藥設(shè)計相比克林霉素具有更好的依從性;其在歐美國家與在我國的耐藥現(xiàn)狀并不一致。結(jié)論 鹽酸克林霉素棕櫚酸酯分散片是克林霉素的前體藥物,在體內(nèi)一步代謝生成克林霉素。鹽酸克林霉素棕櫚酸酯分散片酯化前藥設(shè)計克服了克林霉素的口味缺陷,提高了兒童等特殊患者的應(yīng)用依從性,但在臨床應(yīng)用中也應(yīng)注意結(jié)合藥敏結(jié)果精確臨床定位。

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