近年來，歐盟因為對乙酰氨基酚緩釋制劑的安全性問題已經(jīng)暫停其在歐盟國家的銷售，目前國內(nèi)對于對乙酰氨基酚緩釋制劑的安全性罕見報道。結(jié)合對乙酰氨基酚緩釋制劑的發(fā)展歷史，對正常劑量和過量使用對乙酰氨基酚緩釋制劑、曲馬多-對乙酰氨基酚復(fù)方緩釋制劑的安全性和藥動學(xué)參數(shù)等方面進行詳細論述，為含對乙酰氨基酚的緩釋制劑的安全性評價和合理應(yīng)用提供參考。

In recent years, sustained release formulation of paracetamol has been discontinued in EU market because of its safety issue, but the safety of this drug is rarely reported in China. This review expounds the safety as well as pharmacokinetics parameters of sustained release paracetamol formulation and extended release tramadol/paracetamol formulation following therapeutic dose and overdose combining with the history of drug development,which provide a clue for safety evaluation and rational use of these drugs.

R943;R965.3