ABSTRACT
OBJECTIVE： To provide reference for the establishment and improvement of the post-marketing re-evaluation of drugs （shorted for re-evaluation） legal system in China. METHODS： Through sorting out American re-evaluation system， this paper focused on the current situation and procedures of the implementation of American re-evaluation system and put forward the suggestions for improving drug re-evaluation system in China. RESULTS & CONCLUSIONS： American re-evaluation system takes enterprises as the main body of execution and the government as the main body of supervision. It has the characteristics of highly informatized and transparent process. The work includes the report of ADR implementation of monitoring systems， the periodic reporting system and the post-listing clinical trials and research systems. The implementation process is to find clues， FDA preliminary review and notification， enterprise further self-examination and review， corporate actions and accept FDA supervision. It is suggested that when establishing the legal system of re-evaluation system in China， the main role of patients should be highlighted， and risk communication should be guided by the public. For example， the Medwatch voluntary reporting system of FDA can be imitated. The unified data collection， storage system and scientific data processing methods can be established. Continuously strengthen the main responsibility consciousness of pharmaceutical enterprises in testing and reporting， and constantly reduce the risk of drug use of patients.
ABSTRACT
OBJECTIVE To investigate the incidence rate of Pseudomonas aeruginosa whose ceftazidime resistance was induced by imipenem and the relationship of excretion pump with sensibility of imipenem and ceftazidime.METHODS The sensibility to 15 antibacterials and ceftazidime resistance induced by imipenem were detected by slip diffusion method,detect these bacteriumas′s MIC to Imipenem and Ceftazidime before and after excretion pump inhibitor hydroxide radical cyanogen chlorine phenylhydrazone(CCCP) were added by agar dilution,detect Ceftazidime′s MIC value which were added different concentration imipenem by agar dilution.RESULTS From 325 strains 116 strains(35.7%) were imipenem induced ceftazidime-resistant drug fast,from them 80.2% were imipenem-resistant and ceftazidime-sensitive,19.8% were imipenem and ceftazidime both sensitive.Sensibility to imipenem and ceftazidime was no marked change before and after CCCP added,MIC value of ceftazidime was step up 4-12 times by imipenem.CONCLUSIONS The incidence rate of ceftazidime-resistant P.aeruginosa induced by imipenem is high,clinical microbiological laboratory should evolve D-test to guide clinician use antibacterials more reasonable.