MONITORING STUDIES DURING THE PHASE III CLINIC OF ACETAMINOPEN CODEINE TABLET

The objective of present studies was to monitor the adver-se effects of acetaminophen-codeine tablet witch contains 8. 4mg of codeinephosphate and 500mg of acetaminophen, investigate its possibility of drugabuse and drug dependence in community and continue evaluating its cura-tive effects by using drug utilization studies, doctors' assessment piloted through a designed self-completion question naire, investigation in emergencydepartments and follow-up studies during the phase Ⅲ clinic. Results show:(1) this drug has a good effect and larger spectrum of analgesia with aeffective rate of 81. 3%; (2) side-effects (dizziness, sweating, sleepinessand tiredness) occurred in about 0. 8% of patients but were usually ofminor intensity, no serious adverse effects were observed; (3) no addictsand abuse phenomenon of the drug were monitored during the survey; (4)drug utilization studies in hospitals showed that the number of DDDs con-sumed per day on average was only 24. 24±14. 81 (X±SD) and the drugutilization index (DUI) was usually less than 1. 0, suggesting there was arational use of the drug.