Analysis of 1 289 Cases of Adverse Drug Reactions Induced by Cefatriaxone Sodium for Injection Compatible with Dexamethasone in the Same Bottle / 中国药房

ABSTRACT

OBJECTIVE： To analyze the occurrence of the adverse reactions （ADRs） caused by the compatibility of Ceftriaxone sodium for injection and dexamethasone in the same bottle， and to explore the regularity and characteristics of ADRs， so as to provide reference for clinical rational use of drugs. METHODS： The ADRs caused by the compatibility of ceftriaxone sodium and dexamethasone in the same bottle， reported to the National Adverse Drug Reaction Monitoring System from January 1， 2007 to December 31， 2016 were analyzed statistically， including the type of report， route of administration， type of reporting unit， gender and age of patients， occurrence time and month of occurrence of ADR， involved systems/organs and outcome， etc. the potential reasons were analyzed. RESULTS： A total of 2 111 cases were searched， and 1 289 cases （2 177 case times） were collected， of which 166 cases （12.88％） were severe ADR； route of administration was mainly intravenous drip （1 275 cases， 98.91％）； ADR reports mainly came from primary medical institutions （838 cases， 65.01％）； the male （679 cases， 52.68％） were slightly more than the female （610 cases， 47.32％）； the age of patients ranged 18 days-111 years old. The children under 4 years of age had more ADR （“number/age span” value was 141/5＝28.20 and higher than other age groups）； ADR occurred within 1 min to 14 d after medication， most of which occurred within 30 min （853 cases， 66.18％）； in summer （6-8 months）， ADR occurred more frequently （424 cases， 32.89％）； systems/organs involved in ADR were mainly skin and its appendants （1 059 case times， 48.64％ of total case times）， followed by gastrointestinal system （343 case times， 15.76％ of total case times）， systemic injury （291 case times， 13.37％ of total case times）. Among 1 289 ADR patients， 1 255 cases （97.36％） were cured or recovered， 28 cases （2.17％） were died， 4 cases （0.31％） did not improve， and 2 cases （0.16％） had sequelae. The compatibility of ceftriaxone sodium and dexamethasone in bottles had the risk of physical and chemical changes， which can reduce the efficacy and cause more ADR. Dexamethasone in the same bottle was not enough to completely prevent the allergic reaction of ceftriaxone sodium. CONCLUSIONS： In clinic， ceftriaxone sodium and dexamethasone should be avoided to be administered in the same bottle； clinical pharmacists and physicians can improve the ability of clinical pharmaceutical care in primary medical institutions， strengthen monitoring and publicity for patients， and prevent the occurrence of adverse drug reactions.