Analysis of 1290 Cases of ADR/ADE Induced by Dezocine Injection / 中国药房

ABSTRACT

OBJECTIVE:To investigate general regularity and characteristics of adverse drug reactions/events(ADR/ADE)in-duced by Dezocine injection,and to provide reference for safe and rational drug use in clinic. METHODS:Retrieved from Jiangsu Province ADR Database during Jan. 2009-Aug. 2016,ADR/ADE induced by Dezocine injection was analyzed statistically in re-spects of patient's gender and age,usage and dosage,organs/systems involved in ADR,clinical manifestations and outcome. RE-SULTSAmong 1290 ADR/ADE induced by Dezocine injection,there were 40 cases of severe ADR/ADE(3.10％);medical insti-tutions were main reporting units (1276 cases,98.81％). In ADR/ADE cases,female was more male,with ratio of male to fe-male was 11.45. ADR/ADE mostly occurred in 45-65 age group(43.49％). Intravenous medication was main route of administra-tion (1137 cases,88.14％). Initial dose of 577 cases was excessive dose (50.75％). ADR/ADE mainly involved gastrointestinal system (54.99％),central and peripheral nervous system (24.72％) and systemic lesions (5.20％). Severe ADR/ADE manifested as anaphylactic shock,palpitation and dyspnea,etc. But anaphylactic shock was not mentioned in drug package inserts. 1283 ADR/ADE(99.46％)were cured or improved . CONCLUSIONS:It is necessary to strengthen drug safety reevaluation of Dezocine injec-tion after being on the market,improve drug package inserts and enhance patients education as so as to reduce and avoid the occur-rence of ADR/ADE.