OBJECTIVE: To investigate general regularity and characteristics of adverse drug reactions/events (ADR/ADE) induced 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 respects of patient’s gender and age, usage and dosage, organs/systems involved in ADR, clinical manifestations and outcome. RESULTS: Among 1 290 ADR/ADE induced by Dezocine injection, there were 40 cases of severe ADR/ADE (3.10%); medical institutions were main reporting units (1 276 cases, 98.81%). In ADR/ADE cases, female was more male, with ratio of male to female was 1 ∶ 1.45. ADR/ADE mostly occurred in 45-65 age group (43.49%). Intravenous medication was main route of administration (1 137 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. 1 283 ADR/ADE (99.46%) were cured or improved . CONCLUSIONS: It is necessary to strengthen drug safety reevaluation of Dezocine injection after being on the market, improve drug package inserts and enhance patients education as so as to reduce and avoid the occurrence of ADR/ADE.
关键词
地佐辛注射液药品不良反应药品不良事件合理用药
Keywords
Dezocine injectionadverse drug reactionadverse drug eventRational drug use