地佐辛注射液致ADR/ADE报告1290例分析

Analysis of 1 290 Cases of ADR/ADE Induced by Dezocine Injection

目的:了解地佐辛注射液致药品不良反应/事件(ADR/ADE)的一般规律和特点,为指导临床安全、合理用药提供参考。方法:检索2009年1月-2016年8月江苏省ADR数据库,对地佐辛注射液致ADR/ADE的患者性别与年龄、药品用法用量、ADR累及器官/系统及临床表现和转归等进行统计分析。结果:共纳入1 290例地佐辛注射液致ADR/ADE报告,其中严重的ADR/ADE报告40例(3.10%);报告单位以医疗机构为主(1 276例,98.91%)。ADR/ADE患者女性多于男性,男女比例为1∶1.45;ADR/ADE发生比例最高的年龄段为45~65岁(43.49%)。给药途径以静脉用药为主(1 137例,88.14%);初始剂量超剂量用药577例(50.75%)。ADR/ADE主要累及胃肠系统(54.99%)、中枢及外周神经系统(24.72%)和全身性损害(5.20%);严重的ADR/ADE表现为过敏性休克、心悸、呼吸困难等,其中过敏性休克等在说明书中未提及。1 283例(99.46%)ADR/ADE转归结果为痊愈和好转。结论:应加强地佐辛注射液上市后的药品安全性再评价,完善药品说明书,加强患者宣传教育,以减少和避免ADR/ADE的发生。

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- SULTS ： Among 1 290 ADR/ADE induced by Dezocine injection, there were 40 cases of severe ADR/ADE （3.10%） ; medical insti- tutions were main reporting units （1 276 cases, 98.81% ）. In ADR/ADE cases, female was more male, with ratio of male to fe- male was 1 ： 1.45. ADR/ADE mostly occurred in 45-65 age group （43.49%）. Intravenous medication was main route of administra- tion （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 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.