目的:分析奥硝唑氯化钠注射液不良反应/事件(adverse drug reaction/event,ADR/ADE)发生的特点和规律,为临床合理用药提供依据。方法:从国家药品不良反应监测中心提取重庆市2008.1.1-2014.5.31期间以怀疑药品为奥硝唑氯化钠注射液的不良反应/事件报表,进行回顾性分析。结果:符合纳入标准的奥硝唑氯化钠注射液不良反应/事件共922例,其中女性人数是男性人数的2倍多,20-60岁之间的患者占79.1%,其不良反应多发生在5-30 min内(50.9%),以消化系统、神经系统损害最为常见,有呼吸困难、过敏性休克、昏迷等严重不良反应发生。结论:临床应加强奥硝唑氯化钠注射液不良反应/事件的监测,促进合理使用并注意观察患者用药反应,避免或减少不良反应/事件给患者带来的损失。
OBJECTIVE To study characteristics of adverse drug reactions/events(ADRs/ADEs)induced by ornidazole and sodium chloride injection,provide reference for clinical rational medication.METHODS A total of 922 ADRs/ADEs induced by ornidazole and sodium chloride injection were analyzed retrospectively from Jan2008 to May 2014 in Chongqing.RESULTS Of922 adverse ADRs/ADEs,female patients were twice of male patients,and patients aged 20-60 years accounted for 79.1%.ADRs often happened within5-30 min after medication and involved many organs and systems.Harms to digestive system and nervous system were seen commonly.Serious ADRs(e.g.,dyspnea,anaphylactic shock and coma)could be observed.CONCLUSION Monitoring of ornidazole and sodium chloride injection should be enhanced to ensure safety.Physicians should pay more attentions to avoid or reduce losses caused by ADRs/ADEs.