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目的:总结某院中药注射液不良反应(ADR)发生情况,评价临床药师在预防不良反应发生中的作用。方法:回顾性分析某院2005-2008年住院患者ADR发生事件,统计不良反应表现、发生时间、与患者年龄和性别的关系,并进行归纳分析。结果:男女比例1∶1.2,儿童患者比例为20%,60岁以上老人为23%;按照药品种类归纳,活血化淤类药物ADR发生率为110/265,排第一位,清热解毒类药物为100/265,排第二位;ADR主要表现为皮肤过敏反应(35.6%)、神经系统反应(23.4%)、注射局部损伤(17.39%)、心血管系统反应(14.68%)、呼吸系统损害(13.77%),全身性反应(13.77%)胃肠道系统损害(10.71%)。按照发生时间统计,66%ADR发生在用药24h内,其中32%发生在用药后的30min内,且这部分不良反应主要表现为过敏性休克、心血管系统反应和呼吸系统反应。结论:ADR易于发生在老年人和儿童患者,其临床表现多样,多数ADR在用药早期即发生,且主要为心血管系统和呼吸系统反应,病情急、重,需严密观察,及时处理。临床药师及时监测并向临床医师公布ADR发生情况对于预防ADR的发生具有重要的作用。
Objective: To summarize the incidence of adverse drug reaction (ADR) in a hospital and evaluate the role of clinical pharmacists in preventing adverse reactions. Methods: The incidence of ADR in a hospital from 2005 to 2008 in a hospital was analyzed retrospectively. The relationship between the occurrence of ADR, the time of occurrence, the age and gender of the patients was analyzed retrospectively. Results: The ratio of male to female was 1: 1.2, the proportion of children was 20%, and that of the elderly over 60 was 23%. According to the types of drugs, the incidence of ADR was 110/265, ranking the first place. The detoxification drugs (35.6%), nervous system reaction (23.4%), local injection injury (17.39%), cardiovascular system response (14.68%), respiratory system damage (13.77%), systemic reaction (13.77%) and gastrointestinal system damage (10.71%). According to the time of occurrence statistics, 66% ADR occurred within 24 hours of medication, of which 32% occurred within 30min after treatment, and this part of the adverse reactions mainly manifested as anaphylactic shock, cardiovascular system reactions and respiratory reactions. CONCLUSIONS: ADR is prone to occur in elderly and pediatric patients. The clinical manifestations of ADR are diverse. Most ADR occur early in the medication and are mainly cardiovascular and respiratory reactions. The condition is acute and severe, and should be closely observed and treated promptly. Clinical pharmacists promptly monitor and announce to clinicians the occurrence of ADR plays an important role in preventing the occurrence of ADR.