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目的分析我院2014年中药注射剂药品不良反应报告(ADR)。方法选取2014年芜湖市第一人民医院临床监测的中药注射剂ADR 78例,回顾性分析患者一般情况、累及器官/系统及临床表现、药品种类、ADR发生时间、联合用药、因果关系评价及转归。结果 78例中药注射剂ADR患者中男37例(47.4%),女41例(52.6%);年龄20~80岁,中位年龄65岁;全身性反应最常见,主要临床表现为过敏性休克、药物热、输液反应等;涉及8种药品,其中痰热清注射液18例(23.1%);用药10~30min时ADR发生率较高;单一用药59例(75.6%),联合用药19例(24.4%);因果关系评价:肯定3例(3.8%),很可能45例(57.7%),可能30例(38.5%);治愈67例(85.9%),好转11例(14.1%)。结论中药注射剂ADR的发生与多种因素有关,临床应加强对中药注射剂的监测,以促进临床合理用药,保证患者用药安全。
Objective To analyze the adverse drug reactions (ADRs) of traditional Chinese medicine injections in our hospital in 2014. Methods A total of 78 ADRs were collected from the First People’s Hospital of Wuhu City in 2014. The clinical data were retrospectively analyzed, including organ / systemic and clinical manifestations, drug categories, time of ADR, causality and outcome . Results 37 cases (47.4%) and 41 females (52.6%) were male and female in ADR. The age ranged from 20 to 80 years and the median age was 65 years old. The systemic reactions were the most common. The main clinical manifestations were anaphylactic shock, Drug fever, infusion reaction, etc .; involving 8 kinds of drugs, of which Tanreqing injection in 18 cases (23.1%); ADR 10 ~ 30min when the incidence was higher; single drug in 59 cases (75.6% 24.4%). The evaluation of causality was positive in 3 cases (3.8%), most likely in 45 cases (57.7%), possible in 30 cases (38.5%), cured in 67 cases (85.9%) and improved in 11 cases (14.1%). Conclusion The occurrence of traditional Chinese medicine injections ADR and many factors related to clinical should strengthen the monitoring of traditional Chinese medicine injections to promote clinical rational use of drugs to ensure the safety of patients medication.