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目的:分析葡萄糖酸钙注射液不良反应发生的特点,为临床安全用药提供参考。方法:采用回顾性分析方法,对山东省药品不良反应监测中心ADR报告数据库中2010年1月1日~2015年9月15日葡萄糖酸钙注射液不良反应报告进行统计分析,项目包括:患者性别与年龄、原患疾病、过敏史、用药原因,ADR发生时间,用法用量、联合用药,ADR累及系统-器官类型及分布,ADR转归,以及不良反应类型、评价结果等因素。结果:268例ADR报告中,男女患者比例相当,15~44岁患者构成比最高;ADR多发生于静脉滴注时,ADR发生时间多为前30 min;临床累及器官或系统主要为胃肠道系统、全身性反应和皮肤及其附件;绝大多数患者在停药或对症治疗后好转或痊愈。结论:警惕葡萄糖酸钙注射液引发的不良反应,完善说明书中安全提示信息,提高临床合理用药水平,加强临床监护,防止严重不良反应发生,保障临床用药安全。
Objective: To analyze the characteristics of adverse reactions of calcium gluconate injection and provide reference for clinical safety medication. Methods: A retrospective analysis of adverse drug reactions in Shandong Province ADR database from January 1, 2010 to September 15, 2015 calcium gluconate injection adverse reactions reported statistical analysis, the project includes: the patient’s gender And age, the original disease, history of allergy, medication reasons, the time of ADR, dosage, combination therapy, ADR involving system - organ type and distribution, ADR outcome, and the type of adverse reactions, evaluation results and other factors. Results: 268 cases of ADR report, the proportion of male and female patients, 15 to 44 years old patients with the highest composition ratio; ADR occurred in intravenous drip, ADR occurred for the first 30 min; clinical involvement of organs or systems mainly gastrointestinal Systemic, systemic reactions and skin and its accessories; the vast majority of patients are better or healed after withdrawal or symptomatic treatment. Conclusion: Vigilant calcium gluconate injection caused adverse reactions, improve the instructions in the safety tips to improve the clinical rational use of drugs, strengthen clinical care, prevent serious adverse reactions, to protect the safety of clinical medication.