朱朝艳 鲁广先 丁信园 沈欣 过晓蕾

[摘要] 目的 分析我院β-內酰胺酶抑制剂复方制剂所致药品不良反应（ADR）发生的特点及其规律，提醒临床用药注意，促进临床合理用药。 方法 从国家药品不良反应监测系统中收集我院2011年4月至2021年4月使用β-内酰胺酶抑制剂复方制剂的不良反应报告，利用Excel 2010对200例不良反应进行数据汇总，对其年龄、性别、用药原因及使用情况、发生不良反应的药物及数量、不良反应发生的临床表现、不良反应发生的严重程度等进行统计分析。 结果 200例不良反应报告中，女性发生比例高于男性;0～13岁的患者发生不良反应最为常见，构成比高达50.00%;不良反应发生率最高的是注射用阿莫西林钠舒巴坦钠，发生67例，构成比高达33.50%，占比前3的第二位和第三位分别为注射用美洛西林钠舒巴坦钠（28.00%）及注射用哌拉西林舒巴坦钠（25.00%）;给药方式均为静脉滴注;临床表现以皮肤及其附件损害最为常见。 结论 β-内酰胺酶抑制剂复方制剂所致的不良反应与多种因素有关，医护人员在临床用药过程中应加强不良反应监测并及时处理、减少或避免不良反应的发生，保障患者用药安全。

[关键词] β-内酰胺酶抑制剂;不良反应;复方制剂;合理用药

[中图分类号] R969.3          [文献标识码] B          [文章编号] 1673-9701（2021）35-0117-04

Adverse reaction analysis report of β-lactamase inhibitor compound preparation in our hospital from April 2011 to April 2021

ZHU Chaoyan   LU Guangxian   DING Xinyuan   SHEN Xin   GUO Xiaolei

Department of Pharmacy， Suzhou Hospital Affiliated to Nanjing Medical University， Suzhou   215001， China

[Abstract] Objective To analyze the characteristics and regularity of ADR caused by β-lactamase inhibitor compound preparation in our hospital， to remind clinical medication attention， and to promote clinical rational drug use. Methods The adverse reaction reports of β-lactamase inhibitor compound preparation in our hospital from April 2011 to April 2021 were collected from the national adverse drug reaction monitoring system. Excel 2010 was used to summarize the data of 200 patients of adverse reactions， and statistical analysis was made on their age， gender， medication reasons and usage， drugs and quantity of adverse reactions， clinical manifestations of adverse reactions， and severity of adverse reactions. Results Among 200 patients of adverse reactions reported， the proportion of female was higher than that of male. Adverse reactions were most common in patients aged 0-13 years， with a constituent ratio of up to 50.00%.The highest incidence of adverse reactions was amoxicillin sodium and sulbactam sodium for injection， with 67 cases， accounting for 33.50%. The second and third place in the top 3 were mezlocillin sodium and sulbactam sodium for injection （28.00%） and piperacillin and sulbactam sodium for injection （25.00%）， respectively.The methods of administration were all intravenous drip.The most common clinical manifestations were skin and accessory lesions. Conclusion The adverse reactions caused by β -lactamase inhibitor compound preparations are related to a variety of factors， so medical staff should strengthen the monitoring of adverse reactions and timely deal with， reduce or avoid the occurrence of adverse reactions in clinical medication to ensure the drug safety of patients.

[Key words] β-lactamase inhibitor; Adverse reaction; Compound preparation; Rational use of drugs

β-内酰胺酶抑制剂复方制剂因抗菌范围广、毒性低等优点被临床广泛使用，也成为临床治疗耐β-内酰胺类抗生素细菌所致感染性疾病的重要措施之一。然而一部分患者使用该类药物会……