β-内酰胺酶抑制剂复合制剂4917例不良反应报告分析

Analysis of 4917 cases of adverse drug reaction reports induced by β-lactamase inhibitor compound preparations

目的分析重庆市β-内酰胺酶抑制剂复合制剂所致药物不良反应(ADR)的特点和一般规律,为临床合理用药提供参考。方法对2008—2013年重庆市ADR监测中心接收的β-内酰胺酶抑制剂复合制剂致4 917例ADR报告进行回顾性统计分析。结果 4 917例报告中,老年患者与儿童患者比例较高;静脉滴注给药引发的ADR最多,占92.15%;含舒巴坦复合制剂引起的ADR居首位,占74.27%;所涉及药品前3位分别为头孢哌酮/舒巴坦2 077例(42.24%)、阿莫西林/舒巴坦698例(14.20%)及阿莫西林/克拉维酸钾652例(13.26%);ADR累及器官及系统以皮肤及其附件损害、全身性损害和消化系统损害最为常见。结论临床应重视β-内酰胺酶抑制剂复合制剂的ADR监测工作,减少或避免ADR的发生,保障临床用药安全有效。

ATM To analyze the features and patterns of adverse drug reactions （ADR） induced by β- lactamase inhibitor compound preparations in Chongqing in order to provide reference for clinical rational drug use. METHODS Totally 4 917 cases of ADR induced by β-lactamase inhibitor compound preparations collected by Chongqing ADR monitoring center from 2008 to 2013 were analyzed retrospectively. RESULTS Among the 4 917 ADR reports, elderly patients and children got higher proportions. ADRs were more likely caused by intravenous （92.15%）. The majority of ADRs were caused by the compound preparation with sulbactam 74.27%）. The former three involving drugs were cefoperazonr/sulbactam （42.24%）, amoxicillin/ sulbactam 14.20%） and amoxieillin/clavulanic acid （13.26%）, respectively. The main presentations of ADR were lesion of skin and its appendages, general symptoms and digestive system symptoms. CONCLUSION Great importance should be attached to ADR monitoring work of β- laetamase inhibitor compound preparation, to reduce or avoid the occurrence of ADR and ensure the safety and efficacy of clinical medication.