目的 探討β-內(nèi)酰胺酶抑制劑復(fù)合制劑致藥品不良反應(yīng)(ADR)的規(guī)律和特點(diǎn),為臨床合理用藥提供參考。方法 檢索2004年1月－2015年8月中國期刊全文數(shù)據(jù)庫(CNKI)、萬方數(shù)字化期刊全文庫、中文科技期刊全文數(shù)據(jù)庫(維普)、中國醫(yī)院知識(shí)總庫(CHKD)報(bào)道的β-內(nèi)酰胺酶抑制劑復(fù)合制劑致ADR的文獻(xiàn),并進(jìn)行分析和討論。結(jié)果 β-內(nèi)酰胺酶抑制劑復(fù)合制劑引發(fā)的ADR男性明顯多于女性,年齡多集中在70歲以上;呼吸道感染發(fā)生的ADR例數(shù)最多;在引發(fā)ADR的β-內(nèi)酰胺酶抑制劑復(fù)合制劑中,頭孢哌酮鈉舒巴坦鈉的發(fā)生率最高;用藥1 d之內(nèi)的例數(shù)最多,占72.8%;ADR累及器官/系統(tǒng)以全身性反應(yīng)、皮膚系統(tǒng)、血液系統(tǒng)較為多見,構(gòu)成比分別為49.4%、15.9%、11.6%;新的嚴(yán)重的ADR共138例,占38.8%。其中以過敏性休克最為多見。結(jié)論 β-內(nèi)酰胺酶抑制劑復(fù)合制劑引發(fā)的ADR較為常見,臨床使用時(shí)應(yīng)及時(shí)處理,確保用藥安全。

Objective To investigate the rules and characteristics of adverse drug reactions (ADR) induced by β-lactamase inhibitor combinations, and to provide the references for the rational use of drugs in clinic. Methods China Journal Full-text Database (CNKI), Wangfang Database, Chinese Science and Technology Journal Full-text Database (VIP), China Hospital Knowledge Database (CHKD), etc were retrieved from January 2004 to August 2015, and the documents of adverse drug reaction induced by β-lactamase inhibitor combinations were analyzed and discussed. Results Men with ADR induced by β-lactamase inhibitor combinations were more than women, and more were focused on above 70 years old. Respiratory tract infection patients had the most ADR cases. In the varieties of β-lactamase inhibitor combinations, cefoperazone/sulbactam had the highest ADR incidence. The most cases (72.8%) occured in the medication within 1 day. Organs/systems involved by ADR mainly were systemic reactions (49.4%), dermal system (15.9%), and hematologic system (11.6%). There were 138 cases of new and serious ADR (38.8%), the most common of which was anaphylactic shock. Conclusion ADR induced by β-lactamase inhibitor combinations is common in clinic. The using of them should be treated promptly, to ensure the medication safety.

國家自然科學(xué)基金資助項(xiàng)目(81403198);天津市第四中心醫(yī)院2015年度院級(jí)課題