目的 了解注射用哌拉西林钠舒巴坦钠发生药品不良反应（ADR）的特点及相关因素，探讨其安全性，为临床合理用药提供参考依据。方法 回顾性收集东莞市人民医院2016-2018年上报的药品不良反应中关于注射用哌拉西林钠舒巴坦钠并对其不良反应报告进行描述性统计分析。结果 共收集ADR 1 909例，关于注射用哌拉西林钠舒巴坦钠57例（2.98%）；其中一般不良反应33例（57.89%），新的一般不良反应11例（19.30%），严重不良反应有13例（22.8%），新的严重不良反应6例（10.53%）；从发生的ADR的年龄段分析，主要发生在36~59岁患者（26.32%）和>60岁的患者（63.15%）；主要累及器官为皮肤及其附件（68.42%）、全身性损伤（28.07%）和免疫系统（17.54%），主要临床表现为瘙痒、皮疹、潮红、血小板减少；发生ADR患者停药后症状均减轻，痊愈和好转患者55例（96.5%）；注射用哌拉西林钠舒巴坦钠很可能是不良反应的主要原因。结论 注射用哌拉西林钠舒巴坦钠发生药品不良反应不多，但存在新的不良反应，临床上应重视其所致的ADR，并加强合理用药，确保用药安全。

Objective To study the characteristics and related factors of adverse drug reactions (ADR) induced by piperacillin sodium and sulbactam sodium for injection, and to investigate the safety and provide reference for clinical rational drug use. Methods Retrospective statistical analysis was performed on the adverse drug reactions of piperacillin sodium and sulbactam sodium for injection reported by Dongguan People's Hospital from 2016 to 2018. Results A total of 1 909 cases of ADR were collected, including 57 cases (2.98%) of piperacillin sodium and sulbactam sodium for injection. There were 33 cases (57.89%) of general adverse reactions, 11 cases (19.30%) of new general adverse reactions, 13 cases (22.8%) of severe adverse reactions, and 6 cases (10.53%) of new severe adverse reactions. According to the analysis of the age group of ADR, it had mainly occurred in patients with 36-59 year old (26.32%), and patients above 60 years old (63.15%). The main involved organs were skin and its appendants (68.42%), systemic diseases and various reactions at the site of administration (28.07%), and immune system (17.54%), and the most common clinical manifestations were pruritus, rash, flushing, and thrombocytopenia. All patients had reduced symptoms after drug withdrawal, and 55 cases (96.5%) had recovered. Piperacillin sodium and sulbactam sodium for injection were probably the main causes of adverse reactions. Conclusion There are not many serious adverse drug reactions induced by piperacillin sodium and sulbactam sodium for injection, but still new adverse drug reactions. Clinical monitoring should be applied to the ADR and the rational drug use should be enhanced to ensure drug safety.