摘要目的 探讨口腔用局麻药不良反应发生的原因与规律,为临床用药提供参考.方法 收集2015年1月1日至2017年1月31日滨州医学院附属烟台市口腔医院上报国家药品不良反应监测系统的75例阿替卡因肾上腺素注射液不良反应病例资料(均为门诊及住院患者),对性别、年龄、报告类型、给药途径、药品不良反应发生时间、药品用量、临床表现、关联性评价与转归等进行统计分析.结果 在75例不良反应中,女性40例,男性35例,3～10岁年龄段发生较多[33％ (25/75)];用药后1～10 min和用药后1d药品不良反应发生率较高,均为20％ (15/75),用药后2d次之[15％(11/75)],用药后10～ 21 d不良反应的发生率为8％ (6/75),各时间点药品不良反应发生率差异有统计学意义(X2=12.541,P=0.006).阿替卡因肾上腺素注射液不良反应除说明书中已知的不良反应,还出现了新的药品不良反应,主要表现为注射部位溃疡形成[47％(38/81)],其次为注射部位疼痛、肿胀、坏死、瘙痒等皮肤反应,占20％(16/81).结论 阿替卡因肾上腺素注射液的不良反应主要以注射部位溃疡形成为主,其次是注射部位疼痛、皮疹、瘙痒及嗜睡、心悸、冷汗、头晕恶心、低血压等多见,医师在用药时应详细询问病史,密切注意患者的用药安全.

abstractsObjective To investigate the causes and clinical manifestation of adverse reaction of articaine hydrochloride and epinephrine tartrate injection.Methods A retrospective analysis was conducted on the adverse drug reactions (ADR) of local anesthetic articaine hydrochloride and epinephrine tartrate injection.Results In 75 cases of adverse reactions,there were 40 cases of female and 35 cases of male.Adverse reactions occured more frequently at the age of 3-10 [33％ (25/75)] and 1-10 min and one day after injection,respectively accounting for 20％ (15/75),and two days,accounting for 15％ (15/75),10-21 days accounting for 8％ (6/75).The main manifestations were injection site ulcers,followed by skin reactions such as pain,swelling,necrosis and pruritus at the injection site.Conclusions The main adverse reactions of articaine hydrochloride and epinephrine tartrate injection are the injection site ulceration,followed by injection site pain,rash,pruritus and drowsiness,nausea and dizziness,palpitations,sweat and hypotension.Doctors should ask the medical history in detail and pay close attention to the patient's medication safety.