参麦注射液上市后临床安全性主动监测与被动监测大数据综合评估

Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background

该文在大数据背景下,利用相关分析方法,将来自国家药品不良反应中心自发呈报系统(spontaneous reporting system,SRS)4 220例与前瞻性、多中心、大样本医院集中监测32 358例的参麦注射液上市后临床安全性监测大数据分析综合,计算参麦ADR发生率为0.093%,ADR主要见胸闷、畏寒、皮肤瘙痒、心悸、发热、恶心、头晕、呕吐、面红、麻木、过敏样反应、紫绀、皮疹、腰痛等表现,"憋气"、"过敏样反应"和"潮红"为参麦注射液安全性预警信号,原患疾病为慢性肺心病、甲状腺疾病,以及合并脑血管疾病,注射前连续使用前列地尔、环磷腺苷,合并用喹诺酮类、青霉素类药物等是参麦注射液ADR可疑影响因素,为临床安全合理用药起到促进作用。

This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4 220 cases of SRS and 32 358 cases of muhicenter, prospective, registered hospital centralized monitoring in large data background,calculated ADR incidence rate was 0. 93 per 1 000, main symptoms of ADR includes chest pain, chilis, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and ＂breath＂, ＂anaphylactoid reaction＂ and ＂flush＂ were the safety warning signals of Shenmai injection. Primary disease for chronic pulmo~ nary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of aprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai in- jection, these promot the clinical safety.