Wang Lian-xin, Xie Yan-ming, Ai Qing-hua, Song Nian-bin
Zhongguo Zhong Yao Za Zhi. 2015 Dec;40(24):4752-6.
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 multicenter, 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, chills, 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 pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety.
本文采用一系列相关分析方法，在大数据背景下，对4220例自发呈报系统（SRS）和32358例多中心、前瞻性、注册医院集中监测的参麦注射液上市后临床安全性数据进行综合分析，计算得出不良反应发生率为千分之0.93，不良反应主要症状包括胸痛、寒战、皮肤瘙痒、心悸、发热、恶心、头晕、呕吐、潮红、麻木、过敏反应、发绀、皮疹、腰痛以及“呼吸”“类过敏反应”和“潮红”是参麦注射液的安全警示信号。慢性肺心病、甲状腺疾病等原发性疾病，以及注射前及连续使用前列地尔、环磷腺苷，联用喹诺酮类、青霉素类药物是参麦注射液不良反应的可疑影响因素，这些促进了临床安全性。
