• Zhongguo Zhong Yao Za Zhi · Dec 2015

    Multicenter Study

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

    • Lian-xin Wang, Yan-ming Xie, Qing-hua Ai, and Nian-bin Song.
    • Zhongguo Zhong Yao Za Zhi. 2015 Dec 1; 40 (24): 4752-6.

    AbstractThis 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.

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