10409例丹红注射液上市后安全性医院集中监测研究

Study on 10409 cases of post-marketing safety Danhong injection centralized monitoring of hospital

目的:研究丹红注射液不良反应(ADR)发生率、性质和临床表现,为临床安全用药提供依据。方法:多中心、大样本的医院集中监测法。结果:丹红注射液ADR为速发型,且缓解恢复快,发生率为0.682%,新发现的ADR有便秘、多汗、耳鸣、烦躁、关节病、红斑、静脉痛、静脉炎、局部麻木、疼痛、无力、消化道溃疡出血、血管痉挛、紫绀。结论:丹红注射液不良反应属A型偶见不良反应,医院集中监测法是开展中药注射剂上市后安全性再评价的适宜方法。

Objective： To study Danhong injection adverse reactions （ADR） incidence, nature and clinical performance, provide the basis for the clinical safety of drugs. Method： Multi-center, a large sample of hospitals focused on monitoring method. Resuit： Danhong injection ADR for the rapid onset and ease the quick recovery, the rate was 0. 682% , the newly discovered ADR constipation, sweating, tinnitus, irritability, joint disease, erythema, venous pain, phlebitis, local numbness, pain, weakness, gastrointestinal ulcer bleeding, vasospasm, cyanosis. Conclusion： Danhong injection adverse reactions are type A adverse reactions occasionally, centralized monitoring of hospital medicine injection method is to carry out post-marketing safety re-evaluation of appropriate methods.