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[摘要]
目的 分析红花黄色素注射液与粉针剂的不良反应特点,为临床用药提供参考。方法 收集河北省药品监测评价中心收到的红花黄色素不良反应报告620例,分析患者一般资料、不良反应发生时间和临床表现。结果 红花黄色素注射液导致不良反应的患者年龄低于粉针剂,首次用药和24~48 h发生不良反应比例高于粉针剂。注射液引起的皮肤及附件损害和呼吸系统损害比例高于粉针剂,而中枢及外周神经系统损害、胃肠系统损害、心率及心率紊乱比例均低于粉针剂。两种剂型比较差异有统计学意义(P<0.05)。结论 不同剂型红花黄色素所致不良反应不同,需加强不良反应监测。
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[Abstract]
Objective To investigate the characteristics of adverse drug reactions (ADRs) caused by Saffower Yellower Injection and Saffower Yellower for injection in order to provide reference for safe drug use in clinical practice.Methods 620 Reports of adverse reactions induced by saffower yellower were collected from Center for Drug Monitoring and Evaluation of Hebei. The patient's general informations, occurrence time, and clinical manifestations of ADR were compared.Results The patients with adverse reactions caused by Safflower Yellow Injection were younger than those by Saffower Yellower for injection. The ADR ratio of first dose and 24 — 48 h after the first dose by Saffower Yellower Injection were higher than that by Saffower Yellower for injection. The ratio of skin and appendages disordes, respiratory system disorders caused by liquid-injection were higher than those by powder-injection but the ratio of central and peripheral nervous system disorders, gastro-intestinal system disorders, heart rate and rhythm disorders caused by liquid-injection were lower than those by powder-injection.Conclusion Saffower Yellower Liquid-Injection and Saffower Yellower for injection have some different adverse reactions. The monitoring of adverse reactions should be strengthened.
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