目的  对上海生物制品研究所有限责任公司（上海公司）采用二次病毒灭活工艺生产的人凝血因子Ⅷ（human coagulation factor Ⅷ，FⅧ ）进行上市后安全性观察和分析。   方法  采用双中心、开放、单组设计进行FⅧ上市后安全性观察：符合入选条件的247例血友病A患者接受1次FⅧ输注，以问卷调查的方式收集FⅧ输注后30 min和1个月的不良反应，包括体温变化、过敏反应、输液反应等临床安全性指标。 结果  FⅧ输注后30 min，无一受试者报告发生过敏和输液反应，仅4例受试者（2.26%）报告出现短时37.1~37.5 ℃的轻度发热。FⅧ输注后1个月，所有受试者均未报告有新出现的相关不良反应。 结论  上海公司采用二次病毒灭活工艺生产的FⅧ上市产品具有良好的安全性。 

Objective  To observe and analyze the post-marketing safety of human coagulation factor Ⅷ (FⅧ) produced by Shanghai Institute of Biological Products Co., Ltd. (SIBP) using two-step virus inactivation process. Methods  The post-marketing safety of FⅧ was observed using a double-center, open and single-group design study: 247 hemophilia A patients which met the inclusion and exclusion criteria intravenously FⅧ injected  once. Adverse drug reactions (ADRs) of FⅧ 30 min and 1 month after intravenous injection were collected, including body temperature change, anaphylaxis reaction, and infusion reaction, etc.  Results  Nobody reported anaphylaxis and infusion reactions 30 minutes after injection. Only 4 subjects (2.26%) reported a short-term mild fever (37.1-37.5 ℃). No new related ADRs occured 1 month after injection. Conclusion  The listed FⅧ produced by SIBP using two-step virus inactivation process has a good safety.