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目的研究中国血友病A患者因子Ⅷ(FⅧ)抑制物形成的环境因素。方法监测215例血友病A患者在2年(2007年6月至2009年6月)的连续随访中,FⅧ抑制物发生、变化及转归,并对FⅧ抑制物形成的环境因素进行回顾性分析。结果 215例血友病A患者随访2年FⅧ抑制物累积发生率为11.6%(25/215)。FⅧ抑制物形成的环境因素的多变量分析结果示:①输注原因中短期低剂量预防治疗比按需治疗形成FⅧ抑制物的风险低(OR=0.037,95%CI为0.002～0.616);②血友病越严重,累积暴露日越少,FⅧ抑制物形成风险越高;③发生严重出血事件是FⅧ抑制物形成的高危因素(OR=117.045,95%CI为19.333～708.617);④输注形式和发生重大感染事件与FⅧ抑制物形成无关。结论在中国目前治疗情况下,血友病患者FⅧ抑制物的形成可能与血友病严重程度、输注原因(预防治疗或按需治疗)、累积暴露日和是否发生严重出血事件有关。
Objective To study the environmental factors of factor Ⅷ (F Ⅷ) inhibitor formation in hemophilia A patients in China. Methods The incidence, changes and prognosis of FⅧ inhibitors in 215 consecutive patients with hemophilia A during the follow-up period of 2 years (June 2007 to June 2009) were monitored. The environmental factors for the formation of FⅧ inhibitors were retrospectively analyzed analysis. Results 215 cases of hemophilia A patients were followed up for 2 years FⅧ inhibitor cumulative incidence was 11.6% (25/215). Multivariate analysis of the environmental factors responsible for the formation of FⅧ inhibitors showed that: ① The short-term and low-dose prophylaxis of infusion was associated with a lower risk of FⅧ inhibitors than on-demand treatment (OR = 0.037, 95% CI: 0.002-0.616); The more serious the hemophilia, the less the cumulative exposure date, the higher the risk of FⅧ inhibitor formation; ③ the occurrence of severe bleeding was a risk factor for the formation of FⅧ inhibitors (OR = 117.045, 95% CI 19.333 ~ 708.617); ④ infusion The form and occurrence of a major infection have nothing to do with the formation of FⅧ inhibitors. Conclusions Under the current treatment conditions in China, the formation of FⅧ inhibitors in patients with hemophilia may be related to the severity of hemophilia, the causes of infusion (prophylaxis or on-demand treatment), the cumulative exposure date, and whether a severe bleeding event has occurred.