摘要目的 观察重组人凝血因子Ⅶa(rFⅦa)对血液病及其异基因造血干细胞移植(allo-HSCT)术后出血患者的止血疗效.方法 以2013年5月至2016年5月住院治疗的16例合并中至重度出血的血液病患者为观察对象,非移植组及移植组患者各8例,两组患者应用rFⅦa的用法、用量无明显差异.同时,以同期15例allo-HSCT后发生肠道急性移植物抗宿主病(aGVHD)肠出血患者为对照组(未应用rFⅦa),将其与allo-HSCT后肠道aGVHD肠出血应用rFⅦa患者进行生存比较,总结患者应用rFⅦa治疗的临床疗效.结果 ①非移植组与移植组患者中,rFⅦa止血显效率分别为75.0%(6/8)和37.5%(3/8),显效中位时间分别为38.5和63.0 h,中位总生存(OS)时间分别为201.0和29.0 d,OS率分别为50.0%(4/8)和25.0%(2/8),出血相关死亡率分别为50.0%(2/4)和83.3%(5/6).②16例患者中显效者9例,无效者7例,显效组与无效组患者中,中位OS时间分别为268.0和24.0 d,OS率分别为66.7%(6/9)和0(0/7).③同期肠道aGVHD合并肠出血患者,观察组(6例)与对照组(15例)患者的中位OS时间分别为25.5和20.0 d.结论 血液病患者尤其是allo-HSCT患者出血相关死亡率高,rFⅦa治疗有一定止血疗效;显效组患者OS率较无效组高;allo-HSCT后肠道出血患者采用rFⅦa治疗止血效果不佳的原因可能与移植后导致出血的并发症控制不佳有关.

abstractsObjective To analyze the efficacy of recombinant activated factor Ⅶa(rFⅦa)on hematonosis with moderate or severe bleeding signs. Methods Of total 16 cases with rFⅦa treatment from May 2013 to May 2016, 8 cases received allogeneic hematopoietic stem cells transplantation(allo-HSCT)and the other were non-transplantation patients. In two groups, there was no significant difference on rFⅦa usage and dosage. 15 patients with acute graft-versus-host disease(aGVHD)after allo-HSCT were control group (without rFⅦa). Results ①The total response rate was 75.0%(6/8) in non-transplantation group and 37.5%(3/8) in transplantation group, respectively. Median interval for hemorrhage stop was 38.5 hours in non-transplantation group and 63.0 hours in transplantation group. The median overall survival(OS)was 201.0 and 29.0 days for non-transplantation group and transplantation group, respectively, and the OS rate was 50.0%(4/8)and 25.0%(2/8), respectively. The bleeding-related mortality rate was 50.0%(2/4)and 83.3%(5/6), respectively.②Of the 16 cases, 9 showed response to rFⅦa treatment and the other 7 cases'bleeding signs did not alleviate. The median OS was 268.0 in 9 cases with response and 24.0 days in 7 cases without response, respectively. ③In patients with intestinal aGVHD complicated with intestinal hemorrhage, the median OS of observation group(n=6)and control group (n=15) were 25.5 days and 20.0 days, respectively. Conclusion Patients with hematological diseases, especially patients after allo-HSCT, had high bleeding-related mortality, and rFⅦa therapy had a obvious hemostatic efficacy. The survival rate of patients with response was higher than that of cases without response. The causes of poor hemostasis efficacy of rFⅦa therapy were associated with unsatisfactory control of complications in patients with intestinal bleeding after allo-HSCT.