摘要
目的探讨重组人凝血因子Ⅷ(Kogenate FS,拜科奇)在中国血友病A患者的有效性、安全性及抑制物产生率。方法采用拜科奇治疗30例血友病A患者的出血事件,观察其临床止血效果及用药后4周FⅧ抑制物的产生情况。其中11例患者在用药前后进行血、尿便常规、肝肾功、血清病毒学(HBV、HCV、HIV)、FⅧ抑制物、FⅧ活性检测,并于第1次用药后10min、60min检测FⅧ活性;同时随访2年检测FⅧ抑制物。结果11例患者在用药后10min、60min较用药前FⅧ活性明显提高,达到或接近预期升高值;所有30例患者用药后出血症状停止,显效率达100。每次出血事件约86.7的患者在≤3次输注即可较好的控制症状,提示具有较好的有效性。30例患者共输注重组FⅧ70次,总计51294u,在用药期间无任何不良反应出现。本研究发现1例患者在用药后4周产生FⅧ抑制物,提示短期抑制物产生率为3.3(1/30),11例2年随访未见抑制物产生增加趋势。结论重组人凝血因子Ⅷ(Kogenate FS,拜科奇)在中国血友病A患者使用中具有较好的有效性、安全性及较低的抑制物产生率。
Objective To explore the efficacy, safety and inhibitor generation of recombinant factor Ⅷ（ Kogenate FS） in patients with hemophilia A in China. Methods 30 patients with hemophilia A were treated with Kogenate FS. We observed the effect of its clinical hemostasis and the generation of FⅧ inhibitor in 4 weeks and 2 years followed up. The blood routine, urine and stool routine, liver function and renal function, FⅧ activities, HBV, HCV and HIV, FⅧ inhibitor were detected before and after the treatment in 11 of the 30 patients. The detection of FⅧ activities were performed at 10 rain and 60 rain after the first infusion. Then detected the Fvm inhibitor in 2 years follow-up with this 11 patients. Results It was observed that the FⅧ activities at 10min and 60min after the first infusion significantly increased, reached the expected value and the hemorrhage was stopped. All of the 30 patients＇ bleeding events were stopped after the infusion, so the effectiveness reached 100%. 86.7% patients used less than thrice to stop bleeding. Of all the 30 patients, we used kogenate FS 51 294 u in total with 70 infusions. There was no adverse effect during the medication. Only one patient generated FⅧ inhibitor after 4 weeks. Which indicates that the short term of inbitor genera- tion is 3.3% （1/30）. Conclusion Kogenate FS has better efficacy, safety and lower inhibitor generation in Chinese patients with hemophilia A.
出处
《血栓与止血学》
2008年第6期257-260,共4页
Chinese Journal of Thrombosis and Hemostasis
