阿加曲班治疗急性早幼粒细胞白血病合并DIC的临床研究

Clinical Reasearch of Novastan in Treatment of the Acute Promyelocytic Leukemia Patients with DIC

目的探讨直接抗凝血酶制剂—阿加曲班(商品名诺保思泰,Novastan)对急性早幼粒细胞白病(APL)合并弥散性血管内凝血(DIC)的疗效。方法初治和复发的 APL 合并 DIC 30例,随机分为低相对分子质量肝素钠治疗组(LM- WH 组)和阿加曲班治疗组(NOVAS 组)(对照为正常健康人群)。二组患者均给予我所的联合诱导(双诱导)缓解方案治疗,LMWH 组加用 LMWH,NOVAS 组加用 Novastan,观察二组患者临床出血情况、实验室 DIC 指标改善和完全缓解(CR)程度。结果 APL 合并 DIC 的二组患者治疗前后 PT、aPTT、Fbg 等值对比差异显著(P＜0.01)。LMWH 组与 NOVAS 组疗效比较差异显著(P＜0.05)。LMWH 组临床在血小板恢复方面有波动,其中1例患者并发脑出血死亡。NOVAS 组临床出血情况改善平稳,无相关并发症发生。结论阿加曲班治疗 APL 合并 DIC 疗效确切,无并发症,不依赖抗凝血酶(AT)的存在即可发挥抗凝血酶的作用,对 DIC 的高凝血期尤为适宜。

Objective To study the effect of direct anti-thrombin preparation（Novastan） on patients with APL associated with DIC. Methods 30 patients with Incipiented and relapsed APL associted with DIC were randomly divided into two rgoups：LMWH rgoup and NOVAS group. （Control group：being the normal healthy group）. Two groups of patients received the routing inducted remittent treatment of our institute. Two groups of patients had been observed the situation of clinical bleeding and the degree of laboratory DIC index improving. Results PT, aPTr and Fbg were greatly normalized after treating in comparison with those before treating （P 〈0.01）. The efficacy of NOVAS was more remarkable than that of LMWH （P 〈0.05）. A patient in LMWH group died of cerebral hemorrhage. No significant complications were found in NOVAS group ,the laboratory indices being steadily improved. Conclusion Novastan could safely be used in APL patients associated with DIC. It has direct inhibition on thrombin,not relying on the existence of the anti-thrombin. It is particularly suitable for the high coagalation stage in DIC.