Department of Internal Medicine (III), Kanazawa University School of Medicine, Kanazawa, Japan.
Department of Internal Medicine, Niigata Prefectural Kamo Hospital, Niigata, Japan; The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin(®) Injection.
Thromb Res. 2014 Mar;133(3):364-70. doi: 10.1016/j.thromres.2013.12.033. Epub 2014 Jan 4.
Post-marketing surveillance of thrombomodulin alfa (TM-α) was performed to evaluate safety and efficacy in patients with disseminated intravascular coagulation (DIC) with hematologic malignancy.
All patients treated with TM-α from May 2008 to April 2010 in Japan were included. Information about baseline characteristics, safety, and efficacy were collected. The DIC resolution rate, survival rate on Day 28 after the last TM-α administration, and changes in DIC score and coagulation tests were evaluated.
The underlying diseases associated with DIC were acute myeloid leukemia (except for acute promyelocytic leukemia, n=350), lymphoma (n=199), acute promyelocytic leukemia (n=172), acute lymphoblastic leukemia (n=156), myelodysplastic syndromes (n=61), and other (n=94). The incidence rates of bleeding-related adverse events and adverse drug reactions were 17.8% and 4.6%, respectively. In subjects with bleeding symptoms at baseline, 55.0% were assessed as disappeared or improved based on symptoms after TM-α treatment. The DIC resolution and survival rates were 55.9% and 70.7%, respectively. The DIC score and coagulation tests including thrombin-antithrombin complex (TAT) were significantly improved. Coagulation tests were significantly improved after TM-α treatment even in subjects whose clinical course of underlying disease was assessed as unchanged or exacerbated.
This surveillance confirmed the safety and efficacy of TM-α in clinical practice, thus TM-α may be an ideal treatment for patients with DIC based upon hematologic malignancy.
对血栓调节蛋白 α（TM-α）进行上市后监测，以评估其在伴有血液恶性肿瘤的弥漫性血管内凝血（DIC）患者中的安全性和疗效。
纳入 2008 年 5 月至 2010 年 4 月期间在日本接受 TM-α治疗的所有患者。收集患者的基线特征、安全性和疗效信息。评估 DIC 缓解率、末次 TM-α 给药后 28 天的生存率、DIC 评分和凝血试验的变化。
与 DIC 相关的基础疾病为急性髓细胞白血病（不包括急性早幼粒细胞白血病，n=350）、淋巴瘤（n=199）、急性早幼粒细胞白血病（n=172）、急性淋巴细胞白血病（n=156）、骨髓增生异常综合征（n=61）和其他（n=94）。出血相关不良事件和药物不良反应的发生率分别为 17.8%和 4.6%。在基线时有出血症状的患者中，55.0%的患者根据 TM-α治疗后的症状评估为消失或改善。DIC 缓解率和生存率分别为 55.9%和 70.7%。DIC 评分和凝血试验（包括凝血酶-抗凝血酶复合物[TAT]）均显著改善。即使基础疾病的临床病程被评估为无变化或加重，TM-α治疗后凝血试验也显著改善。
该监测证实了 TM-α在临床实践中的安全性和疗效，因此 TM-α可能是血液恶性肿瘤相关 DIC 的理想治疗药物。
