Shirahata Akira, Mimuro Jun, Takahashi Hoyu, Tsuji Hajime, Kitajima Isao, Matsushita Tadashi, Eguchi Yutaka, Kitamura Naoya, Honda Goichi, Sakata Yoichi
University of Occupational and Environmental Health, Japan, Fukuoka, Japan
Division of Cell and Molecular Medicine, Center for Molecular Medicine, Jichi Medical University, School of Medicine, Tochigi, Japan The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin Injection, Tokyo, Japan.
Clin Appl Thromb Hemost. 2014 Jul;20(5):465-72. doi: 10.1177/1076029614523490. Epub 2014 Feb 20.
Recombinant human soluble thrombomodulin (thrombomodulin α [TM-α]) has been marketed as a novel anticoagulant for disseminated intravascular coagulation (DIC) in Japan since 2008. Postmarketing surveillance (PMS) has been conducted since its approval. As effectiveness and safety were not previously determined in pediatric patients, this study evaluated PMS data and examined the usefulness of TM-α in treating pediatric DIC. After excluding newborn infants, data for 210 pediatric patients were analyzed and compared to 3786 adult patients. The day after the last TM-α administration, DIC had resolved in 58.5% of the patients. At 28 days after the last TM-α administration, the survival rate was 71.6%. Nineteen episodes of adverse drug reactions were observed in 11 patients but no significant differences were noted for effectiveness and safety. Although this study was limited by its retrospective design, including selection biases and no limitation on concomitant use of other anticoagulants, TM-α appears to be useful for the treatment of DIC in both pediatric and adult patients.
自2008年以来，重组人可溶性血栓调节蛋白（血栓调节蛋白α [TM-α]）在日本作为一种用于弥散性血管内凝血（DIC）的新型抗凝剂上市。自其获批以来，一直在进行上市后监测（PMS）。由于此前未在儿科患者中确定其有效性和安全性，本研究评估了PMS数据，并考察了TM-α在治疗儿科DIC中的效用。在排除新生儿后，对210例儿科患者的数据进行了分析，并与3786例成年患者的数据进行了比较。在最后一次使用TM-α后的第二天，58.5%的患者DIC得到缓解。在最后一次使用TM-α后的28天，生存率为71.6%。在11例患者中观察到19次药物不良反应，但在有效性和安全性方面未发现显著差异。尽管本研究受到回顾性设计的限制，包括选择偏倚以及对其他抗凝剂的联合使用没有限制，但TM-α似乎对儿科和成年DIC患者的治疗均有用。
