title: Postmarketing Surveillance of Recombinant Human Soluble Thrombomodulin (Thrombomodulin α) in Pediatric Patients With Disseminated Intravascular Coagulation.
abstract: 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.
authors.affiliation: University of Occupational and Environmental Health, Japan, Fukuoka, Japan a-shirahata@kitakyu-hp.or.jp.
authors.forename: Akira
authors.initials: A
authors.lastname: Shirahata
authors.affiliation: 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.
authors.forename: Jun
authors.initials: J
authors.lastname: Mimuro
authors.affiliation: The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin Injection, Tokyo, Japan Department of Internal Medicine, Niigata Prefectural Kamo Hospital, Niigata, Japan.
authors.forename: Hoyu
authors.initials: H
authors.lastname: Takahashi
authors.affiliation: The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin Injection, Tokyo, Japan Department of Blood Transfusion, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Hajime
authors.initials: H
authors.lastname: Tsuji
authors.affiliation: The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin Injection, Tokyo, Japan Department of Clinical Laboratory and Molecular Pathology, Graduate School of Medical and Pharmaceutical Science, University of Toyama, Toyama, Japan.
authors.forename: Isao
authors.initials: I
authors.lastname: Kitajima
authors.affiliation: The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin Injection, Tokyo, Japan Department of Transfusion Medicine, Nagoya University Hospital, Aichi, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Matsushita
authors.affiliation: The Japanese Society on Thrombosis and Hemostasis Post-Marketing Surveillance Committee for Recomodulin Injection, Tokyo, Japan Critical and Intensive Care Medicine, Shiga University of Medical Science, Shiga, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Eguchi
authors.affiliation: ART Project, Pharmaceutical Sales Division, Asahi Kasei Pharma Corporation, Tokyo, Japan.
authors.forename: Naoya
authors.initials: N
authors.lastname: Kitamura
authors.affiliation: ART Project, Pharmaceutical Sales Division, Asahi Kasei Pharma Corporation, Tokyo, Japan.
authors.forename: Goichi
authors.initials: G
authors.lastname: Honda
authors.affiliation: 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.
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Sakata
mesh_terms: D000293:Adolescent; D000328:Adult; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D004211:Disseminated Intravascular Coagulation / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D011358:Product Surveillance, Postmarketing; D011994:Recombinant Proteins / Q000627:therapeutic use; D018180:Thrombomodulin / Q000008:administration & dosage*
chemical_list: D000925:Anticoagulants; D011994:Recombinant Proteins; C546931:THBD protein, human; D018180:Thrombomodulin
keywords: anticoagulant; disseminated intravascular coagulation; pediatric patients; thrombomodulin