title: Recombinant soluble human thrombomodulin (thrombomodulin alfa) in the treatment of neonatal disseminated intravascular coagulation.
abstract: Recombinant soluble human thrombomodulin (TM-α) has been shown to be useful in the treatment of disseminated intravascular coagulation (DIC) in a heparin-controlled study and has been available for clinical use in Japan since 2008. However, data on its use for neonatal DIC have not been reported from any clinical studies, so efficacy and safety were analyzed in 60 neonatal DIC patients identified in post-marketing surveillance. The DIC resolution rate as of the day after last administration of TM-α was 47.1 %, and the survival rate at 28 days after last administration was 76.7 %. Hemostatic test result profiles revealed decreased levels of fibrin/fibrinogen degradation products and increased platelet counts and antithrombin activity. Incidences of adverse drug reactions, bleeding-related adverse drug reactions, and bleeding-related adverse events were 6.7, 6.7, and 16.7 %, respectively, with no significant differences between neonatal, pediatric (excluding neonates), and adult DIC patients.
  
  
  CONCLUSIONS
  This surveillance provided real-world data on the safety and effectiveness of TM-alpha in the treatment of neonatal DIC in general practice settings.
authors.affiliation: University of Occupational and Environmental Health, Japan, Kitakyushu, Fukuoka, Japan, a-shirahata@kitakyu-hp.or.jp.
authors.forename: Akira
authors.initials: A
authors.lastname: Shirahata
authors.forename: Jun
authors.initials: J
authors.lastname: Mimuro
authors.forename: Hoyu
authors.initials: H
authors.lastname: Takahashi
authors.forename: Isao
authors.initials: I
authors.lastname: Kitajima
authors.forename: Hajime
authors.initials: H
authors.lastname: Tsuji
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Eguchi
authors.forename: Tadashi
authors.initials: T
authors.lastname: Matsushita
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kajiki
authors.forename: Goichi
authors.initials: G
authors.lastname: Honda
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Sakata
mesh_terms: D000328:Adult; D004211:Disseminated Intravascular Coagulation / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D007231:Infant, Newborn; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D015996:Survival Rate; D018180:Thrombomodulin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: C546931:THBD protein, human; D018180:Thrombomodulin