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conferenceseries
.com
Volume 8
Pediatrics & Therapeutics
ISSN: 2161-0665
Pediatrics and Pediatric Gastroenterology 2018
March 21-22, 2018
16
th
Annual World Congress on
3
rd
Annual World Congress on
March 21-22, 2018 | New York, USA
PEDIATRICS
PEDIATRIC NUTRITION,
GASTROENTEROLOGY & CHILD DEVELOPMENT
&
Recombinant soluble human thrombomodulin (thrombomodulin alfa) in the treatment of neonatal
disseminated intravascular coagulation
Satoshi Ibara
1
, Akira Shirahata
2
, Jun Mimuro
3,10
, Hoyu Takahashi
4,10
, Isao Kitajima
5,10
, Hajime Tsuji
6,10
, Yutaka Eguchi
7,10
, Tadashi Matsushita
8,10
,
Masahiro Kajiki
9
, Goichi Honda
9
and
Yoichi Sakata
3,10
1
Kagoshima City Hospital, Japan
2
University of Occupational and Environmental Health, Japan
3
Jichi Medical University, Japan
4
Niigata Prefectural Kamo Hospital, Japan
5
University of Toyama, Japan
6
Kyoto Prefectural University of Medicine, Japan
7
Shiga University of Medical Science, Japan
8
Nagoya University Hospital, Japan
9
Asahi Kasei Pharma Corporation, Japan
10
Japanese Society on Thrombosis and Hemostasis, Japan
Background:
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.
Methods:
The standard dose of TM-α was 380U/kg/day and dose adjustment was based on their reanal function levels.
Therapeutic effects of TM-α on DIC and on the survival of DIC patients were evaluated with the DIC diagnostic criteria of
the Japanese Ministry of Health, Labor and Welfare established, and with the survival rate on day 28 after the completion of
TM-α administration, respectively. Adverse events as well as adverse side effects associated with TM-α administration also
were analyzed.
Results:
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 administrationwas 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.
Conclusion:
This surveillance provided real-world data on the safety and effectiveness of TM-α in the treatment of neonatal
DIC in general practice settings.
Biography
Satoshi Ibara has completed his PhD from Nihon University and postdoctoral studies from University California Irvine. He is the Director of Perinatal Medical center,
Kagoshima City Hospital, Japan. He has published more than 30 papers in reputed journals.
ibara-s40@kch.kagoshima.jpSatoshi Ibara et al., Pediatr Ther 2018, Volume: 8
DOI: 10.4172/2161-0665-C1-049