Efficacy and safety of growth hormone treatment in children born small for gestational age in Japan.
Growth-promoting effects and safety of growth hormone (GH) treatment in prepubertal short-statured children born small for gestational age (SGA) were evaluated in a multicenter, open-label, randomized parallel-group comparison study. Patients were randomized to two dose groups; 34 and 33 patients received GH at 0.033 and 0.067 mg/kg/day for one year, respectively. The increase of the mean height velocity standard deviation score (SDS) was significantly (p <0.0001) higher in the 0.067-mg group (from -1.4 to 4.7) than that in the 0.033-mg group (-1.9 to 2.6). A significant (p <0.0001) increase in the mean height SDS was established in the 0.067-mg group; increases of -3.1 to -2.5 vs -3.1 to -2.2 in the 0.033- and 0.067-mg groups, respectively. The trial was non-eventful. Oral glucose tolerance tests indicated a mostly normal pattern of plasma glucose before and after 12-month GH treatment. The growth-promoting effect was significantly higher with GH treatment at 0.067 mg/kg/day.
Tanaka
Toshiaki
T
Tanaka Growth Clinic, Tokyo, Japan. tanaka-t@ncchd.go.jp
Fujieda
Kenji
K
Yokoya
Susumu
S
Seino
Yoshiki
Y
Tada
Hiroshi
H
Mishina
Jun
J
D001827:Body Height / Q000187:drug effects* / Q000502:physiology; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D006128:Growth / Q000187:drug effects* / Q000502:physiology; D006130:Growth Disorders / Q000188:drug therapy* / Q000208:ethnology / Q000503:physiopathology; D013006:Growth Hormone / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007564:Japan; D008297:Male
D013006:Growth Hormone