[Pharmacokinetic and clinical studies on teicoplanin for sepsis by methicillin-cephem resistant Staphylococcus aureus in the pediatric and neonate field].
Pharmacokinetics, clinical efficacy and safety of teicoplanin (TEIC) were evaluated in pediatric and neonate patients with MRSA sepsis in the dosages approved in overseas. The administrated dose for pediatrics patients was 10 mg/kg once at hour 0, 12 and 24, followed by every 24 hours intervals. In neonates patients, first dose was 16 mg/kg, then 8 mg/kg every 24 hours intervals. 1. Pharmacokinetic results. All 17 patients (9 neonates and 8 pediatrics) who received TEIC were evaluated for pharmacokinetics. Trough concentrations were analyzed in 16 patients (9 neonates and 7 pediatrics) excluding one patient for lack of measurement of drug concentration at day 7. No patient with a concentration exceeding 60 micrograms/mL in peak or trough concentrations were reported. Mean concentrations in trough at day 3, 4 and 7 in neonates were 15.2, 14.7 and 17.8 micrograms/mL, and in pediatrics were 12.5, 12.2 and 13.1 micrograms/mL, respectively. These results were similar to those reported in foreign pediatrics and neonates patients. 2. Efficacy and safety results. Since no patient was excluded, all patients were evaluated for efficacy and safety. Microbiological efficacy as well as clinical cure were secondarily evaluated in 2 patients for whom MRSA was isolated from blood. Clinical efficacy rate was 76.5% (13/17) and number of cases in judgments of excellent, good, fairly improved and no change were 12, 1, 3 and 1 cases respectively. The patients for whom MRSA was isolated from blood were judged as MRSA eradicated case and cured without any additional anti-MRSA drugs. Adverse events were reported in 2 neonates and 3 pediatric patients. Possibly related adverse events to study drug (adverse drug reactions) were: 1 case of respiratory disorder, thrombocythemia, gamma-GTP increased, GOT increased and GPT increased in 3 pediatrics. These results suggest that an application of overseas dose regimen of TEIC for neonate and pediatrics is appropriate in Japan.
Sunakawa
Keisuke
K
Department of Infectious Diseases, Kitasato University School of Medicine.
Nonoyama
Masato
M
Fujii
Ryochi
R
Iwai
Naoichi
N
Sakata
Hiroshi
H
Shirai
Masaru
M
Sato
Takashi
T
Kajino
Mayumi
M
Toyonaga
Yoshikiyo
Y
Sano
Tomoaki
T
Naito
Atsushi
A
Minagawa
Kimio
K
Niida
Yuichi
Y
Oda
Takanori
T
Yokozawa
Masato
M
Asanuma
Hideomi
H
Shimura
Kohji
K
Fujimura
Masanori
M
Kitajima
Hiroyuki
H
Fujinami
Katsura
K
Numazaki
Kei
K
Fujikawa
Tomoko
T
Kobayashi
Yutaka
Y
Sato
Yoshitake
Y
Nishimura
Tadafumi
T
Iwata
Satoshi
S
Tsuchihashi
Nihoko
N
Oishi
Tomohiro
T
Matsumoto
Shinji
S
Motohiro
Takashi
T
Osawa
Makiko
M
Sunahara
Mariko
M
Shirakawa
Seigo
S
Nishida
Hiroshi
H
Takahashi
Naoto
N
Nakano
Reiji
R
Sai
Nobuaki
N
Iyoda
Kuniaki
K
Yoshimitsu
Kazunori
K
Ogawa
Kazunori
K
Okazaki
Tomio
T
Tsukimoto
Ichiro
I
Motoyama
Osamu
O
Takada
Yoshiteru
Y
Kawasaki
Masahiro
M
Sunaoshi
Wataru
W
Nakamura
Shinya
S
Ueda
Yasuhisa
Y
Kamata
Masahiro
M
Kato
Tatsuo
T
Chiba
Mitsuo
M
Ouchi
Kazunobu
K
Sato
Shiro
S
Horiuchi
Takeshi
T
Suzuki
Keiji
K
Shimoyama
Takenori
T
Masaki
Hiroshi
H
Aikyo
Miho
M
Kawada
Momoko
M
Banba
Masahiro
M
Furukawa
Seikyo
S
Okada
Takashige
T
Yamaguchi
Satoru
S
Hirota
Osamu
O
Koizumi
Shoichi
S
Wada
Hideo
H
Ohta
Kazuhide
K
Uehara
Takahiro
T
Yukitake
Ko
K
Mori
Toshiko
T
Takakuwa
Satoshi
S
Matsuyama
Kenji
K
D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D018550:Cephalosporin Resistance; D002675:Child, Preschool; D004334:Drug Administration Schedule; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D016106:Methicillin Resistance; D018805:Sepsis / Q000188:drug therapy* / Q000378:metabolism / Q000382:microbiology; D013211:Staphylococcus aureus / Q000187:drug effects*; D017334:Teicoplanin / Q000008:administration & dosage / Q000493:pharmacokinetics*
D000900:Anti-Bacterial Agents; D017334:Teicoplanin