[Study on the therapeutic effect of panipenem/betamipron on perinatal infection in pregnant women].
An investigation was carried out to determine the therapeutic effect of panipenem/betamipron (PAPM/BP), a injectable carbapenem antimicrobial agent, on infections in pregnant women during perinatal period. Of the 41 patients enrolled in the study, 34 were subjected to the analysis, with 1 exemption because of protocol violations (regimen), 3 because of uncertain evidence symptoms of infection, and 3 because of failure to undergo laboratory tests. PAPM/BP was administered by intravenous drip infusion at doses of 0.5 g twice or three times a day daily for periods of 3 to 14 days. The efficacy rate according to the evaluation of the Drug Efficacy Evaluation Committee and the attending physicians was 79.4% (27/34), with 49 of the 61 clinical isolates (80.3%) being eradicated. Safety was evaluated as "safe" in 39 of the 41 assessable patients (94.1%). Mild headache and nausea were experienced by 1 patient (2.4%) as adverse drug reactions, but the symptoms disappeared after the completion of treatment. Slight elevations of GOT, GPT and LDH in laboratory tests were observed in 1 patient (2.4%), but these values returned to normal after the completion of treatment. These results suggested that PAPM/BP may be a useful drug in the treatment of bacterial infections during the perinatal period. To firmly establish its safety, however, further clinical and pharmacokinetic studies are needed in larger populations.
Mikamo
H
H
Department of Obstetrics and Gynecology, School of Medicine, Gifu University.
Kawazoe
K
K
Sato
Y
Y
Hayasaki
Y
Y
Tamaya
T
T
Izumi
K
K
Ito
K
K
Yamada
Y
Y
D000328:Adult; D004341:Drug Evaluation; D004359:Drug Therapy, Combination / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011645:Puerperal Infection / Q000188:drug therapy*; D012449:Safety; D013845:Thienamycins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015091:beta-Alanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use
D013845:Thienamycins; D015091:beta-Alanine; C075316:panipenem-betamipron