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document
Trial of prophylactic administration of TXA2 synthetase inhibitor , ozagrel hydrochloride , for preeclampsia . OBJECTIVE In an attempt to investigate the prophylactic effect of a thromboxane A2 ( TXA2 ) synthetase inhibitor on pregnant women with a high risk of preeclampsia , the following clinical study was undertaken . METHODS Forty pregnant women were randomly allocated to control or treatment groups . Ozagrel Hydrochloride ( 400 mg/day , orally ) and placebo were started at 20 weeks of gestation and continued until delivery . RESULTS Seventeen of 20 ( 85 % ) women in the control group developed preeclampsia , whereas 9 of 20 ( 45 % ) in the treatment group developed preeclampsia . Ozagrel Hydrochloride significantly ( p < 0.01 ) reduced the occurrence of preeclampsia , and the incidence of both hypertension ( p < 0.05 ) and proteinuria ( p < 0.01 ) was significantly less in the treatment group compared with the control group . One month after administration , the mean plasma concentration of TXB2 , a metabolite of TXA2 , was significantly decreased ( p < 0.01 ) to 62.4 +/- 13.6 % , whereas that of 6-keto prostaglandin F1 alpha , a metabolite of PGI2 , was significantly increased ( p < 0.01 ) to 206.7 +/- 52.8 % . There were no maternal or fetal side effects observed . CONCLUSIONS It seems likely that Ozagrel Hydrochloride could be used for the prevention of preeclampsia in high-risk pregnant women .
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Intervention_Pharmacological
TXA2 synthetase inhibitor , ozagrel hydrochloride
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Intervention_Pharmacological
thromboxane A2 ( TXA2 ) synthetase inhibitor
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Intervention_Pharmacological
Ozagrel Hydrochloride
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Intervention_Control
placebo
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Intervention_Pharmacological
Ozagrel Hydrochloride
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Outcome_Physical
preeclampsia
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Outcome_Physical
preeclampsia
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Outcome_Physical
occurrence of preeclampsia
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Outcome_Physical
hypertension
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Outcome_Physical
proteinuria
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Outcome_Physical
mean plasma concentration of TXB2
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Outcome_Physical
a metabolite of TXA2
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Outcome_Physical
6-keto prostaglandin F1 alpha
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Outcome_Physical
a metabolite of PGI2
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Outcome_Adverse-effects
maternal or fetal side effects observed
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Outcome_Physical
prevention of preeclampsia
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Participant_Condition
preeclampsia
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Participant_Condition
pregnant
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Participant_Sex
women
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Participant_Condition
preeclampsia
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Participant_Sample-size
Forty
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Participant_Condition
pregnant
1759
Participant_Sex
women
1760
Participant_Condition
preeclampsia