Objective To construct predictive model of adverse reaction(ADR) induced by magnesium sulfate injection for the first time in patients with threatened abortion or premature delivery, so as to improve the drug safety.
Methods Data of 1 553 patients diagnosed as threatened abortion or threatened preterm birth were retrospectively summarized. All of them used magnesium sulfate injection for the first time. A total of 73 patients were reported as ADR according to its definition by FDA. A total of 73 patients with ADR were included in ADR group and 1 480 patients without ADR were included in ADR-free group. The clinical data between the ADR group and the non-ADR group were compared, and the risk factors of ADR were screened by multivariate Logistic regression analysis.
Results Compared with the non-ADR group, the age and drug dose of patients were higher, gestational weeks in the ADR group was longer, and proportions of multipara, abortion history and pregnant complications were higher (P < 0.05); there were no differences in body mass index, abortion reason and nurses' working years between the two groups (P>0.05). Logistic regression analysis showed that older age, pregnant complications and higher drug dose were independent risk factors of ADR (P < 0.05). ADR predictive model Y=-0.25+0.42×age+0.68×pregnant complications+0.92×drug dose. Receiver operating curve (ROC) showed that the area under the curve (AUC) of ADR predictive model was 0.856, the critical value scored 3.5, with sensitivity of 82.6%, and specificity of 74.5%.
Conclusion Constructing the ADR predictive model of magnesium sulfate injection for the first time in patients with threatened abortion or premature delivery can better guide clinical pharmacists and doctors to evaluate the drug risk in the early stage, improve drug safety, reduce the incidence of ADR.
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