摘要
目的 建立并验证非标准抗磷脂抗体(NC-aPL)阳性孕妇不良妊娠结局风险预测模型.方法 选取2021年5月至2022年6月就诊于各中心的4000例NC-aPL阳性孕妇作为研究对象,采用随机数字表法分为建模组(2800例)与验证组(1200例);根据妊娠后是否出现不良妊娠结局将建模组分为不良妊娠组和无不良妊娠组;采用R软件通过Logistic回归建立预测模型并绘制列线图.采用受试者工作特征(ROC)曲线、校准曲线和Hosmer-Lemeshow拟合优度检验验证和评价预测模型的区分度和校准度.结果 本研究建模组中出现不良妊娠结局831例,发生率29.68％;验证组中出现357例,发生率29.75％.多因素Logistic回归分析显示有吸烟史、不良生活方式、抗磷脂抗体-抗β2糖蛋白I抗体(aPL-αβ2GPI)阳性、未规范用药是NC-aPL阳性孕妇不良妊娠结局的危险因素(P<0.05).验证结果显示,建模组与验证组ROC曲线下面积(AUC)分别为0.853、0.936,区分度较好;H-L检验显示一致性良好(x2=7.208、7.163,P=0.503、0.510).结论 有吸烟史、不良生活方式、aPL-αβ2GPI阳性、未规范用药是NC-aPL阳性孕妇不良妊娠结局的危险因素,以此构建的列线图模型具有良好的区分度与一致性,能直观地预测NC-aPL阳性孕妇发生不良妊娠结局的风险.
Abstract
Objective Development and validation of a predictive model for the risk of adverse pregnancy outcomes in non-canonical antiphospholipid antibody (NC-aPL)-positive pregnant women. Methods 4000 NC-aPL-positive pregnant women attending the centres from May 2021 to June 2022 were selected as the study subjects,and were divided into a modelling group ( 2800 cases) and a validation group (1200 cases) using the random number table method;the modelling group was divided into the adverse pregnancy group and the no-adverse-pregnancy group according to the presence or absence of an adverse pregnancy outcome after the pregnancy. A prediction model was established and a column chart was drawn using the R software through Logistic regression. The differentiation and calibration of the predictive models were verified and evaluated by using receiver operating characteristics (ROC) curves,calibration curves,and the Hosmer-Lemeshow goodness-of-fit test.Results In this study,831 cases of adverse pregnancy outcomes were seen in the modelling group with an incidence rate of 29.68％ and 357 cases were seen in the validation group with an incidence rate of 29.75％. Multifactorial Logistic regression analysis showed that a history of smoking,poor lifestyle,antiphospholipid antibody-anti-beta2 glycoprotein I antibody (aPL-αβ2GPI) positivity,and unregulated use of medication were the risk factors for adverse pregnancy outcomes in NC-aPL-positive pregnant women (P<0.05). The validation results showed that the area under the ROC curve (AUC) of the modelling and validation groups were 0.853 and 0.936,respectively,with good differentiation;the H-L test showed good agreement (x2=7.208,7.163,P=0.503,0.510).Conclusion A history of smoking,poor lifestyle,aPL-αβ2GPI positivity,and unregulated medication use are risk factors for adverse pregnancy outcomes in NC-aPL-positive pregnant women,and the column-line graphical model constructed in this way has good differentiation and consistency,and is able to intuitively predict the risk of adverse pregnancy outcomes in NC-aPL-positive pregnant women.
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