【作者】 陈玲；

【导师】 蔡文智；

【作者基本信息】 南方医科大学 ， 护理学， 2018， 博士

【摘要】 研究背景孕期及产后压力性尿失禁(Stress Urinary Incontinence,SUI)的早期预防至关重要,目前临床上尚缺乏孕产妇SUI的风险预测工具。研究目的1.建立孕产妇尿失禁风险预测模型,为孕产妇SUI高危人群提供筛查工具;2.将孕产妇SUI风险预测模型应用于临床,探索盆底肌训练(pelvic floor muscles training,PFMT)对SUI高危孕产妇的预防作用,为孕产妇SUI的预防提供证据支持。研究方法1.本研究选取了 2016年7月至2017年2月期间于某两家医院的产科门诊进行盆底三维超声检查的521名孕早/中期孕妇,收集所有孕妇的一般资料,孕期相关资料及盆底超声资料资料。将参与调查的两所医院中的妇幼保健院所收集的数据作为建模数据集,将另外一所综合医院收集的数据作为验证数据集。运用ROC曲线分析结合Logistic多因素回归分析建立SUI风险预测模型;在建立的风险预测模型基础上,采用R软件建立风险预测列线图,对列线图进行验证,分别计算代表模型区分度的C-统计量和一致性的Hosmer-Lemeshow检验,并通过统计作图对比预测概率与实际观察概率,观察列线图的校准能力。2.在产后1个月,对所有孕妇进行电话随访。调查产妇分娩信息、产后SUI的发生情况以及产前PFMT实施情况,对基于孕期SUI风险预测列线图判断的高危孕妇进行单因素及多因素分析,分析产前PFMT对产后1个月SUI是否存在预防效果。3.产后SUI风险预测列线图的建立与验证与孕期SUI预测列线图相同4.在产后3个月通过电话随访对产后SUI风险预测列线图判断出的高危产妇进行随访,回顾性调查在产后实施PFMT的情况,进行单因素及多因素分析,分析产后PFMT对产后3个月SUI是否存在预防效果。研究结果(一)孕期SUI风险预测列线图的构建及验证SUI的总体发生率为35.1%。ROC曲线分析显示纳入时BMI、孕期BMI增加以及6个超声参数对孕期SUI具有预测价值。一般临床资料结合盆底超声变量对孕期SUI进行联合预测具有较好的预测价值,曲线下面积(AreaUnder Curve,AUC)为0.813(95%CI,0.768-0.853)。根据临床超声人员及设备的配置,建立了三种风险预测模型。基于三种预测模型,应用R软件开发了三个风险预测列线图,经内部验证与外部验证均显示出较好的区分度及一致性。(二)孕期SUI风险预测列线图的应用孕期SUI风险预测列线图评估为高危孕妇中SUI的发生率为51.9%(125/241),低危孕妇中SUI的发生率为20.1%(54/269)。高危孕妇中,产前PFMT对产后1个月SUI的发生未显示出预防作用(P=0.390)。(三)产后SUI风险预测列线图的构建及验证产后SUI的发生率为14.2%。超声参数中仅Valsalva状态下的裂孔面积(Hiatal Area,HA)对产后 SUI 有一定的预测效果,AUC 为 0.592(95%CI,0.546-0.638)。最终确立的产后SUI风险预测模型包括孕前BMI、孕期SUI、流产史及此次阴道分娩四个临床因素。基于该模型开发的产后SUI预测列线图经内部验证具有较好的区分度与一致性。(四)产后SUI风险预测列线图的应用产后SUI风险预测列线图评估为高危的产妇中,SUI的发生率为28.8%(53/184),低危孕妇中SUI的发生率为4.4%(12/274)。扣除了混杂因素的影响后,发现产后PFMT是SUI高危产妇产后3个月SUI发生的独立保护因素(P=0.018)。结论1.根据不同的临床条件,本研究开发了适用于孕产妇SUI风险预测的列线图,有望成为孕产妇SUI风险预测的重要工具,也可作为个体化预防方案实施的基础。2.孕期SUI风险预测列线图筛选出的高危孕妇,并未从产前PFMT中获益。而产后PFMT可以预防高危产妇产后3个月SUI的发生,有必要扩大样本量进行进一步的临床前瞻性研究以验证本研究的结论。更多还原

【Abstract】 Background Early prevention of stress urinary incontinence(SUI)during and after pregnancy is crucial.To date,no feasible tool has been found to be useful in identifying high-risk women with SUI during and after pregnancy.Objectives 1.To develop risk predictive models for SUI during and after pregnancy;2.To investigate the implementation and preventive effect of antenatal and postnatal PFMT among the high-risk women of SUI.Methods 1,The study selected 521 pregnant women at their first trimester(9-12 weeks of gestation)or second trimester(20-23 weeks of gestation),who underwent pelvic floor three-dimensional ultrasonography from July 2016 to February 2017 in obstetrics and gynecology of the two hospitals in Shenzhen.The general information,pregnancy-related information and pelvic ultrasound data of pregnant women were collected.The Chi-square test and two-sided Student’s t-test were applied to examine the distribution differences of variables between the training dataset and the validation dataset.All significant continuous variables(P<0.05 at univariable analysis)in the training dataset were analyzed by receiver-operating characteristics(ROC).Three multivariable logistic regressions with backward elimination were built:the first on significant clinical variables(model A);the second on significant clinical and two-dimensional(2D)ultrasound variables(P<0.05 at ROC analysis for continuous parameters,and bladder neck(BN)funneling if P<0.05 at univariable analysis)(model B);and the third on significant clinical and 2D and 3D ultrasound parameters(model C).Areas under the curve(AUC)of the three models were calculated and compared using Medcalc software for Windows.The final predictive model with best performance and fewest variables was selected to establish a nomogram using R for Windows with the rms package.The developed nomogram was evaluated by both discrimination measured by the C-:index and calibration evaluated by the Hosmer-Lemeshow test and calibration plot,which compares the prediction probability and the actual observation probability.A bootstrap technique with 1,000 resamplings was used for internal validation to adjust overfitting and overoptimistic model performance.External validation of the nomograms was performed on the independent validation dataset.2.One month after delivery,all women were followed up by phone.Obstetrics-related information,pelvic floor muscle training during pregnancy and the occurrence of postpartum SUI were investigated.Univariable and multivariable analyses were conducted to analyze whether antenatal PFMT had a preventive effect on SUI at 1 month postpartum for high-risk women based on the risk predictive nomogram for SUI during pregnancy.3.The way of establishment and evaluation of the nomogram for SUI postpartum is the same as SUI during pregnancy.4.Three month after delivery,high-risk women based on the risk predictive nomogram for SUI after pregnancy were followed up by phone.Univariable and multivariable analyses were conducted to analyze whether postnatal PFMT had a preventive effect on SUI at 3 month postpartum:Results1.Development and validation of risk predictive nomogram for SUI during pregnancyThe overall incidence of SUI during pregnancy was 35.1%.ROC curve analysis showed that BMI at inclusive,BMI gain since pregnancy,and six ultrasound parameters,namely the beta angle and rest and Valsalva,the yangle at Valsalva and the HA(rest,Valsalva and AHA)had predictive value for SUI during pregnancy.The clinical model A,including pregnancy BMI gain,constipation,and previous delivery mode,had a C-statistic of 0.709(95%CI,0.658-0.757).Model B,including pregnancy BMI gain,constipation,previous delivery mode,β angle at rest,and BN funneling,had a C-statistic of 0.789(95%CI,0.742-0.831).The C-statistic of model C,including pregnancy BMI gain,constipation,previous delivery mode,β angle at rest,BN funneling,and HA at VM,was 0.813(95%CI,0.768-0.853).Three nomograms were developed using R software based on the three prediction models.The three nomograms showed good discrimination and satisfactory calibration by Internal and external verification.2.Application of risk predictive nomogram for SUI during pregnancyThe incidence of SUI during pregnancy in high-risk women was 51.9%(125/241),and in low-risk pregnant women was 20.1%(54/269).The preventive effect of antenatal PFMT for SUI at 1 month postpartum has not been observed(P=0.390).3.Development and validation of risk predictive nomogram for SUI after pregnancyThe incidence of postpartum SUI was 14.2%.Only the HA at Valsalva had predictive value on postpartum SUI with AUC of 0.592(95%CI,0.546 to 0.638).The final risk prediction model includes pre-pregnancy BMI,SUI during pregnancy,abortion history and vaginal delivery.The nomogram for SUI postpartum showed good discrimination and satisfactory calibration by internal verification.4.Application of risk predictive nomogram for SUI after pregnancyThe incidence of SUI at 1 month postpartum in high-risk women was 28.8%(53/184),and in low-risk women was 4.4%(12/274).The preventive effect of postnatal PFMT for SUI at 3 months postpartum has been observed after deducting the effect of confounding factor(P=0.018).Conclusions1.According to different clinical conditions,this study developed a seris of nomograms for the prediction of SUI during and after pregnancy,which are expected to become important predictive tools,as well as the basis for individualized prevention program implementation.2.High-risk pregnant women of SUI did not benefit from the antenatal PFMT,while the postnatal PFMT had a preventive effect for high-risk women of SUI at 3 months postpartum.Further clinical prospective investigations are necessary to verify the conclusions of this study.更多还原