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Heparin for Women With Recurrent Miscarriage and Inherited Thrombophilia (ALIFE2): An International Open-Label, Randomized Controlled Trial 肝素治疗复发性流产和遗传性血栓形成(ALIFE2):一项国际开放标签随机对照试验
4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2023-10-01 DOI: 10.1097/ogx.0000000000001209
Siobhan Quenby, Katie Booth, Louise Hiller, Arri Coomarasamy, Paulien G. de Jong, Eva N. Hamulyák, Luuk J. Scheres, Thijs F. van Haaps, Lauren Ewington, Shreeya Tewary, Mariëtte Goddijn, Saskia Middeldorp
ABSTRACT Thrombophilia has been implicated in the cause of recurrent miscarriage, which affects approximately 3% of couples trying to conceive. International professional guidelines recommend heparin anticoagulation for antiphospholipid syndrome, an acquired thrombophilia responsible for approximately 15% of recurrent miscarriage, but not for other inherited thrombophilias due to an absence of evidence. Many clinicians prescribe heparin to women with recurrent miscarriage and inherited thrombophilia despite the professional recommendations. This international, open-label, randomized controlled trial aimed to compare the effect of low-molecular weight heparin (LMWH) and standard pregnancy surveillance on livebirth rates in women with recurrent miscarriage and inherited thrombophilia. Women aged 18–42 years with recurrent miscarriages who were attempting to conceive or less than 7 weeks pregnant and had an inherited thrombophilia were recruited across 40 hospitals in 5 countries. Women were randomly assigned to LMWH or no LMWH in a 1:1 ratio. Women randomized to LMWH self-administered it once a day subcutaneously, beginning as soon as possible after a positive pregnancy test and before 7 weeks of gestation and continuing throughout pregnancy. The primary study outcome was livebirth after 24 weeks of gestation. Livebirth was compared across randomized treatment groups using an χ 2 test with continuity correction, then a sensitivity analysis with logistic regression to adjust for stratification factors. A total of 326 women were randomized between August 2012 and January 2021. Of these, 164 were randomized to LMWH plus standard care and 162 to standard care alone. In the standard care group, 30 patients ultimately received LMWH for thromboprophylaxis per professional treatment guidelines. The mean age of participants was 33 years, and the median number of miscarriages before randomization was 3 (interquartile range, 2–4), with two thirds of patients having a history of 3 or more miscarriages. The most common thrombophilia diagnoses were heterozygosity for factor V Leiden, prothrombin G20210A mutation, and protein S deficiency. The livebirth rate was 72% (116/162) in the LMWH group, and 71% (112/158) in the standard care group, and no statistical significant was detected between the groups even after adjustment (odds ratio, 1.08; 95% confidence interval, 0.65–1.78; P = 0.77). No differences in adverse pregnancy outcomes or complications were observed between the groups. Easy bruising was reported by 45% (73) women in the LMWH group and 10% (16) in the standard care group. This randomized controlled trial demonstrates that although LMWH is safe in women with recurrent pregnancy loss and inherited thrombophilia, it does not result in an increased live birth rate compared with standard pregnancy surveillance.
血栓病与复发性流产有关,约有3%的夫妇试图怀孕。国际专业指南推荐使用肝素抗凝治疗抗磷脂综合征,抗磷脂综合征是一种获得性血栓性疾病,约占复发性流产的15%,但由于缺乏证据,不建议用于其他遗传性血栓性疾病。许多临床医生不顾专业建议,给反复流产和遗传性血栓形成的妇女开肝素。这项国际、开放标签、随机对照试验旨在比较低分子肝素(LMWH)和标准妊娠监测对复发性流产和遗传性血栓形成妇女的活产率的影响。在5个国家的40家医院招募了年龄在18-42岁、有复发性流产、试图怀孕或怀孕少于7周且患有遗传性血栓形成症的妇女。女性按1:1的比例随机分配低分子肝素组和非低分子肝素组。随机分配到低分子肝素组的妇女在妊娠试验阳性后和妊娠7周之前尽快开始,并持续整个妊娠期间,每天皮下给药一次。主要研究结果是妊娠24周后的活产。采用连续性校正的χ 2检验比较各随机治疗组的活产,然后采用logistic回归进行敏感性分析以调整分层因素。在2012年8月至2021年1月期间,共有326名女性被随机分配。其中,164例随机分配到低分子肝素加标准治疗组,162例随机分配到单独标准治疗组。在标准治疗组,根据专业治疗指南,30名患者最终接受低分子肝素预防血栓。参与者的平均年龄为33岁,随机分组前流产的中位数为3次(四分位数范围为2-4),其中三分之二的患者有3次或以上的流产史。最常见的血栓病诊断为Leiden因子V杂合性、凝血酶原G20210A突变和蛋白S缺乏。低分子肝素组的活产率为72%(116/162),标准护理组的活产率为71%(112/158),调整后两组间差异无统计学意义(优势比1.08;95%置信区间为0.65-1.78;P = 0.77)。在不良妊娠结局或并发症方面,两组间无差异。低分子肝素组中有45%(73)的妇女易出现瘀伤,标准护理组中有10%(16)的妇女易出现瘀伤。这项随机对照试验表明,尽管低分子肝素对复发性妊娠丢失和遗传性血栓形成的妇女是安全的,但与标准妊娠监测相比,它不会导致活产率增加。
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引用次数: 0
Low-Dose Aspirin for the Prevention of Superimposed Preeclampsia in Women With Chronic Hypertension: A Systematic Review and Meta-analysis 低剂量阿司匹林预防慢性高血压女性合并子痫前期:一项系统综述和荟萃分析
4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2023-10-01 DOI: 10.1097/01.ogx.0000993664.57399.b2
Eleanor M. F. Richards, Veronica Giorgione, Oliver Stevens, Basky Thilaganathan
ABSTRACT Women with chronic hypertension are at increased risk for the development of preeclampsia during pregnancy. Low-dose aspirin treatment has been studied in the context of preeclampsia prevention, but there have been conflicting results among different populations. Some reasons for this are heterogeneous treatment regimens including timing, dosage, and even target outcomes. Among populations where there are limited data on the effect of low-dose aspirin on preeclampsia are women with chronic hypertension. This study is a systematic review and meta-analysis designed to analyze the use of low-dose aspirin during pregnancy and to assess whether the treatment reduces the risk of superimposed preeclampsia in women with chronic hypertension. It also aimed to secondarily assess related outcomes such as small for gestational age (SGA), preterm birth, and perinatal mortality. Systematic searches and assessment isolated 9 articles for final analysis. Six of these were randomized controlled trials, and 3 were retrospective cohort studies. Four studies focused on populations of only women with chronic hypertension, and the others included women with several different risk factors for preeclampsia. The retrospective studies and one of the randomized controlled trials compared aspirin treatment with no treatment, and the others compared with a placebo group; all studies used a dose of aspirin between 60 and 150 mg daily. No studies were excluded from the analysis based on risk of bias, as none were determined to be “critical” or “high” risk, although risk of bias was determined to be a contributing factor to low-quality data. Final analysis included a pooled sample size of 1078 individuals with chronic hypertension on low-dose aspirin, compared with 1072 women with chronic hypertension in control groups. This analysis did not find a decreased odds of superimposed preeclampsia in either randomized controlled trials (odds ratio [OR], 0.83; 95% confidence interval [CI], 0.55–1.25) or observational studies (OR, 1.21; 95% CI, 0.78–1.87). No significant differences were found with aspirin treatment, possibly due to risk of bias, heterogeneity, and imprecision. These findings held true when analyzed based on the timing of aspirin treatment induction (before or after 20 weeks' gestation), still finding no difference in the rate of superimposed preeclampsia. Low-dose aspirin treatment did reduce the odds of preterm birth according to a pooled analysis of 2 randomized controlled trials (OR, 0.62; 95% CI, 0.45–0.89). However, neither SGA nor perinatal mortality was shown to be significantly different in a pooled analysis of the studies that reported this outcome. Although these findings did not show statistical significance in reduction of preeclampsia in women with chronic hypertension due to aspirin treatment, the data are suggestive of benefit; many individuals in each study were lost to follow-up, and thus, the results of the analysis are different than they m
患有慢性高血压的女性在怀孕期间发生子痫前期的风险增加。低剂量阿司匹林治疗已经在预防子痫前期的背景下进行了研究,但在不同的人群中有相互矛盾的结果。造成这种情况的一些原因是治疗方案的不均匀,包括时间、剂量,甚至目标结果。在低剂量阿司匹林对子痫前期影响的数据有限的人群中,有慢性高血压的妇女。本研究是一项系统综述和荟萃分析,旨在分析妊娠期间低剂量阿司匹林的使用情况,并评估该治疗是否能降低慢性高血压妇女合并先兆子痫的风险。它还旨在次要评估相关结果,如小于胎龄(SGA)、早产和围产期死亡率。系统检索和评估分离出9篇文章进行最终分析。其中6项为随机对照试验,3项为回顾性队列研究。四项研究只关注患有慢性高血压的女性人群,其他研究包括患有子痫前期几种不同风险因素的女性。回顾性研究和一项随机对照试验将阿司匹林治疗组与不治疗组进行了比较,其他研究将安慰剂组与安慰剂组进行了比较;所有研究使用的阿司匹林剂量在每天60到150毫克之间。没有研究被排除在基于偏倚风险的分析之外,因为没有研究被确定为“关键”或“高”风险,尽管偏倚风险被确定为低质量数据的一个促成因素。最终分析包括1078名服用低剂量阿司匹林的慢性高血压患者,与对照组的1072名女性慢性高血压患者进行比较。该分析未发现两项随机对照试验中合并先兆子痫的几率降低(比值比[OR], 0.83;95%可信区间[CI], 0.55-1.25)或观察性研究(or, 1.21;95% ci, 0.78-1.87)。阿司匹林治疗组未发现显著差异,可能是由于存在偏倚、异质性和不精确的风险。当基于阿司匹林治疗诱导的时间(妊娠20周之前或之后)进行分析时,这些发现是正确的,仍然没有发现叠加先兆子痫发生率的差异。根据两项随机对照试验的汇总分析,低剂量阿司匹林治疗确实降低了早产的几率(OR, 0.62;95% ci, 0.45-0.89)。然而,在对报道这一结果的研究的汇总分析中,SGA和围产期死亡率均未显示出显著差异。虽然这些发现在阿司匹林治疗导致的慢性高血压妇女子痫前期减少方面没有统计学意义,但这些数据表明是有益的;每项研究中都有许多个体在随访中丢失,因此,分析的结果与保留更大的情况下可能出现的结果不同。观察性研究的结果表明,低剂量阿司匹林治疗可能在统计学上增加合并先兆子痫的可能性,但这些结果存在高度的不确定性。它们增加了先前关于这一主题的相互矛盾的发现;需要更多的研究,以更大和更少的异质样本来澄清这种联系。这项研究的结果与之前的研究结果相矛盾,之前的研究包括了具有各种子痫前期风险因素的个体,但与之前的研究一致,仅包括慢性高血压患者。由于异质性和偏倚,本研究受到证据质量的限制,但应促进对慢性高血压人群低剂量阿司匹林治疗的进一步研究。
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引用次数: 1
Effectiveness and Safety of Prenatal Valacyclovir for Congenital Cytomegalovirus Infection: Systematic Review and Meta-analysis 产前缬昔洛韦治疗先天性巨细胞病毒感染的有效性和安全性:系统评价和荟萃分析
4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2023-10-01 DOI: 10.1097/ogx.0000000000001212
F. D'Antonio, D. Marinceu, S. Prasad, A. Khalil
ABSTRACT One of the most common causes of infection-related fetal malformations is congenital cytomegalovirus (CMV), which affects approximately 0.5% to 2% of newborns. Several approaches have been investigated for screening, prevention, and treatment; one drug that shows activity against CMV is valacyclovir, and prenatal administration of this drug has been investigated in the context of preventing fetal disorders due to CMV. Although studies and clinical trials have been done regarding the safety and effectiveness of valacyclovir, clinical attitudes regarding universal CMV screening and prenatal valacyclovir treatment have yet to change. This article is a systematic review and meta-analysis of the safety and effectiveness of prenatal valacyclovir in CMV-infected pregnancies. Inclusion criteria included pregnancies with CMV infection diagnosed through serology, with a primary outcome of incidence of congenital CMV confirmed by polymerase chain reaction from amniocentesis. Secondary outcomes included symptomatic infection (rash, jaundice, microcephaly, seizures, hepatosplenomegaly, hearing loss, visual loss, retinitis, and central nervous system anomalies), asymptomatic infection, perinatal death, pregnancy termination, fetal anomaly, or severe symptoms. Adverse events related to the administration of valacyclovir were also recorded. Because relatively few studies were available for inclusion, the authors were unable to assess publication bias, but other risk of bias was assessed using standard tools. Final analysis included 8 studies and 620 pregnant women with CMV in 2 randomized controlled trials and 6 observational studies. One randomized controlled trial focused on valacyclovir treatment for CMV infection acquired in early pregnancy, and the other assessed valacyclovir treatment between 34 and 38 weeks' gestation to reduce risk of CMV within 1 year of delivery. The latter of the 2 studies was not included in pooled data synthesis because of inclusion criteria differences. Three studies focused on valacyclovir treatment for confirmed maternal CMV infection; pooled data analysis showed that valacyclovir-treated pregnancies had lower risk of congenital CMV (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.21–0.64; P < 0.001). When contracted in the first trimester, risk of vertical transmission was lower in those who were treated with valacyclovir (OR, 0.34; 95% CI, 0.15–0.74; P = 0.001); however, there was no effect observed in those with CMV in the periconceptual period. Analysis additionally showed that prenatal valacyclovir treatment was more likely to result in asymptomatic children (OR, 2.98; 95% CI, 1.18–7.55; P = 0.021), but no other significant perinatal differences were observed. These results show that treatment of CMV with prenatal valacyclovir reduces the risk of congenital CMV and its associated complications. Limitations of this analysis include the heterogeneity of inclusion and measurement criteria, as well as small sampl
感染相关胎儿畸形的最常见原因之一是先天性巨细胞病毒(CMV),影响约0.5%至2%的新生儿。已经研究了几种筛查、预防和治疗方法;一种显示抗巨细胞病毒活性的药物是valacyclovir,产前给药这种药物已经在预防巨细胞病毒引起的胎儿疾病的背景下进行了研究。尽管关于valacyclovir安全性和有效性的研究和临床试验已经完成,但临床对通用巨细胞病毒筛查和产前valacyclovir治疗的态度尚未改变。这篇文章是一个系统的回顾和荟萃分析的安全性和有效性产前缬昔洛韦在巨细胞病毒感染的妊娠。纳入标准包括通过血清学诊断为巨细胞病毒感染的妊娠,主要结局是羊膜穿刺术的聚合酶链反应证实先天性巨细胞病毒的发病率。次要结局包括症状性感染(皮疹、黄疸、小头畸形、癫痫发作、肝脾肿大、听力丧失、视力丧失、视网膜炎和中枢神经系统异常)、无症状感染、围产期死亡、终止妊娠、胎儿异常或严重症状。与服用伐昔洛韦有关的不良事件也被记录下来。由于可纳入的研究相对较少,作者无法评估发表偏倚,但使用标准工具评估了其他偏倚风险。最终分析包括8项研究和620名巨细胞病毒孕妇,其中2项随机对照试验和6项观察性研究。一项随机对照试验侧重于valacyclovir治疗妊娠早期获得的巨细胞病毒感染,另一项试验评估valacyclovir治疗妊娠34至38周之间以降低分娩后1年内巨细胞病毒的风险。由于纳入标准不同,后一项研究未纳入汇总数据综合。三项研究聚焦于伐昔洛韦治疗确诊的母体巨细胞病毒感染;综合数据分析显示,服用伐昔洛韦的孕妇发生先天性巨细胞病毒的风险较低(优势比[OR], 0.37;95%置信区间[CI], 0.21-0.64;P & lt;0.001)。当在妊娠早期感染时,接受伐昔洛韦治疗的患者垂直传播的风险较低(OR, 0.34;95% ci, 0.15-0.74;P = 0.001);然而,在围孕期的巨细胞病毒患者中没有观察到任何影响。分析还显示,产前使用伐昔洛韦治疗更有可能导致无症状儿童(OR, 2.98;95% ci, 1.18-7.55;P = 0.021),但其他围产儿差异无统计学意义。这些结果表明,产前使用伐昔洛韦治疗巨细胞病毒可降低先天性巨细胞病毒及其相关并发症的风险。该分析的局限性包括纳入和测量标准的异质性,以及评估围产期结局的小样本。与该药物相关的风险很小,并且在患者停用valacyclovir后不良事件得到解决。这一发现与先前的研究一致,表明了valacyclovir的益处。进一步的研究应该评估与valacyclovir治疗相关的围产期结局,以及valacyclovir在继发性感染和原发性感染中的作用。特别是,应该实施更大规模的随机对照试验,以确定伐昔洛韦治疗与胎儿结构异常、症状性感染和神经认知障碍风险的关系。
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引用次数: 0
The Cell-Free DNA Virome of 108,349 Dutch Pregnant Women 108349名荷兰孕妇的无细胞DNA病毒组
4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2023-10-01 DOI: 10.1097/01.ogx.0000993668.06748.a3
Jasper Linthorst, Moezammin M. M. Baksi, Matthijs R. A. Welkers, Erik A. Sistermans
ABSTRACT Pregnancy increases the body's vulnerability to infectious disease, and current guidelines during pregnancy include minimizing possible exposure to viral infection. In cases where viral infection does occur, these can cause mild to severe complications in both mother and fetus; many viruses that result in such complications are DNA viruses. Current diagnosis technology for DNA viruses relies largely on polymerase chain reaction (PCR), which is very sensitive but generally targeted at a specific virus and so tends to not be very comprehensive. In addition, this testing is normally performed only on those who are at high risk or expressing symptoms. To more fully understand the effect and prevalence of DNA viruses in pregnancy, this study used noninvasive prenatal testing (NIPT) that captures cell-free DNA (cfDNA) to examine the DNA virome in pregnant women between 2017 and 2020. Data included deidentified NIPT results for 108,349 individuals, and DNA sequences were used to screen for 224 DNA viruses. Viruses that were genetically similar were differentiated based on taxonomy through a meticulous decision tree to avoid generalized errors in categorizing them. The most commonly detected virus was parvovirus B19, occurring in approximately 1 in 3000 cfDNA reads. High viral loads were also observed for hepatitis B, Bocaparvovirus , papillomavirus, adenovirus, adeno-associated virus, Epstein-Barr virus (EBV)/herpesvirus 4, cytomegalovirus (CMV), herpesvirus 6, and torque teno virus. A cross-examination of demographic and pregnancy factors revealed many associations, most of which remained significant after adjustments for multiple comparisons. Available characteristics included maternal age, body mass index (BMI), gestational age, fetal fraction, and the number of sequenced reads with the presence of viral DNA in the samples. Detection of viral DNA was associated with lower BMI, along with a lower concentration of cfDNA and a higher fetal fraction. When individual viruses were analyzed, CMV had the most significant relationship with gestational age and maternal age. Results additionally showed that low fetal fraction was associated with lower detection of viral DNA for specific viruses. These results show that it is feasible to detect viral DNA in NIPT samples. If viral DNA can be detected, there is potential to diagnose infection and to possibly prevent complications due to the virus. Current clinical practice does not use NIPT as a diagnostic tool for viral infection, but there is potential for this in the future. Further research should focus on clinical utility, sensitivity, specificity, and accuracy, as well as the relationship of viral DNA with low fetal fraction.
怀孕增加了身体对传染病的易感性,目前的怀孕指南包括尽量减少可能的病毒感染。在确实发生病毒感染的情况下,这些可能会导致母亲和胎儿出现轻微到严重的并发症;许多导致这种并发症的病毒是DNA病毒。目前的DNA病毒诊断技术主要依赖于聚合酶链反应(PCR),该技术非常敏感,但通常针对特定的病毒,因此往往不是很全面。此外,这种检测通常只对那些有高风险或有症状的人进行。为了更充分地了解DNA病毒在怀孕期间的影响和流行程度,本研究使用了无细胞DNA (cfDNA)的无创产前检测(NIPT)来检测2017年至2020年间孕妇的DNA病毒组。数据包括108,349人的NIPT鉴定结果,DNA序列用于筛选224种DNA病毒。通过精细决策树的分类方法,对基因相似的病毒进行分类,避免了分类的泛化错误。最常检测到的病毒是细小病毒B19,大约在3000个cfDNA读数中出现1个。乙型肝炎病毒、bocaparvov病毒、乳头瘤病毒、腺病毒、腺相关病毒、eb病毒/疱疹病毒4、巨细胞病毒(CMV)、疱疹病毒6和torque teno病毒的病毒载量也很高。人口统计学和妊娠因素的交叉检查揭示了许多关联,其中大多数在多次比较调整后仍然显着。可用的特征包括母亲年龄、体重指数(BMI)、胎龄、胎儿分数以及样本中存在病毒DNA的测序读数。病毒DNA的检测与较低的BMI、较低的cfDNA浓度和较高的胎儿分数相关。当对单个病毒进行分析时,巨细胞病毒与胎龄和母亲年龄的关系最为显著。结果还表明,低胎儿分数与特定病毒的低病毒DNA检测相关。这些结果表明,在NIPT样品中检测病毒DNA是可行的。如果能检测到病毒DNA,就有可能诊断感染,并可能预防由病毒引起的并发症。目前的临床实践并没有使用NIPT作为病毒感染的诊断工具,但在未来有这种潜力。进一步的研究应侧重于临床应用、敏感性、特异性和准确性,以及病毒DNA与低胎儿分数的关系。
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引用次数: 0
Nicotine Use During Pregnancy: Cessation and Treatment Strategies 怀孕期间使用尼古丁:戒烟和治疗策略
4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2023-10-01 DOI: 10.1097/ogx.0000000000001191
Avan Shirwani, Jeffrey A. Kuller, Sarah K. Dotters-Katz, Kateena Addae-Konadu
ABSTRACT The use of tobacco and nicotine products during pregnancy is known to increase the risk of adverse effects on the fetus. Increased education and research have resulted in greater rates of smoking cessation during pregnancy, with a decline from 13.2% of pregnant individuals smoking in 2006 to 7.2% in 2016. However, smoking while pregnant still proves to be a prevalent issue that is associated with numerous adverse outcomes, including low birth weight, preterm birth, and developmental delays. Smoking cessation before or during pregnancy can help mitigate these effects, but the appropriate treatment can be challenging to ascertain. Accordingly, clinicians should look to provide individualized care composed of behavioral counseling in conjunction with pharmacotherapies when indicated, combined with ongoing support and education. Target Audience Obstetricians and gynecologists, family physicians. Learning Objectives After completing this activity, the learner should be better able to identify the pathophysiologic effects of smoking during pregnancy and the different forms of nicotine use; describe the maternal risk of smoking, along with its neonatal and childhood effects; and explain the potential screening and treatment strategies for smoking cessation during pregnancy.
怀孕期间使用烟草和尼古丁产品会增加胎儿不良反应的风险。教育和研究的增加导致怀孕期间戒烟率上升,从2006年的13.2%下降到2016年的7.2%。然而,怀孕期间吸烟仍然是一个普遍存在的问题,它与许多不良后果有关,包括低出生体重、早产和发育迟缓。在怀孕前或怀孕期间戒烟可以帮助减轻这些影响,但适当的治疗方法可能很难确定。因此,临床医生应该寻求提供个性化的护理,包括行为咨询和药物治疗,并结合持续的支持和教育。目标受众:妇产科医生、家庭医生。学习目标完成本活动后,学习者应能更好地识别怀孕期间吸烟的病理生理影响和不同形式的尼古丁使用;描述母亲吸烟的风险及其对新生儿和儿童的影响;并解释怀孕期间戒烟的潜在筛查和治疗策略。
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引用次数: 0
CME PROGRAM EXAM AND ANSWER SHEET 继续教育课程考试及答题卡
4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2023-10-01 DOI: 10.1097/ogx.0000000000001221
Obstetrical & Gynecological Survey 78(10):p 620-622, October 2023. | DOI: 10.1097/OGX.0000000000001221
妇产科调查78(10):p 620-622, 2023年10月。| doi: 10.1097/ ogx.0000000000001221
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引用次数: 0
Tranexamic Acid to Prevent Obstetrical Hemorrhage After Cesarean Delivery 氨甲环酸预防剖宫产后产科出血
4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2023-10-01 DOI: 10.1097/01.ogx.0000993672.66513.1f
L. D. Pacheco, R. G. Clifton, G. R. Saade, S. J. Weiner, S. Parry, J. M. Thorp, M. Longo, A. Salazar, W. Dalton, A. T. N. Tita, C. Gyamfi-Bannerman, S. P. Chauhan, T. D. Metz, K. Rood, D. J. Rouse, J. L. Bailit, W. A. Grobman, H. N. Simhan, G. A. Macones
ABSTRACT Previous research has presented convincing evidence that the administration of tranexamic acid (TXA) after cesarean delivery can reduce the incidence of postpartum hemorrhage (PPH) and the associated mortality and morbidity. Although there have been several significant studies on this topic, they are limited by small sample sizes, which make the studies difficult to generalize and limit their statistical power. This study aimed to address that gap and assess clinical outcomes related to the administration of TXA in a large sample. This was a multicenter, double-blind, randomized controlled trial including 31 hospitals participating in the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Eligibility criteria included scheduled or unscheduled cesarean delivery of a singleton or twin gestation. Exclusion criteria included maternal age younger than 18 years, blood transfusion before randomization, plan for transfusion after randomization, contraindications to TXA, patient decision not to use blood products, or administration of antifibrolytic agents or uterotonic agents other than oxytocin. The primary outcome was maternal death or blood transfusion before hospital discharge or 7 days after delivery, whichever came first. Secondary outcomes included intraoperative blood loss of more than 1 L and treatments or interventions in response to bleeding or related complications within 7 days of delivery, as well as infectious complications within 6 weeks of delivery. Final analyses included 11,000 patients, with 5529 in the TXA group and 5471 in the placebo group. Baseline characteristics were not significantly different between groups, and no center-dependent differences were observed. The primary outcome was observed in 3.6% of patients in the TXA group and 4.3% of patients in the placebo group (adjusted relative risk, 0.89; P = 0.19). Intraoperative blood loss of more than 1 L was recorded in 7.3% and 8.0% in the tranexamic and placebo groups, respectively (relative risk, 0.90; 95% CI, 0.79–1.05). Treatments and interventions in response to bleeding occurred in 16.1% of individuals in the TXA group and 18.0% of those in the placebo group (relative risk, 0.90; 95% CI, 0.82–0.97). Infectious complications were reported in 3.2% and 2.5% in the TXA and placebo groups, respectively (relative risk, 1.28; 95% CI, 1.02–1.61). Sensitivity analysis showed similar results to initial analysis, and no significant differences were seen between groups in major safety outcomes. This analysis indicates that the administration of TXA during cesarean delivery did not lower the risk of maternal death or blood transfusion. These results are in direct contradiction to previous research showing that TXA is effective at reducing these outcomes. This trial was stronger than any previous studies in sample size and careful randomization ensuring equal representation of scheduled and unscheduled c
既往研究已提供令人信服的证据,表明剖宫产后给予氨甲环酸(TXA)可降低产后出血(PPH)的发生率及相关的死亡率和发病率。虽然已经有一些关于这一主题的重要研究,但它们受到样本量小的限制,这使得研究难以推广,限制了它们的统计能力。本研究旨在解决这一差距,并在大样本中评估与TXA管理相关的临床结果。这是一项多中心、双盲、随机对照试验,包括31家医院参与了尤尼斯肯尼迪施赖弗国家儿童健康和人类发展研究所的母胎医学单位网络。入选标准包括单胎或双胎妊娠的预定或非预定剖宫产。排除标准包括母亲年龄小于18岁,随机化前输血,随机化后输血计划,TXA禁忌症,患者决定不使用血液制品,或使用除催产素以外的抗纤溶药物或子宫舒张药物。主要结局为产妇死亡或出院前输血或分娩后7天输血,以先发生者为准。次要结局包括术中出血量大于1l,分娩7天内出血或相关并发症的治疗或干预措施,以及分娩6周内的感染性并发症。最终的分析包括11000例患者,其中5529例为TXA组,5471例为安慰剂组。各组间基线特征无显著差异,无中心依赖性差异。TXA组3.6%的患者和安慰剂组4.3%的患者观察到主要结局(校正相对风险,0.89;P = 0.19)。氨甲环组和安慰剂组术中出血量大于1l的比例分别为7.3%和8.0%(相对危险度为0.90;95% ci, 0.79-1.05)。在TXA组中,16.1%的个体对出血进行了治疗和干预,而在安慰剂组中,这一比例为18.0%(相对风险,0.90;95% ci, 0.82-0.97)。TXA组和安慰剂组的感染并发症发生率分别为3.2%和2.5%(相对危险度为1.28;95% ci, 1.02-1.61)。敏感性分析结果与初始分析结果相似,各组间主要安全性结果无显著差异。这一分析表明,在剖宫产期间给予TXA并没有降低产妇死亡或输血的风险。这些结果与先前表明TXA能有效降低这些结果的研究结果直接矛盾。该试验在样本量和谨慎的随机化方面强于以往的任何研究,确保了计划和非计划剖宫产的平等代表性,这使得与以往研究的矛盾尤为重要。该试验的一些局限性包括给药时间和剂量的限制。与这两个变量相关的结果在很大程度上仍然未知。该试验还排除了血栓栓塞现象高风险的患者,TXA在这一人群中的作用尚不清楚。进一步的研究应该关注更多样化的人群,并了解随着时间和剂量的变化结果,这是本研究没有解决的问题。
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引用次数: 0
US Infant Pertussis Incidence Trends Before and After Implementation of the Maternal Tetanus, Diphtheria, and Pertussis Vaccine 美国婴儿百日咳发病率趋势前后实施产妇破伤风,白喉,百日咳疫苗
4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2023-10-01 DOI: 10.1097/01.ogx.0000993680.79685.68
Tami H. Skoff, Li Deng, Catherine H. Bozio, Susan Hariri
ABSTRACT Many illnesses can become especially serious when contracted within the first year of life; pertussis remains quite deadly despite recent medical advances in disease prevention. Current guidance on vaccination in the United States includes 3 doses of the DTaP (diphtheria, tetanus toxoid, and acellular pertussis) vaccine beginning at 2 months of age, but this regimen leaves infants younger than that very vulnerable to illness. Research has shown both that vaccinating mothers with tetanus toxoid reduces tetanus, diphtheria, and pertussis (Tdap) between 27 and 36 weeks of gestation significantly reduces instances of pertussis in infants younger than 2 months, and that maternal vaccination rates have risen in the last few years. However, research is lacking in analyzing the relationship between vaccination rates in pregnant mothers and the burden of pertussis in infants in the United States. This study was designed to assess data from 2000 to 2019 and examine the association of Tdap vaccination during pregnancy with trends in infant pertussis. This analysis included data obtained from the National Notifiable Diseases Surveillance System between 2000 and 2019. This included a total of 57,460 cases of pertussis in infants younger than 1 year and a total of 19,322 cases in infants younger than 2 months. The rate of pertussis incidence for infants younger than 2 months in the time period before the implementation of prenatal Tdap was calculated to be 165.3 per 100,000 individuals, with no significant trend observed annually ( P = 0.28). After the implementation of routine maternal Tdap, incidence decreased to 80.9 per 100,000 infants between 2017 and 2019. Accounting for both time periods, the mean annual incidence was calculated as 121.8 per 100,000 infants younger than 2 months. Annual incidence also showed a significant decreasing trend in the period after implementation of maternal Tdap vaccination (slope: −14.53 per 100,000 infants per year; P = 0.001). The change in trends before and after this implementation was also significant ( P = 0.01). In a slightly older age group of 6 to 12 months of age, mean annual incidence of pertussis was 19.7 per 100,000 infants. In the time period before implementation of maternal Tdap, incidence among infants aged 6 to 12 months was consistently 4 to 12 times less than infants younger than 2 months and did not significantly change after the implementation of the maternal vaccine. Comparing the 2 age groups, there was no significant change in the difference in incidence between infants younger than 2 months and those between 6 and 12 months in the period before the maternal vaccine, and after its implementation, there was a significant decrease in the incidence difference between the 2 groups ( P < 0.001). These results suggest an association between the maternal Tdap vaccination and trends of pertussis incidence in infants younger than 2 months. This also indicates a possible reduction in disease burden at
许多疾病在生命的第一年感染时可能会变得特别严重;尽管最近在疾病预防方面取得了医学进步,百日咳仍然是相当致命的。美国目前的疫苗接种指南包括从2个月大开始接种3剂DTaP(白喉、破伤风类毒素和无细胞百日咳)疫苗,但这种方案使年龄小于2个月的婴儿非常容易患病。研究表明,为母亲接种破伤风类毒素疫苗可在妊娠27周至36周期间减少破伤风、白喉和百日咳(Tdap),显著减少2个月以下婴儿的百日咳病例,而且母亲疫苗接种率在过去几年中有所上升。然而,在美国,缺乏对孕妇疫苗接种率与婴儿百日咳负担之间关系的分析研究。本研究旨在评估2000年至2019年的数据,并检查怀孕期间接种百日咳疫苗与婴儿百日咳趋势的关系。该分析包括2000年至2019年期间从国家法定疾病监测系统获得的数据。其中包括1岁以下婴儿百日咳57,460例,2个月以下婴儿百日咳19,322例。在实施产前百日咳百日咳前,2个月以下婴儿百日咳发病率计算为每10万人165.3例,每年无显著趋势(P = 0.28)。在实施常规母亲百白破疫苗后,2017年至2019年期间,发病率降至每10万名婴儿80.9例。考虑到这两个时间段,计算出的年平均发病率为每10万名2个月以下婴儿121.8例。在实施母亲百白破疫苗接种后,年发病率也呈现显著下降趋势(斜率:- 14.53 / 10万婴儿/年;P = 0.001)。实施前后的趋势变化也很显著(P = 0.01)。在年龄稍大的6至12个月的年龄组中,百日咳的年平均发病率为每10万名婴儿19.7例。在实施母亲百白破疫苗之前,6至12个月婴儿的发病率始终比2个月以下婴儿低4至12倍,并且在实施母亲百白破疫苗后没有显着变化。两个年龄组比较,接种疫苗前2个月以下婴儿与6 ~ 12个月婴儿的发病率差异无显著变化,接种疫苗后两组发病率差异显著降低(P <0.001)。这些结果表明,母亲接种百日咳疫苗与2个月以下婴儿百日咳发病率趋势之间存在关联。这也表明,产妇在分娩前接种百白破疫苗可能会减少疾病负担。本研究的局限性包括个体母亲疫苗接种状况的有限可用性,以及无法确定是否有婴儿在2个月前接种过疫苗。进一步的研究应侧重于在后期接种百白破疫苗的背景下接种百白破疫苗的临床影响,并分析与两种疫苗接种相关的疾病趋势。还应审查临床指南,以确保公共卫生趋势和个人健康趋势相一致。
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引用次数: 0
Neurocutaneous Disorders in Pregnancy 妊娠期神经皮肤疾病
4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2023-10-01 DOI: 10.1097/ogx.0000000000001202
Jay Idler, Onur Turkoglu, Kara Patek, Sean Stuart, Birce Taskin, Lalitha Sivaswamy, Amy Whitten
Importance Neurocutaneous disorders have significant implications for care of the pregnant patient. As neurocutaneous disorders are uncommon, obstetricians may be unfamiliar with these disorders and with recommendations for appropriate care of this population. Objective This review aims to summarize existing literature on the interaction between neurocutaneous disorders and pregnancy and to provide a guide for physicians caring for an affected patient. Evidence Acquisition A PubMed, MEDLINE, and Google Scholar search was carried out with a broad range of combinations of the medical subject headings (MeSH) terms “pregnancy,” “Sturge -Weber,” “Neurofibromatosis Type 1,” “neurofibromatosis type 2,” “von Hippel Lindau,” “Tuberous Sclerosis,” “neurocutaneous disorder,” “treatment,” “congenital malformations,” “neurodevelopmental defects,” “miscarriage,” “breastfeeding,” “autoimmune,” “pathophysiology,” and “management.” References of included articles were searched to identify any articles that may have been missed after the above method was used. Results Neurocutaneous disorders are associated with increased pregnancy-associated maternal and fetal/neonatal morbidity, largely surrounding hypertensive disorders, epilepsy, and medication exposure. Some features of neurocutaneous disorders may be worsened or accelerated by pregnancy. Neurocutaneous disorders can often be diagnosed prenatally. Therefore, directed assessment should be offered to affected individuals with a personal or family history of a neurocutaneous disorder. Conclusion and Relevance Patients affected by neurocutaneous disorders who are pregnant or planning for future pregnancy should be carefully followed by a multidisciplinary team, which could include maternal-fetal medicine, neurology, and anesthesia, as well as other relevant subspecialists. Additional research is required regarding optimal counseling and management of these patients. Target Audience Obstetricians and gynecologists, family physician. Learning objectives After completing this activity, the learner will be better able to identify the most common neurocutaneous disorders seen in reproductive women and their implications in pregnancy; propose recommendations for genetic evaluation, diagnosis, management, and a differential diagnosis; describe treatment options including labor and delivery management, emphasizing multidisciplinary approach; and discuss potential maternal and fetal adverse outcomes related to neurocutaneous disorders.
重要性:神经皮肤疾病对妊娠患者的护理具有重要意义。由于神经皮肤疾病是罕见的,产科医生可能不熟悉这些疾病,并建议适当的护理这一人群。目的对神经皮肤疾病与妊娠相互作用的文献进行综述,为临床护理提供参考。对PubMed、MEDLINE和Google Scholar进行了广泛的医学主题搜索(MeSH),包括“怀孕”、“Sturge -Weber”、“1型神经纤维瘤病”、“2型神经纤维瘤病”、“von Hippel Lindau”、“结节性硬化症”、“神经皮肤病”、“治疗”、“先天性畸形”、“神经发育缺陷”、“流产”、“母乳喂养”、“自身免疫”、“病理生理学”和“管理”。检索纳入文章的参考文献,以确定使用上述方法后可能遗漏的任何文章。结果神经皮肤疾病与妊娠相关的孕产妇和胎儿/新生儿发病率增加有关,主要围绕高血压疾病、癫痫和药物暴露。神经皮肤疾病的某些特征可能因怀孕而恶化或加速。神经皮肤疾病通常可以在产前诊断出来。因此,对于有神经皮肤疾病的个人或家族病史的患者,应进行定向评估。结论及意义受神经皮肤疾病影响的孕妇或计划将来怀孕的患者应由包括母胎医学、神经病学、麻醉以及其他相关专科医生在内的多学科团队密切随访。关于这些患者的最佳咨询和管理需要进一步的研究。目标受众:妇产科医生、家庭医生。完成本活动后,学习者将能够更好地识别生殖妇女中最常见的神经皮肤疾病及其对妊娠的影响;提出遗传评估、诊断、管理和鉴别诊断的建议;描述治疗方案,包括劳动和分娩管理,强调多学科方法;并讨论与神经皮肤疾病相关的潜在母体和胎儿不良后果。
{"title":"Neurocutaneous Disorders in Pregnancy","authors":"Jay Idler, Onur Turkoglu, Kara Patek, Sean Stuart, Birce Taskin, Lalitha Sivaswamy, Amy Whitten","doi":"10.1097/ogx.0000000000001202","DOIUrl":"https://doi.org/10.1097/ogx.0000000000001202","url":null,"abstract":"Importance Neurocutaneous disorders have significant implications for care of the pregnant patient. As neurocutaneous disorders are uncommon, obstetricians may be unfamiliar with these disorders and with recommendations for appropriate care of this population. Objective This review aims to summarize existing literature on the interaction between neurocutaneous disorders and pregnancy and to provide a guide for physicians caring for an affected patient. Evidence Acquisition A PubMed, MEDLINE, and Google Scholar search was carried out with a broad range of combinations of the medical subject headings (MeSH) terms “pregnancy,” “Sturge -Weber,” “Neurofibromatosis Type 1,” “neurofibromatosis type 2,” “von Hippel Lindau,” “Tuberous Sclerosis,” “neurocutaneous disorder,” “treatment,” “congenital malformations,” “neurodevelopmental defects,” “miscarriage,” “breastfeeding,” “autoimmune,” “pathophysiology,” and “management.” References of included articles were searched to identify any articles that may have been missed after the above method was used. Results Neurocutaneous disorders are associated with increased pregnancy-associated maternal and fetal/neonatal morbidity, largely surrounding hypertensive disorders, epilepsy, and medication exposure. Some features of neurocutaneous disorders may be worsened or accelerated by pregnancy. Neurocutaneous disorders can often be diagnosed prenatally. Therefore, directed assessment should be offered to affected individuals with a personal or family history of a neurocutaneous disorder. Conclusion and Relevance Patients affected by neurocutaneous disorders who are pregnant or planning for future pregnancy should be carefully followed by a multidisciplinary team, which could include maternal-fetal medicine, neurology, and anesthesia, as well as other relevant subspecialists. Additional research is required regarding optimal counseling and management of these patients. Target Audience Obstetricians and gynecologists, family physician. Learning objectives After completing this activity, the learner will be better able to identify the most common neurocutaneous disorders seen in reproductive women and their implications in pregnancy; propose recommendations for genetic evaluation, diagnosis, management, and a differential diagnosis; describe treatment options including labor and delivery management, emphasizing multidisciplinary approach; and discuss potential maternal and fetal adverse outcomes related to neurocutaneous disorders.","PeriodicalId":19409,"journal":{"name":"Obstetrical & Gynecological Survey","volume":"21 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136009882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Urinary Tract Infections After Urogynecologic Surgery: Risk Factors, Timeline, and Uropathogens 泌尿妇科手术后尿路感染:危险因素、时间和尿路病原体
4区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2023-10-01 DOI: 10.1097/ogx.0000000000001207
Carrie E. Jung, Lie H. Chen, Linda T. Brubaker, Shawn A. Menefee
ABSTRACT Postoperative urinary tract infection (PO-UTI) is seen in 6.4%–32% of stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP) surgeries despite perioperative antibiotic prophylaxis. Postoperative complications associated with PO-UTI include increased mortality and longer hospitalization. Increasing prevalence of resistance to antibiotics and antibiotic stewardship principles necessitate both the improvement of infection prevention strategies and judicious antibiotic prescriptions. Four factors are known to increase PO-UTI risk: (1) recurrent UTI (RUTI) history, (2) preoperative UTI, (3) day-of-surgery UTI, and (4) prolonged postoperative catheterization. This study intended to determine (1) risk factors of PO-UTI and PO-RUTI, (2) preoperative and postoperative UTI temporal distribution, and (3) detected uropathogens in a large database. The study used medical record data of all SUI/POP surgical procedures performed in the Kaiser Southern California Hospital system from January 1, 2008 to December 31, 2016 for women 18 years of age or older. Procedures used Current Procedural Terminology codes for identifying and subcategorizing surgical procedures and their route (SUI or POP; abdominal or vaginal, respectively). The study-wide definition of UTI was as follows: (1) positive standard urine culture of greater than 10 5 CFU/mL of ≤2 uropathogens, or (2) prescription of urinary antibiotics prescribed for the indication of UTI symptoms. The analysis consisted of 21,063 urogynecologic surgical procedures performed on 20,051 women (33,626 POP and/or SUI procedures), with 22,641 UTI events being diagnosed in 10,091 women. Mean age was 56.9 years, and mean BMI was 29.1. The cohort underwent surgery for only SUI (35.4%), only POP (32.7%), or POP/SUI combined (31.9%). In the 13.5 months postoperatively, 11,976 UTIs were diagnosed in 6733 women. The first month experienced a sharp increase compared with the preoperative year, the second month increased further, and the third month showed leveling of PO-UTI incidence. Prescribed antibiotics captured most UTI events (13,337 or 58.3%). Prescribed antibiotics, in order of most-prescribed to least-prescribed, were as follows: ciprofloxacin (33.7%), cephalexin (21.4%), nitrofurantoin (20.4%), and sulfamethoxazole-trimethoprim (17.6%). The study determined that most PO-UTIs occurred within the first 2 months, with many of these being diagnosed within 2 weeks of surgery. For those patients already having a history of RUTI, RUTI significantly increases in postoperative year 1 when compared with the preoperative year. All patients undergoing SUI procedures had increased PO-RUTI risks compared with their POP-only group peers. Escherichia coli was the most common pathogen found. Risk and event timing were affected by surgical indication: although surgery for only SUI had a lower 6-week PO-UTI risk, it was counterintuitively associated with a higher PO-RUTI risk. Multivariate regression revealed pred
术后尿路感染(PO-UTI)见于6.4%-32%的应激性尿失禁(SUI)和/或盆腔器官脱垂(POP)手术,尽管围手术期抗生素预防。PO-UTI相关的术后并发症包括死亡率增加和住院时间延长。日益普遍的抗生素耐药性和抗生素管理原则需要改进感染预防策略和明智的抗生素处方。已知有四个因素会增加PO-UTI风险:(1)复发性UTI (RUTI)病史,(2)术前UTI,(3)手术当天UTI,(4)术后延长导尿时间。本研究旨在确定(1)PO-UTI和PO-RUTI的危险因素,(2)术前和术后UTI的时间分布,(3)在大型数据库中检测尿路病原体。该研究使用了2008年1月1日至2016年12月31日在凯撒南加州医院系统进行的所有SUI/POP手术的医疗记录数据,这些手术针对的是18岁及以上的女性。使用现行程序术语代码对外科手术及其路径进行识别和分类(SUI或POP;腹部或阴道分别)。全研究范围内对尿路感染的定义为:(1)标准尿培养≥105 CFU/mL≤2种尿路病原菌阳性,或(2)有尿路感染症状指征的尿路抗生素处方。该分析包括对20,051名女性进行的21,063例泌尿妇科手术(33,626例POP和/或SUI手术),在10,091名女性中诊断出22,641例尿路感染事件。平均年龄56.9岁,平均BMI为29.1。该队列仅因SUI(35.4%)、POP(32.7%)或POP/SUI合并(31.9%)接受手术。术后13.5个月,6733名妇女中有11976例尿路感染被诊断出来。第1个月与术前相比急剧增加,第2个月进一步增加,第3个月PO-UTI发生率趋于平缓。处方抗生素捕获了大多数尿路感染事件(13,337或58.3%)。处方抗生素从多到少依次为:环丙沙星(33.7%)、头孢氨苄(21.4%)、呋喃妥因(20.4%)、磺胺甲恶唑-甲氧苄啶(17.6%)。该研究确定,大多数po - uti发生在前2个月内,其中许多在手术后2周内被诊断出来。对于已有RUTI病史的患者,术后1年RUTI较术前显著升高。所有接受SUI手术的患者与仅接受pop手术的患者相比,PO-RUTI风险增加。大肠杆菌是最常见的病原体。风险和事件时间受手术指征的影响:尽管仅SUI的手术具有较低的6周PO-UTI风险,但与较高的PO-RUTI风险相反。多因素回归显示可预测的PO-UTI危险因素:OAB、糖尿病史、术前6周内UTI史、RUTI史、支架和导管放置。一个更令人困惑的发现是阴道雌激素处方与短期PO-UTI风险增加的关联,可能与有RUTI病史的女性使用有关,但更可能与数据集中许多女性的绝经后状态有关。该研究建议术前评估,目的是在手术前6周内识别和消除尿路感染,并制定方案,加强对糖尿病患者和术前尿路感染妇女等风险增加的妇女的预防。
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引用次数: 0
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Obstetrical & Gynecological Survey
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