Birth Defects Research最新文献

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COVID-19 Vaccination During Pregnancy and Birth Defects: Results From the CDC COVID-19 Vaccine Pregnancy Registry, United States 2021–2022 怀孕期间接种COVID-19疫苗和出生缺陷:美国CDC COVID-19疫苗妊娠登记处的结果,2021-2022
IF 1.6 4区 医学
Birth Defects Research Pub Date : 2025-05-21 DOI: 10.1002/bdr2.2474
Andrea J. Sharma, Jennita Reefhuis, Lauren Head Zauche, Sabrina A. Madni, Janet D. Cragan, Cynthia A. Moore, John F. Nahabedian, Christine K. Olson, CDC COVID-19 Vaccine Pregnancy Registry team
{"title":"COVID-19 Vaccination During Pregnancy and Birth Defects: Results From the CDC COVID-19 Vaccine Pregnancy Registry, United States 2021–2022","authors":"Andrea J. Sharma,&nbsp;Jennita Reefhuis,&nbsp;Lauren Head Zauche,&nbsp;Sabrina A. Madni,&nbsp;Janet D. Cragan,&nbsp;Cynthia A. Moore,&nbsp;John F. Nahabedian,&nbsp;Christine K. Olson,&nbsp;CDC COVID-19 Vaccine Pregnancy Registry team","doi":"10.1002/bdr2.2474","DOIUrl":"https://doi.org/10.1002/bdr2.2474","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>We calculated prevalences of birth defects among infants of participants in the Centers for Disease Control and Prevention's (CDC) COVID-19 Vaccine Pregnancy Registry (C19VPR).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>C19VPR enrolled women receiving COVID-19 vaccines ≤ 30 days before the last menstrual period or during pregnancy from December 2020 through June 2021. We included 19,931 participants with singleton pregnancies ending ≥ 20 weeks' gestation who did not report COVID-19 illness during pregnancy. Clinicians identified birth defects from participant-reported infant health information up to 4 months after birth. We compared C19VPR birth defect prevalences to published pre-pandemic estimates. For seven defects originating during embryogenesis (cleft lip with/without cleft palate, atrial septal defect, coarctation of the aorta, ventricular septal defect, esophageal atresia or stenosis, hypospadias, kidney agenesis/hypoplasia/dysplasia), we estimated prevalence ratios comparing those vaccinated &lt; 14 weeks' to those vaccinated ≥ 14 weeks' gestation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Participants reported receiving Pfizer-BioNTech vaccines (59.0%), Moderna (38.2%), and Janssen (2.8%) vaccines. Most (65.2%) participants received their first COVID-19 vaccine after the first trimester. The prevalence of major birth defects was 3.8%. Among defects with comparator estimates available (<i>n</i> = 50), 35 were below or within expected ranges. C19VPR prevalences were higher than the comparator confidence interval for 15 defects; however, C19VPR confidence intervals included comparator estimates. Prevalences did not differ by the timing of vaccination for seven defects examined.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Birth defects prevalence estimates among infants born to women receiving COVID-19 vaccines during or just prior to pregnancy were generally similar to pre-pandemic estimates. While there was no strong evidence of associations between vaccination and specific defects, statistical power was low.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9121,"journal":{"name":"Birth Defects Research","volume":"117 5","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/bdr2.2474","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144100805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Protective Impacts of Quercetin and Echinochrome on Female Fertility and Pregnancy Outcomes in Polycystic Ovary Syndrome in Rats 槲皮素和紫皮色素对多囊卵巢综合征大鼠雌性生殖能力和妊娠结局的保护作用
IF 1.6 4区 医学
Birth Defects Research Pub Date : 2025-05-21 DOI: 10.1002/bdr2.2487
Rokia Gamal Mohamed, Ayman Saber Mohamed, Ahmed Imam Dakrory, Mennatallah H. Abdelaziz
{"title":"Protective Impacts of Quercetin and Echinochrome on Female Fertility and Pregnancy Outcomes in Polycystic Ovary Syndrome in Rats","authors":"Rokia Gamal Mohamed,&nbsp;Ayman Saber Mohamed,&nbsp;Ahmed Imam Dakrory,&nbsp;Mennatallah H. Abdelaziz","doi":"10.1002/bdr2.2487","DOIUrl":"https://doi.org/10.1002/bdr2.2487","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Polycystic ovary syndrome (PCOS) is a universal reproductive, endocrine, and metabolic disorder. It affects 9.2% of women worldwide. Echinochrome (Ech) is the most common dark red pigment of sea urchin shells and possesses high antioxidant and hypoglycemic properties. Quercetin (Quer) is a flavonol widely distributed in plants with high antioxidant properties. Therefore, Ech and Quer as a combined protective therapy were investigated against letrozole and high-fat diet-induced PCOS model in rats.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Sixty female rats were divided randomly into five groups: Control: received 2% DMSO with a normal diet, PCOS: received letrozole with HFD, Ech: received letrozole and Ech with HFD, Quer: received letrozole and Quer with HFD, Ech + Quer: received letrozole, Ech, and Quer together daily orally for 4 weeks. Half of the rats in each group were sacrificed, and the remaining rats were examined for their ability to mate and fertility.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Ech and Quer treatment restored normal levels of lipid and hormonal profiles, oxidative status, kidney and liver functions with a marked amelioration in ovarian, uterine histopathology, and a good evidence in pregnancy analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Ech and Quer were found to have a potent protective effect against PCOS, minimal side effects, and improved progeny outcomes in rats.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9121,"journal":{"name":"Birth Defects Research","volume":"117 5","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144100671","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
NEK2 Contributes to the Protection Against Cryptorchidism Outcomes NEK2有助于预防隐睾的结局
IF 1.6 4区 医学
Birth Defects Research Pub Date : 2025-05-19 DOI: 10.1002/bdr2.2485
Xiaomeng Zhou, Songyi Ye, Xuehan Wang, Zhirong Liang, Neng Qian, Linghua Ji, Hua Xian, Ziheng Wang, Wenliang Ge
{"title":"NEK2 Contributes to the Protection Against Cryptorchidism Outcomes","authors":"Xiaomeng Zhou,&nbsp;Songyi Ye,&nbsp;Xuehan Wang,&nbsp;Zhirong Liang,&nbsp;Neng Qian,&nbsp;Linghua Ji,&nbsp;Hua Xian,&nbsp;Ziheng Wang,&nbsp;Wenliang Ge","doi":"10.1002/bdr2.2485","DOIUrl":"https://doi.org/10.1002/bdr2.2485","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Cryptorchidism, characterized by the failure of testicular descent, is a common congenital disorder adversely affecting male reproductive health. Intriguingly, the NIMA-related kinase 2 (<i>NEK2</i>) gene has been implicated in various cellular processes, but its role in cryptorchidism remains underexplored.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>To elucidate NEK2's role, the researchers utilized NEK2 knockout mice, analyzing testes histology with hematoxylin–eosin (HE) staining and assessing sperm morphology by Diff-Quick staining. Immunohistofluorescence evaluated Leydig cell count, while Western blotting and immunohistochemistry analyzed 3β-hydroxysteroid dehydrogenase 1 (HSD3B1), critical for testosterone synthesis. Mouse testosterone levels were quantified by ELISA, and RT-qPCR examined testicular Wnt–β-catenin and HIPPO pathway expression.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>NEK2-deficient mice exhibited significantly increased cryptorchidism incidence, decreased Leydig cell number, reduced testis/body weights, and elevated sperm malformations. Histological analysis revealed pronounced testicular damage. Western blotting and immunohistochemistry showed unchanged nuclear receptor subfamily 5 (NR5A1) and insulin-like protein 3 (INSL3), but decreased HSD3B1 in <i>NEK2</i><sup>−/−</sup> mice, leading to lower testosterone levels. Mechanistically, NEK2 knockout suppressed wingless/integrated (Wnt)–β-catenin and activated HIPPO, causing mammalian sterile 20-like protein kinase 2 (MST2)–large tumor suppressor homolog 2 (LATS2)-mediated downregulation of yes-associated protein (YAP).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>These findings highlight NEK2's essential role in regulating testicular descent and spermatogenesis, implicating it as a potential target for cryptorchidism.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9121,"journal":{"name":"Birth Defects Research","volume":"117 5","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085025","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
The Health of Pregnant Women and Their Unborn Children– Neglected in Vaccine Development 孕妇及其未出生婴儿的健康——在疫苗开发中被忽视
IF 1.6 4区 医学
Birth Defects Research Pub Date : 2025-05-19 DOI: 10.1002/bdr2.2483
Peter Selley, David Healy
{"title":"The Health of Pregnant Women and Their Unborn Children– Neglected in Vaccine Development","authors":"Peter Selley,&nbsp;David Healy","doi":"10.1002/bdr2.2483","DOIUrl":"https://doi.org/10.1002/bdr2.2483","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Randomized Controlled Trials of vaccines given in pregnancy aimed at benefitting the unborn child began in 2015. Their use for licensing purposes now appears established. These trials generate data on possible benefits and harms to infants but also on maternal health impacts. The International Council on Regulations for Pharmaceutical Use in Humans has realized that current safety regulations are not adequate for clinical trials in the second half of pregnancy. They are now drawing up improved guidelines for the conduct of these trials.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>To focus attention on maternal and fetal health that his new willingness to run trials in pregnancy brings into the frame.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>We reviewed all recent maternal vaccine trials and their outcomes, along with potential concerns.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Analysis of data from recent trials of vaccines given in pregnancy suggests that they may be associated with adverse events during the pregnancy that affect both the mother and the fetus.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>The aim of vaccine trials in pregnancy currently centres on measuring the efficacy of prevention of infectious disease, and perinatal outcome. Study of the impact of maternal vaccines on pregnancy physiology has been neglected. New, rapidly developing areas, such as epigenomics, need to be considered. It is a good time for the wider field to have an input on what might be included in the guidelines, and whether other measures are needed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Insufficient attention has been given to monitoring the health of pregnant women and of their fetus during vaccine trials. The need for new guidelines offers an opportunity to require more stringent safety monitoring during pregnancy which will benefit women and their unborn children.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9121,"journal":{"name":"Birth Defects Research","volume":"117 5","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085024","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
Measurement of Androgen-Sensitive Preweaning Developmental Landmarks in Rodents: Best Practices and Toxicological Significance 测量雄性激素敏感的啮齿动物断奶前发育标志:最佳实践和毒理学意义
IF 1.6 4区 医学
Birth Defects Research Pub Date : 2025-05-09 DOI: 10.1002/bdr2.2482
Ross Gillette, Justin D. Vidal, Pragati S. Coder
{"title":"Measurement of Androgen-Sensitive Preweaning Developmental Landmarks in Rodents: Best Practices and Toxicological Significance","authors":"Ross Gillette,&nbsp;Justin D. Vidal,&nbsp;Pragati S. Coder","doi":"10.1002/bdr2.2482","DOIUrl":"https://doi.org/10.1002/bdr2.2482","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Anogenital distance and nipple/areola(e) retention are biomarkers for monitoring normal age-appropriate masculinization of male offspring required by U.S. EPA and OECD guidelines for chemicals. OECD Guidance Document 150 considers both landmarks as sensitive, apical endpoints. For the last century, it has been known that nipple regression in male rodents is complete by late gestation and there are no external or microscopic traces of a nipple at the time of birth. Adverse effects of antiandrogen exposures in humans are well documented, and AGD/NR serve as surrogates for effects on physical and sexual development, although the human relevance of these individual endpoints and endocrine disruption in rodents continues to be debated. The European Chemicals Agency (ECHA) published its reports on the EOGRTS Review Project and ranked 37% AGD and 83% NR datasets across 72 studies as limited or of unacceptable quality.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We retrospectively analyzed AGD/NR data from 142 rodent studies based on sound scientific principles and per the agency's scoring criteria.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results and Conclusion</h3>\u0000 \u0000 <p>For AGD, our data met standards for precision, variability, and separation of sexes. For NR, our data demonstrated that spontaneous nipple/areolae retention is far less common than asserted by the agency. We propose that the 5-point rating scale used by ECHA to rate NR data has considerable limitations as it is based on data from a single publication that evaluated a limited number of litters/studies. Based on our review of the literature, ECHA recommendations, and the data presented herein, we put forth best practice recommendations for data collection, analysis, and reporting in an effort to improve future data quality, interpretation, and coherence for regulatory review.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9121,"journal":{"name":"Birth Defects Research","volume":"117 5","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143926168","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
Blastocyst Cavity Expansion Promotes Cell Polarization During Early Development of Mouse Embryos 小鼠胚胎早期发育过程中囊胚腔扩张促进细胞极化
IF 1.6 4区 医学
Birth Defects Research Pub Date : 2025-05-09 DOI: 10.1002/bdr2.2484
Zheng Guo, Xinxin Lv, Jianwen Li, Shiping Yue, Jing Du
{"title":"Blastocyst Cavity Expansion Promotes Cell Polarization During Early Development of Mouse Embryos","authors":"Zheng Guo,&nbsp;Xinxin Lv,&nbsp;Jianwen Li,&nbsp;Shiping Yue,&nbsp;Jing Du","doi":"10.1002/bdr2.2484","DOIUrl":"https://doi.org/10.1002/bdr2.2484","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Cell polarization is an important morphological process that is crucial for the formation and function of tissues and organs. The blastocyst cavity expansion is an apparent event during the second cell fate specification in mouse embryos, yet its impact on cell polarization remains unclear. In this study, we investigate the effects of blastocyst cavity expansion on cell polarization.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The methods of this study involve hyperosmotic treatment or disruption of TE cortical tension by laser ablation, combined with immunofluorescence.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>We found that inhibition of the blastocyst cavity expansion through hypertonic treatment or disruption of TE cortical tension by laser ablation suppresses the levels of the ζ isotype of protein kinase C (PKC ζ) which is a member of the atypical PKC subfamily involved in cell polarization. We further found that during the embryonic stages E3.5 to E4.0, the expression of extracellular signal-regulated kinase 1 (ERK1), a key upstream regulator of PKC ζ, is altered in a similar tendency to that of PKC ζ, indicating a potential regulatory function of ERK1 in cell polarization during early development of mouse embryos.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This study reveals the function of the mechanical behavior of embryos in cell polarization of early mammalian embryos. The relationship between cell polarization and blastocyst cavity expansion in early embryonic development provides a new understanding, thereby offering fresh insights for the screening and detection of indicators for normal blastocyst development.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9121,"journal":{"name":"Birth Defects Research","volume":"117 5","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143926108","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
Embryo-Fetal Developmental Toxicity and Toxicokinetics Studies of YWS1903, a Novel Potassium-Competitive Acid Blocker, in Pregnant Rats 新型钾竞争酸阻滞剂YWS1903对妊娠大鼠的胚胎-胎儿发育毒性和毒性动力学研究
IF 1.6 4区 医学
Birth Defects Research Pub Date : 2025-05-07 DOI: 10.1002/bdr2.2481
Chaoying Lu, Hongqun Qiao
{"title":"Embryo-Fetal Developmental Toxicity and Toxicokinetics Studies of YWS1903, a Novel Potassium-Competitive Acid Blocker, in Pregnant Rats","authors":"Chaoying Lu,&nbsp;Hongqun Qiao","doi":"10.1002/bdr2.2481","DOIUrl":"https://doi.org/10.1002/bdr2.2481","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>In this study, we investigated the developmental and reproductive toxicity of YWS1903, a novel potassium-competitive acid blocker, in pregnant Sprague–Dawley rats.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>YWS1903 was administered orally at doses of 0 (control), 20, 60, and 200 mg kg<sup>−1</sup> from gestation days 6 to 17 (<i>n</i> = 24 per group). Concurrent toxicokinetic analysis was conducted to characterize the toxicokinetic profile and placental transfer of YWS1903.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Aside from hair loss at the highest dose, no significant maternal toxicity was observed up to 200 mg kg<sup>−1</sup>. Fetal assessments revealed reductions in body weight and crown-rump length at 200 mg kg<sup>−1</sup>, alongside increased skeletal malformations, but no visceral abnormalities were detected. Toxicokinetic linearity studies revealed that within the 20–200 mg kg<sup>−1</sup> dose range, both <i>C</i><sub>max</sub> and AUC<sub>0-t</sub> of YWS1903 exhibited disproportionate increases following initial and final administrations. In the high-dose group, the escalation in AUC<sub>0-t</sub> substantially exceeded the corresponding dose changes, suggesting potential saturation of metabolic pathways at higher exposure levels. YWS1903 was shown to cross the placenta, although fetal plasma concentrations were consistently lower than maternal levels, suggesting reduced direct fetal exposure.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The no observed adverse effect level was established at 60 mg kg<sup>−1</sup>, supporting the compound's safety at moderate doses. These findings provide valuable insights into YWS1903's developmental and reproductive safety profile and offer reference for its clinical application as a therapeutic agent for gastroesophageal reflux disease.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9121,"journal":{"name":"Birth Defects Research","volume":"117 5","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143914128","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
Perspectives on Implementing Virtual Control Groups in Developmental and Reproductive Toxicity Studies 在发育和生殖毒性研究中实施虚拟控制组的观点
IF 1.6 4区 医学
Birth Defects Research Pub Date : 2025-05-05 DOI: 10.1002/bdr2.2479
L. David Wise, Alan M. Hoberman, Christopher J. Bowman, Elise M. Lewis
{"title":"Perspectives on Implementing Virtual Control Groups in Developmental and Reproductive Toxicity Studies","authors":"L. David Wise,&nbsp;Alan M. Hoberman,&nbsp;Christopher J. Bowman,&nbsp;Elise M. Lewis","doi":"10.1002/bdr2.2479","DOIUrl":"https://doi.org/10.1002/bdr2.2479","url":null,"abstract":"<div>\u0000 \u0000 <p>The use of virtual control groups (VCGs) in nonclinical toxicology studies was first proposed in 2020 with the main purpose of reducing animal use while integrating historical control data (HCD) to enhance study interpretation. The use of VCGs has gained increasing attention as evidenced by an increasing number of publications that highlight implementation challenges. Laboratories that conduct harmonized studies with standardized procedures, consistent environmental conditions, and validated electronic databases are well-suited to implement VCGs in future nonclinical safety studies. We suggest that individual laboratories conducting rodent and rabbit developmental and reproductive toxicity studies should begin planning for VCG implementation. If possible, a harmonized approach to VCG implementation by multiple laboratories will lend credence to regulatory approval. We apply the six-step VCG implementation framework from Palazzi et al. to the routine GLP studies covered by international guidelines, which emphasize validation through retrospective and prospective trials. We discuss the risks and challenges to VCG implementation that have been previously presented. To address some of these concerns, a hybrid approach is proposed that combines a small concurrent control group (CCG) with multiple virtual control (VC) animals from the same test facility. The inclusion of a CCG addresses the need to monitor for disease and environmental changes and prevent depletion of HCD. Two approaches to the selection of VC animals are discussed. Given that developmental and reproductive toxicity studies use the most animals in nonclinical safety studies, we support the timely implementation of VCGs to significantly reduce these animal numbers.</p>\u0000 </div>","PeriodicalId":9121,"journal":{"name":"Birth Defects Research","volume":"117 5","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143905115","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
Racial and Ethnic Disparities in California's Use of Agricultural Pesticides 加州农业农药使用中的种族和民族差异
IF 1.6 4区 医学
Birth Defects Research Pub Date : 2025-05-05 DOI: 10.1002/bdr2.2480
Caroline Cox, Jonathan K London
{"title":"Racial and Ethnic Disparities in California's Use of Agricultural Pesticides","authors":"Caroline Cox,&nbsp;Jonathan K London","doi":"10.1002/bdr2.2480","DOIUrl":"https://doi.org/10.1002/bdr2.2480","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The objective of this study is to determine whether the current use of agricultural pesticides in California is unequally distributed with respect to race and ethnicity.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We conducted the analysis using publicly available data from the California Department of Pesticide Regulation and the US Census Bureau. We used two relatively simple statistical techniques to conduct the analysis: concentration curves and linear regression.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>We showed that agricultural pesticide use in California is not distributed equally with respect to racial and ethnic composition. Similar patterns held whether we looked at current data, data from past years, or individual pesticides of public health concern. Importantly for public health, the use of a group of pesticides that, according to California regulations, causes reproductive harm also was concentrated in areas with a lower percentage of non-Hispanic Whites. The percentage of the population that is Hispanic/Latinx is a strong statistical driver of these inequalities. The data also show similar patterns of inequity in pesticide use with respect to three socioeconomic factors: income, education level, and prevalence of agricultural employment.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Policy and regulatory actions are needed to reduce these disparities and maintain California's leadership in environmental justice.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9121,"journal":{"name":"Birth Defects Research","volume":"117 5","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143909249","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
How Does Maternal Lipopolysaccharide Exposure Impact Prenatal Testicular Development in Rats, and Could α-Tocopherol Provide a Protective Effect? A Histological, Immunohistochemical and Biochemical Study 母体脂多糖暴露如何影响大鼠产前睾丸发育,α-生育酚是否有保护作用?A组织、免疫组织化学和生化研究
IF 1.6 4区 医学
Birth Defects Research Pub Date : 2025-05-02 DOI: 10.1002/bdr2.2469
Shimaa Antar Fareed, Heba El-Sayed Mostafa, Yousif Mohamed Saleh, Yasmin Islam Magdi, Islam Mohamed Magdi Ammar
{"title":"How Does Maternal Lipopolysaccharide Exposure Impact Prenatal Testicular Development in Rats, and Could α-Tocopherol Provide a Protective Effect? A Histological, Immunohistochemical and Biochemical Study","authors":"Shimaa Antar Fareed,&nbsp;Heba El-Sayed Mostafa,&nbsp;Yousif Mohamed Saleh,&nbsp;Yasmin Islam Magdi,&nbsp;Islam Mohamed Magdi Ammar","doi":"10.1002/bdr2.2469","DOIUrl":"https://doi.org/10.1002/bdr2.2469","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Lipopolysaccharides or endotoxins trigger proinflammatory cytokines and nitric oxide release, whereas α-tocopherol protects cells from oxidative damage. This study investigated the effects of maternal lipopolysaccharide exposure on prenatal testicular development in male rat offspring and assessed α-tocopherol's protective role.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Forty pregnant female rats were divided into four groups. Group I (control) included a negative control receiving normal saline and a positive control receiving 30 mg/kg of α-tocopherol intraperitoneally from the 3rd to 18th gestational day. Group II received 50 mg/kg of lipopolysaccharides intraperitoneally from the 13th to 17th gestational day, whereas Group III received both α-tocopherol and lipopolysaccharides at the same dosages. On the seventh day postpartum, fetuses were weighed, sexed, and dissected; sera from male fetuses were collected for biochemical analysis, and fetal testes were used for histology, immunohistochemistry, and morphometry.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Rats treated with lipopolysaccharide showed reduced body weight, testosterone, and luteinizing hormone levels, with histopathological changes, including thickened testicular capsules and abnormalities in the number, size, shape, and cellular components of seminiferous tubules. These adverse effects were improved by α-tocopherol supplementation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>We concluded that lipopolysaccharide exposure during pregnancy impairs testicular development and steroidogenesis, which are ameliorated by α-tocopherol coadministration.</p>\u0000 </section>\u0000 </div>","PeriodicalId":9121,"journal":{"name":"Birth Defects Research","volume":"117 5","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143896961","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
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