Pub Date : 2024-03-06eCollection Date: 2024-03-01DOI: 10.1055/a-2237-7727
Shigeki Matsubara
{"title":"Possible Confusion Caused by Journals with Similar Names.","authors":"Shigeki Matsubara","doi":"10.1055/a-2237-7727","DOIUrl":"10.1055/a-2237-7727","url":null,"abstract":"","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 3","pages":"282-283"},"PeriodicalIF":2.7,"publicationDate":"2024-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10917604/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140059040","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}
Pub Date : 2024-03-06eCollection Date: 2024-03-01DOI: 10.1055/a-2243-3784
Sören Lange, Rainer Lange, Elham Tabibi, Thomas Hitschold, Veronika I Müller, Gert Naumann
Introduction: To compare three conservative treatment options, standard care, pelvic floor muscle training (PFMT), and vaginal pessaries, for postpartum urinary incontinence (UI) that are accessible to most patients and practitioners in a generalizable cohort.
Materials and methods: A multicenter, open-label, parallel group, pragmatic randomized controlled clinical trial comparing standard care, PFMT, and vaginal cube pessary for postpartum urinary incontinence was conducted in six outpatient clinics. Sample size was based on large treatment effects (Cramers' V > 0.35) with a power of 80% and an alpha of 0.05 for a 3 × 3 contingency table, 44 patients needed to be included in the trial. Outcomes were analyzed according to the intention-to-treat principle. Group comparisons were made using analysis of variance (ANOVA), Kruskal-Wallis, and chi-square test as appropriate. P < 0.05 was considered statistically significant.
Results: Of the 516 women screened, 111 presented with postpartum UI. Of these, 52 were randomized to one of three treatment groups: standard care (n = 17), pelvic floor muscle training (n = 17), or vaginal cube pessary (n = 18). After 12 weeks of treatment, treatment success, as measured by patient satisfaction, was significantly higher in the vaginal pessary group (77.8%, n = 14/18), compared to the standard care group (41.2%, n = 7/17), and the PFMT (23.5%, n = 4/17; χ 22,n = 52 = 14.55; p = 0.006, Cramer-V = 0.374). No adverse events were reported. SUI and MUI accounted for 88.4% of postpartum UI.
Conclusion: Vaginal pessaries were superior to standard care or PFMT to satisfyingly reduce postpartum UI symptoms. No complications were found.
{"title":"Comparison of Vaginal Pessaries to Standard Care or Pelvic Floor Muscle Training for Treating Postpartum Urinary Incontinence: a Pragmatic Randomized Controlled Trial.","authors":"Sören Lange, Rainer Lange, Elham Tabibi, Thomas Hitschold, Veronika I Müller, Gert Naumann","doi":"10.1055/a-2243-3784","DOIUrl":"10.1055/a-2243-3784","url":null,"abstract":"<p><strong>Introduction: </strong>To compare three conservative treatment options, standard care, pelvic floor muscle training (PFMT), and vaginal pessaries, for postpartum urinary incontinence (UI) that are accessible to most patients and practitioners in a generalizable cohort.</p><p><strong>Materials and methods: </strong>A multicenter, open-label, parallel group, pragmatic randomized controlled clinical trial comparing standard care, PFMT, and vaginal cube pessary for postpartum urinary incontinence was conducted in six outpatient clinics. Sample size was based on large treatment effects (Cramers' V > 0.35) with a power of 80% and an alpha of 0.05 for a 3 × 3 contingency table, 44 patients needed to be included in the trial. Outcomes were analyzed according to the intention-to-treat principle. Group comparisons were made using analysis of variance (ANOVA), Kruskal-Wallis, and chi-square test as appropriate. P < 0.05 was considered statistically significant.</p><p><strong>Results: </strong>Of the 516 women screened, 111 presented with postpartum UI. Of these, 52 were randomized to one of three treatment groups: standard care (n = 17), pelvic floor muscle training (n = 17), or vaginal cube pessary (n = 18). After 12 weeks of treatment, treatment success, as measured by patient satisfaction, was significantly higher in the vaginal pessary group (77.8%, n = 14/18), compared to the standard care group (41.2%, n = 7/17), and the PFMT (23.5%, n = 4/17; χ <sup>2</sup> <sub>2,n = 52</sub> = 14.55; p = 0.006, Cramer-V = 0.374). No adverse events were reported. SUI and MUI accounted for 88.4% of postpartum UI.</p><p><strong>Conclusion: </strong>Vaginal pessaries were superior to standard care or PFMT to satisfyingly reduce postpartum UI symptoms. No complications were found.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 3","pages":"246-255"},"PeriodicalIF":2.7,"publicationDate":"2024-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10917606/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140059014","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}
Pub Date : 2024-03-06eCollection Date: 2024-03-01DOI: 10.1055/a-2238-3181
Jarmila A Zdanowicz, Gülay Yildrim, Andreia Fonseca, Kurt Hecher, Manuela Tavares de Sousa
Introduction: The aim of our study was to compare maternal, chorionicity and neonatal complications in monochorionic (MC) twins between spontaneously conceived (SC) and assisted reproductive technologies (ART) pregnancies.
Material and methods: This was a retrospective cohort study between January 2010 to December 2019 at a tertiary referral University center. All consecutive pregnancies with MC twins that delivered at our University hospital were included. Maternal, chorionicity and neonatal complications were recorded and compared between SC and ART pregnancies.
Results: 393 MC pregnancies were included for final analysis, including 353 (89.8%) SC and 40 (10.2%) pregnancies conceived after ART. Hypothyroidism was the only maternal condition seen significantly more often in ART pregnancies (35.0% vs 12.5%, p = 0.001). There were no significant differences in chorionicity complications, such as twin-twin transfusion syndrome, selective fetal growth restriction and twin anemia-polycythemia sequence (40.0% in ART pregnancies vs 31.6% in SC pregnancies, p = 0.291). At least one congenital anomaly in one twin was seen significantly more often in ART pregnancies (18.8% vs 8.1%, p = 0.004), especially congenital heart defects (16.3% vs 6.2%, p = 0.005). There were no other significant differences in neonatal outcomes between both groups, however, there were non-significant trends in gestational age at delivery (34 weeks in ART pregnancies vs 35 weeks, p = 0.078) and birthweight (1951 g ± 747 in ART pregnancies vs 2143 g ± 579, p = 0.066).
Conclusion: This is the largest cohort study to date comparing maternal, chorionicity and neonatal complications between MC twin pregnancies after ART and after SC. Hypothyroidism was the only maternal condition occurring more frequently in pregnancies conceived after ART. There were no significant differences in chorionicity complications, in contrast to previously reported studies. While MC twins and ART pregnancies per se are known to be at risk for congenital heart defects, there seems to be a cumulative effect in MC pregnancies conceived after ART.
导言:我们的研究旨在比较自然受孕(SC)和辅助生殖技术(ART)妊娠的单绒毛膜双胎(MC)的母体、绒毛膜性和新生儿并发症:这是一项回顾性队列研究,研究时间为 2010 年 1 月至 2019 年 12 月,研究地点在一所大学的三级转诊中心。所有在本大学医院分娩的 MC 双胞胎孕妇均被纳入研究范围。记录母体、绒毛膜性和新生儿并发症,并对SC和ART妊娠进行比较:最终分析共纳入 393 例 MC 胎,其中包括 353 例(89.8%)SC 胎和 40 例(10.2%)经 ART 受孕的胎儿。甲状腺功能减退症是唯一一种在 ART 妊娠中出现频率明显较高的母体疾病(35.0% vs 12.5%,P = 0.001)。绒毛膜性并发症,如双胎输血综合征、选择性胎儿生长受限和双胎贫血多血症序列(ART 妊娠为 40.0%,SC 妊娠为 31.6%,P = 0.291)没有明显差异。ART 妊娠中至少有一个双胎出现先天性异常的比例明显更高(18.8% vs 8.1%,p = 0.004),尤其是先天性心脏缺陷(16.3% vs 6.2%,p = 0.005)。两组之间的新生儿结局没有其他明显差异,但在分娩时胎龄(ART 怀孕 34 周 vs 35 周,p = 0.078)和出生体重(ART 怀孕 1951 g ± 747 vs 2143 g ± 579,p = 0.066)方面有不明显的趋势:这是迄今为止规模最大的队列研究,比较了ART和SC术后MC双胎妊娠的母体、绒毛膜和新生儿并发症。甲状腺功能减退症是 ART 后妊娠中唯一较常发生的母体疾病。在绒毛膜并发症方面没有明显差异,这与之前报道的研究不同。众所周知,MC 双胎和 ART 妊娠本身都有先天性心脏缺陷的风险,但在 ART 后受孕的 MC 妊娠中似乎存在累积效应。
{"title":"Is There a Cumulative Effect for Congenital Heart Defects in Monochorionic Twins after Assisted Reproduction? - A Retrospective Analysis at a Tertiary Referral Center.","authors":"Jarmila A Zdanowicz, Gülay Yildrim, Andreia Fonseca, Kurt Hecher, Manuela Tavares de Sousa","doi":"10.1055/a-2238-3181","DOIUrl":"10.1055/a-2238-3181","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of our study was to compare maternal, chorionicity and neonatal complications in monochorionic (MC) twins between spontaneously conceived (SC) and assisted reproductive technologies (ART) pregnancies.</p><p><strong>Material and methods: </strong>This was a retrospective cohort study between January 2010 to December 2019 at a tertiary referral University center. All consecutive pregnancies with MC twins that delivered at our University hospital were included. Maternal, chorionicity and neonatal complications were recorded and compared between SC and ART pregnancies.</p><p><strong>Results: </strong>393 MC pregnancies were included for final analysis, including 353 (89.8%) SC and 40 (10.2%) pregnancies conceived after ART. Hypothyroidism was the only maternal condition seen significantly more often in ART pregnancies (35.0% vs 12.5%, p = 0.001). There were no significant differences in chorionicity complications, such as twin-twin transfusion syndrome, selective fetal growth restriction and twin anemia-polycythemia sequence (40.0% in ART pregnancies vs 31.6% in SC pregnancies, p = 0.291). At least one congenital anomaly in one twin was seen significantly more often in ART pregnancies (18.8% vs 8.1%, p = 0.004), especially congenital heart defects (16.3% vs 6.2%, p = 0.005). There were no other significant differences in neonatal outcomes between both groups, however, there were non-significant trends in gestational age at delivery (34 weeks in ART pregnancies vs 35 weeks, p = 0.078) and birthweight (1951 g ± 747 in ART pregnancies vs 2143 g ± 579, p = 0.066).</p><p><strong>Conclusion: </strong>This is the largest cohort study to date comparing maternal, chorionicity and neonatal complications between MC twin pregnancies after ART and after SC. Hypothyroidism was the only maternal condition occurring more frequently in pregnancies conceived after ART. There were no significant differences in chorionicity complications, in contrast to previously reported studies. While MC twins and ART pregnancies per se are known to be at risk for congenital heart defects, there seems to be a cumulative effect in MC pregnancies conceived after ART.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 3","pages":"274-281"},"PeriodicalIF":2.7,"publicationDate":"2024-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10917610/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140059015","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}
Pub Date : 2024-02-08eCollection Date: 2024-02-01DOI: 10.1055/a-2225-5883
Ekkehard Schleußner, Susan Jäkel, Christoph Keck, Kirsten Kuhlmann, Mandy Mangler, Wolfgang E Paulus, Johanna Eiblwieser, Theresa Steeb, Pedro-Antonio Regidor
Nausea and vomiting of pregnancy (NVP) is among the most common conditions that pregnant women encounter in the early stages of pregnancy. It can affect up to 85% of pregnant women, thus representing a significant public health concern. NVP results in substantial negative physical, emotional, and financial consequences. Despite its prevalence, the pathogenesis remains elusive. Few guidelines have been published; however, several interventions exist for the symptomatic treatment of NVP. The aim of this review is to provide an overview of modern treatment strategies of NVP with a special focus on the recently approved dual-release formulation of the doxylamine and pyridoxine combination. This combination was approved by the Food and Drug Administration (FDA) in November 2016 for the treatment of NVP when conservative management fails, and it has been introduced to the American market in April 2018. The maximum plasma concentration (T max ) of doxylamine and pyridoxal-5-phosphate is reached 3.5 h and 15 h, respectively, after administration of one tablet twice daily, or 4.5 h and 0.5 h, respectively, when one tablet is administered just once daily. In addition, the delayed-release combination allows sufficient levels of doxylamine and the active metabolite pyridoxal-5-phosphate in the systemic circulation, providing symptoms relief in the subsequent morning. Hence, the dual-release formulation can improve the quality of life of pregnant women suffering from NVP. Additionally, large epidemiological trials have shown no increased risk of adverse effects to newborns, demonstrating that its use is not teratogenic.
妊娠恶心和呕吐(NVP)是孕妇在怀孕初期最常见的症状之一。多达 85% 的孕妇会受到这种疾病的影响,因此它是一个重大的公共卫生问题。妊娠呕吐会对孕妇的身体、情绪和经济造成严重的负面影响。尽管这种疾病很普遍,但其发病机理仍然难以捉摸。几乎没有发布过相关指南;不过,目前已有几种干预措施可用于 NVP 的对症治疗。本综述旨在概述 NVP 的现代治疗策略,并特别关注最近获批的多西拉敏和吡哆醇双释放制剂。该复方制剂于2016年11月获得美国食品药品管理局(FDA)批准,用于保守治疗无效时的NVP治疗,并于2018年4月进入美国市场。每天服用2次,每次1片后,多西拉敏和5-磷酸吡哆醛的最大血浆浓度(T max )分别为3.5小时和15小时;每天服用1次,每次1片后,多西拉敏和5-磷酸吡哆醛的最大血浆浓度(T max )分别为4.5小时和0.5小时。此外,缓释组合使多西拉敏和活性代谢物吡哆醛-5-磷酸在全身循环中达到足够的水平,从而在第二天早上缓解症状。因此,双缓释制剂可以改善妊娠期非乙肝患者的生活质量。此外,大型流行病学试验显示,新生儿受到不良影响的风险并没有增加,这表明使用这种药物不会致畸。
{"title":"Nausea and Vomiting of Pregnancy and its Management with the Dual-Release Formulation of Doxylamine and Pyridoxine.","authors":"Ekkehard Schleußner, Susan Jäkel, Christoph Keck, Kirsten Kuhlmann, Mandy Mangler, Wolfgang E Paulus, Johanna Eiblwieser, Theresa Steeb, Pedro-Antonio Regidor","doi":"10.1055/a-2225-5883","DOIUrl":"https://doi.org/10.1055/a-2225-5883","url":null,"abstract":"<p><p>Nausea and vomiting of pregnancy (NVP) is among the most common conditions that pregnant women encounter in the early stages of pregnancy. It can affect up to 85% of pregnant women, thus representing a significant public health concern. NVP results in substantial negative physical, emotional, and financial consequences. Despite its prevalence, the pathogenesis remains elusive. Few guidelines have been published; however, several interventions exist for the symptomatic treatment of NVP. The aim of this review is to provide an overview of modern treatment strategies of NVP with a special focus on the recently approved dual-release formulation of the doxylamine and pyridoxine combination. This combination was approved by the Food and Drug Administration (FDA) in November 2016 for the treatment of NVP when conservative management fails, and it has been introduced to the American market in April 2018. The maximum plasma concentration (T <sub>max</sub> ) of doxylamine and pyridoxal-5-phosphate is reached 3.5 h and 15 h, respectively, after administration of one tablet twice daily, or 4.5 h and 0.5 h, respectively, when one tablet is administered just once daily. In addition, the delayed-release combination allows sufficient levels of doxylamine and the active metabolite pyridoxal-5-phosphate in the systemic circulation, providing symptoms relief in the subsequent morning. Hence, the dual-release formulation can improve the quality of life of pregnant women suffering from NVP. Additionally, large epidemiological trials have shown no increased risk of adverse effects to newborns, demonstrating that its use is not teratogenic.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 2","pages":"144-152"},"PeriodicalIF":2.7,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10853031/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139722276","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}
Pub Date : 2024-02-08eCollection Date: 2024-02-01DOI: 10.1055/a-2238-3199
Peter A Fasching, Hans Kreipe, Lucia Del Mastro, Eva Ciruelos, Gilles Freyer, Agnieszka Korfel, Nadia Chouaki, Clemens Stoffregen, Francisco Sapunar, David Cameron
Breast cancer incidence has increased in the last two decades and, simultaneously, survival has improved due to earlier detection and improved treatment options. Despite this improvement, locoregional recurrences and distant metastases occur in up to 10 and 30% of women diagnosed with early breast cancer, respectively. Around 70% of breast cancers are hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), and associated with a persistent risk of relapse up to 20 years after diagnosis/initial treatment. We conducted a narrative review by combining PubMed searches with our clinical experience to describe patient characteristics, biomarkers, and genomic profiling tools available to clinicians for the identification of patients with HR+, HER2- early breast cancer at high risk of recurrence and to provide recommendations to classify patients into recurrence risk categories. National and international treatment guidelines are also summarised. Accurate assessment of the risk of recurrence in these patients is crucial as the predicted risk guides treatment decisions; imprecise estimations can result in over- or undertreatment, with either scenario having negative consequences for patients. Multiple prognostic tools and factors are recommended for early breast cancer, and no single test provides accurate prognosis in isolation. Since no single test can provide accurate prognosis in isolation, a combination of tools should be used. Risk thresholds are important to guide optimised and balanced therapeutic decisions in HR+, HER2- early breast cancer. However, prognostic assessment should be performed on a case-by-case basis, making patient-specific prognostic approaches essential to avoid over- or undertreatment.
{"title":"Identification of Patients with Early HR+ HER2- Breast Cancer at High Risk of Recurrence.","authors":"Peter A Fasching, Hans Kreipe, Lucia Del Mastro, Eva Ciruelos, Gilles Freyer, Agnieszka Korfel, Nadia Chouaki, Clemens Stoffregen, Francisco Sapunar, David Cameron","doi":"10.1055/a-2238-3199","DOIUrl":"https://doi.org/10.1055/a-2238-3199","url":null,"abstract":"<p><p>Breast cancer incidence has increased in the last two decades and, simultaneously, survival has improved due to earlier detection and improved treatment options. Despite this improvement, locoregional recurrences and distant metastases occur in up to 10 and 30% of women diagnosed with early breast cancer, respectively. Around 70% of breast cancers are hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), and associated with a persistent risk of relapse up to 20 years after diagnosis/initial treatment. We conducted a narrative review by combining PubMed searches with our clinical experience to describe patient characteristics, biomarkers, and genomic profiling tools available to clinicians for the identification of patients with HR+, HER2- early breast cancer at high risk of recurrence and to provide recommendations to classify patients into recurrence risk categories. National and international treatment guidelines are also summarised. Accurate assessment of the risk of recurrence in these patients is crucial as the predicted risk guides treatment decisions; imprecise estimations can result in over- or undertreatment, with either scenario having negative consequences for patients. Multiple prognostic tools and factors are recommended for early breast cancer, and no single test provides accurate prognosis in isolation. Since no single test can provide accurate prognosis in isolation, a combination of tools should be used. Risk thresholds are important to guide optimised and balanced therapeutic decisions in HR+, HER2- early breast cancer. However, prognostic assessment should be performed on a case-by-case basis, making patient-specific prognostic approaches essential to avoid over- or undertreatment.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 2","pages":"164-184"},"PeriodicalIF":2.7,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10853032/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139722273","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}
Pub Date : 2024-02-08eCollection Date: 2024-02-01DOI: 10.1055/a-2201-2680
Bettina Kuschel, Ute Margaretha Schäfer-Graf, Markus Schmidt, Maritta Kühnert, Carsten Hagenbeck, Klaus Thürmel
Purpose These recommendations issued by the AGG (Section Maternal Diseases in Pregnancy) were developed as a rapid orientation on maternal rheumatic diseases for counselling and disease management in pregnancy and breastfeeding. Methods The standard literature, consensus and position papers, guidelines and recommendations by other specialist associations were evaluated by a task force of the Section and summarized in these recommendations following a joint consensus process. Recommendations This paper provides an orientating overview of the physiology, pathophysiology and definitions of rheumatic diseases which is relevant for gynecologists and obstetricians. The recommendations focus on the maternal, fetal and neonatal diagnostic workup in cases with underlying maternal rheumatic disease.
{"title":"Management of Rheumatic Diseases During Pregnancy and Breastfeeding: Position Paper of the Working Group for Obstetrics and Prenatal Medicine in the German Society for Gynecology and Obstetrics e. V. (AGG - Section Maternal Diseases in Pregnancy).","authors":"Bettina Kuschel, Ute Margaretha Schäfer-Graf, Markus Schmidt, Maritta Kühnert, Carsten Hagenbeck, Klaus Thürmel","doi":"10.1055/a-2201-2680","DOIUrl":"https://doi.org/10.1055/a-2201-2680","url":null,"abstract":"<p><p><b>Purpose</b> These recommendations issued by the AGG (Section Maternal Diseases in Pregnancy) were developed as a rapid orientation on maternal rheumatic diseases for counselling and disease management in pregnancy and breastfeeding. <b>Methods</b> The standard literature, consensus and position papers, guidelines and recommendations by other specialist associations were evaluated by a task force of the Section and summarized in these recommendations following a joint consensus process. <b>Recommendations</b> This paper provides an orientating overview of the physiology, pathophysiology and definitions of rheumatic diseases which is relevant for gynecologists and obstetricians. The recommendations focus on the maternal, fetal and neonatal diagnostic workup in cases with underlying maternal rheumatic disease.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 2","pages":"130-143"},"PeriodicalIF":2.7,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10853030/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139722275","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}
Pub Date : 2024-02-08eCollection Date: 2024-02-01DOI: 10.1055/a-2238-3153
Carolin C Hack, Nicolai Maass, Bahriye Aktas, Sherko Kümmel, Christoph Thomssen, Christopher Wolf, Hans-Christian Kolberg, Cosima Brucker, Wolfgang Janni, Peter Dall, Andreas Schneeweiss, Frederik Marme, Matthias Ruebner, Anna-Katharin Theuser, Nadine M Hofmann, Sybille Böhm, Katrin Almstedt, Sara Kellner, Paul Gass, Marc W Sütterlin, Hans-Joachim Lück, Sabine Schmatloch, Matthias Kalder, Christoph Uleer, Ingolf Juhasz-Böss, Volker Hanf, Christian Jackisch, Volkmar Müller, Brigitte Rack, Erik Belleville, Diethelm Wallwiener, Achim Rody, Claudia Rauh, Christian M Bayer, Sabrina Uhrig, Chloë Goossens, Hanna Huebner, Sara Y Brucker, Lothar Häberle, Tanja N Fehm, Alexander Hein, Peter A Fasching
Introduction: Adjuvant treatment of patients with early-stage breast cancer (BC) should include an aromatase inhibitor (AI). Especially patients with a high recurrence risk might benefit from an upfront therapy with an AI for a minimum of five years. Nevertheless, not much is known about the patient selection for this population in clinical practice. Therefore, this study analyzed the prognosis and patient characteristics of postmenopausal patients selected for a five-year upfront letrozole therapy.
Patients and methods: From 2009 to 2011, 3529 patients were enrolled into the adjuvant phase IV PreFace clinical trial (NCT01908556). Postmenopausal hormone receptor-positive BC patients, for whom an upfront five-year therapy with letrozole (2.5 mg/day) was indicated, were eligible. Disease-free survival (DFS), overall survival (OS) and safety in relation to patient and tumor characteristics were assessed.
Results: 3297 patients started letrozole therapy. The majority of patients (n = 1639, 57%) completed the five-year treatment. 34.5% of patients continued with endocrine therapy after the mandated five-year endocrine treatment. Five-year DFS rates were 89% (95% CI: 88-90%) and five-year OS rates were 95% (95% CI: 94-96%). In subgroup analyses, DFS rates were 83%, 84% and 78% for patients with node-positive disease, G3 tumor grading, and pT3 tumors respectively. The main adverse events (any grade) were pain and hot flushes (66.8% and 18.3% of patients).
Conclusions: The risk profile of postmenopausal BC patients selected for a five-year upfront letrozole therapy showed a moderate recurrence and death risk. However, in subgroups with unfavorable risk factors, prognosis warrants an improvement, which might be achieved with novel targeted therapies.
{"title":"Long-term Follow-up and Safety of Patients after an Upfront Therapy with Letrozole for Early Breast Cancer in Routine Clinical Care - The PreFace Study.","authors":"Carolin C Hack, Nicolai Maass, Bahriye Aktas, Sherko Kümmel, Christoph Thomssen, Christopher Wolf, Hans-Christian Kolberg, Cosima Brucker, Wolfgang Janni, Peter Dall, Andreas Schneeweiss, Frederik Marme, Matthias Ruebner, Anna-Katharin Theuser, Nadine M Hofmann, Sybille Böhm, Katrin Almstedt, Sara Kellner, Paul Gass, Marc W Sütterlin, Hans-Joachim Lück, Sabine Schmatloch, Matthias Kalder, Christoph Uleer, Ingolf Juhasz-Böss, Volker Hanf, Christian Jackisch, Volkmar Müller, Brigitte Rack, Erik Belleville, Diethelm Wallwiener, Achim Rody, Claudia Rauh, Christian M Bayer, Sabrina Uhrig, Chloë Goossens, Hanna Huebner, Sara Y Brucker, Lothar Häberle, Tanja N Fehm, Alexander Hein, Peter A Fasching","doi":"10.1055/a-2238-3153","DOIUrl":"10.1055/a-2238-3153","url":null,"abstract":"<p><strong>Introduction: </strong>Adjuvant treatment of patients with early-stage breast cancer (BC) should include an aromatase inhibitor (AI). Especially patients with a high recurrence risk might benefit from an upfront therapy with an AI for a minimum of five years. Nevertheless, not much is known about the patient selection for this population in clinical practice. Therefore, this study analyzed the prognosis and patient characteristics of postmenopausal patients selected for a five-year upfront letrozole therapy.</p><p><strong>Patients and methods: </strong>From 2009 to 2011, 3529 patients were enrolled into the adjuvant phase IV PreFace clinical trial (NCT01908556). Postmenopausal hormone receptor-positive BC patients, for whom an upfront five-year therapy with letrozole (2.5 mg/day) was indicated, were eligible. Disease-free survival (DFS), overall survival (OS) and safety in relation to patient and tumor characteristics were assessed.</p><p><strong>Results: </strong>3297 patients started letrozole therapy. The majority of patients (n = 1639, 57%) completed the five-year treatment. 34.5% of patients continued with endocrine therapy after the mandated five-year endocrine treatment. Five-year DFS rates were 89% (95% CI: 88-90%) and five-year OS rates were 95% (95% CI: 94-96%). In subgroup analyses, DFS rates were 83%, 84% and 78% for patients with node-positive disease, G3 tumor grading, and pT3 tumors respectively. The main adverse events (any grade) were pain and hot flushes (66.8% and 18.3% of patients).</p><p><strong>Conclusions: </strong>The risk profile of postmenopausal BC patients selected for a five-year upfront letrozole therapy showed a moderate recurrence and death risk. However, in subgroups with unfavorable risk factors, prognosis warrants an improvement, which might be achieved with novel targeted therapies.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 2","pages":"185-195"},"PeriodicalIF":2.7,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10853028/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139722274","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}
Pub Date : 2024-01-09eCollection Date: 2024-02-01DOI: 10.1055/a-1869-1772
Olaf Schoffer, Pauline Wimberger, Michael Gerken, Veronika Bierbaum, Christoph Bobeth, Martin Rößler, Patrik Dröge, Thomas Ruhnke, Christian Günster, Kees Kleihues-van Tol, Theresa Link, Anton Scharl, Elisabeth C Inwald, Karin Kast, Thomas Papathemelis, Olaf Ortmann, Monika Klinkhammer-Schalke, Jochen Schmitt
Introduction: Certified breast cancer centers offer specific quality standards in terms of their structure, diagnostic and treatment approaches with regards to breast surgery, drug-based cancer therapy, radiotherapy, and psychosocial support. Such centers aim to improve treatment outcomes of breast cancer patients. The question investigated here was whether patients with primary breast cancer have a longer overall survival if they are treated in a certified breast cancer center compared to treatment outside these centers.
Methods: We used patient-specific data (demographics, diagnoses, treatments) obtained from data held by mandatory health insurance companies ( gesetzliche Krankenversicherung , GKV) and clinical cancer registries (KKR) for the period 2009-2017 as well as hospital characteristics recorded in standardized quality reports. Using multivariable Cox regression analysis, we investigated differences in survival between patients treated in hospitals certified as breast cancers centers by the German Cancer Society (DKG) and patients treated in hospitals which had not been certified by the DKG.
Results: The sample population consisted of 143720 (GKV data) and 59780 (KKR data) patients with breast cancer, who were treated in 1010 hospitals across Germany (280 DKG-certified, 730 not DKG-certified). 63.5% (GKV data) and 66.7% (KKR data) of patients, respectively, were treated in DKG-certified breast cancer centers. Cox regression analysis for overall survival which included patient and hospital characteristics found a significantly lower mortality risk for patients treated in DKG-certified breast cancer centers (GKV data: HR = 0.77, 95% CI = 0.74-0.81; KKR data: HR = 0.88, 95% CI = 0.85-0.92). This result remained stable even after several sensitivity analyses including stratified estimates for subgroups of patients and hospitals. The effect was even more pronounced for recurrence-free survival (KKR data: HR = 0.78, 95% CI = 0.74-0.82).
Conclusions: Patients who are treated by an interdisciplinary team in a DKG-certified breast cancer had clear and statistically significantly better survival rates. Certification is therefore an effective means of improving the quality of care, and more patients should be treated in certified breast cancer centers.
{"title":"Treatment in Certified Breast Cancer Centers Improves Chances of Survival of Patients with Breast Cancer: Evidence Based on Health Care Data from the WiZen Study.","authors":"Olaf Schoffer, Pauline Wimberger, Michael Gerken, Veronika Bierbaum, Christoph Bobeth, Martin Rößler, Patrik Dröge, Thomas Ruhnke, Christian Günster, Kees Kleihues-van Tol, Theresa Link, Anton Scharl, Elisabeth C Inwald, Karin Kast, Thomas Papathemelis, Olaf Ortmann, Monika Klinkhammer-Schalke, Jochen Schmitt","doi":"10.1055/a-1869-1772","DOIUrl":"https://doi.org/10.1055/a-1869-1772","url":null,"abstract":"<p><strong>Introduction: </strong>Certified breast cancer centers offer specific quality standards in terms of their structure, diagnostic and treatment approaches with regards to breast surgery, drug-based cancer therapy, radiotherapy, and psychosocial support. Such centers aim to improve treatment outcomes of breast cancer patients. The question investigated here was whether patients with primary breast cancer have a longer overall survival if they are treated in a certified breast cancer center compared to treatment outside these centers.</p><p><strong>Methods: </strong>We used patient-specific data (demographics, diagnoses, treatments) obtained from data held by mandatory health insurance companies ( <i>gesetzliche Krankenversicherung</i> , GKV) and clinical cancer registries (KKR) for the period 2009-2017 as well as hospital characteristics recorded in standardized quality reports. Using multivariable Cox regression analysis, we investigated differences in survival between patients treated in hospitals certified as breast cancers centers by the German Cancer Society (DKG) and patients treated in hospitals which had not been certified by the DKG.</p><p><strong>Results: </strong>The sample population consisted of 143720 (GKV data) and 59780 (KKR data) patients with breast cancer, who were treated in 1010 hospitals across Germany (280 DKG-certified, 730 not DKG-certified). 63.5% (GKV data) and 66.7% (KKR data) of patients, respectively, were treated in DKG-certified breast cancer centers. Cox regression analysis for overall survival which included patient and hospital characteristics found a significantly lower mortality risk for patients treated in DKG-certified breast cancer centers (GKV data: HR = 0.77, 95% CI = 0.74-0.81; KKR data: HR = 0.88, 95% CI = 0.85-0.92). This result remained stable even after several sensitivity analyses including stratified estimates for subgroups of patients and hospitals. The effect was even more pronounced for recurrence-free survival (KKR data: HR = 0.78, 95% CI = 0.74-0.82).</p><p><strong>Conclusions: </strong>Patients who are treated by an interdisciplinary team in a DKG-certified breast cancer had clear and statistically significantly better survival rates. Certification is therefore an effective means of improving the quality of care, and more patients should be treated in certified breast cancer centers.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 2","pages":"153-163"},"PeriodicalIF":2.7,"publicationDate":"2024-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10853029/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139722215","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}
M. Sourouni, Ariane Germeyer, Manuel Feißt, Alexandra Balzer, Helen Köster, Annemarie Minte, Dörthe Brüggmann, Celine Kohll, Kristin Reinhardt, Michaela Möginger, Anja Leonhardt, Constanze Banz-Jansen, Michael Bohlmann, Christiane Fröhlich, Clara Backes, Dietrich Hager, Lisa Kaup, Elsa Hollatz-Galuschki, Charlotte Engelbrecht, F. Markfeld-Erol, C. Hagenbeck, Hening Schäffler, Jennifer Winkler, Johannes Stubert, K. Rathberger, Laura Lüber, Linda Hertlein, Antonia Machill, Manuela Richter, Martin Berghäuser, Michael Weigel, Mirjam Morgen, Nora Horn, P. Jakubowski, B. Riebe, B. Ramsauer, Robert Sczesny, Ute Schäfer-Graf, Susanne Schrey, Sven Kehl, J. Lastinger, S. Seeger, Olaf Parchmann, A. Iannaccone, Jens Rohne, Luise Gattung, Christine A. Morfeld, Michael Abou-Dakn, Markus Schmidt, Michaela Glöckner, Anja Jebens, K. Sondern, U. Pecks, Ralf Schmitz, M. Möllers
{"title":"Correction: Multiple Gestation as a Risk Factor for SARS-CoV-2-Associated Adverse Maternal Outcome: Data From the COVID-19 Related Obstetric and Neonatal Outcome Study (CRONOS)","authors":"M. Sourouni, Ariane Germeyer, Manuel Feißt, Alexandra Balzer, Helen Köster, Annemarie Minte, Dörthe Brüggmann, Celine Kohll, Kristin Reinhardt, Michaela Möginger, Anja Leonhardt, Constanze Banz-Jansen, Michael Bohlmann, Christiane Fröhlich, Clara Backes, Dietrich Hager, Lisa Kaup, Elsa Hollatz-Galuschki, Charlotte Engelbrecht, F. Markfeld-Erol, C. Hagenbeck, Hening Schäffler, Jennifer Winkler, Johannes Stubert, K. Rathberger, Laura Lüber, Linda Hertlein, Antonia Machill, Manuela Richter, Martin Berghäuser, Michael Weigel, Mirjam Morgen, Nora Horn, P. Jakubowski, B. Riebe, B. Ramsauer, Robert Sczesny, Ute Schäfer-Graf, Susanne Schrey, Sven Kehl, J. Lastinger, S. Seeger, Olaf Parchmann, A. Iannaccone, Jens Rohne, Luise Gattung, Christine A. Morfeld, Michael Abou-Dakn, Markus Schmidt, Michaela Glöckner, Anja Jebens, K. Sondern, U. Pecks, Ralf Schmitz, M. Möllers","doi":"10.1055/a-2232-5598","DOIUrl":"https://doi.org/10.1055/a-2232-5598","url":null,"abstract":"","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"32 33","pages":""},"PeriodicalIF":2.7,"publicationDate":"2024-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139388762","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}