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Effects of Physical Activity on Blood Lipids and Hemoglobin A1c in Healthy Pregnant Women: The FitMum Randomized Controlled Trial 体育锻炼对健康孕妇血脂和 HbA1c 的影响:FitMum 随机对照试验。
IF 3.7 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-10-01 DOI: 10.1016/j.eprac.2024.07.002

Objective

Maternal blood lipid and glucose concentrations during pregnancy affect fetal growth and the risk of pregnancy and delivery complications.
We aimed to investigate the effects of physical activity (PA) during pregnancy on maternal blood lipid and hemoglobin A1c (HbA1c) concentrations. We hypothesized that higher PA was associated with improved lipid profile and glycemic control.

Methods

In a secondary analysis of a randomized controlled trial, we included 216 pregnant women before week 15 + 0 and tested the effects of two different PA interventions throughout pregnancy compared to standard care on maternal blood lipid and HbA1c concentrations. Additionally, we investigated the effect of PA per se measured by an activity tracker. Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglyceride, and HbA1c concentrations were measured at week ≤15 + 0, 28+0-6, 34+0-6, and at delivery (week 32 + 1 to 42 + 0). Effects of the interventions and PA per se were tested using linear mixed effects models and linear regression analyses, respectively.

Results

No effects of the PA interventions were detected on maternal lipids or HbA1c during pregnancy. In PA per se analyses, more minutes per week of moderate-to-vigorous intensity PA were associated with less increase in TC (−1.3E-04, P = .020) and LDL-C (−8.5E-05, P = .035) as pregnancy progresses. More active kilocalories were associated with less increase in TC (−5.5E-05, P < .001), HDL-C (−9.5E-06, P = .024), and LDL-C (−3.2E-05, P = .005).

Conclusion

Whilst there were no effects of offering PA interventions, higher PA was associated with reduced increases in TC, HDL-C, and LDL-C as pregnancy progressed.
目的孕期母体血脂和血糖浓度会影响胎儿的生长以及妊娠和分娩并发症的风险。我们旨在研究孕期体力活动(PA)对母体血脂和血红蛋白 A1c(HbA1c)浓度的影响。我们假设,较高的体力活动与血脂和血糖控制的改善有关:在一项随机对照试验的二次分析中,我们纳入了第 15+0 周前的 216 名孕妇,并测试了在整个孕期两种不同的 PA 干预方法与标准护理相比对孕妇血脂和 HbA1c 浓度的影响。此外,我们还调查了通过活动追踪器测量的 PA 本身的效果。总胆固醇 (TC)、高密度脂蛋白胆固醇 (HDL-C)、低密度脂蛋白胆固醇 (LDL-C)、甘油三酯和 HbA1c 的浓度分别在第 ≤15+0、28+0-6、34+0-6 周和分娩时(第 32+1 至 42+0 周)进行测量。分别使用线性混合效应模型和线性回归分析检验了干预措施和 PA 本身的效果:结果:未发现 PA 干预对孕期母体血脂或 HbA1c 有任何影响。在 PA 本身的分析中,随着妊娠的进展,每周进行更多分钟的中强度至高强度 PA 与 TC(-1.3E-04,p=0.020)和 LDL-C (-8.5E-05,p=0.035)的增加较少有关。更多的活跃千卡热量与较低的总胆固醇(-5.5E-05,P=0.035)的增加有关:虽然提供 PA 干预没有效果,但随着孕期的延长,较高的 PA 与总胆固醇、高密度脂蛋白胆固醇和低密度脂蛋白胆固醇的增加减少有关。
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引用次数: 0
Reply to the Letter to the Editor, Endocrine Practice for "Role of Teplizumab, a Humanized Anti-CD3 Monoclonal Antibody, in Managing Newly Diagnosed Type 1 Diabetes: An Updated Systematic Review and Meta-Analysis” 回复《内分泌实践》杂志编辑的来信:"Teplizumab(一种人源化抗 CD3 单克隆抗体)在管理新诊断的 1 型糖尿病中的作用:最新系统综述和元分析。
IF 3.7 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-10-01 DOI: 10.1016/j.eprac.2024.07.004
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引用次数: 0
Clinical Review: The Approach to the Evaluation and Management of Bilateral Adrenal Masses 临床回顾:双侧肾上腺肿块的评估和治疗方法。
IF 3.7 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-10-01 DOI: 10.1016/j.eprac.2024.06.015
Ann T. Sweeney MD , Oksana Hamidi DO , Prerna Dogra MD , Shobana Athimulam MD , Ricardo Correa MD , Michael A. Blake MB, BCh , Travis McKenzie MD , Anand Vaidya MD , Karel Pacak MD, PhD, DSc , Amir H. Hamrahian MD , Irina Bancos MD

Objective

This white paper provides practical guidance for clinicians encountering bilateral adrenal masses.

Methods

A case-based approach to the evaluation and management of bilateral adrenal masses. Specific clinical scenarios presented here include cases of bilateral adrenal adenomas, hemorrhage, pheochromocytomas, metastatic disease, myelolipomas, as well as primary bilateral macronodular adrenal hyperplasia.

Results

Bilateral adrenal masses represent approximately 10% to 20% of incidentally discovered adrenal masses. The general approach to the evaluation and management of bilateral adrenal masses follows the same protocol as the evaluation of unilateral adrenal masses, determined based on the patient’s clinical history and examination as well as the imaging characteristics of each lesion, whether the lesions could represent a malignancy, demonstrate hormone excess, or possibly represent a familial syndrome. Furthermore, there are features unique to bilateral adrenal masses that must be considered, including the differential diagnosis, the evaluation, and the management depending on the etiology. Therefore, considerations for the optimal imaging modality, treatment (medical vs surgical therapy), and surveillance are included. These recommendations were developed through careful examination of existing published studies as well as expert clinical opinion consensus.

Conclusion

The evaluation and management of bilateral adrenal masses require a comprehensive systematic approach which includes the assessment and interpretation of the patient’s clinical history, physical examination, dynamic hormone evaluation, and imaging modalities to determine the key radiographic features of each adrenal nodule. In addition, familial syndromes should be considered. Any final treatment options and approaches should always be considered individually.
目的:本白皮书为临床医生在遇到双侧肾上腺肿块时提供实用指导:本白皮书为遇到双侧肾上腺肿块的临床医生提供实用指导:方法:以病例为基础,评估和处理双侧肾上腺肿块。本文介绍的具体临床情景包括双侧肾上腺腺瘤、出血、嗜铬细胞瘤、转移性疾病、髓脂瘤以及原发性双侧大结节性肾上腺增生症等病例:双侧肾上腺肿块约占偶然发现的肾上腺肿块的10%至20%。评估和处理双侧肾上腺肿块的一般方法与评估单侧肾上腺肿块的方法相同,根据患者的临床病史和检查以及每个病变的影像学特征、病变是否可能代表恶性肿瘤、是否显示激素过多或是否可能代表家族综合征来决定。此外,双侧肾上腺肿块还具有一些独特的特征,必须加以考虑,包括鉴别诊断、评估和根据病因进行的处理。因此,建议中包括了最佳成像方式、治疗(药物治疗与手术治疗)和监测的注意事项。这些建议是在仔细研究了现有的已发表研究以及专家临床意见共识的基础上提出的:双侧肾上腺肿块的评估和管理需要全面系统的方法,包括评估和解释患者的临床病史、体格检查、动态激素评估和影像学检查,以确定每个肾上腺结节的主要影像学特征。此外,还应考虑家族综合征。任何最终治疗方案和方法都应单独考虑。
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引用次数: 0
Effect of Combined Low Dose Human Gonadotropic Hormone, Follicle Stimulating Hormone, and Testosterone Therapy (LFT Regimen) Versus Conventional High Dose Human Gonadotropic Hormone and Follicle Stimulating Hormone on Spermatogenesis and Biomarkers in Men With Hypogonadotropic Hypogonadism 小剂量 hCG、FSH 和睾酮联合疗法(LFT 方案)与传统的大剂量 hCG 和 FSH 对促性腺激素低下男性精子发生和生物标志物的影响。
IF 3.7 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-10-01 DOI: 10.1016/j.eprac.2024.07.007
Nikhil Singhania MD , Konsam Biona Devi MD, DM , Japleen Kaur MD , Anil Bhansali MD, DM , Ujjwal Gorsi MD , Naresh Sachdeva PhD , Sunil Arora PhD , Ashutosh Rai PhD , Rama Walia MD, DM

Objective

In male congenital hypogonadotropic hypogonadism (CHH), it was observed that lower dose human gonadotropic hormone (hCG) can maintain normal intratesticular testosterone levels. We propose this study to compare the low-dose hCG, follicle stimulating hormone (FSH), and Testosterone (T) [LFT Regimen] to conventional treatment to induce virilization and fertility.

Design

This open-label randomized pilot study was conducted from June 2020 to December 2021.

Subjects and outcome measures

CHH were randomly assigned to either the LFT regimen (Group A)-low-dose hCG (500U thrice per week), FSH (150U thrice per week), and T(100 mg biweekly) or conventional therapy(GroupB) with high hCG dose(2000U thrice per week) and the same FSH dose. The hCG dosage was titrated to reduce anti-mullerian hormone (AMH) by 50% and normalization of plasma T in groups A and B, respectively. The primary objective was to compare the percentage of individuals who achieved spermatogenesis between the two groups.

Results

Out of 30 patients, 23 (76·7%) subjects achieved spermatogenesis, and the median time was 12 (9-14·9) months. There was no difference in achieving spermatogenesis between the two groups (64·3% vs 7·5%,P = 0·204), and even the median time for spermatogenesis was similar (15months vs 12months,P = 0·248). Both groups had nonsignificant median plasma AMH at spermatogenesis, [6·6 ng/ml (3·3-9·76) vs4·41 ng/ml (2·3-6·47), P = 0·298]. Similarly, the median plasma Inhibin B at spermatogenesis between groups were comparable [152·4 pg/ml (101·7-198·0) vs49·1 pg/ml (128·7-237·3), P = 0·488].

Conclusions

A reasonable approach to induce fertility in male CHH is to initiate combination therapy using FSH, low-dose hCG targeting AMH <6·9 ng/ml, along with T to achieve normal range. Monitoring AMH could serve as a proxy indicator of spermatogenesis.
研究目的在男性先天性性腺功能减退症(CHH)中,观察到低剂量的人类促性腺激素(hCG)可以维持正常的睾丸内睾酮(ITT)水平。我们建议本研究比较低剂量促性腺激素(hCG)、促卵泡激素(FSH)和睾酮(T)[LFT方案]与常规治疗,以诱导男性化和生育:这项开放标签随机试验研究于2020年6月至2021年12月进行:受试者被随机分配到LFT方案(A组)--低剂量hCG(500U,每周三次)、FSH(150U,每周三次)和T(100mg,每两周一次)或常规治疗(B组)--高剂量hCG(2000U,每周三次)和相同剂量的FSH。A组和B组的hCG剂量分别控制在抗苗勒氏管激素(AMH)降低50%和血浆T正常的水平。主要目的是比较两组实现精子发生的比例:结果:30 名患者中,23 人(76-7%)实现了生精,中位时间为 12(9-14-9)个月。两组患者的生精率没有差异(64-3%vs87-5%,P=0-204),甚至生精的中位时间也相似(15个月vs12个月,P=0-248)。两组患者精子发生时的血浆 AMH 中位数均无显著差异(6-6ng/ml(3-3-9-76) vs 4-41ng/ml(2-3-6-47),P=0-298)。同样,各组精子发生时的血浆抑制素 B 中位数也相当[152-4pg/ml(101-7-198-0)vs149-1pg/ml(128-7-237-3),p=0-488]:诱导男性CHH生育的合理方法是使用FSH、小剂量hCG和AMH联合治疗。
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引用次数: 0
Development and Validation of a Prediction Model for Thyroid Dysfunction in Patients During Immunotherapy 免疫疗法期间患者甲状腺功能紊乱预测模型的开发与验证
IF 3.7 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-10-01 DOI: 10.1016/j.eprac.2024.07.006
Qian Wang , Tingting Wu MD , Ru Zhao MD , Yuanqin Li MD , Xuetao Chen MD , Shanmei Shen MD , Xiaowen Zhang PhD

Objective

This study was designed to develop and validate a predictive model for assessing the risk of thyroid toxicity following treatment with immune checkpoint inhibitors.

Methods

A retrospective analysis was conducted on a cohort of 586 patients diagnosed with malignant tumors who received programmed cell death 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors. The patients were randomly divided into training and validation cohorts in a 7:3 ratio. Logistic regression analyses were performed on the training set to identify risk factors of thyroid dysfunction, and a nomogram was developed based on these findings. Internal validation was performed using K-fold cross-validation on the validation set. The performance of the nomogram was assessed in terms of discrimination and calibration. Additionally, decision curve analysis was utilized to demonstrate the decision efficiency of the model.

Results

Our clinical prediction model consisted of 4 independent predictors of thyroid immune-related adverse events, namely baseline thyrotropin (TSH, OR = 1.427, 95%CI:1.163-1.876), baseline thyroglobulin antibody (TgAb, OR = 1.105, 95%CI:1.035-1.180), baseline thyroid peroxidase antibody (TPOAb, OR = 1.172, 95%CI:1.110-1.237), and baseline platelet count (platelet, OR = 1.004, 95%CI:1.000-1.007). The developed nomogram achieved excellent discrimination with an area under the curve of 0.863 (95%CI: 0.817-0.909) and 0.885 (95%CI: 0.827-0.944) in the training and internal validation cohorts respectively. Calibration curves exhibited a good fit, and the decision curve indicated favorable clinical benefits.

Conclusion

The proposed nomogram serves as an effective and intuitive tool for predicting the risk of thyroid immune-related adverse events, facilitating clinicians making individualized decisions based on patient-specific information.
研究目的本研究旨在开发并验证一个预测模型,用于评估免疫检查点抑制剂(ICIs)治疗后的甲状腺毒性风险:该研究对586例接受程序性细胞死亡1(PD-1)/程序性死亡配体1(PD-L1)抑制剂治疗的恶性肿瘤患者进行了回顾性分析。患者按 7:3 的比例随机分为训练组和验证组。对训练组进行逻辑回归分析,以确定甲状腺功能障碍的风险因素,并根据这些结果绘制了提名图。在验证集上使用 K 倍交叉验证进行内部验证。从区分度和校准方面对提名图的性能进行了评估。此外,还利用决策曲线分析(DCA)来证明模型的决策效率:我们的临床预测模型由四个独立的甲状腺免疫相关不良事件(irAEs)预测因子组成,即基线甲状腺素(TSH,OR=1.427,95%CI:1.163-1.876)、基线甲状腺球蛋白抗体(TgAb,OR=1.105,95%CI:1.035-1.180)、基线甲状腺过氧化物酶抗体(TPOAb,OR=1.172,95%CI:1.110-1.237)和基线血小板计数(PLT,OR=1.004,95%CI:1.000-1.007)。所开发的提名图具有极佳的区分度,在训练组和内部验证组中的曲线下面积(AUC)分别为 0.863(95%CI:0.817-0.909)和 0.885(95%CI:0.827-0.944)。校准曲线拟合良好,决策曲线显示了良好的临床效益:所提出的提名图是预测甲状腺虹膜AEs风险的有效而直观的工具,有助于临床医生根据患者的具体信息做出个体化决策。
{"title":"Development and Validation of a Prediction Model for Thyroid Dysfunction in Patients During Immunotherapy","authors":"Qian Wang ,&nbsp;Tingting Wu MD ,&nbsp;Ru Zhao MD ,&nbsp;Yuanqin Li MD ,&nbsp;Xuetao Chen MD ,&nbsp;Shanmei Shen MD ,&nbsp;Xiaowen Zhang PhD","doi":"10.1016/j.eprac.2024.07.006","DOIUrl":"10.1016/j.eprac.2024.07.006","url":null,"abstract":"<div><h3>Objective</h3><div>This study was designed to develop and validate a predictive model for assessing the risk of thyroid toxicity following treatment with immune checkpoint inhibitors.</div></div><div><h3>Methods</h3><div>A retrospective analysis was conducted on a cohort of 586 patients diagnosed with malignant tumors who received programmed cell death 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors. The patients were randomly divided into training and validation cohorts in a 7:3 ratio. Logistic regression analyses were performed on the training set to identify risk factors of thyroid dysfunction, and a nomogram was developed based on these findings. Internal validation was performed using K-fold cross-validation on the validation set. The performance of the nomogram was assessed in terms of discrimination and calibration. Additionally, decision curve analysis was utilized to demonstrate the decision efficiency of the model.</div></div><div><h3>Results</h3><div>Our clinical prediction model consisted of 4 independent predictors of thyroid immune-related adverse events, namely baseline thyrotropin (TSH, OR = 1.427, 95%CI:1.163-1.876), baseline thyroglobulin antibody (TgAb, OR = 1.105, 95%CI:1.035-1.180), baseline thyroid peroxidase antibody (TPOAb, OR = 1.172, 95%CI:1.110-1.237), and baseline platelet count (platelet, OR = 1.004, 95%CI:1.000-1.007). The developed nomogram achieved excellent discrimination with an area under the curve of 0.863 (95%CI: 0.817-0.909) and 0.885 (95%CI: 0.827-0.944) in the training and internal validation cohorts respectively. Calibration curves exhibited a good fit, and the decision curve indicated favorable clinical benefits.</div></div><div><h3>Conclusion</h3><div>The proposed nomogram serves as an effective and intuitive tool for predicting the risk of thyroid immune-related adverse events, facilitating clinicians making individualized decisions based on patient-specific information.</div></div>","PeriodicalId":11682,"journal":{"name":"Endocrine Practice","volume":"30 10","pages":"Pages 943-950"},"PeriodicalIF":3.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141616132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Management of Pancreatic Neuroendocrine Tumors: Surgical Strategies and Controversies 胰腺神经内分泌肿瘤(PNETs)的治疗:手术策略与争议。
IF 3.7 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-10-01 DOI: 10.1016/j.eprac.2024.07.010
Roger R. Perry MD, MS, Eric C. Feliberti MD, Marybeth S. Hughes MD

Objective

Pancreatic neuroendocrine tumors (PNETs) are uncommon tumors which are increasing in incidence. The management of these tumors continues to evolve. This review examines the current role of surgery in the treatment of these tumors.

Methods

Studies published over the past 10 years were identified using several databases including PubMed, MEDLINE, and Science Direct. Search terms included PNETs, treatment, and surgery. Clinical practice guidelines and updates from several major groups were reviewed.

Results

Surgery continues to have a major role in the treatment of sporadic functional and nonfunctional PNETs. Pancreas-sparing approaches are increasingly accepted as alternatives to formal pancreatic resection in selected patients. Options such as watch and wait or endoscopic ablation may be reasonable alternatives to surgery for non-functional PNETs < 2 cm in size. Surgical decision-making in multiple endocrine neoplasia type 1 patients remains complex and in some situations such as gastrinoma quite controversial. The role of surgery has significantly diminished in patients with advanced disease due to the advent of more effective systemic and liver-directed therapies. However, the optimal treatments and sequencing in advanced disease remain poorly defined, and it has been suggested that surgery is underutilized in these patients.

Conclusions

Surgery remains a major treatment modality for PNETs. Given the plethora of available treatments, ongoing controversies and the changing landscape, management has become increasingly complex. An experienced multidisciplinary team which includes surgery is essential to manage these patients.
目的:胰腺神经内分泌肿瘤(PNET胰腺神经内分泌肿瘤(PNET)是一种不常见的肿瘤,其发病率正在不断上升。这些肿瘤的治疗方法也在不断发展。本综述探讨了外科手术目前在这些肿瘤治疗中的作用。 方法:使用多个数据库(包括 PubMed、MEDLINE 和 Science Direct)对过去 10 年间发表的研究进行了鉴定。搜索关键词包括胰腺神经内分泌肿瘤、治疗和手术。此外,还查阅了几个主要团体的临床实践指南和更新内容:手术在治疗散发性功能性和菲利贝尔非功能性胰腺内分泌肿瘤中仍然发挥着重要作用。越来越多的人接受保胰方法,以替代对特定患者的正式胰腺切除术。对于大小小于2厘米的NF-PNET,观察和等待或内镜消融等方法可能是手术的合理替代方案。MEN-1 患者的手术决策仍然很复杂,在胃泌素瘤等某些情况下,手术决策还存在很大争议。由于出现了更有效的全身和肝脏导向疗法,手术在晚期患者中的作用已大大降低。然而,晚期疾病的最佳治疗方法和顺序仍未明确,有人认为手术在这些患者中未得到充分利用:结论:手术仍是治疗 PNET 的主要方式。结论:手术仍是治疗 PNETs 的主要方式。鉴于现有治疗方法繁多、争议不断、情况不断变化,治疗变得越来越复杂。一个包括外科在内的经验丰富的多学科团队对这些患者的治疗至关重要。
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引用次数: 0
Info for Readers/Subscription page 读者信息/订阅页面
IF 3.7 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-10-01 DOI: 10.1016/S1530-891X(24)00633-5
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引用次数: 0
Impact of Teprotumumab on Clinical Practice in Thyroid Eye Disease 泰普单抗对甲状腺眼病临床实践的影响
IF 3.7 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-10-01 DOI: 10.1016/j.eprac.2024.06.010

Background

Following its Food and Drug Administration approval in January 2020, we examined the impact of teprotumumab on thyroid eye disease (TED) clinical practices.

Methods

Across 3 referral centers from January 1, 2018, to December 30, 2022, we retrospectively analyzed demographics, clinical features, treatment choices, and insurance status of patients with active, moderate to severe TED.

Results

Of 74 patients recommended for medical therapy, 53% received collaborative recommendations from endocrinologists and ophthalmologists in a TED clinic. Prior to teprotumumab availability, 19 patients were recommended medical therapy, and all received medical therapy (100%), which consists of corticosteroids (14, 73.7%) or tocilizumab (5, 26.3%). After teprotumumab became available, out of 55 patients that were recommended medical therapy, only 41 (74.6%) received medical therapy, mostly teprotumumab (33, 60%), followed by corticosteroids (5, 9.1%) or tocilizumab (3, 5.4%), while 14 (25.4%) did not receive medical therapy. Discordance between physicians’ recommendations and therapy received or lack thereof was explained by patients’ refusal (9, 64.3%), mostly due to side effect concerns (8, 88.9%), and insurance denial (5, 35.7%). Teprotumumab use was mostly associated with otic changes (10, 30.3%), weight loss (9, 27.3%), and hyperglycemia (6, 18.2%), but 2 (6.1%) patients developed serious infections. Corticosteroids were associated with insomnia (4, 21.1%), and 1 patient in the tocilizumab group had an infusion reaction requiring hospitalization.

Conclusion

Teprotumumab introduction increased TED therapy evaluations, yet not all received recommended treatment due to safety concerns or accessibility issues. Enhancing collaborative care, medication accessibility, and adverse effect management is crucial.
背景在2020年1月获得FDA批准后,我们研究了替普鲁单抗对甲状腺眼病(TED)临床实践的影响:从 2018 年 1 月 1 日至 2022 年 12 月 30 日,我们在三个转诊中心回顾性分析了活动性中重度 TED 患者的人口统计学、临床特征、治疗选择和保险状况:在被推荐接受药物治疗的74名患者中,53%接受了TED诊所内分泌科医生和眼科医生的联合推荐。在替普鲁单抗上市之前,19 名患者被推荐接受药物治疗,所有患者都接受了药物治疗(100%),其中包括皮质类固醇(14 人,73.7%)或妥珠单抗(5 人,26.3%)。在特普罗单抗上市后,55 名被推荐接受药物治疗的患者中,只有 41 人(74.6%)接受了药物治疗,其中大部分是特普罗单抗(33 人,60%),其次是皮质类固醇(5 人,9.1%)或托珠单抗(3 人,5.4%),而 14 人(25.4%)没有接受药物治疗。医生建议与接受治疗或未接受治疗之间不一致的原因是患者拒绝治疗(9 例,占 64.3%),主要是担心副作用(8 例,占 88.9%),以及保险拒绝治疗(5 例,占 35.7%)。使用替普鲁单抗主要与耳部病变(10 例,30.3%)、体重减轻(9 例,27.3%)和高血糖(6 例,18.2%)有关,但有 2 例(6.1%)患者出现严重感染。皮质类固醇与失眠有关(4例,21.1%),托珠单抗组的一名患者出现输液反应,需要住院治疗:结论:泰普单抗的引入增加了对TED治疗的评估,但由于安全性或可及性问题,并非所有患者都接受了推荐的治疗。加强合作护理、药物可及性和不良反应管理至关重要。
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引用次数: 0
The Use of Semaglutide in Patients With Renal Failure-A Retrospective Cohort Study 在肾衰竭患者中使用塞马鲁肽--一项回顾性队列研究
IF 3.7 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-10-01 DOI: 10.1016/j.eprac.2024.07.008
Jane J. Long MD , Sukhdeep S. Sahi MBBS , Adley I. Lemke PharmD, RPh , Jie Na MS , Oscar A. Garcia Valencia MD , Pooja Budhiraja MBBS , Hani M. Wadei MD , Vineeth Sudhindran MBBS , Roberto Benzo MD , Matthew M. Clark PhD, LP , Meera Shah MB, ChB , David Fipps DO , Pavel Navratil MD , Ahmed A. Abdelrheem MB, ChB , Afsana A. Shaik MBBS , Dustin J. Duffy MS , Niv Pencovich MD, PhD , Pankaj Shah MD , Yogish C. Kudva MBBS , Aleksandra Kukla MD , Tayyab S. Diwan MD

Objective

Semaglutide, a glucagon-like peptide-1 receptor agonist is approved for weight loss and diabetes treatment, but limited literature exists regarding semaglutide use in patients with advanced chronic kidney disease (CKD). Therefore, this project assessed the safety and efficacy of semaglutide among patients with estimated glomerular filtration rate (eGFR) 15-29 mL/min/1.73 m2 (CKD stage 4), eGFR<15 mL/min/1.73 m2 (CKD stage 5) or on dialysis.

Methods

This is a retrospective electronic medical record based analysis of consecutive patients with advanced CKD (defined as CKD 4 or greater) who were started on semaglutide (injectable or oral). Data was collected between January 2018 and January 2023. Investigators verified CKD diagnosis and manually extracted data. Data were analyzed using Fisher’s exact test, paired t test, linear mixed effects models and Wilcoxon signed rank test.

Results

Seventy-six patients with CKD 4 or greater who initiated semaglutide were included. Most patients had a history of type 2 diabetes mellitus (96.0%), and most were males (53.9%). The mean age was 66.8 y (SD 11.5) with the mean body mass index was 36.2 (SD 7.5). The initial doses were 3 mg orally and 0.25 mg by injection. Maximum prescribed dose was 1 mg (injectable) in 28 (45.2%) patients and 14 mg (orally) in 2 (14.2%) patients. Patients received semaglutide for a median duration of 17.4 (IQR 0.43, 48.8) months. Forty-eight (63.1%) patients reported no adverse effects associated with the therapy. Mean weight decreased from 106.2 (SD 24.2) to 101.3 (SD 27.3) kg (P < .001). Eight patients (16%) with type 2 diabetes mellitus T2DM discontinued insulin after starting semaglutide. Mean hemoglobin A1c (HbA1c) decreased from 8.0% (SD 1.7) to 7.1% (SD 1.3) (P < .001). Adverse effects were the primary reason for semaglutide discontinuation (37.0%), with nausea, vomiting, and abdominal pain being the most common complaints.

Conclusions

Based on this retrospective study semaglutide appears to be tolerated by most individuals with CKD 4 or greater despite associated gastrointestinal side effects similar to those observed in patients with better kidney function and leads to an improvement of glycemic control and insulin discontinuation in patients with T2DM. Modest weight loss (approximately 4.6% of the total body weight) was observed on the prescribed doses. Larger prospective randomized studies are needed to comprehensively assess the risks and benefits of semaglutide in patients with CKD 4 or greater and obesity.
目的胰高血糖素样肽-1 受体激动剂舍马鲁肽被批准用于减肥和糖尿病治疗,但有关舍马鲁肽用于晚期慢性肾病(CKD)患者的文献有限。因此,该项目评估了估计肾小球滤过率(eGFR)为15-29 mL/min/1.73 m2(CKD 4期)、eGFR<15 mL/min/1.73 m2(CKD 5期)或正在透析的患者使用舍马鲁肽的安全性和疗效。方法这是一项基于电子病历的回顾性分析,分析对象为开始使用舍马鲁肽(注射或口服)的连续晚期CKD(定义为CKD 4期或以上)患者。数据收集时间为 2018 年 1 月至 2023 年 1 月。研究人员核实了 CKD 诊断并手动提取了数据。采用费舍尔精确检验、配对 t 检验、线性混合效应模型和 Wilcoxon 符号秩检验对数据进行分析。结果纳入了 76 名开始使用塞马鲁肽的 CKD 4 级或以上患者。大多数患者有 2 型糖尿病病史(96.0%),大多数为男性(53.9%)。平均年龄为 66.8 岁(SD 11.5),平均体重指数为 36.2(SD 7.5)。初始剂量为口服 3 毫克,注射 0.25 毫克。28名患者(45.2%)的最大处方剂量为1毫克(注射),2名患者(14.2%)的最大处方剂量为14毫克(口服)。患者接受塞马鲁肽治疗的中位时间为 17.4 个月(IQR 0.43 - 48.8)。48名(63.1%)患者未报告与治疗相关的不良反应。平均体重从 106.2(标准差 24.2)公斤降至 101.3(标准差 27.3)公斤(P < .001)。8名(16%)2型糖尿病患者(T2DM)在开始使用semaglutide后停用了胰岛素。平均血红蛋白 A1c (HbA1c) 从 8.0% (SD 1.7) 降至 7.1% (SD 1.3) (P < .001)。结论根据这项回顾性研究,大多数 CKD 4 级或以上的患者似乎都能耐受 semaglutide,尽管相关的胃肠道副作用与肾功能较好的患者相似,并能改善 T2DM 患者的血糖控制和停用胰岛素。在处方剂量下观察到适度的体重减轻(约占总重量的 4.6%)。需要进行更大规模的前瞻性随机研究,以全面评估semaglutide对CKD 4级或以上和肥胖症患者的风险和益处。
{"title":"The Use of Semaglutide in Patients With Renal Failure-A Retrospective Cohort Study","authors":"Jane J. Long MD ,&nbsp;Sukhdeep S. Sahi MBBS ,&nbsp;Adley I. Lemke PharmD, RPh ,&nbsp;Jie Na MS ,&nbsp;Oscar A. Garcia Valencia MD ,&nbsp;Pooja Budhiraja MBBS ,&nbsp;Hani M. Wadei MD ,&nbsp;Vineeth Sudhindran MBBS ,&nbsp;Roberto Benzo MD ,&nbsp;Matthew M. Clark PhD, LP ,&nbsp;Meera Shah MB, ChB ,&nbsp;David Fipps DO ,&nbsp;Pavel Navratil MD ,&nbsp;Ahmed A. Abdelrheem MB, ChB ,&nbsp;Afsana A. Shaik MBBS ,&nbsp;Dustin J. Duffy MS ,&nbsp;Niv Pencovich MD, PhD ,&nbsp;Pankaj Shah MD ,&nbsp;Yogish C. Kudva MBBS ,&nbsp;Aleksandra Kukla MD ,&nbsp;Tayyab S. Diwan MD","doi":"10.1016/j.eprac.2024.07.008","DOIUrl":"10.1016/j.eprac.2024.07.008","url":null,"abstract":"<div><h3>Objective</h3><div>Semaglutide, a glucagon-like peptide-1 receptor agonist is approved for weight loss and diabetes treatment, but limited literature exists regarding semaglutide use in patients with advanced chronic kidney disease (CKD). Therefore, this project assessed the safety and efficacy of semaglutide among patients with estimated glomerular filtration rate (eGFR) 15-29 mL/min/1.73 m<sup>2</sup> (CKD stage 4), eGFR&lt;15 mL/min/1.73 m<sup>2</sup> (CKD stage 5) or on dialysis.</div></div><div><h3>Methods</h3><div>This is a retrospective electronic medical record based analysis of consecutive patients with advanced CKD (defined as CKD 4 or greater) who were started on semaglutide (injectable or oral). Data was collected between January 2018 and January 2023. Investigators verified CKD diagnosis and manually extracted data. Data were analyzed using Fisher’s exact test, paired <em>t</em> test, linear mixed effects models and Wilcoxon signed rank test.</div></div><div><h3>Results</h3><div>Seventy-six patients with CKD 4 or greater who initiated semaglutide were included. Most patients had a history of type 2 diabetes mellitus (96.0%), and most were males (53.9%). The mean age was 66.8 y (SD 11.5) with the mean body mass index was 36.2 (SD 7.5). The initial doses were 3 mg orally and 0.25 mg by injection. Maximum prescribed dose was 1 mg (injectable) in 28 (45.2%) patients and 14 mg (orally) in 2 (14.2%) patients. Patients received semaglutide for a median duration of 17.4 (IQR 0.43, 48.8) months. Forty-eight (63.1%) patients reported no adverse effects associated with the therapy. Mean weight decreased from 106.2 (SD 24.2) to 101.3 (SD 27.3) kg (<em>P</em> &lt; .001). Eight patients (16%) with type 2 diabetes mellitus T2DM discontinued insulin after starting semaglutide. Mean hemoglobin A1c (HbA1c) decreased from 8.0% (SD 1.7) to 7.1% (SD 1.3) (<em>P</em> &lt; .001). Adverse effects were the primary reason for semaglutide discontinuation (37.0%), with nausea, vomiting, and abdominal pain being the most common complaints.</div></div><div><h3>Conclusions</h3><div>Based on this retrospective study semaglutide appears to be tolerated by most individuals with CKD 4 or greater despite associated gastrointestinal side effects similar to those observed in patients with better kidney function and leads to an improvement of glycemic control and insulin discontinuation in patients with T2DM. Modest weight loss (approximately 4.6% of the total body weight) was observed on the prescribed doses. Larger prospective randomized studies are needed to comprehensively assess the risks and benefits of semaglutide in patients with CKD 4 or greater and obesity.</div></div>","PeriodicalId":11682,"journal":{"name":"Endocrine Practice","volume":"30 10","pages":"Pages 963-969"},"PeriodicalIF":3.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141701265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Automated Insulin Delivery Technology in the Hospital: Update on Safety and Efficacy Data 医院中的胰岛素自动输送技术:安全性和有效性数据更新
IF 3.7 3区 医学 Q2 ENDOCRINOLOGY & METABOLISM Pub Date : 2024-10-01 DOI: 10.1016/j.eprac.2024.07.012
Bithika Thompson MD , Mary E. Boyle FNP-BC , Janna C. Castro BS , Christopher Dodoo MS , Curtiss B. Cook MD

Objective

Automated insulin delivery (AID) systems are a rapidly growing component in the area of continuous subcutaneous insulin infusion (CSII) therapy. As more patients use these systems in the outpatient setting, it is important to assess safety if their use is allowed to continue in the inpatient setting.

Methods

Analysis was conducted of the records of patients using AID technology upon admission to our hospital between June 2020 and December 2022. Adverse events and glycemic control of AID users were compared with patients using non-AID systems and with patients who had CSII discontinued.

Results

There were 185 patients analyzed: 64 on AID, 86 on non-AID, and 35 who had CSII discontinued. The number of patients on AID increased over the course of the observation period, whereas non-AID users decreased. Pairwise comparisons indicated that patient-stay mean glucose levels and percentage of hypoglycemic events were similar between all groups, but the percentage of patient hyperglycemic measurements was significantly lower in the AID cohort. No adverse events (diabetic ketoacidosis, pump site complications, equipment malfunction) were reported in any either CSII cohort.

Conclusion

The type of CSII technology encountered in the hospital is shifting from non-AID toward AID technologies. This analysis supports earlier findings that outpatient AID systems can be successfully transitioned into the inpatient setting. Further study is needed to define if AID systems offer any advantage in glycemic control.
背景:自动胰岛素输送系统(AID)是持续皮下胰岛素输注(CSII)治疗领域中发展迅速的组成部分。随着越来越多的患者在门诊环境中使用这些系统,如果允许在住院环境中继续使用这些系统,那么对其安全性进行评估就显得非常重要:方法:对 2020 年 6 月至 2022 年 12 月期间入住本院时使用 AID 技术的患者记录进行分析。将 AID 使用者的不良事件和血糖控制情况与使用非 AID 系统的患者以及停用 CSII 的患者进行比较:结果:共分析了 185 名患者:64 名使用 AID 系统,86 名使用非 AID 系统,35 名停用 CSII。在观察期间,使用 AID 的患者人数有所增加,而非 AID 用户则有所减少。配对比较结果表明,所有组别患者在留期间的平均血糖水平和低血糖事件的百分比相似,但在 AID 组别中,患者高血糖测量值的百分比明显较低。两组 CSII 患者均未发生不良事件(糖尿病酮症酸中毒、泵部位并发症、设备故障):结论:医院使用的 CSII 技术类型正从非 AID 转向 AID 技术。这项分析支持了之前的研究结果,即门诊 AID 系统可以成功过渡到住院环境中。还需要进一步研究来确定 AID 系统在血糖控制方面是否具有优势。
{"title":"Automated Insulin Delivery Technology in the Hospital: Update on Safety and Efficacy Data","authors":"Bithika Thompson MD ,&nbsp;Mary E. Boyle FNP-BC ,&nbsp;Janna C. Castro BS ,&nbsp;Christopher Dodoo MS ,&nbsp;Curtiss B. Cook MD","doi":"10.1016/j.eprac.2024.07.012","DOIUrl":"10.1016/j.eprac.2024.07.012","url":null,"abstract":"<div><h3>Objective</h3><div>Automated insulin delivery (AID) systems are a rapidly growing component in the area of continuous subcutaneous insulin infusion (CSII) therapy. As more patients use these systems in the outpatient setting, it is important to assess safety if their use is allowed to continue in the inpatient setting.</div></div><div><h3>Methods</h3><div>Analysis was conducted of the records of patients using AID technology upon admission to our hospital between June 2020 and December 2022. Adverse events and glycemic control of AID users were compared with patients using non-AID systems and with patients who had CSII discontinued.</div></div><div><h3>Results</h3><div>There were 185 patients analyzed: 64 on AID, 86 on non-AID, and 35 who had CSII discontinued. The number of patients on AID increased over the course of the observation period, whereas non-AID users decreased. Pairwise comparisons indicated that patient-stay mean glucose levels and percentage of hypoglycemic events were similar between all groups, but the percentage of patient hyperglycemic measurements was significantly lower in the AID cohort. No adverse events (diabetic ketoacidosis, pump site complications, equipment malfunction) were reported in any either CSII cohort.</div></div><div><h3>Conclusion</h3><div>The type of CSII technology encountered in the hospital is shifting from non-AID toward AID technologies. This analysis supports earlier findings that outpatient AID systems can be successfully transitioned into the inpatient setting. Further study is needed to define if AID systems offer any advantage in glycemic control.</div></div>","PeriodicalId":11682,"journal":{"name":"Endocrine Practice","volume":"30 10","pages":"Pages 957-962"},"PeriodicalIF":3.7,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141757868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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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Endocrine Practice
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