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Prevalence and Risk Factors of Heart Failure in Patients Diagnosed with Hyperthyroidism: A Systematic Review and Meta-analysis. 甲状腺功能亢进症患者心力衰竭的患病率和风险因素:系统回顾与元分析》。
Pub Date : 2024-10-01 Epub Date: 2024-07-22 DOI: 10.17925/EE.2024.20.2.12
Si Wei David Fan, Leong Tung Ong

Objectives: Hyperthyroidism has a significant impact on the cardiovascular system, causing thyrotoxic cardiomyopathy, which is characterized by atrial fibrillation, left ventricular hypertrophy and diastolic dysfunction, and may lead to heart failure. This study aimed to investigate the prevalence and associated risk factors for heart failure in patients with hyperthyroidism. Methods: A systematic literature search was conducted on PubMed, SCOPUS and Ovid SP up until April 2023. Pooled prevalence and pooled odds ratio for risk factors were calculated using the generic inverse variance method. Results: Studies involving 30,889 patients were included in this meta-analysis. The overall prevalence of heart failure in patients with hyperthyroidism was 8% (95% confidence interval [CI]: 6-11%). Further analyses revealed that the prevalence of heart failure in patients who underwent treatment with radioactive iodine ablation, antithyroid medication and thyroidectomy was 8% (95% CI: -1 to 16%), 6% (95% CI: 2 to 11%) and 4% (95% CI: -2 to 10%), respectively. The risk factors of heart failure in hyperthyroidism include atrial fibrillation, chronic kidney disease, anaemia, hypertension, history of stroke or transient ischaemic attack, history of coronary artery disease and diabetes mellitus. Conclusion: Heart failure occurs in 8% of patients with hyperthyroidism, with the most common risk factor being atrial fibrillation.

目的:甲状腺功能亢进症对心血管系统有重大影响,可引起甲亢性心肌病,其特点是心房颤动、左心室肥大和舒张功能障碍,并可能导致心力衰竭。本研究旨在调查甲亢患者心力衰竭的患病率和相关风险因素。研究方法在PubMed、SCOPUS和Ovid SP上进行了系统性文献检索,检索期截至2023年4月。采用通用反方差法计算风险因素的汇总患病率和汇总几率比。研究结果本次荟萃分析共纳入 30,889 例患者。甲亢患者心力衰竭的总患病率为 8%(95% 置信区间 [CI]:6-11%)。进一步分析显示,接受放射性碘消融、抗甲状腺药物和甲状腺切除术治疗的患者中,心力衰竭的患病率分别为8%(95% CI:-1%至16%)、6%(95% CI:2%至11%)和4%(95% CI:-2%至10%)。甲亢患者出现心力衰竭的风险因素包括心房颤动、慢性肾病、贫血、高血压、中风或短暂性脑缺血发作史、冠状动脉疾病史和糖尿病。结论8%的甲亢患者会出现心力衰竭,最常见的风险因素是心房颤动。
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引用次数: 0
Role of Obeticholic Acid, a Farnesoid X Receptor Agonist, in Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-analysis. 奥贝胆酸(一种类法内酯 X 受体激动剂)在非酒精性脂肪肝中的作用:系统综述与元分析》。
Pub Date : 2024-10-01 Epub Date: 2024-10-09 DOI: 10.17925/EE.2024.20.2.8
Abm Kamrul-Hasan, Sunetra Mondal, Lakshmi Nagendra, Thanikai Sasikanth, Afsar Ahammed, Shahin Ibn Rahman, Ashani Wickramarachchi, Naresh Parajuli, Saurav Khatiwada, Deep Dutta

Background. Obeticholic acid (OCA) has emerged as a promising drug in the management of nonalcoholic fatty liver disease (NAFLD). This meta-analysis aimed to analyse the therapeutic effect of OCA on NAFLD. Methods. Randomized controlled trials (RCTs) involving patients with NAFLD receiving OCA in the intervention arm and placebo in the control arm were searched throughout the electronic databases. The primary outcomes were changes in non-invasive markers of hepatic fibrosis and liver histology. The secondary outcomes included changes in liver enzymes, metabolic parameters from baseline and adverse events (AEs). Results. Four RCTs involving 1,278 subjects met the inclusion criteria. Over 6 weeks to 18 months of clinical use, OCA outperformed placebo in resolving definite nonalcoholic steatohepatitis (odds ratio [OR] 1.60, 95% confidence interval [CI] [1.04-2.48], p=0.03) and improving fibrosis (OR 2.23, 95% CI [1.56-3.20], p<0.0001), hepatocellular ballooning (OR 1.83, 95% CI [1.35-2.47], p<0.0001) and lobular inflammation (OR 1.62, 95% CI [1.13-2.32], p=0.009). OCA did not improve the enhanced liver fibrosis score and steatosis better than placebo, and demonstrated superior efficacy compared with the placebo in reducing serum alanine aminotransferase, aspartate aminotransferase and gamma-glutamyl transferase levels. Although a favourable effect of OCA over placebo was seen in body-weight reduction, the OCA use was associated with adverse changes in lipid parameters. Except for the greater risk of pruritus and constipation, the AE profile was comparable between the OCA and placebo groups. Conclusions. OCA has a favourable efficacy in improving liver histology and liver enzymes. However, the worsening of lipid parameters and other AEs with the OCA use warrants further investigation.

背景。奥贝胆酸(OCA)已成为治疗非酒精性脂肪肝(NAFLD)的一种有前途的药物。本荟萃分析旨在分析奥贝胆酸对非酒精性脂肪肝的治疗效果。方法:随机对照试验在电子数据库中搜索了非酒精性脂肪肝患者在干预组接受OCA治疗、在对照组接受安慰剂治疗的随机对照试验(RCT)。主要结果是非侵入性肝纤维化标志物和肝组织学的变化。次要结果包括肝酶、代谢参数与基线相比的变化以及不良事件(AEs)。研究结果有四项研究符合纳入标准,涉及 1,278 名受试者。临床使用 6 周至 18 个月期间,OCA 在缓解明确的非酒精性脂肪性肝炎(几率比 [OR] 1.60,95% 置信区间 [CI] [1.04-2.48],P=0.03)和改善肝纤维化(OR 2.23,95% CI [1.56-3.20],P=0.03)方面优于安慰剂。奥卡因在改善肝组织学和肝酶方面疗效显著。然而,使用奥卡因后血脂参数和其他AEs的恶化值得进一步研究。
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引用次数: 0
Teprotumumab's Impact on Proptosis in Long-duration Thyroid Eye Disease: A Systematic Review and Meta-analysis. 特罗单抗对长期甲状腺眼病突眼的影响:系统回顾与元分析》。
Pub Date : 2024-10-01 Epub Date: 2024-10-15 DOI: 10.17925/EE.2024.20.2.13
Nicholas A Householder, Coby Ray

Background: Long-duration thyroid eye disease (TED) may present with persistent proptosis despite the absence of inflammatory symptoms, and treatment options have been limited to surgical intervention. Recently, teprotumumab, a monoclonal antibody, has garnered interest as a non-surgical option to reduce proptosis in such cases. This systematic review investigates the impact of teprotumumab on reducing proptosis in long-duration TED. Methods: A search was conducted across major online databases, and data were aggregated from observational studies, clinical trials and case series. Nine studies met the inclusion criteria. Cumulative and weighted effect measures were synthesized. The biases and limitations of each study were assessed. Results: Existing evidence shows teprotumumab to be highly efficacious in reducing proptosis in chronic TED; however, there are significant limitations in the quality of existing evidence. The cumulative meta-analysis reveals a mean proptosis reduction of 3.05 ± 0.54 mm across 182 orbits from nine studies, and the weighted meta-analysis shows a mean reduction of 2.69 ± 0.53 mm across 172 orbits from eight studies. Discussion: While existing clinical studies are open to bias and intrinsically limited, the meta-analysis dilutes the risk of bias by weighting more precise evidence, providing the highest quality evidence to date. Further research is essential to understand teprotumumab's long-term efficacy and comparative advantages over surgical options. These findings have significant implications for treating persistent proptosis in patients with long-duration TED, potentially offering a non-surgical alternative where options were previously limited.

背景:病程较长的甲状腺眼病(TED)尽管没有炎症症状,但可能会出现持续性突眼,治疗方法仅限于手术干预。最近,一种单克隆抗体--替普鲁单抗作为一种非手术疗法引起了人们的兴趣,它可以减轻此类病例的突眼症状。本系统性综述研究了替普鲁单抗对减轻长期 TED 眼球突出的影响。方法:在主要在线数据库中进行搜索,并从观察性研究、临床试验和病例系列中汇总数据。九项研究符合纳入标准。对累积效应和加权效应进行了综合分析。对每项研究的偏倚性和局限性进行了评估。研究结果现有证据显示,替普鲁单抗在减少慢性 TED 的突眼方面具有很高的疗效;但是,现有证据的质量存在很大的局限性。累积荟萃分析显示,9项研究的182个眼眶的眼球突出平均减少了3.05 ± 0.54 mm,加权荟萃分析显示,8项研究的172个眼眶的眼球突出平均减少了2.69 ± 0.53 mm。讨论:虽然现有的临床研究可能存在偏倚,而且本身也有局限性,但荟萃分析通过对更精确的证据进行加权,稀释了偏倚风险,提供了迄今为止最高质量的证据。进一步的研究对于了解特普鲁单抗的长期疗效以及与手术方案的比较优势至关重要。这些研究结果对治疗长期TED患者的持续性突眼具有重要意义,有可能为以前选择有限的患者提供一种非手术疗法。
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引用次数: 0
The Approach to Patients with Disorders of Sex Development (DSD) in the Era of Precision Medicine: The Careful Use of Terminology. 精准医学时代的性发育障碍(DSD)患者治疗方法:谨慎使用术语。
Pub Date : 2024-10-01 Epub Date: 2024-03-28 DOI: 10.17925/EE.2024.20.2.4
Rodolfo A Rey

The term "DSD" was coined for "disorders of sex development", referring to conditions where the chromosomal, gonadal and/or genital sex is discordant or ambiguous, to replace terms considered imprecise and stigmatizing. Recently, the term "disorder" has been questioned and the term "differences" has been proposed as not stigmatizing, reflecting that the term DSD should be depathologized. In this opinion article, I discuss the importance of using precise technical terminologies amongst healthcare professionals, in the era of "precision medicine", to avoid misleading diagnoses or classifications while being extremely careful to use sensitive terminologies when interacting with patients and their families. On the other hand, I challenge the concept that DSD are not disorders.

DSD "一词是为 "性发育障碍 "而创造的,指染色体、性腺和/或生殖器性别不一致或不明确的情况,以取代被认为不准确和带有侮辱性的术语。最近,"失调 "一词受到质疑,有人提出 "差异 "一词不具有侮辱性,这反映出 DSD 一词应该去病理学化。在这篇观点文章中,我讨论了在 "精准医学 "时代,医护专业人员使用精确技术术语的重要性,以避免误导诊断或分类,同时在与患者及其家属交流时要特别注意使用敏感术语。另一方面,我对 "DSD 不是疾病 "这一概念提出了质疑。
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引用次数: 0
Dry Eye in Diabetes: The Indian Diabetic and Endocrine Eye Diseases (INDEED) Review. 糖尿病干眼症:印度糖尿病和内分泌眼病 (INDEED) 综述。
Pub Date : 2024-10-01 Epub Date: 2024-10-14 DOI: 10.17925/EE.2024.20.2.6
Sanjay Kalra, Nikhil Sharad Gokhale, Ganapathi Bantwal, Roopashri Matada, Shehla Shaikh, Varsha Pawar, Maneesha Khalse, Kamlesh Patel

Dry eye disease (DED) is an inadequately addressed condition in the diabetes management process and can significantly impact the quality of life and self-care. Therefore, it was imperative to review DED in the diabetic population. The aim of this article was to obtain insights into the correlation between dry eye and diabetes, with a focus on data published in the Indian population. A comprehensive literature review was performed using MEDLINE and Google Scholar, along with an internet-based search of publicly available information and peer-reviewed publications that may not have been indexed in these databases. The recommendations from several important societies for patients with DED have also been reviewed. Major aspects commonly associated with DED and diabetes have been addressed, and specific suggestions for screening, diagnosis and treatment have been described. Therefore, this review could be an invaluable resource for doctors managing patients with both conditions.

干眼症(DED)是糖尿病治疗过程中一个未得到充分解决的问题,会严重影响患者的生活质量和自我护理。因此,对糖尿病人群中的干眼症进行研究势在必行。本文旨在深入了解干眼症与糖尿病之间的相关性,重点关注在印度人群中发表的数据。我们使用 MEDLINE 和 Google Scholar 进行了全面的文献综述,同时还在互联网上搜索了可能未被这些数据库收录的公开信息和同行评审出版物。此外,还查阅了几个重要学会对 DED 患者的建议。其中讨论了与 DED 和糖尿病相关的主要方面,并介绍了有关筛查、诊断和治疗的具体建议。因此,这篇综述对于管理这两种疾病患者的医生来说是非常宝贵的资源。
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引用次数: 0
Efficacy and Safety of Novel Twincretin Tirzepatide, a Dual GIP/GLP-1 Receptor Agonist, as an Anti-obesity Medicine in Individuals Without Diabetes: A Systematic Review and Meta-analysis. 新型 Twincretin Tirzepatide(一种 GIP/GLP-1 双重受体激动剂)作为抗肥胖药物对非糖尿病患者的疗效和安全性:系统综述与元分析》。
Pub Date : 2024-10-01 Epub Date: 2024-06-06 DOI: 10.17925/EE.2024.20.2.10
Deep Dutta, A B M Kamrul-Hasan, Lakshmi Nagendra, Saptarshi Bhattacharya

Aims: To date, no meta-analysis has analyzed the efficacy and safety of tirzepatide as an anti-obesity medication in individuals without diabetes. This meta-analysis was undertaken to address this knowledge gap. Materials and methods: Electronic databases were searched for randomized controlled trials (RCTs) involving individuals with obesity without diabetes receiving tirzepatide in the intervention arm and placebo in the control arm. The primary outcome was the percentage change in weight from baseline, and the secondary outcomes included the change in weight from baseline; a weight reduction of ≥5%, ≥10%, ≥15%, ≥20% and ≥25%; glycaemic parameters; lipid parameters and adverse events. Results: From 281 initially screened articles, data from 2 RCTs involving 1,852 participants were analyzed. The efficacy and safety of tirzepatide 15 mg (or the highest tolerable dose) versus placebo were analyzed. The percentage change in body weight was higher with tirzepatide than with placebo (mean difference [MD]: -19.44%; 95% confidence interval [CI]: -22.48 to -16.41; p<0.00001). Tirzepatide also had a higher absolute reduction in body weight (MD: -17.55 kg; 95% CI: -32.15 to -2.95; p<0.00001). Higher percentages of people on tirzepatide had a weight reduction of ≥5%, ≥10%, ≥15%, ≥20% and ≥25% compared with placebo. Improvements in glycaemic and cardiometabolic parameters were observed with tirzepatide. Tirzepatide was associated with a higher number of participants with one or more adverse events, which leads to treatment discontinuation, and severe or serious gastrointestinal events. Conclusion: This meta-analysis provides exciting data on the impressive weight loss properties of tirzepatide over 72 weeks of clinical use in individuals with obesity without diabetes.

目的:迄今为止,还没有一项荟萃分析分析了替哌肽作为抗肥胖药物对非糖尿病患者的疗效和安全性。本荟萃分析旨在填补这一知识空白。材料和方法:在电子数据库中搜索了涉及无糖尿病肥胖症患者的随机对照试验(RCT),干预组服用替扎帕肽,对照组服用安慰剂。主要结果是体重与基线相比的百分比变化,次要结果包括体重与基线相比的变化;体重减轻≥5%、≥10%、≥15%、≥20%和≥25%;血糖参数;血脂参数和不良事件。结果:从初步筛选的 281 篇文章中,分析了 2 项 RCT 的数据,涉及 1,852 名参与者。分析了 15 毫克(或最高耐受剂量)替唑帕肽与安慰剂的疗效和安全性。与安慰剂相比,使用替扎帕肽后体重变化的百分比更高(平均差 [MD]:-19.44%;95% 置信区间 [CI]:-22.48 至 -16.41;p):这项荟萃分析提供了令人兴奋的数据,说明在对无糖尿病的肥胖症患者进行 72 周的临床治疗后,替扎帕肽具有令人印象深刻的减肥特性。
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引用次数: 0
Seliciclib: A New Treatment for Cushing's Disease? 塞利克利布(Seliciclib):库欣病的新疗法?
Pub Date : 2024-04-01 Epub Date: 2023-11-08 DOI: 10.17925/EE.2023.20.1.4
Eleni Armeni, Ashley Grossman

Previous studies have suggested that corticotroph tumours are associated with the overexpression of cyclin E and that the inactivation of cyclin-dependent kinases, which activate cyclin E, may have antisecretory and antiproliferative effects. Seliciclib, also known as R-roscovitine, is a pituitary-targeting agent shown to inhibit the growth of corticotroph tumour cells via cyclin E and retinoblastoma protein-mediated pathways. A recent study investigated the role of seliciclib in regulating biochemical parameters in a small number of patients with Cushing's disease, providing preliminary data on its possible therapeutic effectiveness in treating this disorder.

以往的研究表明,皮质营养肿瘤与细胞周期蛋白 E 的过度表达有关,而激活细胞周期蛋白 E 的细胞周期蛋白依赖性激酶失活可能具有抗分泌和抗增殖作用。Seliciclib 又称 R-roscovitine,是一种垂体靶向药物,可通过细胞周期蛋白 E 和视网膜母细胞瘤蛋白介导的途径抑制肾上腺皮质肿瘤细胞的生长。最近的一项研究调查了赛力昔单抗在调节少数库欣病患者生化指标方面的作用,为其在治疗这种疾病方面可能的疗效提供了初步数据。
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引用次数: 0
Challenges in Risk Stratification of Solid Atypical Mixed Echogenicity Thyroid Nodules. 对实性非典型混合回声甲状腺结节进行风险分层的挑战。
Pub Date : 2024-04-01 Epub Date: 2023-11-09 DOI: 10.17925/EE.2023.20.1.2
Evana Valenzuela-Scheker, David N Bimston, Hubert Golingan, Allan Golding, R Mack Harrell

Background: To determine the prevalence and risk of malignancy (ROM) in solid atypical mixed echogenicity thyroid nodules (SAMENs) with sonographic patterns not classifiable by the 2015 American Thyroid Association Ultrasound Risk Stratification System (NC ATA). Methods: We searched our prospectively collected endocrine surgery thyroid nodule (TN) database, with particular attention to those solid nodules that were NC ATA. An algorithm assigned each into one of the five ATA risk groups per the 2015 American Thyroid Association Ultrasound Risk Stratification System (ATA USRSS). TNs that the algorithm could not assign to a risk group were deemed NC ATA and were subsequently analyzed. Additionally, we categorized this group using an algorithm based on the 2017 American College of Radiology Thyroid Imaging Reporting and Data System (ACR-TIRADS). We were specifically interested in the characteristics that resulted in non-classification by the 2015 ATA USRSS and the fine needle aspiration biopsy (FNAB) cytology and surgical pathology results from the group. Results: We evaluated data from 5,040 nodules, of which 1,772 had surgical pathology. There were 150 solid nodules not classified by 2015 ATA USRSS, all of which demonstrated atypical features along with iso-, hetero-, hyper-and mixed echogenicity (solid atypical mixed echogenicity nodules-SAMENs). Sixty of these nodules were excised and sent for surgical pathology, while 90 were followed without surgical excision. Out of the 90 that did not undergo surgery, 82 underwent FNAB with cytologic evaluation. Of our 150 SAMENs, 40 were malignant by surgical histology and six were likely malignant by cytology (total SAMEN ROM without noninvasive follicular thyroid neoplasm with papillary-l ike nuclear features 31%). The most common sonographic pattern present in our SAMEN group consisted of an isoechoic solid component with microcalcifications (28/40-70% of all excised malignant nodules). In our excised malignant SAMENs, 50% demonstrated follicular-patterned neoplastic architecture while 48% displayed papillary architecture. Conclusion: Our study demonstrates that SAMENs with at least one suspicious sonographic feature: including (1) microcalcifications; (2) irregular or other suspicious margins,;opulation, and a higher ROM (31%) than the intermediate-risk group of the 2015 ATA USRSS (10-20%).

背景:目的:确定具有2015年美国甲状腺协会超声风险分层系统(NC ATA)无法分类的声像图模式的实性非典型混合回声甲状腺结节(SAMENs)的患病率和恶性风险(ROM)。研究方法我们搜索了前瞻性收集的内分泌手术甲状腺结节(TN)数据库,尤其关注那些属于 NC ATA 的实性结节。根据 2015 年美国甲状腺协会超声风险分层系统(ATA USRSS),一种算法将每个结节划分为五个 ATA 风险组之一。算法无法分配到风险组的 TN 被视为 NC ATA,随后进行分析。此外,我们还使用基于 2017 年美国放射学会甲状腺成像报告和数据系统(ACR-TIRADS)的算法对该组进行了分类。我们特别关注导致 2015 ATA USRSS 未分类的特征以及该组患者的细针穿刺活检 (FNAB) 细胞学和手术病理学结果。结果:我们评估了 5040 个结节的数据,其中 1772 个进行了手术病理检查。有150个实性结节未按2015 ATA USRSS分类,所有这些结节都表现出非典型特征,同时伴有等、异、高和混合回声(实性非典型混合回声结节-SAMENs)。其中 60 个结节被切除并送去做手术病理检查,90 个结节则没有做手术切除。在未进行手术的 90 个结节中,82 个进行了 FNAB 和细胞学评估。在我们的150例SAMEN中,40例经手术组织学检查为恶性,6例经细胞学检查可能为恶性(不伴有乳头状类核特征的非侵袭性滤泡性甲状腺肿瘤的SAMEN ROM总数占31%)。在我们的SAMEN组中,最常见的声像图模式是等回声实性成分伴微钙化(占所有切除恶性结节的28/40-70%)。在我们切除的恶性 SAMEN 中,50% 表现为滤泡型肿瘤结构,48% 表现为乳头状结构。结论我们的研究表明,SAMENs至少有一个可疑的声像图特征:包括(1)微钙化;(2)边缘不规则或其他可疑特征;opulation,且ROM(31%)高于2015 ATA USRSS的中危组(10-20%)。
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引用次数: 0
Clinical Pharmacology of Oral Octreotide Capsules for the Treatment of Acromegaly. 口服奥曲肽胶囊治疗肢端肥大症的临床药理学。
Pub Date : 2024-04-01 Epub Date: 2024-01-22 DOI: 10.17925/EE.2024.20.1.9
Meliha Melin Uygur, Marta Villanova, Stefano Frara, Andrea Giustina

The primary goal of acromegaly treatment is to normalize biochemical parameters as it significantly reduces the risks of complications and comorbidities associated with the disease. First-line medical treatment is commonly represented by injectable somatostatin analogues (SRLs) after surgery. In June 2020, with the integration of Transient Permeation Enhancer® technology, oral octreotide capsules (OOCs) received regulatory approval from the US Food and Drug Administration for long-term maintenance treatment in patients with acromegaly who have responded to and tolerated treatment with octreotide or lanreotide. We reviewed the clinical pharmacological data on the development and clinical use of OOCs. The pharmacokinetic and pharmacodynamic data on OOCs showed a dose-dependent increase in octreotide levels and remarkable suppression of growth hormone secretion. The efficacy and safety of OOCs were investigated in four clinical trials conducted on patients with complete or partially controlled acromegaly. The trials resulted in the maintenance of biochemical control after switching from injectable SRLs to OOCs, with a comparable side-effect profile. Moreover, the acromegaly symptoms improved in patients on OOC. The data showed a patient preference to continue in the OOC arm for the extension phase of the trials. From the clinical pharmacological perspective, oral formulation of octreotide has the advantage of efficacy and safety with respect to injectable octreotide.

肢端肥大症治疗的首要目标是使生化指标恢复正常,因为这可以大大降低与该疾病相关的并发症和合并症的风险。一线药物治疗通常以手术后注射用体生长抑素类似物(SRL)为代表。2020 年 6 月,口服奥曲肽胶囊(OOCs)整合了瞬时渗透增强剂® 技术,获得了美国食品药品管理局的监管批准,用于对奥曲肽或兰瑞肽治疗有反应且耐受的肢端肥大症患者的长期维持治疗。我们回顾了有关 OOCs 开发和临床应用的临床药理数据。OOCs 的药代动力学和药效学数据显示,奥曲肽水平的升高呈剂量依赖性,生长激素分泌受到显著抑制。在对完全或部分受控的肢端肥大症患者进行的四项临床试验中,对 OOCs 的疗效和安全性进行了研究。试验结果表明,从注射用 SRLs 转为 OOCs 后,生化控制得以维持,且副作用不相上下。此外,使用 OOC 的患者的肢端肥大症症状也有所改善。数据显示,在试验的延长阶段,患者更倾向于继续服用口服OCT。从临床药理角度来看,口服奥曲肽制剂在疗效和安全性方面均优于注射奥曲肽。
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引用次数: 0
Oral Octreotide Capsules and Paltusotine in Management of Acromegaly. 口服奥曲肽胶囊和帕曲肽治疗肢端肥大症。
Pub Date : 2024-04-01 Epub Date: 2023-11-08 DOI: 10.17925/EE.2023.20.1.3
David S McLaren, Khyatisha Seejore, Julie Lynch, Robert D Murray

Injectable somatostatin receptor ligands (iSRL) are the most frequently utilized medical therapy in patients with acromegaly; however, satisfaction rates are suboptimal. Injections can result in local erythema, discomfort and subcutaneous nodule formation, encompassed with the inconvenience of attending either primary or secondary care medical facilities for injections every 4 weeks. Some patients also note breakthrough of acromegaly-related symptoms towards the end of the injection cycle. To improve acceptance and ultimately improve wellbeing of these individuals, two oral SRLs, oral octreotide capsules (OOC) and paltusotine, have been developed. The OOC combines an enteric coating to allow delivery to the small intestines and a transient permeability enhancer to enable oral bioavailability. Comparable octreotide levels are obtained with twice-daily OOC and subcutaneous octreotide 100 µg. Phase III studies show OOC to maintain equivalent biochemical control in at least 60% of patients previously receiving a stable dose of iSRL. In longer-term studies, the response to OOC was durable up to 3 years. Paltusotine is a novel potent orally available non-peptidyl somatostatin receptor subtype-2 ligand. Studies in healthy volunteers show dose-dependent suppression of growth hormone-releasing hormone-induced growth hormone secretion and suppression of insulin-like growth factor-I (IGF-I) with repeat doses. In the recent phase II study, patients with acromegaly who were partial responders (IGF-I 1.0 - 2.5 x upper limit of normal) to monotherapy with iSRL when switched to once-daily paltusotine maintained control of IGF-I within 20% of baseline or lower in 87% after 13 weeks. Adverse events with both OOC and paltusotine were reflective of those recognized with iSRL and occurred at a similar frequency. OOC and paltusotine are well-received additions to the therapeutic armamentarium in medical therapy for the management of acromegaly; however, further data on efficacy, tumour control and shrinkage are required to allow positioning of this medication within the management algorithm for acromegaly.

注射用体生长抑素受体配体(iSRL)是肢端肥大症患者最常用的药物疗法,但满意率却不尽如人意。注射会导致局部红斑、不适和皮下结节的形成,每 4 周还需前往初级或二级医疗机构进行注射,十分不便。一些患者还注意到,在注射周期即将结束时,与肢端肥大症相关的症状会有所突破。为了提高这些患者的接受度并最终改善他们的健康状况,我们开发了两种口服SRL,即口服奥曲肽胶囊(OOC)和帕妥索汀。口服奥曲肽胶囊结合了肠溶衣和瞬时渗透增强剂,前者可将奥曲肽输送到小肠,后者可提高口服生物利用度。每天两次的 OOC 和皮下注射奥曲肽 100 µg 可获得相似的奥曲肽水平。III 期研究显示,在之前接受稳定剂量 iSRL 治疗的患者中,至少有 60% 的患者使用 OOC 可维持同等的生化控制。在长期研究中,对 OOC 的反应可持续 3 年之久。Paltusotine 是一种新型强效口服非肽基体生长抑素受体亚型-2 配体。对健康志愿者的研究显示,该药对生长激素释放激素诱导的生长激素分泌和胰岛素样生长因子-I(IGF-I)的抑制与重复剂量有关。在最近的 II 期研究中,对 iSRL 单药治疗部分应答(IGF-I 为正常值上限的 1.0 - 2.5 倍)的肢端肥大症患者在改用每日一次的帕曲托汀治疗 13 周后,87% 的患者的 IGF-I 控制在基线的 20% 或更低水平。OOC和帕妥索汀的不良反应与iSRL的不良反应相似,发生频率也相似。在治疗肢端肥大症的药物疗法中,OOC和帕妥索汀是备受欢迎的新药;然而,还需要更多有关疗效、肿瘤控制和缩小的数据,才能将这种药物纳入肢端肥大症的治疗方案中。
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TouchREVIEWS in endocrinology
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