Clinical therapeutics最新文献

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The Impact of Azithromycin on Lung Function in Children And Adolescents with Cystic Fibrosis: A Systematic Review And Meta-Analysis 阿奇霉素对儿童和青少年囊性纤维化患者肺功能的影响:一项系统综述和荟萃分析
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-10-01 DOI: 10.1016/j.clinthera.2025.07.008
Kangping Wu MBBS , Suling Wu MBBS , Lina Wang MMed
{"title":"The Impact of Azithromycin on Lung Function in Children And Adolescents with Cystic Fibrosis: A Systematic Review And Meta-Analysis","authors":"Kangping Wu MBBS ,&nbsp;Suling Wu MBBS ,&nbsp;Lina Wang MMed","doi":"10.1016/j.clinthera.2025.07.008","DOIUrl":"10.1016/j.clinthera.2025.07.008","url":null,"abstract":"<div><h3>Purpose</h3><div>This study aims to evaluate the effects of azithromycin on lung function in children with cystic fibrosis (CF) through a systematic review and meta-analysis of randomized controlled trials (RCTs). The study primarily focuses on its impact on FEV1 (forced expiratory volume in 1 second), FVC (forced vital capacity), and the progression of lung function decline.</div></div><div><h3>Methods</h3><div>Electronic searches were conducted across PubMed,Cochrane Central, Embase, Web of Science, and China National Knowledge Infrastructure databases, including studies published up to November 1, 2024. Inclusion criteria required RCTs involving children with CF, azithromycin as the intervention, and placebo controls. Meta-analyses were performed using random-effects models, and heterogeneity was assessed using the I² statistic. Sensitivity analyses were conducted to ensure the robustness of results.</div></div><div><h3>Findings</h3><div>Eight RCTs were included, covering a total of 625 participants. Meta-analysis revealed that azithromycin significantly improved FEV1 compared to the control group, with a standardized mean difference (SMD) of 0.58 (95% CI: 0.03–1.14), though substantial heterogeneity was observed (I² = 82.8%). However, no statistically significant improvement in FVC was detected (SMD: 0.62, 95% CI: -0.04 to 1.29, I² = 85.4%). Additionally, azithromycin reduced the relative risk of lung function decline (RR: 0.79, 95% CI: 0.62–1.00), with moderate heterogeneity (I² = 45.5%). Sensitivity analyses confirmed the stability of these results.</div></div><div><h3>Implications</h3><div>Azithromycin shows potential in improving FEV1 and slowing lung function decline in children with cystic fibrosis, likely through its anti-inflammatory and immunomodulatory effects. Further large-scale studies are warranted to confirm its long-term efficacy, evaluate safety, and optimize treatment strategies, including potential combination therapies.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 10","pages":"Pages 918-924"},"PeriodicalIF":3.6,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144793697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Association of Plasma Septin9 Methylation Status With Therapeutic Response to Antitumor Agents in Colorectal Cancer Patients 结直肠癌患者血浆Septin9甲基化状态与抗肿瘤药物治疗反应的关系
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-10-01 DOI: 10.1016/j.clinthera.2025.07.005
Han Shan MS , Qiong Du MS , Mengmeng Wang MS
{"title":"Association of Plasma Septin9 Methylation Status With Therapeutic Response to Antitumor Agents in Colorectal Cancer Patients","authors":"Han Shan MS ,&nbsp;Qiong Du MS ,&nbsp;Mengmeng Wang MS","doi":"10.1016/j.clinthera.2025.07.005","DOIUrl":"10.1016/j.clinthera.2025.07.005","url":null,"abstract":"<div><h3>Purpose</h3><div>Although the diagnostic potential of septin 9 methylation (mSEPT9) in colorectal cancer (CRC) has been well documented in numerous studies, its predictive role in determining therapeutic response to antitumor agents among patients with advanced CRC remains unexplored.</div></div><div><h3>Methods</h3><div>This real-world, large-scale retrospective study analyzed 1098 CRC cases selected from a comprehensive database of 1490 patients who underwent mSEPT9 testing. We first investigated the association between mSEPT9 status and clinicopathological characteristics in the overall CRC cohort. Subsequently, in a subset of 479 stage IV CRC patients receiving systemic antitumor therapy, we evaluated the predictive value of mSEPT9 status by assessing treatment outcomes, including objective response rate (ORR) and progression-free survival (PFS).</div></div><div><h3>Findings</h3><div>mSEPT9 positivity was significantly elevated in stage Ⅳ versus stage Ⅰ–Ⅲ patients and correlated with Eastern Cooperative Oncology Group (ECOG) score, but not with other clinicopathological features. mSEPT9-positive patients demonstrated significantly higher ORR to fluoropyrimidines, oxaliplatin, and bevacizumab compared with mSEPT9-negative patients, whereas no significant ORR differences were observed for irinotecan or cetuximab. Conversely, mSEPT9-positive patients showed shorter PFS with fluoropyrimidines, oxaliplatin, irinotecan, and cetuximab, but comparable PFS with bevacizumab between the 2 groups.</div></div><div><h3>Implications</h3><div>mSEPT9 status significantly correlated with CRC stage and ECOG score, influencing antitumor agents efficacy in advanced CRC. Although mSEPT9-positive patients showed higher ORR to certain agents, they exhibited shorter PFS, suggesting more aggressive tumor biology. Bevacizumab appeared to partially counteract the adverse prognostic impact of mSEPT9 positivity. This first demonstration of mSEPT9′s predictive value for advanced CRC treatment outcomes provides new insights for personalized therapy.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 10","pages":"Pages 830-836"},"PeriodicalIF":3.6,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144768446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical Study of Cardiac Electrophysiology Affected After Percutaneous Transluminal Septal Myocardial Ablation for Obstructive Cardiomyopathy. 阻塞性心肌病经皮腔内间隔心肌消融术对心脏电生理的影响。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-10-01 DOI: 10.1016/j.clinthera.2025.09.006
Tianzhu Li, Jinzhao Li, Jun Zhang, Nimin Lu
{"title":"Clinical Study of Cardiac Electrophysiology Affected After Percutaneous Transluminal Septal Myocardial Ablation for Obstructive Cardiomyopathy.","authors":"Tianzhu Li, Jinzhao Li, Jun Zhang, Nimin Lu","doi":"10.1016/j.clinthera.2025.09.006","DOIUrl":"https://doi.org/10.1016/j.clinthera.2025.09.006","url":null,"abstract":"<p><strong>Purpose: </strong>Hypertrophic cardiomyopathy has an estimated prevalence of approximately 1/200, driven by advancements in genetic testing and high-sensitivity cardiac imaging. This study evaluates the efficacy of percutaneous transluminal septal myocardial ablation (PTSMA) in treating hypertrophic obstructive cardiomyopathy (HOCM) and its impact on cardiac electrophysiology.</p><p><strong>Methods: </strong>A cohort of 38 patients with HOCM, admitted between June 2022 and June 2023, underwent PTSMA. Cardiac function classifications, interventricular septal thickness, left ventricular end-diastolic diameter (LVEDD), left ventricular outflow tract (LVOT) diameter, mitral valve early diastolic velocity (E peak), mitral annular early diastolic velocity (e'), and cardiac electrophysiological parameters (Tp-Te interval and QTcd) were assessed before and 1 month postprocedure.</p><p><strong>Findings: </strong>One month post-PTSMA, significant reductions were observed in cardiac function classification, interventricular septal thickness, and E/e' ratio (P < 0.05), alongside increases in LVEDD and LVOT diameter (P < 0.05). The Tp-Te interval and QTcd were significantly shortened (P < 0.05).</p><p><strong>Implications: </strong>PTSMA shows potential to improve cardiac function and reduce LVOT obstruction in HOCM patients, with favorable effects on cardiac electrophysiology. However, further multi-center studies with long-term follow-up are required to validate these findings and establish its broader therapeutic role.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145212038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Retraction notice to “Models for the prediction of mycophenolic acid area under the curve using a limited-sampling strategy and an enzyme multiplied immunoassay technique in chinese patients undergoing liver transplantation” [Clinical Therapeutics 30 (2008) 2387-2401] 关于“利用有限采样策略和酶倍增免疫测定技术预测中国肝移植患者霉酚酸曲线下面积的模型”的撤回通知[临床治疗学30 (2008)2387-2401]
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-10-01 DOI: 10.1016/j.clinthera.2025.08.008
Hao Chen MD, PhD , Zhidong Gu MD , Bing Chen MD, PhD , Huarong Mao MD , Weixia Zhang MD, PhD , Qishi Fan MD
{"title":"Retraction notice to “Models for the prediction of mycophenolic acid area under the curve using a limited-sampling strategy and an enzyme multiplied immunoassay technique in chinese patients undergoing liver transplantation” [Clinical Therapeutics 30 (2008) 2387-2401]","authors":"Hao Chen MD, PhD ,&nbsp;Zhidong Gu MD ,&nbsp;Bing Chen MD, PhD ,&nbsp;Huarong Mao MD ,&nbsp;Weixia Zhang MD, PhD ,&nbsp;Qishi Fan MD","doi":"10.1016/j.clinthera.2025.08.008","DOIUrl":"10.1016/j.clinthera.2025.08.008","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 10","pages":"Page 956"},"PeriodicalIF":3.6,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145236448","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Access to EU-Authorized Nonreimbursed Anticancer Medicines: An Explorative Survey Among Dutch Medical Oncologists 获得欧盟批准的非报销抗癌药物:荷兰医学肿瘤学家的探索性调查。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-10-01 DOI: 10.1016/j.clinthera.2025.07.003
H. Colinda Post , Charlotte H. C. Bomhof , Maartje Schermer , Carla E. M. Hollak , Hanneke W. M. van Laarhoven , Tim Schutte , Eline M. Bunnik
{"title":"Access to EU-Authorized Nonreimbursed Anticancer Medicines: An Explorative Survey Among Dutch Medical Oncologists","authors":"H. Colinda Post ,&nbsp;Charlotte H. C. Bomhof ,&nbsp;Maartje Schermer ,&nbsp;Carla E. M. Hollak ,&nbsp;Hanneke W. M. van Laarhoven ,&nbsp;Tim Schutte ,&nbsp;Eline M. Bunnik","doi":"10.1016/j.clinthera.2025.07.003","DOIUrl":"10.1016/j.clinthera.2025.07.003","url":null,"abstract":"<div><h3>Purpose</h3><div>Timelines for market authorization and reimbursement for anticancer medicines differ across European countries. Therefore, medical oncologists may face periods when promising anticancer medicines are not reimbursed, prompting ethical concerns about equitable access, particularly in publicly funded healthcare systems, such as the Netherlands. This study explores Dutch medical oncologists’ experiences and moral perspectives regarding access to EU-authorized nonreimbursed anticancer medicines and assesses practice variation.</div></div><div><h3>Methods</h3><div>A survey targeted 378 Dutch medical oncologists from all hospitals to explore their experiences, perspectives, and perceived responsibilities, as well as hospital policies regarding nonreimbursed EU-authorized anticancer medicines and their opinions on out-of-pocket payments and information provision.</div></div><div><h3>Findings</h3><div>Responses were provided by 132 medical oncologists (response rate of 34.9%), with 104 (78.8%) reporting that they sought access to nonreimbursed medicines in the past three years for one or more patients, primarily through manufacturer-funded “free-of-charge” programs (<em>n</em> = 77/104; 74,0%), clinical trials referral (<em>n</em> = 46/104; 44.2%) or clinical trials at their own hospital (<em>n</em> = 45/104; 43.3%), insurance leniency (<em>n</em> = 45/104; 43.3%), or the Dutch Drug Access Protocol (<em>n</em> = 42/104; 40.4%). While 48.5% felt responsible for seeking access to nonreimbursed medicines, 40.9% did not. Respondents mentioned different hospital policies on drug access. In the past three years, 69.5% (<em>n</em> = 91/131) of respondents had received patient inquiries about out-of-pocket (OOP) payment, but only 3.1% (<em>n</em> = 4/131) had actually prescribed OOP financed medicines. Fewer than half of the respondents (44.7%; <em>n</em> = 59/132) informed patients about nonreimbursed treatment options. Oncologists expressed strong concerns about financial toxicity, inequities in access, and threats to solidarity-based health care.</div></div><div><h3>Implications</h3><div>The majority of Dutch medical oncologists encounter EU-authorized, nonreimbursed anticancer medicines and report substantial variation in related practices and ethical views. In the absence of a national access framework, availability often depends on individual physicians, leading to potential inequities. National regulation is recommended to ensure consistent and equitable access for all patients.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 10","pages":"Pages 894-903"},"PeriodicalIF":3.6,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144728484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Genetic Polymorphisms as Treatment Biomarkers for Gynecological Malignancies Treated With Carboplatin and Paclitaxel: A Systematic Review 遗传多态性作为卡铂和紫杉醇治疗妇科恶性肿瘤的治疗生物标志物:系统综述。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-10-01 DOI: 10.1016/j.clinthera.2025.07.012
Nadine de Godoy Torso MSc , Yasmim Gabriele Matos PharmB , Giovana Fernanda Santos Fidelis BPharm , Carolina Dagli-Hernandez PhD , Marília Berlofa Visacri PhD , Eder de Carvalho Pincinato PhD , Jefman Efendi Marzuki MD , Baharuddin Baharuddin MSc , Paulo Caleb J.L. Santos PhD , Patricia Moriel PhD
{"title":"Genetic Polymorphisms as Treatment Biomarkers for Gynecological Malignancies Treated With Carboplatin and Paclitaxel: A Systematic Review","authors":"Nadine de Godoy Torso MSc ,&nbsp;Yasmim Gabriele Matos PharmB ,&nbsp;Giovana Fernanda Santos Fidelis BPharm ,&nbsp;Carolina Dagli-Hernandez PhD ,&nbsp;Marília Berlofa Visacri PhD ,&nbsp;Eder de Carvalho Pincinato PhD ,&nbsp;Jefman Efendi Marzuki MD ,&nbsp;Baharuddin Baharuddin MSc ,&nbsp;Paulo Caleb J.L. Santos PhD ,&nbsp;Patricia Moriel PhD","doi":"10.1016/j.clinthera.2025.07.012","DOIUrl":"10.1016/j.clinthera.2025.07.012","url":null,"abstract":"<div><h3>Purpose</h3><div>Gynecological tumors, which correspond to the group of neoplasms that affect the female reproductive system, have high incidence and mortality rates. This systematic review aimed to summarize the most recent advances in identifying pharmacogenetic variants associated with the clinical outcomes of carboplatin-paclitaxel chemotherapy in these patients.</div></div><div><h3>Methods</h3><div>A comprehensive literature search was conducted across eight databases to identify studies published up to July 17, 2024. Two reviewers independently selected the studies and extracted the data; disagreements were resolved by two additional reviewers.</div></div><div><h3>Findings</h3><div>Out of the 2375 records that were found, only 20 met the eligibility criteria. The main findings were: (1) The three most extensively investigated genes were ATP binding cassette subfamily C member 1 (<em>ABCB1</em>), cytochrome P450 2C8 (<em>CYP2C8</em>), and glutathione S-transferase P1 (<em>GSTP1</em>); (2) three variants, rs1128503 (<em>ABCB1</em>), rs10509681 and rs11572080 (<em>CYPC28</em>), appear to have a significant association with important adverse drug reactions (in particular, neutropenia, thrombocytopenia, and peripheral sensory neuropathy). Others, as is the case with rs1045642 (<em>ABCB1</em>) and rs1695 (<em>GSTP1</em>), have inconsistent results, and the extent to which these results can be extrapolated is still limited; and (c) most of the included studies concerned Asian or European patients.</div></div><div><h3>Implications</h3><div>Therefore, future research should include more extensive analyses with more inclusive cohorts. As a limitation of the study, a meta-analysis was not possible due to the significant heterogeneity among the studies.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 10","pages":"Pages 904-917"},"PeriodicalIF":3.6,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144816026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Real-World Utilization Patterns of Immune Checkpoint Inhibitors Based on the National Health Insurance Service Data in Korea 基于韩国国民健康保险服务数据的免疫检查点抑制剂的实际使用模式。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-10-01 DOI: 10.1016/j.clinthera.2025.07.014
Eunji Kim MS , Yu-Seon Jung PhD , Jongmin Lee PharmD, MS , Dal Ri Nam PharmD, MS , Seung-Hun You PhD , Ju Won Lee MS , Sook Ryun Park MD, PhD , Ji Seon Oh MD, PhD , Ye-Jee Kim PhD , Eun-Jung Jo MD, PhD , Nakyung Jeon PhD , Won-Jung Jung , Sun-Young Jung PhD
{"title":"Real-World Utilization Patterns of Immune Checkpoint Inhibitors Based on the National Health Insurance Service Data in Korea","authors":"Eunji Kim MS ,&nbsp;Yu-Seon Jung PhD ,&nbsp;Jongmin Lee PharmD, MS ,&nbsp;Dal Ri Nam PharmD, MS ,&nbsp;Seung-Hun You PhD ,&nbsp;Ju Won Lee MS ,&nbsp;Sook Ryun Park MD, PhD ,&nbsp;Ji Seon Oh MD, PhD ,&nbsp;Ye-Jee Kim PhD ,&nbsp;Eun-Jung Jo MD, PhD ,&nbsp;Nakyung Jeon PhD ,&nbsp;Won-Jung Jung ,&nbsp;Sun-Young Jung PhD","doi":"10.1016/j.clinthera.2025.07.014","DOIUrl":"10.1016/j.clinthera.2025.07.014","url":null,"abstract":"<div><h3>Purpose</h3><div>This study was conducted to comprehensively understand the utilization patterns of immune checkpoint inhibitors (ICIs) in Korea, including their use in combination with traditional anticancer therapies.</div></div><div><h3>Methods</h3><div>We investigated the utilization of ICIs using claims data from Korea between 2017 and 2022. Patients with cancer were included in the study if they received at least one dose of ICIs, defined by drug codes in the claims data. We used descriptive statistics to identify patterns of ICIs use in combination with other anticancer therapies and ICIs use by year and cancer type.</div></div><div><h3>Findings</h3><div>During the study period, 41,208 patients received at least one dose of ICIs. Lung cancer (66.6%), urinary tract cancer (11.3%), and liver/biliary tract cancer (10.6%) were the most frequent cancer types. The prescription of ICIs particularly surged between 2020 and 2022 for liver/biliary tract cancer. Between 2017 and 2022, the use of ICIs increased from 1,155 to 15,034, with an increase every year. Since 2020, the use of ICIs in combination with other anticancer therapies and concurrent use of ICIs has increased sharply.</div></div><div><h3>Implications</h3><div>The number of patients utilizing ICIs in Korea has been steadily increasing. As regulatory approval of indications for ICIs has expanded, so has the range of indications for ICIs. In addition, the combination of ICIs with other anticancer therapies and the concurrent use of ICIs has increased in recent years, reflecting expanded treatment options for advanced cancers.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 10","pages":"Pages 837-843"},"PeriodicalIF":3.6,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144858973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparison of Combined Letrozole and Clomiphene Citrate With Gonadotropin Microstimulation Protocols on Fertility Outcomes 来曲唑与枸橼酸克罗米芬联合应用与促性腺激素微刺激方案对生育结果的比较。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-10-01 DOI: 10.1016/j.clinthera.2025.07.025
Na Zhou MSc, Jiao Xu BSc, Ling Liu PhD, Yichen Yang BSc, Xuejiao Fan MSc, Haiqin Ren MSc
{"title":"Comparison of Combined Letrozole and Clomiphene Citrate With Gonadotropin Microstimulation Protocols on Fertility Outcomes","authors":"Na Zhou MSc,&nbsp;Jiao Xu BSc,&nbsp;Ling Liu PhD,&nbsp;Yichen Yang BSc,&nbsp;Xuejiao Fan MSc,&nbsp;Haiqin Ren MSc","doi":"10.1016/j.clinthera.2025.07.025","DOIUrl":"10.1016/j.clinthera.2025.07.025","url":null,"abstract":"<div><h3>Purpose</h3><div>Large-scale data comparing the effects of combined letrozole (LE) and clomiphene citrate (CC) with gonadotropin (Gn) microstimulation protocols on pregnancy outcomes are lacking. This study aimed to compare the effects of CC + Gn and LE + Gn microstimulation protocols on fertility outcomes.</div></div><div><h3>Methods</h3><div>A retrospective cohort study was conducted to include infertile patients between January 1, 2018, and December 31, 2022. All patients underwent a microstimulation protocol and treatment was administered using either CC + Gn or LE + Gn. The main study outcomes included clinical pregnancy, miscarriage, and live birth rates.</div></div><div><h3>Findings</h3><div>Of the 1697 included patients, 875 were treated with CC + Gn, while the remaining 822 were treated with LE + Gn. We noted that CC + Gn was associated with a lower clinical pregnancy rate (odds ratio (OR): 0.324; 95% confidence interval (CI): 0.127–0.829; <em>P</em> = 0.019) and live birth rate (OR: 0.332; 95% CI: 0.112–0.988; <em>P</em> = 0.048) than LE + Gn; however, there was no significant difference between CC + Gn and LE + Gn regarding the abortion rate (OR: 0.523; 95% CI: 0.028–9.720; <em>P</em> = 0.664). Moreover, there were significant differences between the CC + Gn and LE + Gn groups in the number of embryos transferred (<em>P</em> &lt; 0.001), number of frozen embryos (<em>P</em> &lt; 0.001), and number of embryos at the frozen cleavage stage (<em>P</em> = 0.002).</div></div><div><h3>Implications</h3><div>LE + Gn microstimulation protocol was associated with better fertility outcomes than CC + Gn in terms of clinical pregnancy and live birth rates in patients with infertility.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 10","pages":"Pages 884-888"},"PeriodicalIF":3.6,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Leveraging Real-world Evidence for Antihypertensive Fixed-dose Combinations: A Multidimensional Narrative Review From European Industry Perspective 利用真实世界的证据抗高血压固定剂量组合:从欧洲工业角度的多维叙事回顾。
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-10-01 DOI: 10.1016/j.clinthera.2025.07.024
Mariusz Mogielnicki MPharm , Volodymyr Stus MD , Artur Banaszak MD, MBA
{"title":"Leveraging Real-world Evidence for Antihypertensive Fixed-dose Combinations: A Multidimensional Narrative Review From European Industry Perspective","authors":"Mariusz Mogielnicki MPharm ,&nbsp;Volodymyr Stus MD ,&nbsp;Artur Banaszak MD, MBA","doi":"10.1016/j.clinthera.2025.07.024","DOIUrl":"10.1016/j.clinthera.2025.07.024","url":null,"abstract":"<div><h3>Purpose</h3><div>Real-world data (RWD) and real-world evidence (RWE) offer significant potential for clinical development and clinical evidence generation. This review addresses the complexity surrounding the use of RWD and RWE in drug repurposing, such as antihypertensive fixed-dose combinations of known compounds from the 5 major pharmacological classes.</div></div><div><h3>Methods</h3><div>We performed a narrative review examining RWD and RWE use in the development and registration of antihypertensive fixed-dose combinations, covering their role as examples of value-added medicines, regulatory policies, scientific perceptions, application in hypertension research, regulatory use cases, and economic factors.</div></div><div><h3>Findings</h3><div>Well-designed RWE studies can yield clinical performance data comparable with findings of randomized controlled trials while addressing certain limitations. However, current European Union (EU) legislation regarding the usability of RWD and RWE is conservative and needs to be updated. Divergent opinions among EU member states pose uncertainty and risk for industry in marketing authorization applications involving RWD and RWE.</div></div><div><h3>Implications</h3><div>Real-world data and RWE offer a transformative opportunity through data sourced beyond traditional clinical trials. This approach can expedite regulatory decisions, reduce development timelines and costs, and accelerate the delivery of valuable therapies to patients. Discussions at the centralized EU regulatory level are needed to recognize and accept RWE as valid for demonstrating clinical efficacy and safety.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 10","pages":"Pages 935-943"},"PeriodicalIF":3.6,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
BRINSUPRI (brensocatib)
IF 3.6 4区 医学
Clinical therapeutics Pub Date : 2025-10-01 DOI: 10.1016/j.clinthera.2025.08.011
Paul Beninger MD, MBA
{"title":"BRINSUPRI (brensocatib)","authors":"Paul Beninger MD, MBA","doi":"10.1016/j.clinthera.2025.08.011","DOIUrl":"10.1016/j.clinthera.2025.08.011","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 10","pages":"Pages 952-953"},"PeriodicalIF":3.6,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145085104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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