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Efficacy and dose-response relationships of antidepressants in the acute treatment of major depressive disorders: a systematic review and network meta-analysis. 抗抑郁药急性治疗重度抑郁障碍的疗效和剂量反应关系:系统综述和网络荟萃分析。
IF 7.5 3区 医学
Chinese Medical Journal Pub Date : 2025-06-20 Epub Date: 2024-06-20 DOI: 10.1097/CM9.0000000000003138
Shuzhe Zhou, Pei Li, Xiaozhen Lyu, Xuefeng Lai, Zuoxiang Liu, Junwen Zhou, Fengqi Liu, Yiming Tao, Meng Zhang, Xin Yu, Jingwei Tian, Feng Sun
{"title":"Efficacy and dose-response relationships of antidepressants in the acute treatment of major depressive disorders: a systematic review and network meta-analysis.","authors":"Shuzhe Zhou, Pei Li, Xiaozhen Lyu, Xuefeng Lai, Zuoxiang Liu, Junwen Zhou, Fengqi Liu, Yiming Tao, Meng Zhang, Xin Yu, Jingwei Tian, Feng Sun","doi":"10.1097/CM9.0000000000003138","DOIUrl":"10.1097/CM9.0000000000003138","url":null,"abstract":"<p><strong>Background: </strong>The optimal antidepressant dosages remain controversial. This study aimed to analyze the efficacy of antidepressants and characterize their dose-response relationships in the treatments of major depressive disorders (MDD).</p><p><strong>Methods: </strong>We searched multiple databases, including the Embase, Cochrane Central Register of Controlled Trials, PubMed, and Web of Science, for the studies that were conducted between January 8, 2016, and April 30, 2023. The studies are double-blinded, randomized controlled trials (RCTs) involving the adults (≥18 years) with MDD. The primary outcomes were efficacy of antidepressant and the dose-response relationships. A frequentist network meta-analysis was conducted, treating participants with various dosages of the same antidepressant as a single therapy. We also implemented the model-based meta-analysis (MBMA) using a Bayesian method to explore the dose-response relationships.</p><p><strong>Results: </strong>The network meta-analysis comprised 135,180 participants from 602 studies. All the antidepressants were more effective than the placebo; toludesvenlafaxine had the highest odds ratio (OR) of 4.52 (95% confidence interval [CI]: 2.65-7.72), and reboxetine had the lowest OR of 1.34 (95%CI: 1.14-1.57). Moreover, amitriptyline, clomipramine, and reboxetine showed a linear increase in effect size from low to high doses. The effect size of toludesvenlafaxine increased significantly up to 80 mg/day and subsequently maintained the maximal dose up to 160 mg/day while the predictive curves of nefazodone were fairly flat in different dosages.</p><p><strong>Conclusions: </strong>Although most antidepressants were more efficacious than placebo in treating MDD, no consistent dose-response relationship between any antidepressants was observed. For most antidepressants, the maximum efficacy was achieved at lower or middle prescribed doses, rather than at the upper limit.</p><p><strong>Registration: </strong>No. CRD42023427480; https://www.crd.york.ac.uk/prospero/display_record.php?</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"1433-1438"},"PeriodicalIF":7.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12180811/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141431502","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
Association between life's essential 8 and risk of heart failure: A prospective community-based study. 生活必需品与心力衰竭风险之间的关系:一项前瞻性社区研究。
IF 7.5 3区 医学
Chinese Medical Journal Pub Date : 2025-06-20 Epub Date: 2025-04-16 DOI: 10.1097/CM9.0000000000003598
Zhijun Wu, Zhe Huang, Yaqi Li, Shuohua Chen, Shouling Wu, Xiang Gao
{"title":"Association between life's essential 8 and risk of heart failure: A prospective community-based study.","authors":"Zhijun Wu, Zhe Huang, Yaqi Li, Shuohua Chen, Shouling Wu, Xiang Gao","doi":"10.1097/CM9.0000000000003598","DOIUrl":"10.1097/CM9.0000000000003598","url":null,"abstract":"","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"1496-1498"},"PeriodicalIF":7.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12180806/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143982215","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
Incidence, prevalence, and burden of type 2 diabetes in China: Trend and projection from 1990 to 2050. 中国2型糖尿病的发病率、患病率和负担:1990 - 2050年的趋势和预测。
IF 7.5 3区 医学
Chinese Medical Journal Pub Date : 2025-06-20 Epub Date: 2025-05-16 DOI: 10.1097/CM9.0000000000003536
Haojie Zhang, Qingyi Jia, Peige Song, Yongze Li, Lihua Jiang, Xianghui Fu, Sheyu Li
{"title":"Incidence, prevalence, and burden of type 2 diabetes in China: Trend and projection from 1990 to 2050.","authors":"Haojie Zhang, Qingyi Jia, Peige Song, Yongze Li, Lihua Jiang, Xianghui Fu, Sheyu Li","doi":"10.1097/CM9.0000000000003536","DOIUrl":"10.1097/CM9.0000000000003536","url":null,"abstract":"<p><strong>Background: </strong>The epidemiological pattern and disease burden of type 2 diabetes have been shifting in China over the past decades. This analysis described the epidemiological transition of type 2 diabetes in the past three decades and projected the trend in the future three decades in China.</p><p><strong>Methods: </strong>Age-, sex-, and year-specific incidence, prevalence, death, and disability-adjusted life years (DALYs) for people with 15 years or older and diabetes or high fasting glucose in China and related countries from 1990 to 2021 were obtained from the Global Burden of Disease. We obtained the trends of age-, sex-, and year-specific rates and absolute numbers of incidence, prevalence, deaths, and DALYs attributable to type 2 diabetes in China from 1990 to 2021. Using the Lee-Carter model, we projected the incidence, prevalence, death, and DALYs attributable to type 2 diabetes to 2050 stratified by age and sex.</p><p><strong>Results: </strong>The age-standardized incidence of type 2 diabetes was 341.5 per 100,000 persons (1.6 times in 1990) and the age-standardized prevalence was 9.96% (9960.0 per 100,000 persons, 2.5 times in 1990) in China 2021. In 2021, there were 0.9 million deaths and 26.8 million DALYs due to type 2 diabetes or hyperglycemia, as 2.9 and 2.7 times the data in 1990, respectively. The age-standardized rates of type 2 diabetes and hyperglycemia were projected to raise to 449.5 per 100,000 persons for incidence, 18.17% for prevalence, 244.6 per 100,000 persons for death, and 4720.2 per 100,000 persons for DALYs by 2050. The incidence of type 2 diabetes kept growing among individuals under the age of 20 years in the past three decades (128.7 per 100,000 persons in 1990 and 439.9 per 100,000 persons in 2021) and estimating 1870.8 per 100,000 in 2050.</p><p><strong>Conclusions: </strong>The incidence, prevalence, and disease burden of type 2 diabetes grew rapidly in China in the past three decades. The prevention of type 2 diabetes in young people and the care for elder adults will be the greatest challenge for the country.</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"1447-1455"},"PeriodicalIF":7.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12180826/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076384","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
Effects of pulmonary telerehabilitation in patients with chronic obstructive pulmonary disease. 慢性阻塞性肺疾病患者肺远程康复的效果。
IF 7.5 3区 医学
Chinese Medical Journal Pub Date : 2025-06-20 Epub Date: 2025-05-23 DOI: 10.1097/CM9.0000000000003650
Jing Qi, Qing Cai, Wanting Zhang, Yan Gu
{"title":"Effects of pulmonary telerehabilitation in patients with chronic obstructive pulmonary disease.","authors":"Jing Qi, Qing Cai, Wanting Zhang, Yan Gu","doi":"10.1097/CM9.0000000000003650","DOIUrl":"10.1097/CM9.0000000000003650","url":null,"abstract":"","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"1493-1495"},"PeriodicalIF":7.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12180807/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141688","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
Alzheimer's disease diagnosis among dementia patients via blood biomarker measurement based on the AT(N) system. 基于AT(N)系统的血液生物标志物检测对痴呆患者阿尔茨海默病的诊断。
IF 7.5 3区 医学
Chinese Medical Journal Pub Date : 2025-06-20 Epub Date: 2025-03-03 DOI: 10.1097/CM9.0000000000003496
Tianyi Wang, Li Shang, Chenhui Mao, Longze Sha, Liling Dong, Caiyan Liu, Dan Lei, Jie Li, Jie Wang, Xinying Huang, Shanshan Chu, Wei Jin, Zhaohui Zhu, Huimin Sui, Bo Hou, Feng Feng, Bin Peng, Liying Cui, Jianyong Wang, Qi Xu, Jing Gao
{"title":"Alzheimer's disease diagnosis among dementia patients via blood biomarker measurement based on the AT(N) system.","authors":"Tianyi Wang, Li Shang, Chenhui Mao, Longze Sha, Liling Dong, Caiyan Liu, Dan Lei, Jie Li, Jie Wang, Xinying Huang, Shanshan Chu, Wei Jin, Zhaohui Zhu, Huimin Sui, Bo Hou, Feng Feng, Bin Peng, Liying Cui, Jianyong Wang, Qi Xu, Jing Gao","doi":"10.1097/CM9.0000000000003496","DOIUrl":"10.1097/CM9.0000000000003496","url":null,"abstract":"","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"1505-1507"},"PeriodicalIF":7.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12180850/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143536594","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
Molecular characterization of FGFR fusion in a large real-world population and clinical utility of bidirectional fusion. FGFR融合在现实世界大量人群中的分子特征和双向融合的临床应用。
IF 7.5 3区 医学
Chinese Medical Journal Pub Date : 2025-06-20 Epub Date: 2025-04-28 DOI: 10.1097/CM9.0000000000003531
Xinyi Zhang, Jing Zhao, Ling Ma, Yitong Tian, Jiaguang Zhang, Hejian Zheng, Junling Zhang, Runyu He, Luhang Jin, Jing Ma, Mengli Huang, Xiao Li, Xiaofeng Chen
{"title":"Molecular characterization of FGFR fusion in a large real-world population and clinical utility of bidirectional fusion.","authors":"Xinyi Zhang, Jing Zhao, Ling Ma, Yitong Tian, Jiaguang Zhang, Hejian Zheng, Junling Zhang, Runyu He, Luhang Jin, Jing Ma, Mengli Huang, Xiao Li, Xiaofeng Chen","doi":"10.1097/CM9.0000000000003531","DOIUrl":"10.1097/CM9.0000000000003531","url":null,"abstract":"","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"1510-1512"},"PeriodicalIF":7.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12180825/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143983181","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
Lipid metabolism in health and disease: Mechanistic and therapeutic insights for Parkinson's disease. 健康和疾病中的脂质代谢:帕金森病的机制和治疗见解。
IF 7.5 3区 医学
Chinese Medical Journal Pub Date : 2025-06-20 Epub Date: 2025-05-26 DOI: 10.1097/CM9.0000000000003627
Bingqing Qin, Yuan Fu, Ana-Caroline Raulin, Shuangyu Kong, Han Li, Junyi Liu, Chunfeng Liu, Jing Zhao
{"title":"Lipid metabolism in health and disease: Mechanistic and therapeutic insights for Parkinson's disease.","authors":"Bingqing Qin, Yuan Fu, Ana-Caroline Raulin, Shuangyu Kong, Han Li, Junyi Liu, Chunfeng Liu, Jing Zhao","doi":"10.1097/CM9.0000000000003627","DOIUrl":"10.1097/CM9.0000000000003627","url":null,"abstract":"<p><strong>Abstract: </strong>Parkinson's disease (PD) is a neurodegenerative disorder characterized by the progressive loss of dopaminergic neurons and the accumulation of Lewy bodies, leading to motor and nonmotor symptoms. While both genetic and environmental factors contribute to PD, recent studies highlight the crucial role of lipid metabolism disturbances in disease progression. Altered lipid homeostasis promotes protein aggregation and oxidative stress, with significant changes in lipid classes such as sphingolipids and glycerolipids observed in patients with PD. These disturbances are involved in key pathological processes, such as α-synuclein aggregation, organelle dysfunction, lipid-mediated neuroinflammation, and impaired lipid homeostasis. This review examines the relationship between lipid species and PD progression, focusing on the physiological roles of lipids in the central nervous system. It explores the mechanistic links between lipid metabolism and PD pathology, along with lipid-related genetic risk factors. Furthermore, this review discusses lipid-targeting therapeutic strategies to mitigate PD progression, emphasizing the potential of lipid modulation for effective treatment development.</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"1411-1423"},"PeriodicalIF":7.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12180847/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144149578","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
Effect of prostaglandin analogs on macular microcirculation in patients with ocular hypertension and early glaucoma. 前列腺素类似物对高眼压和早期青光眼患者黄斑微循环的影响。
IF 7.5 3区 医学
Chinese Medical Journal Pub Date : 2025-06-20 Epub Date: 2025-02-26 DOI: 10.1097/CM9.0000000000003522
Xuying Li, Yan He, Shiyu Liao, Xin Wei
{"title":"Effect of prostaglandin analogs on macular microcirculation in patients with ocular hypertension and early glaucoma.","authors":"Xuying Li, Yan He, Shiyu Liao, Xin Wei","doi":"10.1097/CM9.0000000000003522","DOIUrl":"10.1097/CM9.0000000000003522","url":null,"abstract":"","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"1502-1504"},"PeriodicalIF":7.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12180849/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143499646","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
Hub biomarkers and their clinical relevance in glycometabolic disorders: A comprehensive bioinformatics and machine learning approach. 中枢生物标志物及其在糖代谢紊乱中的临床意义:一种综合的生物信息学和机器学习方法。
IF 7.5 3区 医学
Chinese Medical Journal Pub Date : 2025-06-20 DOI: 10.1097/CM9.0000000000003525
Liping Xiang, Bing Zhou, Yunchen Luo, Hanqi Bi, Yan Lu, Jian Zhou
{"title":"Hub biomarkers and their clinical relevance in glycometabolic disorders: A comprehensive bioinformatics and machine learning approach.","authors":"Liping Xiang, Bing Zhou, Yunchen Luo, Hanqi Bi, Yan Lu, Jian Zhou","doi":"10.1097/CM9.0000000000003525","DOIUrl":"10.1097/CM9.0000000000003525","url":null,"abstract":"<p><strong>Background: </strong>Gluconeogenesis is a critical metabolic pathway for maintaining glucose homeostasis, and its dysregulation can lead to glycometabolic disorders. This study aimed to identify hub biomarkers of these disorders to provide a theoretical foundation for enhancing diagnosis and treatment.</p><p><strong>Methods: </strong>Gene expression profiles from liver tissues of three well-characterized gluconeogenesis mouse models were analyzed to identify commonly differentially expressed genes (DEGs). Weighted gene co-expression network analysis (WGCNA), machine learning techniques, and diagnostic tests on transcriptome data from publicly available datasets of type 2 diabetes mellitus (T2DM) patients were employed to assess the clinical relevance of these DEGs. Subsequently, we identified hub biomarkers associated with gluconeogenesis-related glycometabolic disorders, investigated potential correlations with immune cell types, and validated expression using quantitative Polymerase Chain Reaction in the mouse models.</p><p><strong>Results: </strong>Only a few common DEGs were observed in gluconeogenesis-related glycometabolic disorders across different contributing factors. However, these DEGs were consistently associated with cytokine regulation and oxidative stress (OS). Enrichment analysis highlighted significant alterations in terms related to cytokines and OS. Importantly, osteomodulin (OMD), apolipoprotein A4 (APOA4), and insulin like growth factor binding protein 6 (IGFBP6) were identified with potential clinical significance in T2DM patients. These genes demonstrated robust diagnostic performance in T2DM cohorts and were positively correlated with resting dendritic cells.</p><p><strong>Conclusions: </strong>Gluconeogenesis-related glycometabolic disorders exhibit considerable heterogeneity, yet changes in cytokine regulation and OS are universally present. OMD, APOA4, and IGFBP6 may serve as hub biomarkers for gluconeogenesis-related glycometabolic disorders.</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":""},"PeriodicalIF":7.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144332502","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
Abemaciclib plus non-steroidal aromatase inhibitor or fulvestrant in women with HR+/HER2- advanced breast cancer: Final results of the randomized phase III MONARCH plus trial. Abemaciclib 联合非甾体类芳香化酶抑制剂或氟维司群治疗 HR+/HER2- 晚期乳腺癌女性患者:随机III期MONARCH plus试验的最终结果。
IF 7.5 3区 医学
Chinese Medical Journal Pub Date : 2025-06-20 Epub Date: 2024-10-10 DOI: 10.1097/CM9.0000000000003151
Xichun Hu, Qingyuan Zhang, Tao Sun, Yongmei Yin, Huiping Li, Min Yan, Zhongsheng Tong, Man Li, Yue'e Teng, Christina Pimentel Oppermann, Govind Babu Kanakasetty, Ma Coccia Portugal, Liu Yang, Wanli Zhang, Zefei Jiang
{"title":"Abemaciclib plus non-steroidal aromatase inhibitor or fulvestrant in women with HR+/HER2- advanced breast cancer: Final results of the randomized phase III MONARCH plus trial.","authors":"Xichun Hu, Qingyuan Zhang, Tao Sun, Yongmei Yin, Huiping Li, Min Yan, Zhongsheng Tong, Man Li, Yue'e Teng, Christina Pimentel Oppermann, Govind Babu Kanakasetty, Ma Coccia Portugal, Liu Yang, Wanli Zhang, Zefei Jiang","doi":"10.1097/CM9.0000000000003151","DOIUrl":"10.1097/CM9.0000000000003151","url":null,"abstract":"<p><strong>Background: </strong>In the interim analysis of MONARCH plus, adding abemaciclib to endocrine therapy (ET) improved progression-free survival (PFS) and objective response rate (ORR) in predominantly Chinese postmenopausal women with HR+/HER2- advanced breast cancer (ABC). This study presents the final pre-planned PFS analysis.</p><p><strong>Methods: </strong>In the phase III MONARCH plus study, postmenopausal women in China, India, Brazil, and South Africa with HR+/HER2- ABC without prior systemic therapy in an advanced setting (cohort A) or progression on prior ET (cohort B) were randomized (2:1) to abemaciclib (150 mg twice daily [BID]) or placebo plus: anastrozole (1.0 mg/day) or letrozole (2.5 mg/day) (cohort A) or fulvestrant (500 mg on days 1 and 15 of cycle 1 and then on day 1 of each subsequent cycle) (cohort B). The primary endpoint was PFS of cohort A. Secondary endpoints included cohort B PFS (key secondary endpoint), ORR, overall survival (OS), safety, and health-related quality of life (HRQoL).</p><p><strong>Results: </strong>In cohort A (abemaciclib: n  = 207; placebo: n  = 99), abemaciclib plus a non-steroidal aromatase inhibitor improved median PFS vs . placebo (28.27 months vs . 14.73 months, hazard ratio [HR]: 0.476; 95% confidence interval [95% CI]: 0.348-0.649). In cohort B (abemaciclib: n  = 104; placebo: n  = 53), abemaciclib plus fulvestrant improved median PFS vs . placebo (11.41 months vs . 5.59 months, HR: 0.480; 95% CI: 0.322-0.715). Abemaciclib numerically improved ORR. Although immature, a trend toward OS benefit with abemaciclib was observed (cohort A: HR: 0.893, 95% CI: 0.553-1.443; cohort B: HR: 0.512, 95% CI: 0.281-0.931). The most frequent grade ≥3 adverse events in the abemaciclib arms were neutropenia, leukopenia, anemia (both cohorts), and lymphocytopenia (cohort B). Abemaciclib did not cause clinically meaningful changes in patient-reported global health, functioning, or most symptoms vs . placebo.</p><p><strong>Conclusions: </strong>Abemaciclib plus ET led to improvements in PFS and ORR, a manageable safety profile, and sustained HRQoL, providing clinical benefit without a high toxicity burden or reduced quality of life.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov (NCT02763566).</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":"1477-1486"},"PeriodicalIF":7.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12180841/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388477","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
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