Clinical therapeutics最新文献

{"title":"Comparative Analysis of Adverse Events Linked to PEG-rhG-CSF and rhG-CSF in Real-World Settings: Disproportionate Examination of the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) Database","authors":"Ying Qu BE,&nbsp;Li’an Zuo MSc,&nbsp;Shuting Zhang MSc,&nbsp;Wanyi Zhou BE,&nbsp;Rong Chen MM","doi":"10.1016/j.clinthera.2025.04.017","DOIUrl":"10.1016/j.clinthera.2025.04.017","url":null,"abstract":"<div><h3>Purpose</h3><div>Granulocyte-colony stimulating factor (G-CSF) is widely acknowledged for its efficacy in managing chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN), albeit accompanied by a spectrum of potential adverse effects. This study conducted a comprehensive analysis utilizing real-world data sourced from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database, spanning the years 2004 to 2023, to assess and compare adverse events (AEs) associated with recombinant human G-CSF (rhG-CSF) and its polyethylene glycol-modified form (PEG-rhG-CSF).</div></div><div><h3>Methods</h3><div>A comprehensive analysis was conducted using FAERS data to evaluate the reporting proportion of AEs, gender-based disparities, and specific AEs such as bone pain. Statistical analyses included Reporting Odds Ratio (ROR) calculations and comparisons of median time to AE onset between PEG-rhG-CSF and rhG-CSF.</div></div><div><h3>Findings</h3><div>The study revealed that PEG-rhG-CSF was associated with a significantly higher number of adverse events (AEs) compared to rhG-CSF (76,155 vs. 10,953 cases). Female patients experienced a higher reporting proportion of AEs than males for both treatments, with PEG-rhG-CSF showing 54.2% of cases in females and rhG-CSF showing 46.1%, compared to 27.1% and 34.7% in males, respectively. Bone pain emerged as the most common AE, with PEG-rhG-CSF linked to 2,473 cases and rhG-CSF to 581 cases, and a higher reporting odds ratio (ROR = 1.17, 95% CI: 1.07–1.29) for PEG-rhG-CSF. Additionally, the median time to onset of AEs was shorter for PEG-rhG-CSF (3 days, IQR: 1–9) than for rhG-CSF (9 days, IQR: 2–42). Delayed AEs, such as splenomegaly, capillary leak syndrome, interstitial lung disease, and lung infiltration, were also identified, emphasizing the importance of close patient follow-up.</div></div><div><h3>Implications</h3><div>The study highlights significant differences in AE reporting proportion, gender disparities, and onset timing between PEG-rhG-CSF and rhG-CSF. These findings emphasize the need for close patient monitoring, especially for delayed AEs that may manifest after discharge. Further assessment of real-world data is warranted.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 624-630"},"PeriodicalIF":3.6,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144132251","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}

{"title":"Action Plan for Advancing Biomedical Research, Therapeutic Development, and Patient Care","authors":"Patricia Furlong RN ,&nbsp;Donna Appell RN ,&nbsp;Kaitlyn Esposito MPH ,&nbsp;Sharon F. Terry MA","doi":"10.1016/j.clinthera.2025.04.015","DOIUrl":"10.1016/j.clinthera.2025.04.015","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 7","pages":"Pages 481-483"},"PeriodicalIF":3.2,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144132247","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}

{"title":"Efficacy and Tolerability of Single-Dose Timolol Eye Drops in the Sequential Treatment of Acute Angle-Closure Crisis: A Double-Blind, Randomized, Placebo-Controlled Trial","authors":"Guang Chen MM ,&nbsp;Jing Wang MM ,&nbsp;Kunling Li MM","doi":"10.1016/j.clinthera.2025.04.005","DOIUrl":"10.1016/j.clinthera.2025.04.005","url":null,"abstract":"<div><h3>Purpose</h3><div>To observe and compare the efficacy of timolol eye drops in sequential treatment of acute angle-closure crisis (AACC).</div></div><div><h3>Methods</h3><div>In this prospective, randomized, double-blind case-control study, patients diagnosed with AACC at the Affiliated Hospital of Hebei University from April 2021 to October 2023 were continuously enrolled. The patient data were collected and randomly divided into timolol group (group A) and placebo group (group B). All patients were sequentially treated with drug therapy, anterior chamber paracentesis, and argon laser peripheral iridoplasty. The primary outcomes were decreased intraocular pressure (IOP), success rate, and treatment time.</div></div><div><h3>Findings</h3><div>At 2 hours, 4 hours, and 6 hours after the start of treatment, the reduction in IOP in group A was 13.87 ± 13.85 mm Hg, 28.42 ± 12.87 mm Hg, and 35.69 ± 8.51 mm Hg, respectively, and the number of controlled eyes was 23 (29.87%), 51 (66.23%), and 71 (92.20%), respectively. The reduction in IOP in group B was 15.88 ± 14.95 mm Hg, 28.17 ± 13.63 mm Hg, and 33.90 ± 13.59 mm Hg, respectively, and the number of controlled eyes was 30 (36.59%), 58 (70.73%), and 75 (91.46%) eyes, respectively. Among patients whose crises were relieved, the times for AACC relief were 3.29 ± 1.31 hours in group A and 3.38 ± 1.34 hours in group B. There were no significant differences in IOP reduction, numbers of eyes remission, and times for AACC relief between the 2 groups at each point of sequential treatment (<em>P</em> &gt; 0.05).</div></div><div><h3>Implications</h3><div>In the sequential treatment of AACC, timolol is not helpful to improve the success rate of treatment.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 7","pages":"Pages 499-503"},"PeriodicalIF":3.2,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119121","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}

{"title":"Response: Analgesic Effects and Pharmacokinetics of Ropivacaine at Different Concentrations in Serratus Anterior Plane Block in patients undergoing Video-Assisted Thoracoscopic Surgery: a prospective randomized trial","authors":"Lingkai Tang MSc ,&nbsp;Caomei Xu MSc ,&nbsp;Jianfen Xie MSc ,&nbsp;Jiahao Xu MSc ,&nbsp;Chen Chen PhD ,&nbsp;Jiang Shen BS ,&nbsp;Nan Hu PhD ,&nbsp;Lan Qiu PhD","doi":"10.1016/j.clinthera.2025.04.009","DOIUrl":"10.1016/j.clinthera.2025.04.009","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 7","pages":"Pages 528-529"},"PeriodicalIF":3.2,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119125","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}

{"title":"Executive Orders and Health Care","authors":"Marcia M. Boumil MS, JD, LLM","doi":"10.1016/j.clinthera.2025.04.006","DOIUrl":"10.1016/j.clinthera.2025.04.006","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 7","pages":"Pages 471-473"},"PeriodicalIF":3.2,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119123","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}

{"title":"Kaleidoscope: Bringing Into Focus the Short- and Long-Term Effects of the Trump Administration’s Executive Orders on Global Research, Medicine, and Science","authors":"Jill L. Maron MD, MPH","doi":"10.1016/j.clinthera.2025.04.013","DOIUrl":"10.1016/j.clinthera.2025.04.013","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 7","pages":"Pages 463-464"},"PeriodicalIF":3.2,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119124","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}

{"title":"In Law as in Science: The Importance of Process","authors":"Paul Beninger MD, MBA","doi":"10.1016/j.clinthera.2025.04.012","DOIUrl":"10.1016/j.clinthera.2025.04.012","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 7","pages":"Pages 469-470"},"PeriodicalIF":3.2,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093096","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}

{"title":"Socioeconomic Disparities in Intravitreal Injection Use and Anti-VEGF Agent Selection: Aflibercept/Ranibizumab Versus Bevacizumab","authors":"Michelle Y. Ko BA ,&nbsp;Ramin Talebi BS ,&nbsp;Fei Yu PhD ,&nbsp;Victoria L. Tseng MD, PhD ,&nbsp;Anne L. Coleman MD, PhD ,&nbsp;Hamid Hosseini MD","doi":"10.1016/j.clinthera.2025.04.010","DOIUrl":"10.1016/j.clinthera.2025.04.010","url":null,"abstract":"<div><h3>Purpose</h3><div>There is a paucity of research on socioeconomic factors associated with intravitreal injection use or type of anti–vascular endothelial growth factor (anti-VEGF) use. The purpose of this cross-sectional analysis is to examine the association between demographic and socioeconomic factors and intravitreal injections and type of anti-VEGF (bevacizumab, aflibercept, and ranibizumab) use for patients with diabetic macular edema, proliferative diabetic retinopathy, retinal vein occlusion, and wet age-related macular degeneration in the AllofUs Database, which is a nationwide health database initiative conducted by the National Institutes of Health in the United States to enroll participants from groups that are considered to be historically underrepresented in biomedical research.</div></div><div><h3>Methods</h3><div>The study population included patients diagnosed with diabetic macular edema, proliferative diabetic retinopathy, retinal vein occlusion, or wet age-related macular degeneration based on the International Classification of Diseases Ninth/10th Revision, Clinical Modification diagnosis codes. Exposures included age, sex, race/ethnicity, income, and education. Outcomes included IVI use based on the Current Procedural Terminology 4 codes and anti-VEGF type based on RxNorm codes.</div></div><div><h3>Findings</h3><div>Of 3010 participants, 25.9% ever had IVI use. In multivariate logistic regression analyses, those with older age (adjusted odds ratio [aOR] = 1.27; 95% CI, 1.18–1.37) and income &gt;$150,000 (aOR = 1.71; CI, 1.27–2.32) were more likely to have had IVI use. Those with older age (aOR = 1.46; CI, 1.22–1.75), Asian/other race/ethnicity (aOR = 3.81; CI, 1.09–13.34), Hispanic race/ethnicity (aOR = 3.16; CI, 1.59–6.26), income &gt;$150,000 (aOR = 3.20; CI, 1.45–7.06), and college graduate/advanced degree (aOR = 1.83; CI, 1.01–3.31) were more likely to have aflibercept/ranibizumab only versus bevacizumab use.</div></div><div><h3>Implications</h3><div>Interventions are needed to increase health literacy and access to IVI for at-risk, low-income populations. Future research should investigate patient and provider decision-making for anti-VEGF drug choice, which may have implications for cost-saving measures and policies.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 559-565"},"PeriodicalIF":3.6,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093112","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}

{"title":"Analysis of the Total Immunoglobulin G (IgG) and Its Subclasses Over Time in Coronavirus Disease 2019–Recovered Patients and Its Association With Disease Severity: A Single-Center Prospective Cohort Study","authors":"Dablu Lal Gupta PhD ,&nbsp;Jhasketan Meher MD ,&nbsp;Fagun Sharma MSc ,&nbsp;Arvind K. Shukla PhD ,&nbsp;Anjan K Giri MD ,&nbsp;Eli Mohapatra MD ,&nbsp;Manisha M. Ruikar MD ,&nbsp;Donthamsetty Nageswara Rao PhD","doi":"10.1016/j.clinthera.2025.04.011","DOIUrl":"10.1016/j.clinthera.2025.04.011","url":null,"abstract":"<div><h3>Purpose</h3><div>In order to address concerns regarding the diminishing levels of antibodies over time and the variations in response between mild and severe cases, efforts are being made to determine how long immunoglobulin G (IgG) antibodies persist in patients with coronavirus disease 2019 (COVID-19).</div></div><div><h3>Methods</h3><div>The present study was conducted in a longitudinal setting over a period of 6 months in 37 unvaccinated COVID-19–recovered patients. The spike protein and receptor-binding domain (RBD)–specific serum levels of IgG and IgG subclasses were measured at 3 time points (within ≤1 month, 1–3 months, and 3–6 months) of recovery from COVID-19.</div></div><div><h3>Findings</h3><div>Our study found a significant (<em>P</em> &lt; 0.05) reduction in the levels of antispike and anti-RBD antibodies within 3 to 6 months after recovery from COVID-19 infections. The group of patients who developed severe illness had higher levels of antispike and anti-RBD IgG compared with the group of patients who recovered from mild disease. There was a statistically significant difference in the contribution of IgG1 and IgG3 over time in COVID-19-recovered patients, indicating a potential alteration in the distribution of IgG subclasses. Serum levels of IgG1 were found to be 1.5 folds higher within 1 to 3 months of recovery from severe acute respiratory syndrome coronavirus 2 infections in severe cases than mild cases.</div></div><div><h3>Implications</h3><div>This study found that severe COVID-19 cases in unvaccinated patients had higher antibody titers and a greater likelihood of antispike antibodies persisting after infection. The levels of IgG1 and IgG3 increased significantly with the severity of COVID-19, indicating a heightened immune response in more severe cases. The estimation of serum levels of IgG subclass may determine the vaccination strategy and the process of treatment.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages e12-e18"},"PeriodicalIF":3.6,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093095","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}

{"title":"Short-term Prognostic Value of Heart Rate Variability in Pulmonary Embolism Patients: 2-Center Cohort Study","authors":"Junjie Mao MD ,&nbsp;Chao Guan MD ,&nbsp;Jun Zhang MD ,&nbsp;Ayman A. Mohammed MD ,&nbsp;Ge Zhang MD ,&nbsp;Jie Huang MD ,&nbsp;Ying Huang MD","doi":"10.1016/j.clinthera.2025.03.012","DOIUrl":"10.1016/j.clinthera.2025.03.012","url":null,"abstract":"<div><h3>Purpose</h3><div>Pulmonary thromboembolism (PTE) is the third most frequent acute cardiovascular syndrome, with serious sequelae in untreated patients. Heart rate variability (HRV) has emerged as a crucial and established prognostic indicator for adverse events. Nevertheless, its correlation with PTE and its prognostic significance in anticipating adverse outcomes warrant additional investigation. This study sought to examine the 30-day prognostic utility of HRV in predicting major adverse cardiovascular events (MACEs) in individuals with PTE.</div></div><div><h3>Methods</h3><div>This retrospective cohort study, conducted at 2 centers, enrolled 170 patients diagnosed with PTE and 174 control subjects who underwent 24-hour Holter recording, with an evaluation of time-domain HRV. PTE patients with simplified-Pulmonary-Embolism-Severity Index = 0 points are classified as a low-risk group, and ≥1 as an intermediate-risk group. The association between HRV and MACE was assessed using receiver operating characteristic curve analysis, Cox-regression, and Kaplan–Meier curve tests.</div></div><div><h3>Findings</h3><div>Time-domain HRV was reduced in all PTE patients compared with the control group and intermediate-risk PTE than in low-risk PTE groups (<em>P</em> &lt; 0.05). A total of 22 PTE patients developed MACE during follow-up. PTE patients with reduced HRV have an increased risk of MACE (log-rank <em>P</em> &lt; 0.05). HRV was an independent predictor of MACE, the standard deviation of all normal-to-normal RR intervals (hazard ratio [HR], 0.968; 95% CI, 0.950–0.986, <em>P</em> = 0.001), and the standard deviation of 5-minute mean N-N interval (HR, 0.974; 95% CI, 0.958–0.990, <em>P</em> = 0.002).</div></div><div><h3>Implications</h3><div>HRV is an independent risk factor and is associated with 30-day poor outcomes in PTE. Thus, HRV can be considered as a tool in the risk stratification of PTE patients.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 7","pages":"Pages 492-498"},"PeriodicalIF":3.2,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093110","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}