Christina L. Kazarov, Richard D. Boyce, Sanya B. Taneja, Kojo Abanyie, Maryann R. Sestito, Sandra L. Kane-Gill
{"title":"Identifying Cardiac Adverse Event Signals for Natural Products Using Disproportionality Analysis of the FDA Adverse Event Reporting System (FAERS)","authors":"Christina L. Kazarov, Richard D. Boyce, Sanya B. Taneja, Kojo Abanyie, Maryann R. Sestito, Sandra L. Kane-Gill","doi":"10.1155/jcpt/8979418","DOIUrl":"https://doi.org/10.1155/jcpt/8979418","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Marketing regulations for natural products (NPs), such as herbal supplements, are less stringent than for prescription or over-the-counter medications. This paucity of regulations and widespread use demonstrates the need to better understand potential safety risks of NPs. The aim of this disproportionality analysis was to use the FDA Adverse Event Reporting System (FAERS) database to identify cardiac adverse event (AE) signals associated with NPs.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>FAERS reports (2004 Q1–2021 Q3) were searched for cardiac AEs and NP use. Reporting odds ratios (ROR) were calculated for each cardiac AE–NP pair. Pairs with ≥ 3 reports and a 95% confidence interval for the ROR ≥ 2.0 underwent further analysis using the observed-to-expected (OE) ratio with shrinkage. Signals with an OE ratio 95% credibility interval > 1.0 were considered significant safety signals. Detailed assessments of each report were conducted for content validity based on clinical interpretation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 2484 spontaneous reports listing cardiac AEs and NPs were identified, resulting in 705 preliminary NP–AE pairs for 74 unique NPs. Subsequent OE ratio calculations identified 10 significant safety signals for 8 unique NPs.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Several AE signals for NPs had a disproportionate number of reports when compared to all other product reports within FAERS. After a literature search for supporting evidence, we found that four NPs are likely associated with cardiac AEs (guarana, hemp extract, licorice, and ginkgo) and four require further investigation (seawrack, soybean, celery, and <i>Panax ginseng</i>). Despite limitations inherent to spontaneous reporting systems, this study highlights potential cardiac safety risks associated with NP use.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15381,"journal":{"name":"Journal of Clinical Pharmacy and Therapeutics","volume":"2026 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2026-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/jcpt/8979418","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148752378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"EXPRESSION OF CONCERN: Hydroxychloroquine: Pharmacokinetics and Toxicity","authors":"","doi":"10.1155/jcpt/9791837","DOIUrl":"https://doi.org/10.1155/jcpt/9791837","url":null,"abstract":"<p>EXPRESSION OF CONCERN: P. Brouqui, E. Chabriere, and D. Raoult, “Hydroxychloroquine: Pharmacokinetics and Toxicity,” <i>Journal of Clinical Pharmacy and Therapeutics</i>, 2024, 6500340, 12 pages, 2024. https://doi.org/10.1155/2024/6500340.</p><p>This Expression of Concern is for the above article, published online on 24 January 2024 in Wiley Online Library (https://wileyonlinelibrary.com), and has been issued by John Wiley & Sons Ltd. The Expression of Concern has been agreed due to questions raised about the study’s adherence to French legal and ethical requirements for research involving human subjects. Additionally, concerns have been raised for ten of the referenced articles. The investigation into these concerns is ongoing. Therefore, the journal has decided to issue an Expression of Concern to inform and alert readers.</p>","PeriodicalId":15381,"journal":{"name":"Journal of Clinical Pharmacy and Therapeutics","volume":"2026 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2026-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/jcpt/9791837","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148616235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Association of Clinical Pharmacist Interventions With Outcomes in Severe Diabetic Foot Infections: A Retrospective Cohort Study","authors":"Ping Wu, Chunyan Ni, Xuemei Sun, Wendong Xu","doi":"10.1155/jcpt/5279339","DOIUrl":"https://doi.org/10.1155/jcpt/5279339","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>It is common for clinical pharmacists to participate in the management of antimicrobial therapy in many countries, but not all countries have clinical pharmacists participating in the antimicrobial treatment of patients with diabetic foot.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>To evaluate the effects of the involvement of clinical pharmacists in the management of severe infection in patients with diabetic foot.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Method</h3>\u0000 \u0000 <p>A total of 89 patients with severe diabetic foot infection were enrolled in this retrospective study from January 2020 to December 2024, and they were divided into the study group (SG, <i>n</i> = 44) and the control group (CG, <i>n</i> = 45). Patients in the SG received clinical pharmacist intervention during hospitalization, while those in the CG received only general services. The Student′s <i>t</i>-test and the Mann–Whitney <i>U</i> test were used for intergroup comparison of continuous variables, while the Chi-square test was adopted for categorical variables.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>No significant differences were identified between the SG and CG with respect to their sociodemographic or infection characteristics. The median duration of fever was shorter in the SG (3.00 days) than in the CG (6.00 days). After 3 days of antimicrobial treatment, the SG showed significantly larger decreases in the WBC count, C-reactive protein (CRP), and procalcitonin (PCT) than the CG (<i>p</i> < 0.05). The SG had a significantly higher prevalence of appropriate initial empirical antimicrobial therapy (93.18% vs. 48.89%, <i>p</i> = 0.001), fewer drug-related complications (13.64% vs. 51.11%, <i>p</i> < 0.001), and a lower prevalence of readmission over the first 12 months following discharge (2.27% vs. 17.78%, <i>p</i> = 0.030). The prevalence of antimicrobial regimen adjustments of ≥ 2 was also lower in the SG group (9.10% vs. 35.56%, <i>p</i> = 0.004). There were no significant differences in the prevalence of amputation or the defined daily dose between the groups.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The involvement of clinical pharmacists in the management of severe infection in patients with diabetic foot was associated with improved acute infection control and the alleviation of drug-related problems associated with antimicrobial agents, thereby providing a valuable reference for antimicrobial therapy management in such patients.</p>\u0000","PeriodicalId":15381,"journal":{"name":"Journal of Clinical Pharmacy and Therapeutics","volume":"2026 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2026-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/jcpt/5279339","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148615974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Influence of Glomerular Filtration Rate on Potentially Inappropriate Medications in Older Adults: A Cross-Sectional Study","authors":"Qingmin Yao, Yanxia Liu, Ting Yuan, Wen Zhang, Yahui Zhang, Wen Chen, Xiaojuan Zhu, Jianchun Wang","doi":"10.1155/jcpt/6682398","DOIUrl":"https://doi.org/10.1155/jcpt/6682398","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>This study aimed to assess the association between estimated glomerular filtration rate (eGFR) levels and the prevalence of potentially inappropriate medications (PIMs) based on three criteria: the Beers (2019 version), Chinese, and Screening Tool of Older Persons’ Prescriptions (STOPP) criteria.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This retrospective cross-sectional study analyzed 191 inpatients aged ≥ 65 years. Using the Beers, Chinese, and STOPP criteria, we assessed the prevalence of PIMs across stratified eGFR levels. Nonparametric analyses (Mann–Whitney <i>U</i> test), chi-square tests, and logistic regression analysis were employed to evaluate the association between eGFR and PIMs exposure.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Participants were stratified into three groups based on eGFR: Group I (≥ 90 mL/min/1.73 m<sup>2</sup>), Group II (60–89 mL/min/1.73 m<sup>2</sup>), and Group III (< 60 mL/min/1.73 m<sup>2</sup>). Prevalence rates of PIMs were 72.25% by Beers criteria, 60.73% by Chinese criteria, and 28.80% by STOPP criteria, with STOPP demonstrating significantly lower PIMs detection rates than the other two criteria. Analysis by eGFR stratification revealed escalating PIMs prevalence with declining kidney function under Beers criteria: 67.35% in Group I, 74.29% in Group II, and 86.96% in Group III (<i>p</i> < 0.05). Notably, Group III (eGFR < 60 mL/min/1.73 m<sup>2</sup>) exhibited higher proportions of patients with ≥ 2 PIMs across all criteria. By Beers criteria, 56.52% of Group III patients had ≥ 2 PIMs versus 22.45% (Group I) and 25.71% (Group II). Similar trends were observed by Chinese and STOPP criteria (<i>p</i> < 0.05). Logistic regression analysis identified polypharmacy and eGFR decline as independent risk factors for PIMs exposure.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The prevalence of PIMs gradually increases with the decline of eGFR in older adults, particularly when compounded by polypharmacy.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15381,"journal":{"name":"Journal of Clinical Pharmacy and Therapeutics","volume":"2026 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2026-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/jcpt/6682398","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148615636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jing Kai Lam, Xiaoyan Yang, Baharudin Ibrahim, Amirrudin Kamsin, Jinxin Zhao, S. Y. Amy Cheung, Xiaofen Liu, Jamaludin Elis, Nusaibah Abdul Rahim, Yu-Wei Lin
{"title":"Advances and Challenges in Model-Informed Precision Dosing of Antimicrobials for Pediatric Patients","authors":"Jing Kai Lam, Xiaoyan Yang, Baharudin Ibrahim, Amirrudin Kamsin, Jinxin Zhao, S. Y. Amy Cheung, Xiaofen Liu, Jamaludin Elis, Nusaibah Abdul Rahim, Yu-Wei Lin","doi":"10.1155/jcpt/7870942","DOIUrl":"https://doi.org/10.1155/jcpt/7870942","url":null,"abstract":"<p>Precision medicine has transformed healthcare by moving toward individualized treatment strategies, yet dosing optimization for pediatric patients remains a complex challenge. Therapeutic drug monitoring (TDM), a widely used practice in clinical settings, provides a foundation for achieving therapeutic goals but poses significant limitations, particularly in the pediatric population, due to the frequent need for blood sampling and delayed adjustments. Model-informed precision dosing (MIPD) is an emerging strategy that combines population pharmacokinetic (pop-PK) models with patient-specific data to enhance therapeutic outcomes while minimizing the need for invasive procedures. This narrative review highlights the potential of MIPD in pediatric antimicrobial therapy, with an emphasis on its applications, advantages, and current challenges. By analyzing recent advancements in pop-PK models for antimicrobials, this review article underscores MIPD’s ability to optimize dosing strategies and improve clinical outcomes for pediatric patients. Despite the barriers to widespread implementation, such as data availability and regulatory hurdles, MIPD offers a path forward for precision medicine in pediatrics. By bridging the gap between computational modeling and clinical practice, MIPD has the potential to reshape the future of pediatric pharmacotherapy.</p>","PeriodicalId":15381,"journal":{"name":"Journal of Clinical Pharmacy and Therapeutics","volume":"2026 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2026-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/jcpt/7870942","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148615697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Artificial Intelligence in Clinical Pharmacy: From Decision Support to Prescription Execution","authors":"Wenshuo Jiang, Yuntian Wang, Weizhong Shi, Cao Li, Mingda Li, Yongqiang Tang, Xiaolin Yue, Zhigang Zhao","doi":"10.1155/jcpt/4675298","DOIUrl":"https://doi.org/10.1155/jcpt/4675298","url":null,"abstract":"<p>Artificial intelligence (AI) is emerging and showing great potential in optimizing clinical pharmacy. This review aims to provide an overview of applications and advances of AI in clinical pharmacy. The findings illustrated that AI can assist in various stages from decision support to prescription execution supporting safer and more effective therapeutic practice. Machine learning and natural language processing are useful tools for tasks such as drug therapy recommendation, precision dosing, adverse drug event prediction and improving medication adherence. This study summarizes the latest progress in AI technologies within clinical medication from the view of both pharmacists and AI specialists. Future efforts should focus on addressing challenges like data quality issues to steadily advance AI-driven clinical medication development.</p>","PeriodicalId":15381,"journal":{"name":"Journal of Clinical Pharmacy and Therapeutics","volume":"2026 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2026-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/jcpt/4675298","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148615425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Thalia Berenice Jacobo Vargas, Miriam del Carmen Carrasco Portugal, Renata Báez Saldaña, Odalis Rodríguez Ganen, Francisco Javier Flores Murrieta, Victor Hugo Ahumada Topete, Ricardo Stanley Vega Barrientos
{"title":"Prevalence and Characteristics of Deoxycholate and Liposomal Amphotericin B Adverse Reactions in a Third-Level Care Hospital: A Retrospective Observational Study","authors":"Thalia Berenice Jacobo Vargas, Miriam del Carmen Carrasco Portugal, Renata Báez Saldaña, Odalis Rodríguez Ganen, Francisco Javier Flores Murrieta, Victor Hugo Ahumada Topete, Ricardo Stanley Vega Barrientos","doi":"10.1155/jcpt/2980716","DOIUrl":"https://doi.org/10.1155/jcpt/2980716","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>We aimed to establish the prevalence of adverse reactions associated with the use of deoxycholate and/or liposomal amphotericin B and to determine adherence to World Health Organization (WHO) recommendations to minimize the risk of toxicity.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Clinical data were collected from records of 143 patients over 18 years of age who were under treatment with amphotericin B (deoxycholate and/or liposomal) for at least 5 days from January 2016 to March 2019 at National Institute of Respiratory Diseases “Ismael Cosío Villegas” in Mexico City. We used MeSH terms to name each formulation of amphotericin B, adverse reactions, and diagnoses. Definitions and classification of the adverse reactions were made in accordance with the Common Terminology Criteria for Adverse Events Version 5.0 and other bibliographic references. Preventability assessment was evaluated using the Schumock and Thornton scale. To determine adherence to WHO recommendations, we evaluated intravenous preemptive hydration, electrolyte supplementation, and laboratory test monitoring.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>105 patients (73.4%) were exposed to deoxycholate amphotericin B, 25 patients (17.5%) to liposomal amphotericin B, and 13 patients (9.1%) to both amphotericin B types. Hypokalemia was the most common adverse reaction (76.2%), followed by hypomagnesemia (47.6%), acute kidney injury (40.6%), infusion reactions (33.6%), anemia (20.3%), thrombocytopenia (7%), and neutropenia (4.9%). Electrolyte supplementation was the WHO recommendation that was less performed (28%), while preemptive hydration and laboratory test monitoring were well applied (82.5% and 84.6%).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>This study highlights the need to adhere to amphotericin B toxicity prevention recommendations as some of the most common adverse reactions are mostly preventable.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15381,"journal":{"name":"Journal of Clinical Pharmacy and Therapeutics","volume":"2026 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2026-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/jcpt/2980716","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148324032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Systemic Cancer Therapy-Related Adverse Drug Reactions and Associated Clinical Outcomes Among Lymphoma Patients at Kenyatta National Hospital","authors":"Ivy Kerubo Mochere, Amsalu Degu","doi":"10.1155/jcpt/1766313","DOIUrl":"https://doi.org/10.1155/jcpt/1766313","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Combination chemotherapy regimens are the mainstay of treatment for Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). Their narrow therapeutic indices often result in adverse drug reactions (ADRs) that can interrupt therapy, increase resource utilization, and worsen patient outcomes. Data on the burden and characteristics of systemic cancer therapy-related ADRs among lymphoma patients in Kenya are scarce. Hence, this study aimed to assess the prevalence, types, severity, preventability, and clinical outcomes of systemic cancer therapy-related ADRs among adult HL and NHL patients treated at Kenyatta National Hospital (KNH).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This retrospective cohort study involved 100 adult patients (≥ 18 years) diagnosed with HL or NHL who received systemic cancer therapy at KNH between January 2020 and December 2024. Data were extracted using a structured abstraction tool and included patient demographics, lymphoma subtype, systemic cancer therapy, ADR types, severity, preventability, and associated clinical outcomes. Statistical analysis was conducted using SPSS Version 29.0.01 software.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Systemic cancer therapy-related ADRs occurred in 98% of patients, demonstrating a very high burden in this population. The most frequently observed ADRs were anemia (31%), followed by nausea/vomiting (24%) and neutropenia (14%). Most ADRs were mild (51%) or moderate (33%), though 14% were classified as severe. Preventability analysis showed that 57% of ADRs were definitely preventable and 27% probably preventable. Clinical consequences included treatment interruptions (47%), hospital admissions (19%), and ADR-related mortality in 8% of patients.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The prevalence of systemic cancer therapy-related ADRs among lymphoma patients at KNH is extremely high. While many reactions are not severe, most are preventable, indicating gaps in monitoring and regimen optimization. Strengthening pharmacovigilance, early toxicity detection, and individualized regimen selection could help reduce toxicities and improve outcomes for lymphoma patients in Kenya.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15381,"journal":{"name":"Journal of Clinical Pharmacy and Therapeutics","volume":"2026 1","pages":""},"PeriodicalIF":1.1,"publicationDate":"2026-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/jcpt/1766313","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148282335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Di Du, Yanna Zhu, Hongmei Zheng, Suying Xu, Yuke Li, Peng Zhan, Jun Yang, Yanting Wang
{"title":"HER2-Targeted Antibody–Drug Conjugates–Associated Interstitial Lung Disease: A Pharmacovigilance Study Based on FDA Adverse Event Reporting System Data","authors":"Di Du, Yanna Zhu, Hongmei Zheng, Suying Xu, Yuke Li, Peng Zhan, Jun Yang, Yanting Wang","doi":"10.1155/jcpt/7121390","DOIUrl":"https://doi.org/10.1155/jcpt/7121390","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Antibody–drug conjugates (ADCs) targeting the human epidermal growth factor receptor 2 (HER2), including trastuzumab deruxtecan (T-DXd) and trastuzumab emtansine (T-DM1), have already altered the treatment landscape for HER2-positive malignancies. Interstitial lung disease (ILD) associated with ADCs presents as a fatal adverse reaction, yet it remains inadequately characterized in real-world contexts.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>This study was to refine the risk profiles of these agents using ILD cases drawn from the FDA Adverse Event Reporting System (FAERS) to examine the clinical features.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Method</h3>\u0000 \u0000 <p>ILD cases were extracted from FAERS. Disproportionality analyses and survival analyses were used to assess risk signals, onset kinetics, and mortality.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>T-DXd exhibited stronger ILD signals and shorter time-to-onset than T-DM1 (acute respiratory distress syndrome [73d vs. 403d, <i>p</i> = 0.033], pneumonitis [62.5d vs. 106d, <i>p</i> = 0.035]). No statistically significant differences were observed in fatal cases.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>T-DXd exhibits more reporting cases and an earlier onset time of ILD compared to T-DM1. Proactive monitoring, including earlier radiographic screening, is warranted, particularly for patients at risk of acute respiratory distress syndrome and pneumonitis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Impact Statements</h3>\u0000 \u0000 <p>This study provides crucial evidence through large-scale real-world data that T-DXd is associated with a significantly higher number of reported cases of ILD and a shorter time to onset compared to T-DM1. This comprehensive characterization of ILD signals and timing in real-world clinical practice provides direct evidence for clinicians to conduct risk–benefit assessments and highlights the importance of early detection strategies starting within months of T-DXd therapy.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15381,"journal":{"name":"Journal of Clinical Pharmacy and Therapeutics","volume":"2026 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/jcpt/7121390","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148238238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xun Yan, Nan Gao, Hui Cheng, Kangkang Ji, Feng Lu, Chengchen Liu
{"title":"Integrating WNT10B Into a Prognostic Model to Stratify Survival Risk and Immune Phenotype in Colon Cancer","authors":"Xun Yan, Nan Gao, Hui Cheng, Kangkang Ji, Feng Lu, Chengchen Liu","doi":"10.1155/jcpt/8861954","DOIUrl":"https://doi.org/10.1155/jcpt/8861954","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The optimization of therapeutic safety in oncology requires precise biomarkers to stratify patients and anticipate treatment interactions. While dysregulation of the Wnt pathway is a hallmark of colon cancer, the clinical and immunological significance of noncanonical Wnt ligands, particularly WNT10B, remains poorly defined, limiting their utility in personalized risk assessment.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We conducted an integrative bioinformatics analysis using The Cancer Genome Atlas (TCGA) colon adenocarcinoma (COAD) cohort (<i>n</i> = 478). <i>WNT10B</i> expression was analyzed for its association with clinicopathological features, overall survival (OS), and disease-specific survival (DSS). Multivariate Cox regression was used to determine its independent prognostic value. Immune cell infiltration was estimated using CIBERSORTx and ssGSEA algorithms. A prognostic nomogram incorporating <i>WNT10B</i> was developed and validated.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p><i>WNT10B</i> was significantly upregulated in tumor tissues and associated with advanced <i>T</i> stage (<i>p</i> = 0.022). High <i>WNT10B</i> expression predicted inferior OS (HR = 3.304, <i>p</i> = 0.010) and DSS (HR = 3.879, <i>p</i> = 0.014), remaining an independent prognostic factor after adjusting for age and TNM stage. Tumors with high <i>WNT10B</i> exhibited an immunosuppressive microenvironment, characterized by increased M2 macrophage infiltration and reduced CD8<sup>+</sup> T cell abundance, which has been well-acknowledged as a phenotype with reduced immunotherapy response in previous studies. The <i>WNT10B</i>-incorporated nomogram showed robust calibration for predicting 1-, 3-, and 5-year survival.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Our study establishes <i>WNT10B</i> as a novel, independent prognostic biomarker in colon cancer, directly linked to an immunosuppressive tumor microenvironment.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15381,"journal":{"name":"Journal of Clinical Pharmacy and Therapeutics","volume":"2026 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/jcpt/8861954","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148238169","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}