Clinical therapeutics最新文献

{"title":"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, Caomei Xu, Jianfen Xie, Jiahao Xu, Chen Chen, Jiang Shen, Nan Hu, Lan Qiu","doi":"10.1016/j.clinthera.2024.11.003","DOIUrl":"https://doi.org/10.1016/j.clinthera.2024.11.003","url":null,"abstract":"<p><strong>Purpose: </strong>Investigate the analgesia effects and pharmacokinetics of ropivacaine at different concentrations in Serratus Anterior Plane Block (SAPB) and assess the efficacy and safety.</p><p><strong>Methods: </strong>Thirty-six patients undergoing video-assisted thoracoscopic surgery (VATS) pulmonary resections were enrolled. Ultrasound-guided SAPB was induced with 3 mg/kg ropivacaine at different concentrations (0.25%, 0.5%, and 0.75%, referred to as Group L, Group M, and Group H, respectively). The concentration of ropivacaine in the plasma at 1, 15, 30, 45, 60 min, 2, 4, 8, 12, and 24 h after SAPB was determined by LC-MS/MS. Other evaluated measures included the Numerical Rating Scale (NRS) scores at rest and on movement, the frequency of dermatomes blocked, onset time and effective plane, Quality of Requirements(QoR)-15 scale, chronic postsurgical pain, and the level of IL-6 and IL-8.</p><p><strong>Findings: </strong>The NRS scores were significantly higher in Group L than those in other groups (P < 0.05), indicating that the analgesic effect of Group L was the worst among the three groups. Group H had a lower effective plane of anesthesia and significantly higher incidence of chronic postsurgical pain. The IL-8 level was significantly lower in Group H than in other groups at 1 min, 1 h, and 24 h after SAPB. The ropivacaine concentrations were the highest in Group H, followed by Group M and Group L. The high blood concentration of ropivacaine in Group H may increase the risk of systemic toxicity from local anesthetics. Compared to Group L and Group H, Group M had superior analgesic effects and better safety. Among the three groups, C_max, t_1/2, and AUC_0-∞ differed significantly.</p><p><strong>Implications: </strong>For patients undergoing VATS, using 0.5% ropivacaine for SAPB is recommended.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142784299","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":"Data Mining and Analysis for Iodinated Contrast Media Adverse Event Signals Based on the Food and Drug Administration Adverse Event Reporting System Database.","authors":"Juntao Tan, Yue Yu, Yuxin He, Jiangyuan Zheng, Qingzhu Tan, Xiao Zhang, Chao Wan, Zhengyu Zhang, Xiaoxin Wu, Rui Tan","doi":"10.1016/j.clinthera.2024.11.007","DOIUrl":"https://doi.org/10.1016/j.clinthera.2024.11.007","url":null,"abstract":"<p><strong>Background: </strong>The purpose of this study was to employ the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to mine and analyze adverse events related to iodinated contrast media (ICM), explore the characteristics of adverse events (AEs) including their occurrence and correlation strength between AEs and drugs, and to provide valuable insights for clinical use.</p><p><strong>Methods: </strong>The FAERS database was queried, data from Q1 of 2004 to Q2 of 2023 were extracted, and AE reports targeting 5 ICMs as the primary suspects were collected. Data mining and analysis were carried out on relevant reports using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayes geometric mean (EBGM), while the standardized medical dictionary for regulatory activities (MedDRA) queries (SMQ) was used for systematic classification.</p><p><strong>Results: </strong>A total of 11,155,106 AE reports were retrieved from FAERS, with 2,412 for ioversol, 2,001 for iohexol, 987 for iodixanol, 1,154 for iopamidol, and 3,835 for iopromide. ICM-induced AE occurrence targeted 21 system organ classes (SOCs). A total of 329 significant disproportionality Preferred terms (PTs) conforming to the 4 algorithms were simultaneously retained. The results revealed that the medium and strong adverse drug reaction (ADR) signals of the 5 ICMs largely focused on \"respiratory, thoracic and mediastinal disorders,\" \"general disorders and administration site conditions,\" \"immune system disorders,\" and \"skin and subcutaneous tissue disorders.\" Ioversol (log₂ROR = 1.21, P_adj = 0.034) and iopromide (log₂ROR = 1.32, P_adj = 0.004) were both correlated with a higher incidence of a significant ADR signal, namely throat irritation, particularly in females. In addition, ioversol and iopromide also suggested that toxic nephropathy (log₂ROR = -2.47, P_adj < 0.001) and hyperhidrosis (log₂ROR = -1.22, P_adj = 0.001) were significant ADR signals, especially in males, respectively.</p><p><strong>Conclusions: </strong>While the AE distribution of the 5 ICMs was consistent, there were variations in specific ADR signal characteristics, warranting further consideration and exploration.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767048","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":"Toxic Epidermal Necrolysis Observed in a Patient With the HLA-B*1502 Treated With Levofloxacin.","authors":"Xiufang Wang, Gangying Cheng, Xiaofang Liang, Junhui Yang, Aiping Deng, Dan Chen, Chao Liu, Ying Gao, Juyi Li","doi":"10.1016/j.clinthera.2024.09.014","DOIUrl":"10.1016/j.clinthera.2024.09.014","url":null,"abstract":"<p><strong>Purpose: </strong>To determine the relationship between HLA-B gene mutations and levofloxacin-induced toxic epidermal necrolysis (TEN).</p><p><strong>Methods: </strong>A 71-year-old Chinese woman developed TEN after oral administration of solifenacin (5 mg) and levofloxacin (0.5 g) for cystitis. HLA-B*5801 and HLA-B*1502 alleles were detected using real-time PCR.</p><p><strong>Findings: </strong>After supportive therapy (antiallergic treatments, plasma exchange, etc) and withdrawal of the culprit medication levofloxacin, the patient was discharged with re-epithelialization of the exfoliated skin. The patient was HLA-B*1502 allele positive and HLA-B*5801 allele negative.</p><p><strong>Implications: </strong>This is the first report of levofloxacin-induced TEN suspected to be caused by mutations in the HLA-B*1502 allele.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1082-1085"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364682","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":"The Evolving Roles of Sex and Gender in Acute Care Medicine.","authors":"Angela F Jarman, Sarah M Perman","doi":"10.1016/j.clinthera.2024.11.001","DOIUrl":"10.1016/j.clinthera.2024.11.001","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"943-944"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750283","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":"Comment on \"Pancreatitis and Pancreatic Cancer Risk Among Patients With Type 2 Diabetes Receiving Dipeptidyl Peptidase 4 Inhibitors: An Updated Meta-Analysis of Randomized Controlled Trials\".","authors":"Yuki Nakano, Kazuki Adachi, Kazumasa Kotake","doi":"10.1016/j.clinthera.2024.08.021","DOIUrl":"10.1016/j.clinthera.2024.08.021","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1086"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343082","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":"Sex Differences in Testing for Pulmonary Embolism Among Emergency Department Patients Aged 18-49 by Chief Complaint.","authors":"Angela F Jarman, Brandon C Maughan, Richard White, Sandra L Taylor, Zainab Akinjobi, Bryn E Mumma","doi":"10.1016/j.clinthera.2024.10.008","DOIUrl":"10.1016/j.clinthera.2024.10.008","url":null,"abstract":"<p><strong>Background: </strong>Women undergo diagnostic testing for pulmonary embolism (PE) in greater numbers than men, despite the disease incidence being higher in men overall. It is unknown if testing for PE varies based on patient chief complaint.</p><p><strong>Methods: </strong>This retrospective cohort study was conducted at two academic tertiary care hospitals. Nonpregnant adult patients (aged 18-49 years) were included if they presented to the ED between 1/1/2016 and 12/31/2018 with nontraumatic mechanisms and any of the following chief complaints: chest pain, shortness of breath, hemoptysis, or syncope AND had objective testing for PE. Data were obtained from the electronic medical record and analyzed descriptively. Four outcome variables were assessed: receipt of D-dimer testing, D-dimer positivity, receipt of pulmonary vascular imaging, and diagnosis of PE.</p><p><strong>Results: </strong>We studied 1,991 unique patient encounters, most of whom (63%; 1,256/1,991) were female. Overall, female patients had higher odds of receiving D-dimer testing than male patients (OR 1.30, CI 1.06-1.59, P = 0.015), while they had lower odds of being diagnosed with PE (OR 0.57, CI 0.36-0.90, P = 0.019). However, this trend varied by chief complaint. Among patients with chest pain, females had higher odds of having a D-dimer performed (OR 1.35, CI 1.01-1.80, P = 0.049) and lower odds of being diagnosed with PE (OR 0.36, CI 0.18-0.70, P = 0.003) than males.</p><p><strong>Conclusions: </strong>Both patient sex and chief complaint were associated with trends in diagnostic testing for PE. Among patients with chest pain, females are significantly more likely to be tested with a D-dimer and less likely to be diagnosed with PE.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"995-1000"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616379","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":"Impact of Preliminary Bronchodilator Dose in Chronic Obstructive Pulmonary Disease Patients With Suboptimal Peak Inspiratory Flow.","authors":"Mohamed Ismail Hassan, Nabila Ibrahim Laz, Yasmin M Madney, Mohamed E A Abdelrahim, Hadeer S Harb","doi":"10.1016/j.clinthera.2024.09.016","DOIUrl":"10.1016/j.clinthera.2024.09.016","url":null,"abstract":"<p><strong>Purpose: </strong>Suboptimal peak inspiratory flow rate (PIFR) is highly prevalent in patients with chronic obstructive pulmonary disease (COPD) owing to the mismatch of their PIFR with the corresponding inhaler-device resistance. This study aimed to investigate the impact of a preliminary dose of pressurized metered dose inhalers (pMDIs) on patients with COPD with suboptimal PIFR using Diskus dry powder inhalers (DPIs).</p><p><strong>Methods: </strong>A prospective, randomized, case-control study included 24 patients with COPD. PIFR was measured using the In-Check Dial G16 with low-to-medium resistance. Spirodoc was used to measure baseline spirometric data and compare it before and 30 minutes after the administration of Diskus DPI. On a different day, the study dose was given to each suboptimal patient by the same aerosol generator with preceded 2 puffs of salbutamol pMDI and re-evaluated for spirometric parameters 30 minutes after the study dose.</p><p><strong>Findings: </strong>There was a significant difference between the optimal and suboptimal groups in peak expiratory flow (2.38 ± 1.20 vs 1.49 ± 1.06 L/s, P = 0.050). PIFR showed a statistically significant difference between the optimal and suboptimal groups (71.66 ± 6.15 vs 41.25 ± 9.79 L/min, P < 0.0001). There was a significant difference in forced vital capacity (ΔFVC) between optimal and suboptimal groups without a preliminary dose (0.42 ± 0.21 vs 0.16 ± 0.11 L, P = 0.002), forced expiratory volume in 6 seconds (ΔFEV₆) (0.53 ± 0.49 vs 0.17 ± 0.11 L, P = 0.022), forced expiratory volume in 3 seconds (ΔFEV₃) (0.41 ± 0.38 vs 0.1 ± 0.16 L, P = 0.013), forced expiratory volume in 1 second (ΔFEV₁)/FVC (-2.38 ± 8.41 vs 2.96% ± 2.95%, P = 0.033), and ΔFEV₁/FEV₆ (-4.32 ± 11.23 vs 2.91% ± 4.35%, P = 0.015). There was a significant difference in ΔFVC between optimal and suboptimal groups with a preliminary dose (0.42 ± 0.21 vs 0.23 ± 0.18 L, P = 0.046), ΔFEV₁/FVC (-2.38 ± 8.41 vs 5.67% ± 6.53%, P = 0.009), ΔFEV₁/FEV₆ (-4.32 ± 11.23 vs 5.16% ± 4.99%, P = 0.008), and forced expiratory time (ΔFET) (0.28 ± 0.45 vs -0.31 ± 0.70 seconds, P = 0.022). The only parameter that showed a significant difference between suboptimal groups without and with a preliminary dose is Δ peak expiratory flow (0.24 ± 0.59 vs 0.65 ± 0.68 L/s, P = 0.004).</p><p><strong>Implications: </strong>Administering a preliminary dose of pMDI can minimally enhance the effectiveness of DPIs in patients with COPD with suboptimal PIFR and health outcomes.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"e16-e24"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364679","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":"Real-world Use of Mogamulizumab Among Patients With Mycosis Fungoides and Sézary Syndrome Before and During COVID-19 in the United States.","authors":"Chunlan Chang, Robert Ristuccia, Zhishui Zheng, Takeshi Takahashi, Takanobu Nomura, Eslie Dennis","doi":"10.1016/j.clinthera.2024.09.011","DOIUrl":"10.1016/j.clinthera.2024.09.011","url":null,"abstract":"<p><strong>Purpose: </strong>During the coronavirus disease 2019 (COVID-19) pandemic, professional organizations suggested extending dosing intervals for systemic cancer therapies to limit in-person visits. Mogamulizumab, indicated for adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after ≥1 prior systemic therapy, should be administered every 7 days of the first 28-day cycle (loading) and every 14 days of each subsequent cycle (maintenance) according to the approved prescribing information in the United States (US). This study examined the real-world use of mogamulizumab before and during the COVID-19 pandemic in the US.</p><p><strong>Methods: </strong>Using Symphony Health's Integrated Dataverse (IDV) database, adults with ≥1 diagnosis of MF or SS and ≥1 mogamulizumab claim between October 1, 2018 and December 22-, 2022 were identified. Patients in MF and SS cohorts were divided into 3 subgroups based on the date they initiated mogamulizumab treatment: pre-COVID-19 (October 1, 2018-March 31, 2020), COVID-19 Phase 1 (April 1, 2020-July 31, 2021), and COVID- 19 Phase 2 (August 1, 2021-December 22, 2022).</p><p><strong>Findings: </strong>During the study, 270 patients with MF and 337 patients with SS initiated mogamulizumab. The pre-COVID-19, COVID-19 Phase 1, and COVID-19 Phase 2 subgroups included 95, 81, and 94 patients with MF and 124, 119, and 94 patients with SS, respectively. In the MF cohort, mean loading dosing intervals were 13, 12, and 9 days for the pre-COVID-19, COVID-19 Phase 1, and COVID-19 Phase 2 subgroups, respectively, and mean maintenance dosing intervals were 16, 16, and 16 days, respectively. In the SS cohort, mean loading dosing intervals were 16, 11, and 11 days, and mean maintenance dosing intervals were 19, 18, and 16 days, respectively. For both cohorts, more patients in the COVID-19 Phase 1 and Phase 2 subgroups than in the pre-COVID-19 subgroup had gaps of ≤10 days between loading doses and ≤21 days between maintenance doses.</p><p><strong>Implications: </strong>In patients with MF and SS, loading dosing intervals in the pre-COVID-19 period were longer than the loading schedule per the approved prescribing information, but there was a trend towards closer concordance in the COVID-19 periods. Maintenance dosing intervals in patients with MF were consistently similar to the approved schedule across treatment periods, and in patients with SS became more closely aligned over time. Thus, dosing intervals for mogamulizumab in both loading and maintenance cycles do not appear to have been extended during the COVID-19 Phase 1 and Phase 2 periods compared with the pre-COVID-19 period, despite recommendations to extend dosing intervals for systemic cancer therapies during COVID-19.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1024-1033"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388679","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":"Miplyffa (arimoclomol).","authors":"Paul Beninger","doi":"10.1016/j.clinthera.2024.10.010","DOIUrl":"10.1016/j.clinthera.2024.10.010","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1089-1090"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686347","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":"Choice of Postintubation Sedation Strategy by Sex: A Conjoint Analysis.","authors":"Caroline Raymond-King, Ryan Cook, Rachel Beekman, Ryan Buckley, Nicholas J Johnson, Cindy H Hsu, Sarah Perman","doi":"10.1016/j.clinthera.2024.10.014","DOIUrl":"10.1016/j.clinthera.2024.10.014","url":null,"abstract":"<p><strong>Purpose: </strong>To assess if patient sex is an important attribute in physician decision-making for postintubation sedation strategies in the emergency department and intensive care units.</p><p><strong>Methods: </strong>We designed a survey of eight fictional cases utilizing a fractional factorial design varying fictional patient sex, race/ethnicity, and history of substance use disorder. We surveyed emergency medicine and critical care fellows and attendings at three geographically diverse academic medical centers in the US. We analyzed data using conjoint analysis to assess importance weights (IW). For this analysis, we compared physician beliefs of stated importance of sex to IW derived from cases.</p><p><strong>Findings: </strong>Eighty-six participants started the survey; 75 (87.2%) participants completed demographic information and at least one vignette and were included in analysis. Most physicians were white, male, worked primarily in an emergency department and were attending physicians. Sex had the lowest weight in affecting decisions when considering using midazolam (IW = 3.2%) or propofol (IW = 3.6%) as postintubation sedation strategies, and the second lowest weight when considering fentanyl (IW = 7.3%). Respondents stated they believed physicians rarely considered patient sex when making decisions about postintubation sedation.</p><p><strong>Implications: </strong>Physicians managing postintubation sedation reported sex rarely affected decision-making when choosing propofol, midazolam, or fentanyl as sedation strategies, despite evidence that these medications are metabolized differently in females. Further research is needed to identify ideal postintubation sedation strategies that account for patient sex.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":"1001-1004"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142726687","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}