Clinical therapeutics最新文献

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Assessing Experiences With Trofinetide for Rett Syndrome: Interviews With Caregivers of Participants in Clinical Trials 评估使用特罗非肽治疗Rett综合征的经验:与临床试验参与者的护理人员的访谈。
IF 3.2 4区 医学
Clinical therapeutics Pub Date : 2025-01-16 DOI: 10.1016/j.clinthera.2024.12.012
Amy M. Barrett MSPH, MA , Oyebimpe Olayinka-Amao PharmD, MPH , Susan Martin MSPH , Dilesh Doshi PharmD , Kathie M. Bishop PhD , James M. Youakim MD
{"title":"Assessing Experiences With Trofinetide for Rett Syndrome: Interviews With Caregivers of Participants in Clinical Trials","authors":"Amy M. Barrett MSPH, MA ,&nbsp;Oyebimpe Olayinka-Amao PharmD, MPH ,&nbsp;Susan Martin MSPH ,&nbsp;Dilesh Doshi PharmD ,&nbsp;Kathie M. Bishop PhD ,&nbsp;James M. Youakim MD","doi":"10.1016/j.clinthera.2024.12.012","DOIUrl":"10.1016/j.clinthera.2024.12.012","url":null,"abstract":"<div><h3>Purpose</h3><div>Rett syndrome (RTT) is a rare neurodevelopmental disorder that mainly affects girls and women. Trofinetide is approved for the treatment of RTT in adults and children aged ≥2 years. To gain insight into experiences with RTT and effects of trofinetide treatment at different stages of RTT, interviews with caregivers of individuals with RTT were conducted upon their exit from the open-label trofinetide trials.</div></div><div><h3>Methods</h3><div>Interviews were conducted with caregivers of participants in the LILAC/LILAC-2 open-label extension trials of the phase 3 LAVENDER trial in participants aged 5 to 20 years, and in DAFFODIL, an open-label trial in participants aged 2 to 4 years. Caregivers were asked about the RTT effects, experiences with trofinetide, meaningfulness of treatment effects, and satisfaction. Qualitative thematic analysis was performed.</div></div><div><h3>Findings</h3><div>Caregivers of 33 participants from the open-label trials were interviewed, including 26 from LILAC/LILAC-2 (mean age, 12.3 years) and 7 from DAFFODIL (mean age, 4.5 years). The most commonly reported effects of RTT in LILAC/LILAC-2 were no verbal communication (24/26 [92.3%]), unable to use hands (15/26 [57.7%]), repetitive hand movements (15/26 [57.7%]), unable to walk (15/26 [57.7%]), and seizures (14/26 [53.8%]). In DAFFODIL, the most commonly reported effects of RTT were no verbal communication (7/7 [100%]), impaired balance (4/7 [57.1%]), unable to use hands (3/7 [42.9%]), repetitive hand movements (3/7 [42.9%]), mood disturbance (3/7 [42.9%]), constipation (3/7 [42.9%]), and limited ability to use hands (3/7 [42.9%]). Caregivers most commonly reported improvements in hand use (11/26 [42.3%]), engagement with others (11/26 [42.3%]), eye gaze (8/26 [30.8%]), use of the Tobii eye tracking device (7/26 [26.9%]), and attention/focus/concentration (7/26 [26.9%]) in LILAC/LILAC-2. In DAFFODIL, caregivers reported improvements in new words (5/7 [71.4%]), hand use (4/7 [57.1%]), and eye contact (4/7 [57.1%]). Nearly all (31/32) caregivers were very satisfied or satisfied with trofinetide.</div></div><div><h3>Implications</h3><div>Caregivers of participants in open-label trofinetide trials reported improvements in RTT with meaningful impact in areas of motor function, communication, and engagement.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 3","pages":"Pages 181-188"},"PeriodicalIF":3.2,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143001610","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}
引用次数: 0
Optimizing the Design of a Lateral Oscillating Device for Pressure Ulcer Prevention: Results of a Quasi-experimental Study 一种预防压疮的横向振荡装置的优化设计:一项准实验研究的结果。
IF 3.2 4区 医学
Clinical therapeutics Pub Date : 2025-01-11 DOI: 10.1016/j.clinthera.2024.12.009
Ángeles Hernández Sánchez MSc , Jesus M. Lavado-Garcia PhD , Jesús M. Rodríguez-Rego PhD , Laura Mendoza-Cerezo MSc , Antonio Macías-García PhD
{"title":"Optimizing the Design of a Lateral Oscillating Device for Pressure Ulcer Prevention: Results of a Quasi-experimental Study","authors":"Ángeles Hernández Sánchez MSc ,&nbsp;Jesus M. Lavado-Garcia PhD ,&nbsp;Jesús M. Rodríguez-Rego PhD ,&nbsp;Laura Mendoza-Cerezo MSc ,&nbsp;Antonio Macías-García PhD","doi":"10.1016/j.clinthera.2024.12.009","DOIUrl":"10.1016/j.clinthera.2024.12.009","url":null,"abstract":"<div><h3>Purpose</h3><div>The aim of this study was to propose a lateral oscillating device for the prevention of pressure ulcers by understanding the mechanisms of tissue protection in healthy individuals during prolonged decubitus. We also sought to determine the optimal time interval for oscillation, considering peak pressure peaks and tolerable pressure limits as a function of individual characteristics such as age, weight, height, gender, and BMI.</div></div><div><h3>Methods</h3><div>A quasi-experimental, descriptive and analytical observational study was conducted between January 2022 and June 2023 with a sample of 25 healthy volunteers. Sacral, heel and trochanter pressure measurements were performed using sensors. Descriptive and bivariate statistical analyses were applied, and a linear regression model was used to analyze the relationship between independent variables and peak pressures recorded.</div></div><div><h3>Findings</h3><div>Peak pressure at the trochanter was significantly associated with age, weight and gender, while pressure at the sacrum showed a relationship only with gender. No significant associations were found for other variables. The 80th percentile was used to determine the maximum tolerable pressure, and the independent variables collectively explained 60% of the variance in maximum trochanter pressure (R<sup>2</sup> = 0.60; <em>p</em> = 0.0006). These findings helped to establish optimal time intervals for lateral oscillation, tailored to individual variability.</div></div><div><h3>Implications</h3><div>The designed lateral oscillating device proved to be effective in promoting tissue perfusion and reducing pressure build-up, thus contributing to pressure ulcer prevention. This personalized approach could significantly improve the care of immobilized patients in clinical settings.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 3","pages":"Pages e1-e11"},"PeriodicalIF":3.2,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969343","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Health Care Resource Use and Medical Costs Among Patients With Major Depressive Disorder and Acute Suicidal Ideation or Behavior Initiated on Esketamine Nasal Spray or Traditional Treatments in the United States 美国艾氯胺酮鼻腔喷雾剂或传统治疗引发的重度抑郁症患者急性自杀意念或行为的卫生保健资源使用和医疗费用
IF 3.2 4区 医学
Clinical therapeutics Pub Date : 2025-01-04 DOI: 10.1016/j.clinthera.2024.12.006
Lisa Harding MD , Maryia Zhdanava MA , Amanda Teeple DrPH , Aditi Shah MA , Porpong Boonmak MA , Dominic Pilon MA , Kruti Joshi MPH
{"title":"Health Care Resource Use and Medical Costs Among Patients With Major Depressive Disorder and Acute Suicidal Ideation or Behavior Initiated on Esketamine Nasal Spray or Traditional Treatments in the United States","authors":"Lisa Harding MD ,&nbsp;Maryia Zhdanava MA ,&nbsp;Amanda Teeple DrPH ,&nbsp;Aditi Shah MA ,&nbsp;Porpong Boonmak MA ,&nbsp;Dominic Pilon MA ,&nbsp;Kruti Joshi MPH","doi":"10.1016/j.clinthera.2024.12.006","DOIUrl":"10.1016/j.clinthera.2024.12.006","url":null,"abstract":"<div><h3>Purpose</h3><div>Major depressive disorder with acute suicidal ideation or behavior (MDSI) is a substantial humanistic, economic, and clinical burden on patients. Data on health care resource use (HRU) and costs among patients with MDSI initiated on esketamine nasal spray relative to traditional treatments are limited. This study sought to describe HRU and medical costs of patients with MDSI initiated on esketamine, electroconvulsive therapy (ECT), antidepressant with second-generation antipsychotic (SGA) augmentation, and antidepressant monotherapy in the United States.</div></div><div><h3>Methods</h3><div>Adults with MDSI from Merative® MarketScan® Commercial Databases (January 2016 to January 2022) were categorized into esketamine, ECT, SGA augmentation, and antidepressant monotherapy cohorts based on treatments initiated on or after August 5, 2020 (index date). Baseline period spanned 12 months before index date; follow-up period spanned from the index date till the end of data/health plan eligibility. Acute care HRU (inpatient and emergency department days) and medical costs excluding index treatment costs were described per-patient-per-month among all cohorts.</div></div><div><h3>Findings</h3><div>The number of patients in the respective cohorts was 122 for esketamine, 336 for ECT, 9958 for SGA augmentation, and 4496 for antidepressant monotherapy. Across cohorts, mean patient age ranged from 29.1 to 41.2 years, and the majority of patients were female (range, 57.2%–65.6%). During the follow-up period, mean all-cause acute care HRU was 0.59 days in the esketamine cohort, which trended lower than in the ECT (3.17 days) and SGA augmentation (0.92 days) cohorts, and higher than in the antidepressant monotherapy cohort (0.32 days). Mean acute care HRU decreased from baseline in the esketamine, SGA augmentation, and antidepressant monotherapy cohorts by 58%, 21%, and 37% and increased in the ECT cohort by 44%. Mean follow-up medical costs per-patient-per-month were $1869 in the esketamine cohort, which trended lower than in the ECT ($4624) and SGA augmentation ($2163) cohorts, and higher than in the antidepressant monotherapy ($863) cohort. Relative to baseline, medical costs decreased in all cohorts (esketamine, 50%; ECT, 22%; SGA augmentation, 17%; antidepressant monotherapy, 32%).</div></div><div><h3>Implications</h3><div>Acute care HRU and medical costs trended lower among patients with MDSI initiated on esketamine nasal spray versus ECT or SGA augmentation; HRU and costs reduced most from pretreatment levels among patients treated with esketamine nasal spray versus patients treated with ECT, SGA augmentation, and antidepressant monotherapy. Results of this study may aid physicians in determining optimal treatments for the vulnerable MDSI population.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 3","pages":"Pages 189-195"},"PeriodicalIF":3.2,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930752","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}
引用次数: 0
Meta-Analysis of Randomized, Controlled Trials Assessing the Effectiveness and Safety of Biological Treatments in Chronic Obstructive Pulmonary Disease Patients 评估慢性阻塞性肺疾病患者生物治疗的有效性和安全性的随机对照试验的meta分析。
IF 3.2 4区 医学
Clinical therapeutics Pub Date : 2025-01-04 DOI: 10.1016/j.clinthera.2024.12.001
Khai-Chi Hu MD , Min-Hsiang Chuang MD , Chih-Cheng Lai MD , Kuang-Ming Liao MD, PhD
{"title":"Meta-Analysis of Randomized, Controlled Trials Assessing the Effectiveness and Safety of Biological Treatments in Chronic Obstructive Pulmonary Disease Patients","authors":"Khai-Chi Hu MD ,&nbsp;Min-Hsiang Chuang MD ,&nbsp;Chih-Cheng Lai MD ,&nbsp;Kuang-Ming Liao MD, PhD","doi":"10.1016/j.clinthera.2024.12.001","DOIUrl":"10.1016/j.clinthera.2024.12.001","url":null,"abstract":"<div><div>Anti-interleukin-5 (IL-5), anti-IL-5 receptor and anti-interleukin-4 (IL-4) have emerged as potential treatments for severe eosinophilic asthma, yet their role in treating chronic obstructive pulmonary disease (COPD) is unclear. A literature review was conducted up to May 31, 2024. Only randomized controlled trials (RCTs) assessing the clinical efficacy and adverse effects of biological treatment (anti-IL-5/ anti-IL-5 receptor /anti-IL-4) in COPD patients were included in this meta-analysis. Primary outcomes focused on COPD exacerbation risk, with secondary outcomes examining lung function, quality of life, and adverse events. Four articles comprising 6 RCTs were analyzed. Among 2837 patients receiving anti-IL-5/anti-IL-5 receptor therapies, 468 receiving anti-IL-4 therapies, and 1913 receiving placebo. Overall, biological treatment therapies collectively demonstrated a reduced risk of COPD exacerbation compared to placebo (rate ratio, 0.88; 95% CI, 0.80–0.97, I<sup>2</sup> = 53%). Specifically, dupilumab statistically significant reduction in exacerbation risk (rate ratio 0.70, 95% CI 0.58–0.84). Benralizumab showed a borderline reduction in exacerbation risk (rate ratio, 0.92; 95% CI, 0.85–1.00, I<sup>2</sup> = 0%, while Mepolizumab exhibited a trend towards lower exacerbation risk that did not reach statistical significance (rate ratio 0.90, 95% CI 0.77–1.06, I<sup>2</sup> = 62%). Subgroup analysis showed that patients with COPD and eosinophils ≥300 per cubic millimeter who received biological treatment may experience a reduced risk of acute exacerbation. Changes in lung function from baseline did not significantly differ between biological therapies and placebo. Analysis of St. George's Respiratory Questionnaire (SGRQ) scores indicated significant improvements with biological therapies compared to placebo (mean difference -1.30, 95% CI -2.46 to -0.14, I<sup>2</sup> = 28%). Biological therapies showed comparable risks of adverse events compared to placebo. This meta-analysis suggests that biological therapies may reduce the risk of acute exacerbations and improve quality of life in COPD patients compared to placebo. However, these therapies did not demonstrate significant improvements in pulmonary function. Future studies are needed to delineate the role of these biologic therapies in managing COPD exacerbations.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 3","pages":"Pages 226-234"},"PeriodicalIF":3.2,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930754","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}
引用次数: 0
Comparison of Effects on 6-Thioguanine Nucleotides According to Mesalazine Formulation in Pediatric Patients with Ulcerative Colitis 不同美沙拉嗪剂型对6-硫鸟嘌呤核苷酸治疗小儿溃疡性结肠炎的疗效比较。
IF 3.2 4区 医学
Clinical therapeutics Pub Date : 2025-01-02 DOI: 10.1016/j.clinthera.2024.12.007
Hansol Kim MD, Yoon Zi Kim MD, Seon Young Kim MD, Yon Ho Choe MD, PhD, Mi Jin Kim MD, PhD
{"title":"Comparison of Effects on 6-Thioguanine Nucleotides According to Mesalazine Formulation in Pediatric Patients with Ulcerative Colitis","authors":"Hansol Kim MD,&nbsp;Yoon Zi Kim MD,&nbsp;Seon Young Kim MD,&nbsp;Yon Ho Choe MD, PhD,&nbsp;Mi Jin Kim MD, PhD","doi":"10.1016/j.clinthera.2024.12.007","DOIUrl":"10.1016/j.clinthera.2024.12.007","url":null,"abstract":"<div><h3>Purpose</h3><div>Mesalazine and thiopurines are important therapeutic agents for pediatric patients with ulcerative colitis (UC). Mesalazine, which may be administered in different forms depending on delivery mechanisms, can affect thiopurine metabolism, leading to increased 6-thioguanine nucleotides (6-TGN) levels. Therefore, when using these two drugs simultaneously, their interactions must be considered. This study aimed to analyze 6-TGN according to mesalazine formulation in pediatric patients with UC.</div></div><div><h3>Methods</h3><div>We retrospectively reviewed the data of 236 pediatric patients with UC who visited a single health center between January 2021 and December 2023. Among the enrolled patients, 198 were administered thiopurines, and of these, 136 underwent testing for 6-TGN.</div></div><div><h3>Findings</h3><div>The mean dose of azathioprine (AZA) was 0.66 mg/kg, and the mean 6-TGN level was 211.64 pmol/8 × 10^8 red blood cells (RBCs). The mean 6-TGN level for the group concurrently using time-dependent mesalazine and AZA was 245.00 pmol/8 × 10^8 RBCs, while that for the group concurrently using multimatrix mesalazine (MMX) and AZA was 141.97 pmol/8 × 10^8 RBCs (<em>P</em> &lt; 0.001). In the same patients, the mean 6-TGN level during time-dependent mesalazine treatment was 290.34 pmol/8 × 108 RBCs, whereas the mean 6-TGN level measured after switching to MMX was 148.54 pmol/8 × 108 RBCs (<em>P</em> = 0.016).</div></div><div><h3>Implications</h3><div>The group treated with MMX and AZA had a lower mean 6-TGN level than the group treated with time-dependent mesalazine and AZA. The mean 6-TGN level significantly decreased after switching from time-dependent mesalazine to MMX in the same patients. Therefore, when administering MMX, a higher dose of AZA is necessary to reach the target 6-TGN level, compared to the dose required when using time-dependent mesalazine.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 3","pages":"Pages 196-203"},"PeriodicalIF":3.2,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Inappropriate Prescribing of Nirmatrelvir/Ritonavir in Solid Organ Transplantation With COVID-19 Infection: A Multicenter Retrospective Study COVID-19感染实体器官移植中尼马替韦/利托那韦处方不当:一项多中心回顾性研究
IF 3.2 4区 医学
Clinical therapeutics Pub Date : 2025-01-01 DOI: 10.1016/j.clinthera.2024.10.013
Ying Zhang MPharm , Kuifen Ma PhD , Wenjing Hou MD , Xiangduan Liu MD , Jiaojiao Chen MD , Ying Wang MD , Ying Zhu MM , Qing Qian PhD , Zhuoling An PhD , Hui Yang MS
{"title":"Inappropriate Prescribing of Nirmatrelvir/Ritonavir in Solid Organ Transplantation With COVID-19 Infection: A Multicenter Retrospective Study","authors":"Ying Zhang MPharm ,&nbsp;Kuifen Ma PhD ,&nbsp;Wenjing Hou MD ,&nbsp;Xiangduan Liu MD ,&nbsp;Jiaojiao Chen MD ,&nbsp;Ying Wang MD ,&nbsp;Ying Zhu MM ,&nbsp;Qing Qian PhD ,&nbsp;Zhuoling An PhD ,&nbsp;Hui Yang MS","doi":"10.1016/j.clinthera.2024.10.013","DOIUrl":"10.1016/j.clinthera.2024.10.013","url":null,"abstract":"<div><h3>Background</h3><div>Nirmatrelvir-ritonavir (NR) has demonstrated effectiveness in halting the progression to severe coronavirus disease 2019 (COVID-19) among solid organ transplant recipients (SOTRs) infected with Severe Acute Respiratory Syndrome Coronavirus 2. However, it has a wide range of interactions, especially with immunosuppressants. The study aimed to comprehensively evaluate the Inappropriate prescribing of NR and immunosuppressants in SOTRs with COVID-19, while also highlighting the essential aspects.</div></div><div><h3>Methods</h3><div>We included hospitalized SOTRs who received NR at five tertiary hospitals between December 2022 and June 2023, and evaluated their prescription.</div></div><div><h3>Results</h3><div>A total of 211 patients were enrolled, of which 205 did not meet all criteria for appropriate prescribing (97.16%). Inappropriateness primarily stemmed from starting treatment more than 5 days after symptom onset (87.68%), followed by application in severe-to-critical cases of COVID-19 (52.13%), the inappropriate dosages based on renal function (47.87%). Contraindications encompassed 17.06% of patients with severe renal impairment and 5.69% with contraindicated drug interactions. Inappropriate resumption of immunosuppressants accounted for a larger proportion than inappropriate discontinuation or dose adjustment (30.16% vs 8.99%). More than one-third of patients neglected to monitor concentrations. About 8% experienced abnormal high concentrations.</div></div><div><h3>Conclusion</h3><div>Inappropriate prescribing of NR is widespread among hospitalized SOTRs. Adjusting doses based on patients’ renal function and paying attention to concurrent use of immunosuppressive drugs are crucial, and therapeutic drug monitoring is necessary. Clinical practitioners should enhance their vigilance and attention.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages e1-e8"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767050","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Effect of Dexmedetomidine on Inflammatory Factors and Clinical Outcomes in Patients With Septic Shock: A Randomized Clinical Trial 右美托咪定对感染性休克患者炎症因子和临床结局的影响:一项随机临床试验。
IF 3.2 4区 医学
Clinical therapeutics Pub Date : 2025-01-01 DOI: 10.1016/j.clinthera.2024.11.004
Mahdi Mokhlesian MD, BCA , Fatemeh Heydari MD, BCA , Seyyed Javad Boskabadi Pharma.D, BCPS , Afshin Gholipour Baradari MD, BCA , Abolghasem Ajami MD, PhD , Reza Alizadeh-Navaei MD, PhD
{"title":"The Effect of Dexmedetomidine on Inflammatory Factors and Clinical Outcomes in Patients With Septic Shock: A Randomized Clinical Trial","authors":"Mahdi Mokhlesian MD, BCA ,&nbsp;Fatemeh Heydari MD, BCA ,&nbsp;Seyyed Javad Boskabadi Pharma.D, BCPS ,&nbsp;Afshin Gholipour Baradari MD, BCA ,&nbsp;Abolghasem Ajami MD, PhD ,&nbsp;Reza Alizadeh-Navaei MD, PhD","doi":"10.1016/j.clinthera.2024.11.004","DOIUrl":"10.1016/j.clinthera.2024.11.004","url":null,"abstract":"<div><h3>Purpose</h3><div>Dexmedetomidine is a sedative-analgesic that is widely used in sepsis. However, its effect on septic shock remains unclear. This study aimed to investigate dexmedetomidine's effect on inflammatory biomarkers in septic shock.</div></div><div><h3>Methods</h3><div>The present study was a randomized controlled clinical trial. Patients with inclusion criteria were randomly allocated into either the dexmedetomidine (n = 24) or morphine + midazolam group (n = 24). The primary outcome was changes in inflammatory factors, including IL-1, IL-6, TNF-α, ESR, and CRP. The serum levels of inflammatory factors were measured at baseline and the end of the intervention. Secondary outcomes included the change in norepinephrine dose, vital signs, and SOFA scores.</div></div><div><h3>Findings</h3><div>Of the 48 subjects, 52.08% were male. After intervention, IL-1, IL-6, and TNF-α levels significantly differed between the 2 groups (<em>p</em> = 0.011 and <em>p</em> &lt; 0.001 and <em>p</em> &lt; 0.001, respectively). Heart rate and systolic blood pressure decreased over time, but the two groups had no significant difference (<em>p</em>-value &gt; 0.05). In addition, there was no significant difference in norepinephrine dose and SOFA score between the 2 groups (<em>p</em>-value &gt; 0.05).</div></div><div><h3>Implications</h3><div>Sedation with dexmedetomidine can attenuate the inflammatory factors in septic shock. Also, dexmedetomidine did not worsen the hemodynamic parameters in septic shock patients.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages e9-e17"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142784314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Note of Thanks
IF 3.2 4区 医学
Clinical therapeutics Pub Date : 2025-01-01 DOI: 10.1016/S0149-2918(24)00431-4
{"title":"Note of Thanks","authors":"","doi":"10.1016/S0149-2918(24)00431-4","DOIUrl":"10.1016/S0149-2918(24)00431-4","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages A1-A3"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143167517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effect of Intravenous Lidocaine on Postoperative Cognitive Dysfunction in Patients Undergoing General Anesthesia Surgery: A Systematic Review of a Randomized Controlled Trial 静脉注射利多卡因对全身麻醉手术患者术后认知功能障碍的影响:随机对照试验的系统回顾
IF 3.2 4区 医学
Clinical therapeutics Pub Date : 2025-01-01 DOI: 10.1016/j.clinthera.2024.09.027
Xian-Xue Wang MD, Jing Dai MM, Hui-wei Deng MM, Qi Wang MBBS, Yun Liu MM, Hua-Jing Guo MBBS
{"title":"Effect of Intravenous Lidocaine on Postoperative Cognitive Dysfunction in Patients Undergoing General Anesthesia Surgery: A Systematic Review of a Randomized Controlled Trial","authors":"Xian-Xue Wang MD,&nbsp;Jing Dai MM,&nbsp;Hui-wei Deng MM,&nbsp;Qi Wang MBBS,&nbsp;Yun Liu MM,&nbsp;Hua-Jing Guo MBBS","doi":"10.1016/j.clinthera.2024.09.027","DOIUrl":"10.1016/j.clinthera.2024.09.027","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Purpose&lt;/h3&gt;&lt;div&gt;Postoperative cognitive dysfunction (POCD) is a common neurologic complication that occurs after surgery, which prolongs the hospital stay of patients to a certain extent, increases the occurrence of complications, and even leads to the patient's death. Intravenous lidocaine can reduce perioperative inflammatory response in patients undergoing surgery, but its effect on postoperative cognitive function has not been systematically evaluated. Notably, prior findings regarding the impact of intravenous lidocaine on postoperative cognitive function have been variable. Therefore, on this basis, this study explored the effects of intravenous lidocaine on postoperative cognitive function of patients undergoing general anesthesia through a systematic review and meta-analysis.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;Pubmed, Cochrane Library, Embase, Medline, Wanfang Medical Database, China Biomedical Literature Database, and China Academic Journals Full-Text Database were searched from inception to February 2024 for relevant studies that investigated effect of intravenous lidocaine on POCD in patients undergoing general anesthesia surgery. Key data obtained from the referenced literature included the prevalence of POCD, scores from the Mini-Mental State Examination (MMSE), and perioperative serum concentrations of neuron-specific enolase (NSE) and central nervous specific protein &lt;strong&gt;(&lt;/strong&gt;S-100β) protein, serving as biomarkers for central nervous system specificity. Meta-analysis of data was performed using RevMan5.3 software. The software Trial Sequential Analysis (version 0.9) (TSA) was used to analyze high-quality literature focusing on POCD outcome indicators to explore the reliability of the results of meta-analysis.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Findings&lt;/h3&gt;&lt;div&gt;Twenty-five studies were included for quality evaluation and data analysis. The studies compared the effect of intravenous lidocaine on the incidence of POCD in patients undergoing surgery at different time points. Subgroup analysis was used to investigate the incidence of POCD at different time points. The results showed that intravenous lidocaine significantly reduced the incidence of POCD at 1, 3, 7, 9 days and 1 year after surgery compared with the control group (on the first day postoperatively: odds ratio (OR) = 0.48, 95% CI: 0.32–0.69, &lt;em&gt;P&lt;/em&gt; &lt; 0.001; postoperative day 3: OR = 0.42, 95% CI: 0.25–0.72, &lt;em&gt;P =&lt;/em&gt; 0.002; postoperative day 7: OR = 0.34, 95% CI: 0.21–0.55, &lt;em&gt;P&lt;/em&gt; &lt; 0.001; postoperative day 9: OR = 0.32, 95% CI: 0.17–0.61, &lt;em&gt;P&lt;/em&gt; &lt; 0.001; 1 year postoperatively: OR = 0.39, 95% CI: 0.28–0.54, &lt;em&gt;P&lt;/em&gt; &lt; 0.001). The incidence of POCD in patients undergoing general anesthesia at postoperative day 1 with lidocaine was analyzed sequentially. The results showed that with the increase of the included sample size, the Z-curve still did not exceed the TSA boundary and did not reach the required information size. Fourteen studies co","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 91-101"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142557342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Corrigendum to “Pancreatitis and Pancreatic Cancer Risk Among Patients With Type 2 Diabetes Receiving Dipeptidyl Peptidase 4 Inhibitors: An Updated Meta-Analysis of Randomized Controlled Trials” [Clinical Therapeutics 2024 Aug;46(8):650–656/CLINTHER-D-24-00055R1] 接受二肽基肽酶 4 抑制剂治疗的 2 型糖尿病患者的胰腺炎和胰腺癌风险:随机对照试验的最新 Meta 分析" [Clinical Therapeutics 2024 Aug;46(8):650-656/CLINTHER-D-24-00055R1] 的更正。
IF 3.2 4区 医学
Clinical therapeutics Pub Date : 2025-01-01 DOI: 10.1016/j.clinthera.2024.11.010
Adili Tuersun MS , Guanxin Hou BS , Gang Cheng PhD
{"title":"Corrigendum to “Pancreatitis and Pancreatic Cancer Risk Among Patients With Type 2 Diabetes Receiving Dipeptidyl Peptidase 4 Inhibitors: An Updated Meta-Analysis of Randomized Controlled Trials” [Clinical Therapeutics 2024 Aug;46(8):650–656/CLINTHER-D-24-00055R1]","authors":"Adili Tuersun MS ,&nbsp;Guanxin Hou BS ,&nbsp;Gang Cheng PhD","doi":"10.1016/j.clinthera.2024.11.010","DOIUrl":"10.1016/j.clinthera.2024.11.010","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Page 113"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142726688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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