Clinical therapeutics最新文献

{"title":"Two-Way Randomized Crossover Study to Establish Pharmacodynamic Bioequivalence Between Oxylanthanum Carbonate and Lanthanum Carbonate","authors":"Vandana Mathur MD, FASN ,&nbsp;Michael Walker PhD ,&nbsp;Steve Hasal PhD ,&nbsp;Guru Reddy PhD ,&nbsp;Shalabh Gupta MD","doi":"10.1016/j.clinthera.2024.11.009","DOIUrl":"10.1016/j.clinthera.2024.11.009","url":null,"abstract":"<div><h3>Purpose</h3><div>Phosphate binders (PB) are integral to hyperphosphatemia management in patients with end-stage kidney disease. PB efficacy is adversely affected by nonadherence and limited phosphate-binding capacity relative to dietary intake. Oxylanthanum carbonate is an investigational novel nanotechnology product that combines lanthanum, which has the highest binding capacity of available PBs, with a smaller pill size that is swallowed with water rather than chewed. This study's objective was to demonstrate the pharmacodynamic equivalence of orally administered oxylanthanum carbonate to lanthanum carbonate (LC) in healthy subjects.</div></div><div><h3>Methods</h3><div>In this phase one, single-center, randomized, open-label study, healthy subjects were treated with oxylanthanum carbonate swallowable tablets 1000 mg three times/day and LC chewable tablets 1000 mg three times/day in a two-way crossover design. The primary pharmacodynamic variable was the least squares mean (LSM) change in urinary phosphate excretion from baseline to the evaluation period (Days 1–4 of treatment).</div></div><div><h3>Findings</h3><div>A total of 80 subjects were randomized and 75 received all doses. The LSM change in urinary phosphate excretion from Baseline to the Evaluation (Treatment) Period was similar for both oxylanthanum carbonate (–320.4 mg/day [90% CI: –349.7, –291.0]) and LC (–324.0 mg/day [90% CI: –353.3, –294.7]); the between-group LSM difference was 3.6 [90% CI: –37.8, 45.1] mg/day. Both drugs were well tolerated with an equal incidence of adverse events.</div></div><div><h3>Implications</h3><div>Thus, oxylanthanum carbonate was bioequivalent to LC in healthy subjects and well tolerated. Oral oxylanthanum carbonate may provide an option for patients with chronic kidney disease and hyperphosphatemia for whom chewing tablets is disliked, inconvenient, or difficult.</div></div><div><h3>Clinical Trial Registration Number</h3><div>NCT06218290.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 70-75"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142766999","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":"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 ,&nbsp;Yue Yu ,&nbsp;Yuxin He ,&nbsp;Jiangyuan Zheng ,&nbsp;Qingzhu Tan ,&nbsp;Xiao Zhang ,&nbsp;Chao Wan ,&nbsp;Zhengyu Zhang ,&nbsp;Xiaoxin Wu ,&nbsp;Rui Tan","doi":"10.1016/j.clinthera.2024.11.007","DOIUrl":"10.1016/j.clinthera.2024.11.007","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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 &lt; 0.001) and hyperhidrosis (log₂ROR = −1.22, P_adj = 0.001) were significant ADR signals, especially in males, respectively.</div></div><div><h3>Conclusions</h3><div>While the AE distribution of the 5 ICMs was consistent, there were variations in specific ADR signal characteristics, warranting further consideration and exploration.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 82-90"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","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":"Clinical Burden and Health Care Resource Utilization Associated With Managing Sickle Cell Disease With Recurrent Vaso-occlusive Crises in England","authors":"Chuka Udeze PharmD, MS ,&nbsp;Nelly F. Ly PharmD, MScRes ,&nbsp;Fiona C. Ingleby PhD ,&nbsp;Sophia D. Fleming MSc ,&nbsp;Sarah C. Conner PhD, MPH ,&nbsp;Jo Howard MB BChir, MRCP, FRCPath ,&nbsp;Nanxin Li PhD, MBA ,&nbsp;Farrukh Shah MBBS, FRCP, FRCPath, MD","doi":"10.1016/j.clinthera.2024.09.023","DOIUrl":"10.1016/j.clinthera.2024.09.023","url":null,"abstract":"<div><h3>Purpose</h3><div>Sickle cell disease (SCD) is an inherited red blood cell disease caused by a mutation in the gene encoding the β-subunit of adult hemoglobin that leads to hemolysis, anemia, vaso-occlusive crises (VOCs), morbidity, and mortality. This study provides a real-world assessment of the clinical burden and health care resource utilization (HCRU) associated with SCD with recurrent VOCs in England.</div></div><div><h3>Methods</h3><div>This retrospective study linked primary care records from the Clinical Practice Research Datalink database with secondary care records from the Hospital Episode Statistics database to identify patients with SCD with recurrent VOCs between July 1, 2008, and June 30, 2018. A VOC was defined as SCD with crisis, acute chest syndrome, or priapism. Eligible patients had SCD, ≥2 VOCs/year in any 2 consecutive years after a diagnosis of SCD, and ≥1 year of follow-up data from the index date. Patients were exact matched with 5 controls from the general population in the databases. Demographics were assessed at index. Mortality, clinical complications, and HCRU were summarized during follow-up.</div></div><div><h3>Findings</h3><div>After applying eligibility criteria, 1117 patients with SCD with recurrent VOCs and 5585 controls were included in the study. Mean age at index was 25 years in both groups. The proportion of deaths (3.67% vs 0.68%; <em>P</em> &lt; 0.001) and mortality rate (0.78 deaths per 100 person-years vs 0.16 deaths per 100 person-years) were substantially higher in patients with SCD with recurrent VOCs versus matched controls. Mean (standard deviation [SD]) age of death in patients with SCD with recurrent VOCs who died during the follow-up period was 40.17 (14.09) years. The mean (SD) rate of VOCs for patients with SCD with recurrent VOCs was 5.84 (12.50) per patient per year (PPPY) during follow-up. Compared with matched controls, patients with SCD with recurrent VOCs had substantially higher mean [SD] rates PPPY of inpatient hospitalizations (7.59 [14.50] vs 0.32 [2.71]), prescriptions (31.06 [60.62] vs 7.58 [27.77]), and outpatient visits (9.60 [10.69] vs 1.78 [4.18]). Older patients and those with increased numbers of VOCs had increased mortality, frequency of clinical complications, and HCRU.</div></div><div><h3>Implications</h3><div>Despite currently available care, patients with SCD with recurrent VOCs in England have increased mortality, substantial clinical complications, and significant HCRU driven by VOCs and hospitalizations. Elevated mortality and clinical complications in patients with SCD with recurrent VOCs highlight the need for novel therapies in this space.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 29-36"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142603455","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":"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 B.S. ,&nbsp;Jiahao Xu MSc ,&nbsp;Chen Chen PhD ,&nbsp;Jiang Shen B.S. ,&nbsp;Nan Hu PhD ,&nbsp;Lan Qiu PhD","doi":"10.1016/j.clinthera.2024.11.003","DOIUrl":"10.1016/j.clinthera.2024.11.003","url":null,"abstract":"<div><h3>Purpose</h3><div>Investigate the analgesia effects and pharmacokinetics of ropivacaine at different concentrations in Serratus Anterior Plane Block (SAPB) and assess the efficacy and safety.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Findings</h3><div>The NRS scores were significantly higher in Group L than those in other groups (<em>P</em> &lt; 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, <em>C</em>_max, t_1/2, and AUC_0-∞ differed significantly.</div></div><div><h3>Implications</h3><div>For patients undergoing VATS, using 0.5% ropivacaine for SAPB is recommended.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 62-69"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","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":"Hympavzi (Marstacimab-hncq)","authors":"Paul Beninger MD, MBA","doi":"10.1016/j.clinthera.2024.11.020","DOIUrl":"10.1016/j.clinthera.2024.11.020","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 111-112"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853487","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":"Correlation Between Vitamin D, Inflammatory Markers, and T Lymphocytes With the Severity of Chronic Obstructive Pulmonary Disease and its Effect on the Risk of Acute Exacerbation: A Single Cross-sectional Study","authors":"Yeqian Jiang ,&nbsp;Mingzhu Li ,&nbsp;Yan Yu ,&nbsp;Hejun Liu ,&nbsp;Qianbing Li MM","doi":"10.1016/j.clinthera.2024.10.003","DOIUrl":"10.1016/j.clinthera.2024.10.003","url":null,"abstract":"<div><h3>Purpose</h3><div>Chronic obstructive pulmonary disease (COPD) will become the fourth largest cause of death of chronic diseases in the world in 2030. The incidence of COPD ranked top among chronic diseases in the world. At present, there is a lack of simple and effective drugs for the treatment of COPD and for slowing the progression of the disease. The application of vitamin D as a drug in clinical treatment has been a research hotspot. In this study, we investigated the correlation between serum 25-hydroxyvitamin D (25(OH)D), inflammatory markers, and T lymphocytes with the severity of COPD and its effect on the risk of acute exacerbation.</div></div><div><h3>Methods</h3><div>In this study, we recruited hospital inpatients and outpatient clinic patients with COPD. Their levels of 25(OH)D, inflammatory markers, and T lymphocytes were assessed. We built a nomogram model to evaluate the risk of acute exacerbation of COPD.</div></div><div><h3>Findings</h3><div>The inflammatory mediators were higher in patients with acute exacerbation of COPD (AECOPD) than those in patients with COPD, but 25(OH)D showed the opposite phenomenon. In logistic regression analysis, high levels of neutrophil-lymphocyte ratio, C-reactive protein, and partial pressure of carbon dioxide and low levels of vitamin D, partial pressure of oxygen, and forced expiratory volume in the first as a percentage of predicted were regarded as independent risk factors for AECOPD. These variables were used for the construction of the nomogram model. The AUCs of the model were 0.971 (95% CI, 0.952–0.989), and 0.981 (95% CI, 0.959–1.000) in the training and testing set respectively, demonstrating that the model exhibited high accuracy for the prediction of the risk of acute exacerbation of COPD. The calibration curve of the nomogram found a high degree of consistency between the expected and actual values. The decision curve analysis and clinical impact curve indicated that the nomogram has clinical applicable for patients with COPD.</div></div><div><h3>Implications</h3><div>A considerable percentage of patients with COPD were found to have insufficient vitamin D levels. Patients with AECOPD reported more symptoms than those with COPD. The variables neutrophil-lymphocyte ratio, C-reactive protein, partial pressure of carbon dioxide, 25(OH)D, partial pressure of oxygen, and forced expiratory volume in the first as a percentage of predicted can be used for the prediction of AECOPD. Accordingly, this study provided experimental rationales for the role of 25(OH)D in the prevention and the potential anti-inflammatory mechanisms involved in the control of the COPD process.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 44-54"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616368","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":"Cost-effectiveness Analysis of Tumor Treating Fields Therapy Combined With Immune Checkpoint Inhibitor in Metastatic Non-small-cell Lung Cancer","authors":"Mengwei Zhang ,&nbsp;Ping Yue ,&nbsp;Yuanying Feng ,&nbsp;Yuan Gao ,&nbsp;Chao Sun ,&nbsp;Peng Chen","doi":"10.1016/j.clinthera.2024.09.022","DOIUrl":"10.1016/j.clinthera.2024.09.022","url":null,"abstract":"<div><h3>Background</h3><div>The LUNAR clinical trial revealed that incorporating Tumor Treating Fields (TTFields) therapy alongside immune checkpoint inhibitor (ICI) significantly prolonged the overall survival of patients with metastatic, platinum-resistant non-small-cell lung cancer (NSCLC). However, the cost of TTFields therapy is high and may further increase the financial burden for patients. Our research aims to evaluate the cost-effectiveness of TTFields therapy addition with ICI for metastatic NSCLC.</div></div><div><h3>Methods</h3><div>We constructed a Markov model to evaluate the healthcare costs associated with TTFields therapy combined with ICI for the treatment of advanced NSCLC. In this model, the clinical data utilized came from the LUNAR trial, while drug costs and health state utility values were extracted from public databases and relevant scholarly publications. The major outcomes incorporated costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).</div></div><div><h3>Results</h3><div>Compared with ICI therapy alone, ICI combination with TTFields therapy resulted in 0.42 QALYs at the cost of $167,329, with an ICER of $398,402.38 per year. The calculated ICER surpassed the generally accepted US willingness-to-pay (WTP) threshold of 150,000 per QALY. One-way sensitivity analyses demonstrated that the utility of progression disease is the most influential factor, followed by the cost of TTFields therapy, the utility of progression-free survival, the cost of ICI, and the cost of adverse events in TTFields therapy combined with ICI. Only when the cost of TTFields therapy is reduced by approximately 80.48%, it would be cost-effective within the commonly accepted WTP threshold of $150,000/QALY.</div></div><div><h3>Conclusions</h3><div>According to the US WTP, the combination of TTFields therapy with ICI does not currently represent a cost-effective strategy for metastatic NSCLC followed progression on platinum-resistant therapy. Considering its promising clinical outcomes for metastatic NSCLC, it is necessary to control the expenses of this therapeutic strategy in future applications.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 15-20"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496507","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":"When Politics Influence Access to Care: The United States Maternal and Infant Health Divide","authors":"Jill L. Maron MD, MPH","doi":"10.1016/j.clinthera.2024.11.025","DOIUrl":"10.1016/j.clinthera.2024.11.025","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 1-2"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142892679","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":"Effectiveness of Remimazolam on Preventing Adverse Reactions Caused by Carboprost Tromethamine During Cesarean Section","authors":"Jianjun Fan MD,&nbsp;Zhiguo Zhang MD,&nbsp;Jie Wang BD,&nbsp;Dianwei Han BD,&nbsp;Yongbo Zhen BD,&nbsp;Jinpei Fan BD,&nbsp;Shuai Wang BD,&nbsp;Fei Wang BD","doi":"10.1016/j.clinthera.2024.09.020","DOIUrl":"10.1016/j.clinthera.2024.09.020","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate the effectiveness of remimazolam in preventing adverse reactions triggered by carboprost tromethamine during cesarean section procedures.</div></div><div><h3>Methods</h3><div>A total of 200 parturients scheduled for cesarean sections at risk of postpartum hemorrhage in our hospital from October 2022 to July 2023 were included. The participants were assigned via random number table method to either a study group or a control group, resulting in 100 cases in each. All parturients received combined spinal and epidural anesthesia (CSEA) during cesarean section, followed by administration of carboprost tromethamine (250 µg) for preventing postpartum hemorrhage after childbirth. CSEA was performed with 1.8 to 2 mL of 0.5% bupivacaine and 7 to 10 mL of 2% lidocaine. The study group was given remimazolam via intravenous infusion at a rate of 0.3 mg/kg/h commencing at 1 minute prior to CSEA and concluding with a final dosage adjustment 20 minutes preceding the end of surgery, while the control group was given the same volume of saline within this time frame. Primary outcome measures were adverse reactions and sedative effects of the parturients.</div></div><div><h3>Findings</h3><div>Nausea and vomiting were the only adverse reactions that exhibited significant differences between groups. The study group reported significantly fewer cases (32 cases) of nausea and vomiting when compared to the 48 cases observed in the control group. Moreover, the use of remimazolam appeared to alleviate the severity of nausea and vomiting, as evidenced by the significantly lower incidence of Grade III event and the higher risk of Grade I event in comparison with the control group (<em>P</em> &lt; 0.05). The Apgar scores of newborns at birth and 5 minutes after birth were compared, and no statistically significant difference was found (<em>P</em> &gt; 0.05). Parturients receiving remimazolam exhibited better effective sedation outcomes and were more satisfied with the treatment when compared with controls (<em>P</em> &lt; 0.05). There were no significant differences in postpartum bleeding volume at 2 and 12 hours postpartum, as well as in the duration of postpartum bleeding between the two groups (<em>P</em> &gt; 0.05).</div></div><div><h3>Implications</h3><div>Intravenous administration of remimazolam effectively prevents adverse reactions induced by carboprost tromethamine during cesarean section performed under CSEA, thereby improving sedative effects.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 3-8"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567941","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":"Risk Factors for INtubation-SURfactant-Extubation Failure in Infants With Neonatal Respiratory Distress Syndrome","authors":"Haoming Chen MSc,&nbsp;Qingfei Hao MD,&nbsp;Jing Zhang MD,&nbsp;Yanna Du MD,&nbsp;Hafiz Muhammad Sohail Sarwar MSc,&nbsp;Jing Li MSc,&nbsp;Tiantian Yang MSc,&nbsp;Xiuyong Cheng MD","doi":"10.1016/j.clinthera.2024.10.009","DOIUrl":"10.1016/j.clinthera.2024.10.009","url":null,"abstract":"<div><h3>Purpose</h3><div>To identify clinical characteristics predictive of failure or success of the INtubation-SURfactant-Extubation (INSURE) strategy, to distinguish infants who could be managed using this strategy to prevent mechanical ventilation (MV).</div></div><div><h3>Methods</h3><div>Infants with a gestational age &lt;32 weeks were classified into two groups according to whether they required reintubation and MV within 72 h after birth. The clinical characteristics of the two groups were subsequently analyzed.</div></div><div><h3>Results</h3><div>INSURE was unsuccessful in 77 infants (20.7%). Infants in the INSURE failure group had a higher incidence of severe respiratory distress syndrome, as evidenced by radiological grade; lower blood pH, partial oxygen pressure, and base excess (BE) levels; higher partial carbon dioxide pressure levels at the first arterial blood gas analysis; lower Apgar scores at 1 and 5 min; lower use of antenatal steroids; and higher occurrence of gestational diabetes mellitus, versus those in the INSURE success group. Multiple regression analysis confirmed severe radiological grade, lower BE levels at the first arterial blood gas analysis, and decreased use of antenatal steroids as independent risk factors for INSURE failure. Compared with infants in the INSURE success group, those in the INSURE failure group also had higher mortality.</div></div><div><h3>Conclusions</h3><div>We successfully identified specific predictors of an unsuccessful INSURE strategy. Maintaining high-risk preterm infants with one or several predictors intubated and treated with MV after surfactant administration can prevent reintubation and reduce mortality.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 9-14"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142681265","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}