Therapeutic Advances in Drug Safety最新文献

{"title":"Effect of a closed-loop medication order executive system on safe medication administration at a tertiary hospital: a quasi-experimental study.","authors":"Xuwen Yin, Haiyan Song, Jieyu Lu, Jing Yang, Rong Wang, Zheng Lin, Shudi Jiang, Hui Yuan, Xumei Wang, Dongmei Xu, Chunhong Gao, Yuan Zhou, Jiayi Xu, Chen Chen, Chenyu Gu, Qingqing Diao, Fang Li, Zejuan Gu","doi":"10.1177/20420986241288421","DOIUrl":"https://doi.org/10.1177/20420986241288421","url":null,"abstract":"<p><strong>Background: </strong>Closed-loop electronic medication management systems are effective measures for preventing medication errors (MEs). However, there is limited evidence supporting this, and few studies have evaluated the long-term effects of these systems on safe medication.</p><p><strong>Objective: </strong>To evaluate the long-term effects of implementing a closed-loop medication order executive system on the safe clinical use of medications.</p><p><strong>Design: </strong>A quasi-experimental design.</p><p><strong>Method: </strong>Data from 2017 to 2023 were extracted and retrospectively analyzed. The primary outcome indicator was the ME rate. Secondary outcome indicators were the accuracy of order verification and patient identification and the implementation rate of fresh medicine dispensing. The autoregressive integrated moving average (ARIMA) model in time-series analysis was used to evaluate the level and trend changes in ME rates using SPSS 25.0 before and after system implementation. Root cause analysis and descriptive statistics were used to assess changes in types, stages, and causes of ME rates. The independent samples <i>t</i>-test was used to analyze secondary outcomes.</p><p><strong>Results: </strong>Overall, 295 MEs were reported with a mean of 0.26 ± 0.26 ME rates per month during 2017-2023. The ARIMA model showed a decrease in the average level of ME rates after system implementation, with no statistically significant decrease in the long term, and a significant drop in the ME rate in the short and medium term (<i>p</i> < 0.01). Nurses' administration accounted for more than 60% of errors post-implementation, and lack of communication was a prominent factor. The accuracy of order verification and patient identification and the implementation rate of fresh medicine dispensing all increased after implementation.</p><p><strong>Conclusion: </strong>Adopting a closed-loop executive system is beneficial for ensuring patient medication safety, but a single integrated system does not completely eliminate MEs. Optimizing system functionalities and applying structured handoff tools are recommended to meet clinical needs and enhance system usability.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241288421"},"PeriodicalIF":3.4,"publicationDate":"2024-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11472417/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142475408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the community pharmacist's knowledge, attitude, and practices regarding adverse drug reactions and its reporting in the United Arab Emirates: a survey-based cross-sectional study.","authors":"Javedh Shareef, Sathvik Belagodu Sridhar, Mullaicharam Bhupathyraaj, Atiqulla Shariff, Sabin Thomas","doi":"10.1177/20420986241285930","DOIUrl":"https://doi.org/10.1177/20420986241285930","url":null,"abstract":"<p><strong>Background: </strong>Adverse drug reactions (ADRs) contribute significant clinical and economic burden to the country's healthcare system globally. Prompt reporting of ADRs by the community pharmacist is essential to the active pharmacovigilance program.</p><p><strong>Objectives: </strong>This study assesses private community pharmacists' knowledge, attitude, and practice (KAP) about ADRs and reporting.</p><p><strong>Design: </strong>A cross-sectional, qualitative study was performed using a pre-validated self-administered questionnaire.</p><p><strong>Methods: </strong>This self-administered questionnaire was conducted at community pharmacies between March and July 2022. The data collected were analyzed using the Mann-Whitney and Kruskal-Wallis tests to examine the differences in overall KAP scores with a subgroup of sociodemographic characteristics of the study participants. Logistic regression analysis was used to analyze the predictors of practice.</p><p><strong>Results: </strong>In total, 156 fully completed questionnaires were collected by the community pharmacists. A positive association between the designation, qualification, and work experience with the total scores of the respondents was observed (<i>p</i> < 0.05). Among the predictors of ADR reporting practice, a significant association was observed with knowledge score (⩾6, <i>p</i> = 0.0219), designation (pharmacists, <i>p</i> = 0.0102), qualification (masters, <i>p</i> = 0.0002), and work experience (⩾11 years, <i>p</i> = 0.0184). Most community pharmacists had good knowledge and attitude but poor practice toward reporting ADRs. Uncertainty of how and where to report, lack of training, lack of reporting forms, and insufficient clinical knowledge were the practice-based barriers in the ADR reporting process.</p><p><strong>Conclusion: </strong>Though the study found sufficient understanding and favorable views on ADR reporting, participants reported poor practices and barriers to reporting ADR. Therefore, structured continuing professional development programs for community pharmacists are needed to overcome the barriers and enhance the practice of ADR reporting.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241285930"},"PeriodicalIF":3.4,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11459486/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142393593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing medication management of older adults in Qatar: healthcare professionals' perspectives on challenges, barriers and enabling solutions.","authors":"Ameena Alyazeedi, Carrie Stewart, Roy L Soiza, Derek Stewart, Ahmed Awaisu, Cristin Ryan, Moza Alhail, Abdulaziz Aldarwish, Phyo Kyaw Myint","doi":"10.1177/20420986241272846","DOIUrl":"https://doi.org/10.1177/20420986241272846","url":null,"abstract":"<p><strong>Background: </strong>Polypharmacy and potentially inappropriate medications are significant challenges in older adults' medication management. The Consolidated Framework for Implementation Research (CFIR) is a comprehensive approach used to explore barriers and enablers to the healthcare system in guiding the effective implementation of evidence-based practices.</p><p><strong>Objectives: </strong>This study examines the barriers and enablers to promote safe medication management among older adults in Qatar from healthcare professionals' perspectives. This includes identifying critical factors within the healthcare system influencing medication management and suggesting practical solutions to improve it.</p><p><strong>Design: </strong>The study employs a qualitative design. Focus Groups (FGs) were conducted with healthcare professionals from the geriatric, mental health and medicine departments of Hamad Medical Corporation (HMC), the leading governmental sector in Qatar serving the older adult population.</p><p><strong>Methods: </strong>Utilising the CFIR, this study analysed feedback from healthcare professionals through FGs at HMC. A combined inductive and deductive thematic analysis was applied to transcripts from five FGs, focusing on identifying barriers and enablers to safe medication management among older adults. Two researchers transcribed the audio-recorded FG discussions verbatim, and two researchers analysed the data using a mixed inductive and deductive thematic analysis approach utilising CFIR constructs.</p><p><strong>Results: </strong>We engaged 53 healthcare professionals (31 physicians, 10 nurses and 12 clinical pharmacists) in FGs. The analysis identified current barriers and enabler themes under different CFIR constructs, including inner settings, outer settings, individual characteristics and intervention characteristics. We identified 44 themes, with 25 classifieds as barriers and 19 as enablers. The findings revealed that barriers and enablers within the inner settings were primarily related to structural characteristics, resources, policies, communication and culture. On the other hand, barriers and enablers from the outer settings included patients and caregivers, care coordination, policies and laws, and resources.</p><p><strong>Conclusion: </strong>This study identified several barriers and enablers to promote medication management for older adults using the CFIR constructs from the perspective of healthcare professionals. The multifaceted findings emphasise involving stakeholders like clinical leaders, policymakers and decision-makers to address medication safety factors. A robust action plan, continuously monitored under Qatar's national strategy, is vital. Further research is needed to implement recommended interventions.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241272846"},"PeriodicalIF":3.4,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11483847/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142475409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Disproportionality analysis of reslizumab based on the FDA Adverse Event Reporting System.","authors":"Huqun Li, Cuilian Guo, Chongshu Wang","doi":"10.1177/20420986241284112","DOIUrl":"https://doi.org/10.1177/20420986241284112","url":null,"abstract":"<p><strong>Background: </strong>With the increasing prescription of reslizumab for severe asthma with an eosinophilic phenotype, a real-world pharmacovigilance analysis of reslizumab is urgently required to detect potential unreported adverse events (AEs) in clinical practice.</p><p><strong>Objectives: </strong>We aimed to provide a comprehensive evaluation of reslizumab-related AEs in the real world.</p><p><strong>Design: </strong>Disproportionality analysis based on the FDA Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>Reslizumab-related AEs between the second quarter of 2016 and the fourth quarter of 2022 from the FAERS database were obtained. A disproportionality analysis was performed to evaluate the safety profile of reslizumab using the reporting odds ratio.</p><p><strong>Results: </strong>A total of 10,450,353 reports were collected from the FAERS database. Of the 403 reslizumab-related AEs, 42 distinct AEs were identified with positive signals. The most common AEs including dyspnea and oropharyngeal pain were identified, consistent with the instruction and clinical studies. Unexpected AEs of disproportionality such as bronchospasm and chest pain were also observed. Drug ineffective was identified as a noteworthy concern that accounted for 13.90% (56/403) of the overall reslizumab-related reports.</p><p><strong>Conclusion: </strong>While reslizumab offered a promising treatment option for severe eosinophilic asthma, more attention should be paid to the common AEs and new unexpected AEs. Based on the current findings of signal detection, further prospective studies are needed for the next signal validation and confirmation.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241284112"},"PeriodicalIF":3.4,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11459504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142393592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A disproportionality analysis for assessing the safety of FLT3 inhibitors using the FDA Adverse Event Reporting System (FAERS).","authors":"Jie Zhou, Jinping Zhang, Qiaoyun Wang, Miaoxin Peng, Yun Qian, Fang Wu, Qi Rao, Laji DanZhen, Yonggong Yang, Siliang Wang, Mengying Liu","doi":"10.1177/20420986241284105","DOIUrl":"https://doi.org/10.1177/20420986241284105","url":null,"abstract":"<p><strong>Objectives: </strong>This pharmacovigilance analysis was conducted to assess the safety signals of FMS-related tyrosine kinase 3 (FLT3) inhibitors in a real-world setting using the United States Food and Drug Administration Adverse Event Reporting System (FAERS).</p><p><strong>Design: </strong>We analyzed adverse event (AE) reports related to FLT3 inhibitors submitted to the FAERS database from the first quarter of 2015 to the fourth quarter of 2022. Disproportionality analysis was used to identify AEs of FLT3 inhibitors in the FAERS database.</p><p><strong>Results: </strong>A total of 55,393 AE reports were identified, of which 5938, 44,013, and 5442 were attributed to midostaurin, sorafenib, and gilteritinib, respectively, as primary suspects. Compared to the full database, significant safety signals at the system organ class level were observed for midostaurin (blood and lymphatic system disorders and hepatobiliary disorders), sorafenib (skin and subcutaneous tissue disorders and hepatobiliary disorders), and gilteritinib (investigations, blood and lymphatic system disorders, infections and infestations, and hepatobiliary disorders). All the drugs studied were associated with hepatobiliary disorders. The most prominent AEs associated with midostaurin, sorafenib, and gilteritinib were cytopenia, palmar-plantar erythrodysesthesia syndrome, and increased blast cell count, respectively. Compared with chemotherapy, midostaurin and gilteritinib showed a higher risk of electrocardiogram QT prolongation, gastrointestinal hemorrhage, cerebral hemorrhage, and increased white blood cell count. Gilteritinib had the highest overall death percentage (30.28%), whereas sorafenib had the lowest (23.06%).</p><p><strong>Conclusion: </strong>Mining AE signals using the FAERS database provides a method for analyzing the safety of FLT3 inhibitors in post-marketing. We found several significant AE signals that corresponded to previous studies; however, some AE signals were not mentioned in the drug instructions. Our study could provide a direction for follow-up real-world studies to verify the results further.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241284105"},"PeriodicalIF":3.4,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11459563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142393590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety profile of drugs used in non-cystic fibrosis bronchiectasis: a narrative review.","authors":"Henil Upadhyay, Stefano Aliberti, Andrew Husband, James D Chalmers, Katy Hester, Anthony De Soyza","doi":"10.1177/20420986241279213","DOIUrl":"10.1177/20420986241279213","url":null,"abstract":"<p><p>Non-cystic fibrosis bronchiectasis is a long-term lung disease characterised by abnormal dilatation of the bronchi, with patients experiencing chronic productive cough and recurrent exacerbations. Currently, there are no licensed drugs for use in bronchiectasis while clinical trials have been conducted to either test new drugs or repurpose existing ones. These drugs target the underlying pathophysiology of bronchiectasis which is known to include infection, inflammation, mucus hypersecretion and retention. Most of the drugs used in daily clinical practice for bronchiectasis are off-label with no randomised trials exploring their safety. This review aims at exploring the safety profile of drugs frequently used in clinical practice to manage bronchiectasis, including antibiotics (e.g. macrolides, aminoglycosides, polymyxins, fluoroquinolones, aztreonam), mucoactive therapy (e.g. hypertonic saline, mannitol, DNase and carbocisteine), anti-inflammatory therapy (inhaled corticosteroids) and drugs currently in development for use in bronchiectasis (e.g. brensocatib, benralizumab and itepekimab).</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241279213"},"PeriodicalIF":3.4,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11450733/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142381613","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing pharmacovigilance for robust drug safety monitoring: addressing underreporting and collaborative solutions.","authors":"Tanguturi Yella Sree Sudha, Bhumika Meena, Sumit Pareek, Harminder Singh","doi":"10.1177/20420986241285927","DOIUrl":"10.1177/20420986241285927","url":null,"abstract":"","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241285927"},"PeriodicalIF":3.4,"publicationDate":"2024-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11447715/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142372942","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adverse event profiles of CDK4/6 inhibitors: data mining and disproportionality analysis of the FDA adverse event reporting system.","authors":"Jun Shen, Pingli Luo, Jianmei Xu","doi":"10.1177/20420986241278498","DOIUrl":"https://doi.org/10.1177/20420986241278498","url":null,"abstract":"<p><strong>Background: </strong>Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors are targeted therapies designed to selectively block CDK4/6, crucial regulators of the cell cycle. These inhibitors play a pivotal role in restoring cell cycle control, particularly in breast cancer cases marked by abnormal CDK regulation, ultimately inhibiting uncontrolled cell division and tumor growth.</p><p><strong>Objectives: </strong>This analysis aimed to comprehensively examine adverse effects in CDK4/6 inhibitors using the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.</p><p><strong>Design: </strong>Disproportionality analysis was conducted to analyze the adverse event (AE) reports related to CDK4/6 inhibitor submitted to the FAERS database.</p><p><strong>Methods: </strong>We collected AE reports regarding palbociclib, ribociclib, abemaciclib, trilaciclib, and dalpiciclib submitted to the FAERS from 2015Q1 to 2023Q1. We used the system organ class and the Standardized MedDRA Query to perform a comprehensive search for AEs at the preferred term (PT) level, using case reports as our data source. After removing duplicate reports, we performed disproportionality analysis and sensitivity analysis to identify safety signals.</p><p><strong>Results: </strong>A total of 85,635 reports encompassing 280,211 AEs were extracted for analysis. Among 3681 scrutinized PTs, approximately 484 were detected as statistically significant signals associated with CDK4/6 inhibitors. It was noteworthy that palbociclib and ribociclib had comparable safety profiles, whereas abemaciclib exhibited distinctive safety patterns. Notably, our analysis found novel safety signals linked to CDK4/6 inhibitors, including nail-related disorders such as onychoclasis, nail disorder, and nail discoloration, and psychiatric concerns, including eating disorders and emotional disorder.</p><p><strong>Conclusion: </strong>Overall, the present study identified several new safety signals of CDK4/6 inhibitors, as well as differences among various drugs within the CDK4/6 category, through the use of the FDA FAERS, which deserve more careful monitoring in the clinic.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241278498"},"PeriodicalIF":3.4,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11457275/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142393591","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of a risk prediction model for linezolid-induced anemia in elderly patients: a retrospective cohort study.","authors":"Hongling Ma, Zhaotang Gong, Rihan Wu, GuLeng SiRi","doi":"10.1177/20420986241279128","DOIUrl":"https://doi.org/10.1177/20420986241279128","url":null,"abstract":"<p><strong>Background: </strong>Linezolid-induced anemia (LI-AN) is a severe adverse reaction, but risk factors of the LI-AN for elderly patients have not been established.</p><p><strong>Objectives: </strong>The objective of this study was to develop a nomogram capable of predicting LI-AN in elderly patients.</p><p><strong>Design: </strong>This is a retrospective study to develop and validate a nomogram for anemia prediction in elderly patients treated with linezolid.</p><p><strong>Methods: </strong>We retrospectively screened elderly patients treated with linezolid at Inner Mongolia People's Hospital from January 2020 to December 2023 and validated our findings using the MIMIC-IV 2.2 database. Anemia was defined as hemoglobin reduction to 75% of baseline value. Univariate and multivariable logistic regression models were used to identify predictors and construct the nomogram, which was evaluated using receiver operating characteristic (ROC) curve analysis, calibration plot, and decision curve analysis.</p><p><strong>Results: </strong>A total of 231 patients were enrolled in this study. The training set comprised 151 individuals, and anemia occurred in 28 cases (18.54%). In the external validation set of 80 individuals, 26 (32.5%) were diagnosed with anemia. The predictors included duration of linezolid therapy, patient estimated glomerular filtration rate value, and sequential organ failure assessment score ⩾2. The ROC curve for the training set was 0.830 (95% CI: 0.750-0.910), while a similar ROC curve of 0.743 (95% CI: 0.621-0.865) was obtained for the validation set. The calibration curve demonstrated good correlation between predicted and observed results, indicating that this study effectively predicts risk factors associated with LI-AN in elderly patients.</p><p><strong>Conclusion: </strong>The developed prediction model can provide valuable guidance for clinicians to prevent anemia and facilitate rational linezolid use in elderly patients.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"15 ","pages":"20420986241279128"},"PeriodicalIF":3.4,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11425751/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142354308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of different doses of esketamine on the incidence of hypotension in propofol-based sedation for colonoscopy: a randomized controlled trial","authors":"Mengyue Fu, Bo Sheng, Rui Liu, Yongjie Li, Guizhen Chen, Hai Chen, Xuehan Chen, Guangyou Duan, He Huang, Jie Chen, Yuanjing Chen","doi":"10.1177/20420986241278499","DOIUrl":"https://doi.org/10.1177/20420986241278499","url":null,"abstract":"Background:Hypovolemia is common in colonoscopy due to fasting and bowel preparation, and propofol itself can reduce systemic vascular resistance, resulting in relative hypovolemia. Therefore, hypotension is not a rare event during propofol-based sedation for colonoscopy.Objectives:Our objective was to explore the efficacy of esketamine as a sedative adjuvant in reducing the incidence of hypotension during colonoscopy.Design:This was a prospective randomized trial. The trial was registered with the Chinese Clinical Trial Registry (ID: ChiCTR 2100047032).Methods:We included 100 eligible patients who planned to receive a colonoscopy and randomly divided them into 4 groups with 25 patients in each group, which were propofol 2 mg/kg (Group P), propofol 1 mg/kg with esketamine 0.2 mg/kg (Group E1), propofol 1 mg/kg with esketamine 0.3 mg/kg (Group E2), and propofol 1 mg/kg with esketamine 0.4 mg/kg (Group E3). The hemodynamic and respiratory parameters were documented at various times during the procedure, including the patient’s entry into the endoscopic room (T0), the induction of sedation (T1), the insertion of the colonoscope (T2), the removal of the colonoscope (T3), and the awakening of the patient (T4). The primary outcome was the incidence of hypotension. Secondary outcomes were cardiovascular side effects other than hypotension, incidence of hypoxia, cumulative changes in cardiovascular and respiratory parameters, total propofol dosage, anesthesia recovery time, and satisfactory levels of both patients and endoscopists.Results:The incidence of hypotension in Group E1 (16%), Group E2 (16%), and Group E3 (12%) was significantly lower than in Group P (60%), with p values 0.003, 0.003, and &lt;0.001 respectively. The cumulative changes in diastolic blood pressure and mean arterial pressure in Groups E1, E2, and E3 were significantly higher than in Group P ( p = 0.024, p &lt; 0.001, p = 0.006, respectively). Cumulative changes in systolic blood pressure in Group E3 were significantly higher than those in Group P ( p = 0.012). The respiratory-related parameters were not statistically significant.Conclusions:This study showed that the application of 0.4 mg/kg esketamine in propofol-based sedation reduced the incidence of hypotension during colonoscopy while providing satisfactory sedation.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"22 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142269303","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}