Therapeutic Advances in Drug Safety最新文献

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Characterizing medication safety incidents in surgical patients: a retrospective cross-sectional analysis of incident reports 外科患者用药安全事故的特点:对事故报告的回顾性横断面分析
IF 4.4 3区 医学
Therapeutic Advances in Drug Safety Pub Date : 2024-09-14 DOI: 10.1177/20420986241271881
Noah Sagua, Andrew Carson-Stevens, Kathryn Lynette James
{"title":"Characterizing medication safety incidents in surgical patients: a retrospective cross-sectional analysis of incident reports","authors":"Noah Sagua, Andrew Carson-Stevens, Kathryn Lynette James","doi":"10.1177/20420986241271881","DOIUrl":"https://doi.org/10.1177/20420986241271881","url":null,"abstract":"Background:Medication-related safety incidents (MSIs) are among the most frequent contributors to preventable harm in hospital patients. There is a paucity of research that explores the factors that contribute to MSIs across the departments of high-risk specialties such as surgery.Objectives:To characterize MSIs involving surgical patients across two secondary care sites at a University Health Board.Design:Retrospective cross-sectional convergent analysis of anonymous MSI reports extracted from the risk management system between 1st January 2017 and 31st October 2020 was undertaken.Methods:Incident reports contained categorical data pertaining to the type and nature of the incident as well as free-text reporter accounts. Categorical data were analyzed quantitatively, undergoing descriptive analysis using IBM SPSS Statistics © software (Version 26.0.01; 2019). Content analysis of free-text responses was undertaken using the Organizational Accident Causation model as the underpinning theoretical framework.Results:Of a total of 670 incidents, most MSIs did not result in harm ( n = 495, 73.9%). Most MSIs occurred during administration ( n = 439, 65.5%). Half of the incidents ( n = 335, 50%) were related to one of three medication types: opioids, antimicrobials, and antithrombotic agents. Communication failures were the most frequent error-producing condition ( n = 39, 5.8%) and drug omission was the most frequent active failure ( n = 156, 23.3%).Conclusion:To the knowledge of the authors, this is the first study in the United Kingdom that reports the medications most frequently involved in MSI reports for surgical patients. Staff in the surgical setting should be informed of the high frequency of incidents involving opioids, antimicrobials, heparin, and other antithrombotic agents as they appear in half of MSI reports in the surgical setting. Further research should explore administration error reduction strategies as well as tools to improve communication between staff to mitigate the risk of medicines-related harm associated with key medications.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142259645","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}
引用次数: 0
Assessing the risk of tumor lysis syndrome associated with the use of antineoplastic agents: a real-world pharmacovigilance study based on the FDA Adverse Event Reporting System database. 评估与使用抗肿瘤药物相关的肿瘤溶解综合征风险:基于美国食品药物管理局不良事件报告系统数据库的真实世界药物警戒研究。
IF 3.4 3区 医学
Therapeutic Advances in Drug Safety Pub Date : 2024-09-06 eCollection Date: 2024-01-01 DOI: 10.1177/20420986241274909
Dongxuan Li, Chunmeng Qin, Hongli Wang, Dan Du, Yalan Wang, Qian Du, Songqing Liu
{"title":"Assessing the risk of tumor lysis syndrome associated with the use of antineoplastic agents: a real-world pharmacovigilance study based on the FDA Adverse Event Reporting System database.","authors":"Dongxuan Li, Chunmeng Qin, Hongli Wang, Dan Du, Yalan Wang, Qian Du, Songqing Liu","doi":"10.1177/20420986241274909","DOIUrl":"10.1177/20420986241274909","url":null,"abstract":"<p><strong>Background: </strong>The use of antineoplastic agents is one of the important triggers of tumor lysis syndrome (TLS), but there is still a lack of comprehensive understanding of antineoplastic agents that may trigger TLS and the TLS risk differences between different antineoplastic agents.</p><p><strong>Objectives: </strong>This study aims to investigate the TLS risk of different antineoplastic agents and provide reference information for clinical practice.</p><p><strong>Design: </strong>Real-world adverse events data in the FDA Adverse Event Reporting System (FAERS) database were used as the basis for the disproportionality analysis.</p><p><strong>Methods: </strong>We reviewed the TLS reports in the FAERS database from 2004 to 2022 to summarize an antineoplastic agent list that was reported to trigger TLS, based on which we conducted disproportionality analysis to assess the TLS risk of each antineoplastic agent.</p><p><strong>Results: </strong>In all, 164 antineoplastic agents were reported to trigger TLS. On the whole, rituximab was the most reported antineoplastic agent in TLS reports, followed by cyclophosphamide, venetoclax, doxorubicin, and etoposide, while tagraxofusp was the antineoplastic agent with the highest adverse drug reaction (ADR) signal strength in signal detection, followed by floxuridine, pentostatin, tebentafusp, and venetoclax. Integrating ADR signal detection results, 129 of 164 antineoplastic agents showed at least one positive ADR signal, and six antineoplastic agents (bevacizumab, carboplatin, cisplatin, fluorouracil, lenvatinib, and paclitaxel) have the highest total number of positive signals. Further classifying the 164 antineoplastic agents into 46 chemical subgroups to conduct ADR signal detection, nitrogen mustard analogs were the most reported antineoplastic agent subclasses, followed by clusters of differentiation 20 inhibitors, and pyrimidine analogs, while clusters of differentiation 22 inhibitors were the antineoplastic agent subclass with the highest ADR signal strength, followed by podophyllotoxin derivatives and actinomycines.</p><p><strong>Conclusion: </strong>Our study showed the TLS risk characteristics of 164 antineoplastic agents by detecting and integrating ADR signals, which may help to optimize clinical practice.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11380128/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142154984","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}
引用次数: 0
Interventions and impact of pharmacist-delivered services in perioperative setting on clinically important outcomes: a systematic review and meta-analysis 围手术期药剂师提供的服务对临床重要结果的干预和影响:系统回顾和荟萃分析
IF 4.4 3区 医学
Therapeutic Advances in Drug Safety Pub Date : 2024-07-31 DOI: 10.1177/20420986241260169
Lina Naseralallah, Somaya Koraysh, Bodoor Aboujabal, May Alasmar
{"title":"Interventions and impact of pharmacist-delivered services in perioperative setting on clinically important outcomes: a systematic review and meta-analysis","authors":"Lina Naseralallah, Somaya Koraysh, Bodoor Aboujabal, May Alasmar","doi":"10.1177/20420986241260169","DOIUrl":"https://doi.org/10.1177/20420986241260169","url":null,"abstract":"Background:The perioperative arena is a unique and challenging environment that requires coordination of the complex processes and involvement of the entire care team. Pharmacists’ scope of practice has been evolving to be patient-centered and to expand to variety of settings including perioperative settings.Objectives:To critically appraise, synthesize, and present the available evidence of the characteristics and impact of pharmacist-led interventions on clinically important outcomes in the perioperative settings.Design:A systematic review and meta-analysis.Methods:We searched PubMed, Embase, and CINAHL from index inception to September 2023. Included studies compared the effectiveness of pharmacist-led interventions on clinically important outcomes (e.g. length of stay, readmission) compared to usual care in perioperative settings. Two independent reviewers extracted the data using the DEPICT-2 (Descriptive Elements of Pharmacist Intervention Characterization Tool) and undertook quality assessment using the Crowe Critical Appraisal (CCAT). A random-effect model was used to estimate the overall effect [odds ratio (OR) for dichotomous and standard mean difference (SMD) for continuous data] with 95% confidence intervals (CIs).Results:Twenty-five studies were eligible, 20 (80%) had uncontrolled study design. Most interventions were multicomponent and continuous over the perioperative period. The intervention components included clinical pharmacy services (e.g. medication management/optimization, medication reconciliation, discharge counseling) and education of healthcare professionals. While some studies provided a minor description in regards to the intervention development and processes, only one study reported a theoretical underpinning to intervention development. Pooled analyses showed a significant impact of pharmacist care compared to usual care on length of stay (11 studies; SMD −0.09; 95% CI −0.49 to −0.15) and all-cause readmissions (8 studies; OR 0.60; 95% CI 0.39–0.91). The majority of included studies ( n = 21; 84%) were of moderate quality.Conclusion:Pharmacist-led interventions are effective at improving clinically important outcomes in the perioperative setting; however, most studies were of moderate quality. Studies lacked the utilization of theory to develop interventions; therefore, it is not clear whether theory-derived interventions are more effective than those without a theoretical element. Future research should prioritize the development and evaluation of multifaceted theory-informed pharmacist interventions that target the whole surgical care pathway.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141868244","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}
引用次数: 0
Vonoprazan-associated Clostridioides difficile infection: an analysis of the Japanese Adverse Drug Event Report and the FDA Adverse Event Reporting System 沃诺普拉赞相关艰难梭菌感染:对日本药物不良事件报告和美国食品药品管理局不良事件报告系统的分析
IF 4.4 3区 医学
Therapeutic Advances in Drug Safety Pub Date : 2024-07-31 DOI: 10.1177/20420986241260211
Mengling Ouyang, Shupeng Zou, Qian Cheng, Xuan Shi, Yazheng Zhao, Minghui Sun
{"title":"Vonoprazan-associated Clostridioides difficile infection: an analysis of the Japanese Adverse Drug Event Report and the FDA Adverse Event Reporting System","authors":"Mengling Ouyang, Shupeng Zou, Qian Cheng, Xuan Shi, Yazheng Zhao, Minghui Sun","doi":"10.1177/20420986241260211","DOIUrl":"https://doi.org/10.1177/20420986241260211","url":null,"abstract":"Background:Prolonged or excessive use of acid suppressants may increase the risk of Clostridioides difficile infection (CDI) by altering the intestinal microecosystem. Vonoprazan, a novel potassium-competitive acid blocker, exhibits a faster and more sustained acid-suppressive effect than proton pump inhibitors (PPIs). Therefore, vonoprazan may have a greater impact on the gut microbiota, potentially resulting in CDI.Objectives:This study aimed to explore the potential relationship between acid suppressants and CDI by the Japan Adverse Drug Event Report (JADER) and the FDA Adverse Event Reporting System (FAERS) databases.Design:A retrospective analysis of the JADER and FAERS databases was examined by disproportionality analysis.Methods:We performed signal detection analyses of CDI induced by vonoprazan and PPIs using the JADER and FAERS databases. The association between acid suppressants and CDI was calculated using the reporting odds ratio (ROR) and corresponding 95% confidence interval (95% CI). When the lower limit of the 95% CI is exceeded by 1, the association is considered statistically significant.Results:In the JADER database, the ROR (95% CI) for vonoprazan and PPIs based on suspect drug reports was 15.84 (12.23–20.50) and 2.51 (1.92–3.28), respectively. In the FAERS database, the ROR (95% CI) for vonoprazan and PPIs based on primary and secondary suspect drug reports was 11.50 (6.36–20.82) and 1.42 (1.34–1.51), respectively. Subgroup analysis showed that elderly patients aged 60 years and older were more strongly associated with CDI. The ROR (95% CI) for vonoprazan and PPIs in patients aged 60 years and older in the JADER database was 15.35 (11.59–20.33) and 1.65 (1.14–2.39), respectively. Similarly, the ROR (95% CI) for vonoprazan and PPIs in the FAERS database was 12.56 (6.26–25.20) and 1.43 (1.31–1.57), respectively. Excluding the effect of Helicobacter pylori ( H. pylori) infection, the use of acid suppressants was still associated with CDI.Conclusion:While signal detection analysis based on the JADER and FAERS databases could not establish causality, our study demonstrated that both vonoprazan and PPIs were significantly associated with CDI. Vonoprazan showed a stronger association with CDI in both databases.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141868161","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}
引用次数: 0
Oxaliplatin-associated shock in stage III colorectal cancer patients: real-world evidence in Taiwan. III 期结直肠癌患者与奥沙利铂相关的休克:台湾的实际证据。
IF 3.4 3区 医学
Therapeutic Advances in Drug Safety Pub Date : 2024-07-30 eCollection Date: 2024-01-01 DOI: 10.1177/20420986241266439
Ling-Yi Wang, Hui-Hsia Hsieh, Sung-Chao Chu, Wei-Chuan Chang, Yi-Ting Kuo, Tien-Yuan Wu
{"title":"Oxaliplatin-associated shock in stage III colorectal cancer patients: real-world evidence in Taiwan.","authors":"Ling-Yi Wang, Hui-Hsia Hsieh, Sung-Chao Chu, Wei-Chuan Chang, Yi-Ting Kuo, Tien-Yuan Wu","doi":"10.1177/20420986241266439","DOIUrl":"10.1177/20420986241266439","url":null,"abstract":"<p><strong>Background: </strong>Oxaliplatin-associated shock (referred to as shock) is a rare but life-threatening adverse event.</p><p><strong>Objectives: </strong>This pioneering cohort study aimed to quantitatively investigate the association between oxaliplatin use and shock in patients with stage III colorectal cancer (CRC), identify potential independent risk factors for shock, and assess the cycle-to-shock during oxaliplatin treatment.</p><p><strong>Design: </strong>The study utilized a nested case-control (NCC) design to assess the association between oxaliplatin and shock and employed a case-crossover approach to address unmeasured confounders.</p><p><strong>Methods: </strong>All newly diagnosed stage III CRC patients were identified from the CRC Health Database (2012-2016). Conditional logistic regression was used to calculate odds ratios (OR) and 95% confidence intervals (CIs) for oxaliplatin's link to shock incidence.</p><p><strong>Results: </strong>Among 6932 oxaliplatin recipients, 331 suffered shock. In all, 3309 controls were selected <i>via</i> risk-set sampling for the shock cases. Oxaliplatin use is associated with a doubled risk of shock (adjusted OR: 2.08, 95% CI: 1.23-3.52). Two independent risk factors were male sex (adjusted OR: 1.33, 95% CI: 1.05-1.69) and heart diseases (adjusted OR: 1.65, 95% CI: 1.17-2.32). The case-crossover analysis revealed a more than fourfold risk (OR: 4.4, 95% CI: 1.67-11.62). In total, 22 of 331 shock cases were exposed to oxaliplatin within 2 days of shock onset, with a median cycle-to-shock time at the seventh cycle.</p><p><strong>Conclusion: </strong>Oxaliplatin use significantly increased shock risk in stage III CRC patients. Male sex and heart disease are two independent risk factors.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11289823/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141861032","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}
引用次数: 0
Anticholinergic burden among in-patients: a cross-sectional study on prevalence, determinants, and impact on mortality in Ethiopia. 埃塞俄比亚住院病人的抗胆碱能负担:关于流行率、决定因素和对死亡率影响的横断面研究。
IF 4.4 3区 医学
Therapeutic Advances in Drug Safety Pub Date : 2024-06-14 eCollection Date: 2024-01-01 DOI: 10.1177/20420986241259624
Eyob Alemayehu Gebreyohannes, Wagaye Atalay Taye, Biniam Siyum Shibe, Emneteab Mesfin Ayele, Kenneth Lee, Segenet Bizuneh Mengistu, Roy Louis Soiza, Phyo Kyaw Myint, Ousman Abubeker Abdela
{"title":"Anticholinergic burden among in-patients: a cross-sectional study on prevalence, determinants, and impact on mortality in Ethiopia.","authors":"Eyob Alemayehu Gebreyohannes, Wagaye Atalay Taye, Biniam Siyum Shibe, Emneteab Mesfin Ayele, Kenneth Lee, Segenet Bizuneh Mengistu, Roy Louis Soiza, Phyo Kyaw Myint, Ousman Abubeker Abdela","doi":"10.1177/20420986241259624","DOIUrl":"10.1177/20420986241259624","url":null,"abstract":"<p><strong>Background: </strong>Numerous studies report that anticholinergic burden (ACB) has been linked with several health consequences, including increased hospital admissions, prolonged hospitalization, and physical and cognitive impairment. However, low- and middle-income settings, as well as younger individuals, are underrepresented.</p><p><strong>Objectives: </strong>To assess the prevalence and determinants of ACB, and to assess the impact of ACB on in-hospital mortality among adult in-patients at University of Gondar Comprehensive Specialized Hospital (UOGCSH).</p><p><strong>Design: </strong>A cross-sectional study was conducted from June to August 2022 at UOGCSH among adult in-patients.</p><p><strong>Methods: </strong>A pre-tested questionnaire was utilized to collect data from patients and their corresponding medical charts. A consecutive sampling technique was used to select the participants. Descriptive statistics were used to summarize socio-demographic and clinical characteristics. Chi-squared, Fisher's exact, and Wilcoxon rank sum tests, as appropriate, were used to determine associations between independent variables and ACB. Kaplan-Meier survival curve and Cox proportional hazards regression test were used to assess the impact of ACB on in-hospital mortality.</p><p><strong>Results: </strong>A total of 420 adult in-patients, median (interquartile range) age of 38 (26, 55) years, participated in this study. Over half (58.3%) were exposed to anticholinergic medicines, with a high ACB (⩾3) seen in 11.2% of participants. High ACB was associated with higher median number of medicines per patient (<i>p</i> = 0.003) higher median hospital length of stay (<i>p</i> = 0.033), and having mental and behavioral disorders (<i>p</i> < 0.001). No significant association was found between ACB and in-hospital mortality (log-rank test <i>p</i> = 0.26, Cox regression adjusted hazard ratio: 1.47, 95% CI: 0.335-6.453, <i>p</i> = 0.61).</p><p><strong>Conclusion: </strong>Among adult in-patients, a significant majority (58.3%) were subjected to medications possessing anticholinergic properties, with a noteworthy 11.2% of the study subjects exhibiting a high ACB. Participants with higher median length of hospital stay were more likely to have high ACB even in this relatively younger adult patient population.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11179449/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141331741","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}
引用次数: 0
A retrospective pharmacovigilance study of post-marketing safety concerns with cefuroxime. 关于头孢呋辛上市后安全问题的回顾性药物警戒研究。
IF 4.4 3区 医学
Therapeutic Advances in Drug Safety Pub Date : 2024-06-13 eCollection Date: 2024-01-01 DOI: 10.1177/20420986241258049
Cheng Jiang, Xiaoxiao Zheng, Ping Li, Jiancheng Qian, Qin Li
{"title":"A retrospective pharmacovigilance study of post-marketing safety concerns with cefuroxime.","authors":"Cheng Jiang, Xiaoxiao Zheng, Ping Li, Jiancheng Qian, Qin Li","doi":"10.1177/20420986241258049","DOIUrl":"10.1177/20420986241258049","url":null,"abstract":"<p><strong>Background: </strong>Cefuroxime has played a crucial role in the prevention and treatment of bacterial infections. However, the differences in adverse events across formulations and routes remain unclear.</p><p><strong>Objectives: </strong>This study aimed to investigate the post-marketing safety of cefuroxime, particularly concerning formulations and routes.</p><p><strong>Design: </strong>A retrospective pharmacovigilance study of cefuroxime was conducted using the data from Food and Drug Administration Adverse Event Reporting System database.</p><p><strong>Methods: </strong>The clinical characteristics and concomitant drugs reported with cefuroxime were investigated. Adverse event signals of cefuroxime were identified based on four disproportionality algorithms. The signal differences of cefuroxime across formulations and routes were further examined.</p><p><strong>Results: </strong>A total of 1810 adverse event reports associated with cefuroxime were identified, and 181 cefuroxime-associated signals were detected. Compared with tablets, injections were more likely to cause preferred terms 'blood pressure decreased' and 'anaphylactic shock'. In addition, system organ class 'eye disorders' significantly increased when cefuroxime was administered intraocularly, underscoring the importance of exercising caution regarding ocular toxicity.</p><p><strong>Conclusion: </strong>The adverse events associated with cefuroxime were significantly different across formulations and routes, which deserve special attention in clinical use.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11177735/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141331740","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}
引用次数: 0
Effect of heparin for the prevention of venous thromboembolism in patients with spontaneous intracranial cerebral hemorrhage: a meta-analysis. 肝素对自发性颅内脑出血患者静脉血栓栓塞症的预防效果:一项荟萃分析。
IF 4.4 3区 医学
Therapeutic Advances in Drug Safety Pub Date : 2024-05-22 eCollection Date: 2024-01-01 DOI: 10.1177/20420986241253469
Yifu Zhou, Gang Wang, Chunxiao Xue, Guojun He, Yan Zhang, Feilong He, Chenjun He, Xiaosong Liang
{"title":"Effect of heparin for the prevention of venous thromboembolism in patients with spontaneous intracranial cerebral hemorrhage: a meta-analysis.","authors":"Yifu Zhou, Gang Wang, Chunxiao Xue, Guojun He, Yan Zhang, Feilong He, Chenjun He, Xiaosong Liang","doi":"10.1177/20420986241253469","DOIUrl":"10.1177/20420986241253469","url":null,"abstract":"<p><strong>Background: </strong>Venous thromboembolism (VTE) has a serious impact on the prognosis of patients with spontaneous intracranial hemorrhage (sICH). However, the use of prophylactic heparin remains controversial.</p><p><strong>Objectives: </strong>This study investigated the safety and timing of prophylactic heparin for VTE in patients with sICH.</p><p><strong>Design: </strong>This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines.</p><p><strong>Methods: </strong>Two authors systematically searched Web of Science, Cochrane Library, Embase, and PubMed to find all published research before June 2023. The incidence of deep venous thrombosis (DVT) and mortality were set as primary endpoints.</p><p><strong>Results: </strong>This meta-analysis included seven randomized controlled trials (RCTs) and five observational studies involving a total of 4419 sICH patients in the heparin (<i>n</i> = 2808) and control (<i>n</i> = 1183) groups. Among these patients, 205 received early heparin administration, while 223 received late heparin administration. The results suggested that, compared to the control group, patients in the heparin group had a lower incidence of VTE [odds ratio (OR), 0.47; 95% CI, 0.31-0.71; <i>p</i> < 0.001], DVT (OR, 0.53; 95% CI, 0.33-0.85; <i>p</i> = 0.009), pulmonary embolism (OR, 0.31 95% CI, 0.15-0.65; <i>p</i> = 0.002), and mortality (OR, 0.70; 95% CI, 0.54-0.90; <i>p</i> = 0.006), but there were no statistical differences in hematoma enlargement, extracranial hematoma, and major disability (<i>p</i> > 0.05). There was no statistically significant difference in DVT, mortality, hematoma enlargement, and extracranial hemorrhage between the early heparin group (<24-48 h) and the late heparin group (<i>p</i> > 0.05).</p><p><strong>Conclusion: </strong>In patients with sICH, prophylactic use of heparin may be beneficial because it reduces the incidence of VTE and mortality without increasing the risk of additional bleeding. In addition, early prophylactic use of heparin appears to be safe. However, large-scale RCTs are lacking to support this evidence.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11113067/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141087792","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}
引用次数: 0
The crucial role of pharmacovigilance in managing infectious diseases in lower and middle-income countries. 药物警戒在中低收入国家管理传染病方面的关键作用。
IF 4.4 3区 医学
Therapeutic Advances in Drug Safety Pub Date : 2024-05-14 eCollection Date: 2024-01-01 DOI: 10.1177/20420986241251593
Zakir Khan, Ali Ahmed, Umair Ilyas
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引用次数: 0
The American Program in Pharmacovigilance (Am2P): a new accredited online training program in pharmacovigilance and pharmacoepidemiology. 美国药物警戒项目(Am2P):药物警戒和药物流行病学方面新的认证在线培训项目。
IF 4.4 3区 医学
Therapeutic Advances in Drug Safety Pub Date : 2024-05-10 eCollection Date: 2024-01-01 DOI: 10.1177/20420986241249905
Veronique Kugener, Karine Palin, Maribel Salas, Peggy Webster, Abimbola Cole, John Price, Sepideh Habibi, Christa Naboulet, Dona Ely, Pinak Joshi, Marina A Malikova
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引用次数: 0
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