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Effect of breathing exercises to prevent pulmonary complications in patients undergoing coronary artery bypass graft surgery: a prospective randomized controlled trials study protocol.
IF 3.1 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-15 eCollection Date: 2024-01-01 DOI: 10.3389/fmed.2024.1424291
Chao Li, Ping Zhang, Zichang Zhang, Delin Qi, Hongli Li

Purpose: To study the effects of breathing exercises on preventing pulmonary complications in patients undergoing coronary artery bypass graft surgery.

Methods: Observing whether preoperative breathing exercises can reduce the incidence of postoperative pulmonary complications in patients undergoing coronary artery bypass graft surgery; observing whether these exercises can improve postoperative arterial oxygen pressure, oxygen saturation, and the distance walked in a six-minute walk test after surgery; as well as reduce hospital stay duration, lower treatment costs, and improve the quality of life as measured by the Short Form-36 Health Survey (SF-36).

Design: The study population includes patients undergoing coronary artery bypass graft surgery under general anesthesia; the research center is Capital Medical University Xuanwu Hospital; the sample size is 120. Preoperative standardized breathing exercises are utilized, and the incidence of postoperative pulmonary complications, postoperative arterial blood gases, oxygen saturation, six-minute walk test distances, and comparisons of hospital stay durations and costs will be observed.

{"title":"Effect of breathing exercises to prevent pulmonary complications in patients undergoing coronary artery bypass graft surgery: a prospective randomized controlled trials study protocol.","authors":"Chao Li, Ping Zhang, Zichang Zhang, Delin Qi, Hongli Li","doi":"10.3389/fmed.2024.1424291","DOIUrl":"https://doi.org/10.3389/fmed.2024.1424291","url":null,"abstract":"<p><strong>Purpose: </strong>To study the effects of breathing exercises on preventing pulmonary complications in patients undergoing coronary artery bypass graft surgery.</p><p><strong>Methods: </strong>Observing whether preoperative breathing exercises can reduce the incidence of postoperative pulmonary complications in patients undergoing coronary artery bypass graft surgery; observing whether these exercises can improve postoperative arterial oxygen pressure, oxygen saturation, and the distance walked in a six-minute walk test after surgery; as well as reduce hospital stay duration, lower treatment costs, and improve the quality of life as measured by the Short Form-36 Health Survey (SF-36).</p><p><strong>Design: </strong>The study population includes patients undergoing coronary artery bypass graft surgery under general anesthesia; the research center is Capital Medical University Xuanwu Hospital; the sample size is 120. Preoperative standardized breathing exercises are utilized, and the incidence of postoperative pulmonary complications, postoperative arterial blood gases, oxygen saturation, six-minute walk test distances, and comparisons of hospital stay durations and costs will be observed.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1424291"},"PeriodicalIF":3.1,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757886/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045846","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
Primary hepatic carcinosarcoma: a case report with insights from retrospective analysis of clinical characteristics and prognostic factors.
IF 3.1 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-10 eCollection Date: 2024-01-01 DOI: 10.3389/fmed.2024.1470419
Zonglei Zhao, Tao Wang, Zhexuan Sun, Xuefeng Cao, Xingyuan Zhang

Primary hepatic carcinosarcoma (HCS) is an extremely rare malignant tumor with carcinomatous and sarcomatous elements. Few reported cases of HCS exist, especially with sufficient records to describe imaging and pathological features, making the diagnosis, treatment, and prognosis of HCS a significant challenge for physicians. Here, we report a case of HCS with spontaneous rupture as the initial symptom in a 77-year-old elderly male who was admitted with right upper abdominal pain for 8 days. The computed tomography enhancement scan revealed one intrahepatic enhancement with mixed density and a massive, enhanced shadow located mainly outside the liver. We performed a hepatectomy of segment 4 through a laparotomy. The postoperative pathology results demonstrated HCS. The patient recovered smoothly and was discharged after surgery. However, the patient experienced a recurrence and died 5 months after surgery. This case underscores the importance of identifying high-risk populations and personalized treatment strategies in HCS cases.

{"title":"Primary hepatic carcinosarcoma: a case report with insights from retrospective analysis of clinical characteristics and prognostic factors.","authors":"Zonglei Zhao, Tao Wang, Zhexuan Sun, Xuefeng Cao, Xingyuan Zhang","doi":"10.3389/fmed.2024.1470419","DOIUrl":"https://doi.org/10.3389/fmed.2024.1470419","url":null,"abstract":"<p><p>Primary hepatic carcinosarcoma (HCS) is an extremely rare malignant tumor with carcinomatous and sarcomatous elements. Few reported cases of HCS exist, especially with sufficient records to describe imaging and pathological features, making the diagnosis, treatment, and prognosis of HCS a significant challenge for physicians. Here, we report a case of HCS with spontaneous rupture as the initial symptom in a 77-year-old elderly male who was admitted with right upper abdominal pain for 8 days. The computed tomography enhancement scan revealed one intrahepatic enhancement with mixed density and a massive, enhanced shadow located mainly outside the liver. We performed a hepatectomy of segment 4 through a laparotomy. The postoperative pathology results demonstrated HCS. The patient recovered smoothly and was discharged after surgery. However, the patient experienced a recurrence and died 5 months after surgery. This case underscores the importance of identifying high-risk populations and personalized treatment strategies in HCS cases.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1470419"},"PeriodicalIF":3.1,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757265/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143046087","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 an individualized bismuth quadruple regimen guided by 10-day or 14-day antibiotic susceptibility testing for first-line eradication treatment of Helicobacter pylori in Ningxia, China.
IF 3.1 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-10 eCollection Date: 2024-01-01 DOI: 10.3389/fmed.2024.1510376
Xiaoming Su, Yanhong Deng, Xianmei Chen, Yanling Li, Qian Hao, Yuanyuan Tang, Rui Mu, Yuting Wu, Yan Zhou, Shengjuan Hu

Introduction: Helicobacter pylori (H. pylori) is becoming more resistant to antibiotics, and the implementation of individualized therapy is highly valuable for its eradication. This study aimed to investigate the efficacy and safety of individualized treatment guided by antibiotic susceptibility testing (AST) with a 10-day or 14-day course for the eradication of H. pylori.

Methods: This was a prospective, open-label, single-center, quasi-randomized trial in which 220 participants were randomized into groups based on AST results as AST-10-day (n = 98) and AST-14-day (n = 112) treatment groups. All participants were retested for a 14-carbon urease breath test at weeks 4-8 after the end of the treatment.

Results: The primary resistance rates of H. pylori to metronidazole, levofloxacin, clarithromycin, and amoxicillin were 94.1% (207/220), 42.7% (95/220), 41.4% (91/220), and 0.9% (2/220), respectively; however, no resistance to furazolidone and tetracycline was observed. In the AST-10-day and AST-14-day groups, the intention-to-treat (ITT) eradication rates were 89.8% (88/98) and 90.2% (110/122), respectively, with no statistically significant difference (p = 0.928). The per-protocol (PP) eradication rates were 92.6% (88/95) and 98.2% (110/112), respectively, with a statistically significant difference (p = 0.049). The incidence rates of adverse events (AEs) in the AST-10-day and AST-14-day groups were 6.3% (6/95) and 7.2% (8/112), respectively, with no statistically significant difference (p = 0.813). No statistically significant difference was observed in compliance between the two groups (p = 0.467).

Conclusion: Both 10-day and 14-day AST guided individualized therapy can achieve satisfactory eradication effect. Compared with the 14-day regimen, the 10-day regimen has similar eradication rate and incidence of adverse events and compliance but shorter duration and lower cost.

{"title":"Effect of an individualized bismuth quadruple regimen guided by 10-day or 14-day antibiotic susceptibility testing for first-line eradication treatment of <i>Helicobacter pylori</i> in Ningxia, China.","authors":"Xiaoming Su, Yanhong Deng, Xianmei Chen, Yanling Li, Qian Hao, Yuanyuan Tang, Rui Mu, Yuting Wu, Yan Zhou, Shengjuan Hu","doi":"10.3389/fmed.2024.1510376","DOIUrl":"https://doi.org/10.3389/fmed.2024.1510376","url":null,"abstract":"<p><strong>Introduction: </strong><i>Helicobacter pylori</i> (<i>H. pylori</i>) is becoming more resistant to antibiotics, and the implementation of individualized therapy is highly valuable for its eradication. This study aimed to investigate the efficacy and safety of individualized treatment guided by antibiotic susceptibility testing (AST) with a 10-day or 14-day course for the eradication of <i>H. pylori</i>.</p><p><strong>Methods: </strong>This was a prospective, open-label, single-center, quasi-randomized trial in which 220 participants were randomized into groups based on AST results as AST-10-day (<i>n</i> = 98) and AST-14-day (<i>n</i> = 112) treatment groups. All participants were retested for a 14-carbon urease breath test at weeks 4-8 after the end of the treatment.</p><p><strong>Results: </strong>The primary resistance rates of <i>H. pylori</i> to metronidazole, levofloxacin, clarithromycin, and amoxicillin were 94.1% (207/220), 42.7% (95/220), 41.4% (91/220), and 0.9% (2/220), respectively; however, no resistance to furazolidone and tetracycline was observed. In the AST-10-day and AST-14-day groups, the intention-to-treat (ITT) eradication rates were 89.8% (88/98) and 90.2% (110/122), respectively, with no statistically significant difference (<i>p</i> = 0.928). The per-protocol (PP) eradication rates were 92.6% (88/95) and 98.2% (110/112), respectively, with a statistically significant difference (<i>p</i> = 0.049). The incidence rates of adverse events (AEs) in the AST-10-day and AST-14-day groups were 6.3% (6/95) and 7.2% (8/112), respectively, with no statistically significant difference (<i>p</i> = 0.813). No statistically significant difference was observed in compliance between the two groups (<i>p</i> = 0.467).</p><p><strong>Conclusion: </strong>Both 10-day and 14-day AST guided individualized therapy can achieve satisfactory eradication effect. Compared with the 14-day regimen, the 10-day regimen has similar eradication rate and incidence of adverse events and compliance but shorter duration and lower cost.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1510376"},"PeriodicalIF":3.1,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757245/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045845","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
Surgical interventions for simple phakic fovea-splitting rhegmatogenous retinal detachment: a comparative study of scleral buckling and pars plana vitrectomy.
IF 3.1 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-10 eCollection Date: 2024-01-01 DOI: 10.3389/fmed.2024.1537416
Haiqin Zhu, Qintuo Pan, Zhaoliang Zhang, Zongduan Zhang, Xiaoyin Ma, Xuting Hu

Aims: To compare the efficiency of scleral buckling (SB) and pars plana vitrectomy (PPV) with or without SB in patients with primary simple phakic fovea-splitting rhegmatogenous retinal detachment (RRD).

Methods: A retrospective case-control study included 101 patients aged <55 years diagnosed with phakic fovea-splitting RRD. The primary outcome was functional success, defined as achieving a postoperative logarithm of the minimum angle of resolution best-corrected visual acuity of 0.3 or better at 6 months post-surgery. Secondary outcomes included primary and final anatomical success and postoperative complications.

Results: Fifty-one eyes underwent SB, and 50 eyes underwent PPV. In the SB group, 31 eyes (60.8%) achieved functional success compared with 22 eyes (44.0%) in the PPV group (p = 0.091). There was no significant difference in the primary anatomical success (SB = 94.1%, PPV = 94.0%) and final anatomical success (SB = 100%, PPV = 100%). The incidences of ocular hypertension, epiretinal proliferation, cystoid macular edema, and persistent subretinal fluid in the SB group were 37.3% (p = 0.059), 5.9% (p = 0.034), 3.9% (p = 0.051), and 74.5% (p < 0.001), respectively, whereas in the PPV group they were 56.0, 20.0, 16.0, and 22.0%, respectively. In multivariable analyses, PPV was significantly associated with epiretinal proliferation formation (OR: 4.000, 95% CI: 1.030-15.534, p = 0.045).

Conclusion: SB may offer comparable outcomes to PPV in managing phakic fovea-splitting RRD, and careful surgical technique selection is advised due to postoperative complications.

{"title":"Surgical interventions for simple phakic fovea-splitting rhegmatogenous retinal detachment: a comparative study of scleral buckling and pars plana vitrectomy.","authors":"Haiqin Zhu, Qintuo Pan, Zhaoliang Zhang, Zongduan Zhang, Xiaoyin Ma, Xuting Hu","doi":"10.3389/fmed.2024.1537416","DOIUrl":"https://doi.org/10.3389/fmed.2024.1537416","url":null,"abstract":"<p><strong>Aims: </strong>To compare the efficiency of scleral buckling (SB) and pars plana vitrectomy (PPV) with or without SB in patients with primary simple phakic fovea-splitting rhegmatogenous retinal detachment (RRD).</p><p><strong>Methods: </strong>A retrospective case-control study included 101 patients aged <55 years diagnosed with phakic fovea-splitting RRD. The primary outcome was functional success, defined as achieving a postoperative logarithm of the minimum angle of resolution best-corrected visual acuity of 0.3 or better at 6 months post-surgery. Secondary outcomes included primary and final anatomical success and postoperative complications.</p><p><strong>Results: </strong>Fifty-one eyes underwent SB, and 50 eyes underwent PPV. In the SB group, 31 eyes (60.8%) achieved functional success compared with 22 eyes (44.0%) in the PPV group (<i>p</i> = 0.091). There was no significant difference in the primary anatomical success (SB = 94.1%, PPV = 94.0%) and final anatomical success (SB = 100%, PPV = 100%). The incidences of ocular hypertension, epiretinal proliferation, cystoid macular edema, and persistent subretinal fluid in the SB group were 37.3% (<i>p</i> = 0.059), 5.9% (<i>p</i> = 0.034), 3.9% (<i>p</i> = 0.051), and 74.5% (<i>p</i> < 0.001), respectively, whereas in the PPV group they were 56.0, 20.0, 16.0, and 22.0%, respectively. In multivariable analyses, PPV was significantly associated with epiretinal proliferation formation (OR: 4.000, 95% CI: 1.030-15.534, <i>p</i> = 0.045).</p><p><strong>Conclusion: </strong>SB may offer comparable outcomes to PPV in managing phakic fovea-splitting RRD, and careful surgical technique selection is advised due to postoperative complications.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1537416"},"PeriodicalIF":3.1,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11758278/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143046093","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 efficacy of sequentially comprehensive treatment based on surgery in the treatment of keloids: a retrospective study.
IF 3.1 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-10 eCollection Date: 2024-01-01 DOI: 10.3389/fmed.2024.1492407
Kun Yang, Mengdong Shi, Shubo Li, Jianning Sun, Ran Huo, Cong Fu

Purpose: The objective of this study is to investigate the clinical efficacy of sequentially comprehensive treatment based on surgery and to furnish clinical evidence for the management of keloids.

Patients and methods: The patients with keloids were retrospectively analyzed who underwent surgery-based sequentially comprehensive treatment at the Plastic Surgery Department of Shandong Provincial Hospital from January 2018 to August 2021. The recurrence rate and incidence of adverse reactions were explored for all the included patients. For patients who were followed up for more than 1 year, the clinical response rate was calculated, and the chi-square test was used to analyze which factors could influence clinical effectiveness. Binary logistic analysis was performed on the factors with statistical differences. For patients with a follow-up time of less than 1-year, paired t-test was used to evaluate their Vancouver Scar Scale (VSS) before and after treatment.

Results: A total of 67 patients with 80 keloids were included. The clinical response rate was 81.5% (44/54), the recurrence rate was 15.0% (12/80) and the adverse reaction rate was 4.5% (3/67). The clinical response rate of tumor-type keloids (95.8%) was higher than that of inflammatory-type (70.0%) with a significant difference (P = 0.040). After treatment, the color, blood vessel distribution, softness, thickness, and VSS score were all decreased, and the difference was statistically significant (P < 0.001).

Conclusion: The sequentially comprehensive treatment based on surgery has a significant curative effect, as well as a low recurrence rate and a low adverse effect rate. The type of keloid has a statistically significant effect on clinical efficacy, and tumor-type keloids are more suitable for sequentially comprehensive treatment based on surgery.

{"title":"The efficacy of sequentially comprehensive treatment based on surgery in the treatment of keloids: a retrospective study.","authors":"Kun Yang, Mengdong Shi, Shubo Li, Jianning Sun, Ran Huo, Cong Fu","doi":"10.3389/fmed.2024.1492407","DOIUrl":"https://doi.org/10.3389/fmed.2024.1492407","url":null,"abstract":"<p><strong>Purpose: </strong>The objective of this study is to investigate the clinical efficacy of sequentially comprehensive treatment based on surgery and to furnish clinical evidence for the management of keloids.</p><p><strong>Patients and methods: </strong>The patients with keloids were retrospectively analyzed who underwent surgery-based sequentially comprehensive treatment at the Plastic Surgery Department of Shandong Provincial Hospital from January 2018 to August 2021. The recurrence rate and incidence of adverse reactions were explored for all the included patients. For patients who were followed up for more than 1 year, the clinical response rate was calculated, and the chi-square test was used to analyze which factors could influence clinical effectiveness. Binary logistic analysis was performed on the factors with statistical differences. For patients with a follow-up time of less than 1-year, paired <i>t</i>-test was used to evaluate their Vancouver Scar Scale (VSS) before and after treatment.</p><p><strong>Results: </strong>A total of 67 patients with 80 keloids were included. The clinical response rate was 81.5% (44/54), the recurrence rate was 15.0% (12/80) and the adverse reaction rate was 4.5% (3/67). The clinical response rate of tumor-type keloids (95.8%) was higher than that of inflammatory-type (70.0%) with a significant difference (<i>P</i> = 0.040). After treatment, the color, blood vessel distribution, softness, thickness, and VSS score were all decreased, and the difference was statistically significant (<i>P</i> < 0.001).</p><p><strong>Conclusion: </strong>The sequentially comprehensive treatment based on surgery has a significant curative effect, as well as a low recurrence rate and a low adverse effect rate. The type of keloid has a statistically significant effect on clinical efficacy, and tumor-type keloids are more suitable for sequentially comprehensive treatment based on surgery.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1492407"},"PeriodicalIF":3.1,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757127/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143046105","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
Comparison of good review practices of seven countries participating in the ECOWAS medicines regulatory harmonisation initiative: identifying opportunities for improvement.
IF 3.1 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-10 eCollection Date: 2024-01-01 DOI: 10.3389/fmed.2024.1520892
Mercy Owusu-Asante, Delese Mimi Darko, Seth Seaneke, Aminata Nacoulma, Oula Ibrahim Olivier Traore, Christianah Mojisola Adeyeye, Abayomi Akinyemi, Coulibaly Assane, Clarisse Épse Kaul Meledje Clamoungou, Oumy Kalsoum Ndao, Rokhaya Ndiaye Kande, James Komeh, Sheku Mansaray, Dalkoi Lamboni, Maheza Agba, Stuart Walker, Sam Salek

Introduction: When implemented by national and regional regulatory agencies good review practices (GRevPs) support the timely high-quality review of medicines for enhanced patients' availability to safe, quality and efficacious innovative and generic products. It is important that all aspects of GRevPs are continuously evaluated and updated to promote the continuous improvement of regulatory systems at national and regional levels. The aim of this study was to assess and compare the GRevPs of the national medicines regulatory agencies (NMRAs) of Burkina Faso, Cote d'Ivoire, Ghana, Nigeria, Senegal, Sierra Leone and Togo, who are active participants of the ECOWASMRH initiative to identify opportunities for improvement.

Methods: The Optimising Efficiencies in Regulatory Agencies questionnaire, was completed by each of the NMRAs, which facilitates the assessment of GRevPs, which in turn affect the regulatory review processes.

Results: Except for Cote d'Ivoire and Nigeria which are autonomous, the other five NMRAs operate within the administrative structure of their respective Health Ministry, to regulate medical products for human use, medical devices and diagnostics. Apart from Togo, the agencies receive partial funding from their governments as well as from regulatory fees. Population in the seven countries ranges from 8.6 million to 211.4 million. All the NMRAs had measures in place to achieve quality in their review processes, although there were some remaining initiatives related to transparency and communication, continuous improvement and training and education, to be implemented. Of the ten quality decision-making practices Ghana had implemented nine into a framework, Togo eight, Cote d'Ivoire seven, Nigeria six, and Burkina Faso five; while Sierra Leone has partially implemented all ten and Senegal had not implemented any of the quality decision-making practices.

Conclusion: The study compared the organisation, GRevPs and quality decision-making processes of the NMRAs that actively participate in the ECOWAS-MRH initiative. Though some differences were identified with regard to organisation, a significant number of good review practice initiatives and quality decision-making practices were identified yet to be implemented to promote continuous improvement in the regulatory processes of the NMRAs.

{"title":"Comparison of good review practices of seven countries participating in the ECOWAS medicines regulatory harmonisation initiative: identifying opportunities for improvement.","authors":"Mercy Owusu-Asante, Delese Mimi Darko, Seth Seaneke, Aminata Nacoulma, Oula Ibrahim Olivier Traore, Christianah Mojisola Adeyeye, Abayomi Akinyemi, Coulibaly Assane, Clarisse Épse Kaul Meledje Clamoungou, Oumy Kalsoum Ndao, Rokhaya Ndiaye Kande, James Komeh, Sheku Mansaray, Dalkoi Lamboni, Maheza Agba, Stuart Walker, Sam Salek","doi":"10.3389/fmed.2024.1520892","DOIUrl":"https://doi.org/10.3389/fmed.2024.1520892","url":null,"abstract":"<p><strong>Introduction: </strong>When implemented by national and regional regulatory agencies good review practices (GRevPs) support the timely high-quality review of medicines for enhanced patients' availability to safe, quality and efficacious innovative and generic products. It is important that all aspects of GRevPs are continuously evaluated and updated to promote the continuous improvement of regulatory systems at national and regional levels. The aim of this study was to assess and compare the GRevPs of the national medicines regulatory agencies (NMRAs) of Burkina Faso, Cote d'Ivoire, Ghana, Nigeria, Senegal, Sierra Leone and Togo, who are active participants of the ECOWASMRH initiative to identify opportunities for improvement.</p><p><strong>Methods: </strong>The Optimising Efficiencies in Regulatory Agencies questionnaire, was completed by each of the NMRAs, which facilitates the assessment of GRevPs, which in turn affect the regulatory review processes.</p><p><strong>Results: </strong>Except for Cote d'Ivoire and Nigeria which are autonomous, the other five NMRAs operate within the administrative structure of their respective Health Ministry, to regulate medical products for human use, medical devices and diagnostics. Apart from Togo, the agencies receive partial funding from their governments as well as from regulatory fees. Population in the seven countries ranges from 8.6 million to 211.4 million. All the NMRAs had measures in place to achieve quality in their review processes, although there were some remaining initiatives related to transparency and communication, continuous improvement and training and education, to be implemented. Of the ten quality decision-making practices Ghana had implemented nine into a framework, Togo eight, Cote d'Ivoire seven, Nigeria six, and Burkina Faso five; while Sierra Leone has partially implemented all ten and Senegal had not implemented any of the quality decision-making practices.</p><p><strong>Conclusion: </strong>The study compared the organisation, GRevPs and quality decision-making processes of the NMRAs that actively participate in the ECOWAS-MRH initiative. Though some differences were identified with regard to organisation, a significant number of good review practice initiatives and quality decision-making practices were identified yet to be implemented to promote continuous improvement in the regulatory processes of the NMRAs.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1520892"},"PeriodicalIF":3.1,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757867/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045768","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 efficacy and safety of PD-1 inhibitors combined with chemotherapy treatment for advanced esophageal cancer: a network meta-analysis.
IF 3.1 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-10 eCollection Date: 2024-01-01 DOI: 10.3389/fmed.2024.1515263
Jian-Zhou Tian, Li Zhang, Fu-Yong Lin, Ren-Jiao He, Wen-Rong Tian, Liu Yan, Guo-Xin Huang, Jin-Wei Ai, Bin Pei, De-Sheng Li

Objective: This study systematically evaluated the efficacy of programmed death 1 (PD-1) inhibitors combined with chemotherapy for advanced esophageal cancer (EC).

Methods: PubMed, Embase, Web of Science, Scopus, and Cochrane Library were searched to identify related randomized controlled trials (RCTs).

Results: Seven RCTs involving 4,363 participants were included. The results of the direct comparison showed that, compared with chemotherapy alone, PD-1 inhibitors combined with chemotherapy significantly improved overall survival (OS) (HR = 0.69, 95%CI = 0.63-0.74), progression-free survival (PFS) (HR = 0.63, 95%CI = 0.58-0.67), objective response rate (ORR) (RR = 1.41, 95%CI = 1.28-1.57), but were associated with a slight increase in treatment-related adverse events (AEs) (RR = 1.08, 95%CI = 1.03-1.14). The results of the network meta-analysis showed that toripalimab, sintilimab or camrelizumab, and nivolumab combined with chemotherapy were the best in OS, PFS, and ORR, respectively, with camrelizumab showing the lowest incidence of AEs.

Conclusion: These results suggest that PD-1 inhibitors combined with chemotherapy provide superior clinical benefits over chemotherapy alone, albeit with a moderate increase in AEs. However, further verification through multi-center, high-quality RCTs with larger sample sizes is needed to confirm these findings.

Systematic review registration https//wwwcrdyorkacuk/prospero/display_recordphp?id=crd42024627485:

{"title":"The efficacy and safety of PD-1 inhibitors combined with chemotherapy treatment for advanced esophageal cancer: a network meta-analysis.","authors":"Jian-Zhou Tian, Li Zhang, Fu-Yong Lin, Ren-Jiao He, Wen-Rong Tian, Liu Yan, Guo-Xin Huang, Jin-Wei Ai, Bin Pei, De-Sheng Li","doi":"10.3389/fmed.2024.1515263","DOIUrl":"https://doi.org/10.3389/fmed.2024.1515263","url":null,"abstract":"<p><strong>Objective: </strong>This study systematically evaluated the efficacy of programmed death 1 (PD-1) inhibitors combined with chemotherapy for advanced esophageal cancer (EC).</p><p><strong>Methods: </strong>PubMed, Embase, Web of Science, Scopus, and Cochrane Library were searched to identify related randomized controlled trials (RCTs).</p><p><strong>Results: </strong>Seven RCTs involving 4,363 participants were included. The results of the direct comparison showed that, compared with chemotherapy alone, PD-1 inhibitors combined with chemotherapy significantly improved overall survival (OS) (HR = 0.69, 95%CI = 0.63-0.74), progression-free survival (PFS) (HR = 0.63, 95%CI = 0.58-0.67), objective response rate (ORR) (RR = 1.41, 95%CI = 1.28-1.57), but were associated with a slight increase in treatment-related adverse events (AEs) (RR = 1.08, 95%CI = 1.03-1.14). The results of the network meta-analysis showed that toripalimab, sintilimab or camrelizumab, and nivolumab combined with chemotherapy were the best in OS, PFS, and ORR, respectively, with camrelizumab showing the lowest incidence of AEs.</p><p><strong>Conclusion: </strong>These results suggest that PD-1 inhibitors combined with chemotherapy provide superior clinical benefits over chemotherapy alone, albeit with a moderate increase in AEs. However, further verification through multi-center, high-quality RCTs with larger sample sizes is needed to confirm these findings.</p><p><strong>Systematic review registration https//wwwcrdyorkacuk/prospero/display_recordphp?id=crd42024627485: </strong></p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1515263"},"PeriodicalIF":3.1,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759289/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143046096","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 bibliometric and visualization analysis of electrochemical biosensors for early diagnosis of eye diseases.
IF 3.1 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-10 eCollection Date: 2024-01-01 DOI: 10.3389/fmed.2024.1487981
Fushen Zhang, Weiye Xu, Zejun Deng, Jufang Huang

Electrochemical biosensors can provide an economical, accurate and rapid method for early screening of disease biomarkers in clinical medicine due to their high sensitivity, selectivity, portability, low cost and easy manufacturing, and multiplexing capability. Tear, a fluid naturally secreted by the human body, is not only easily accessible but also contains a great deal of biological information. However, no bibliometric studies focus on applying electrochemical sensors in tear/eye diseases. Therefore, we utilized VOSviewer and CiteSpace, to perform a detailed bibliometric analysis of 114 papers in the field of research on the application of tear in electrochemical biosensors screened from Web of Science with the combination of Scimago Graphica and Microsoft Excel for visualization to show the current research hotspots and future trends. The results show that the research in this field started in 2008 and experienced an emerging period in recent years. Researchers from China and the United States mainly contributed to the thriving research areas, with 41 and 29 articles published, respectively. Joseph Wang from the University of California San Diego is the most influential author in the field, and Biosensors & Bioelectronics is the journal with the most published research and the most cited journal. The highest appearance keywords were "biosensor" and "tear glucose," while the most recent booming keywords "diagnosis" and "in-vivo" were. In conclusion, this study elucidates current trends, hotspots, and emerging frontiers, and provides future biomarkers of ocular and systemic diseases by electrochemical sensors in tear with new ideas and opinions.

{"title":"A bibliometric and visualization analysis of electrochemical biosensors for early diagnosis of eye diseases.","authors":"Fushen Zhang, Weiye Xu, Zejun Deng, Jufang Huang","doi":"10.3389/fmed.2024.1487981","DOIUrl":"https://doi.org/10.3389/fmed.2024.1487981","url":null,"abstract":"<p><p>Electrochemical biosensors can provide an economical, accurate and rapid method for early screening of disease biomarkers in clinical medicine due to their high sensitivity, selectivity, portability, low cost and easy manufacturing, and multiplexing capability. Tear, a fluid naturally secreted by the human body, is not only easily accessible but also contains a great deal of biological information. However, no bibliometric studies focus on applying electrochemical sensors in tear/eye diseases. Therefore, we utilized VOSviewer and CiteSpace, to perform a detailed bibliometric analysis of 114 papers in the field of research on the application of tear in electrochemical biosensors screened from Web of Science with the combination of Scimago Graphica and Microsoft Excel for visualization to show the current research hotspots and future trends. The results show that the research in this field started in 2008 and experienced an emerging period in recent years. Researchers from China and the United States mainly contributed to the thriving research areas, with 41 and 29 articles published, respectively. Joseph Wang from the University of California San Diego is the most influential author in the field, and <i>Biosensors & Bioelectronics</i> is the journal with the most published research and the most cited journal. The highest appearance keywords were \"biosensor\" and \"tear glucose,\" while the most recent booming keywords \"diagnosis\" and \"in-vivo\" were. In conclusion, this study elucidates current trends, hotspots, and emerging frontiers, and provides future biomarkers of ocular and systemic diseases by electrochemical sensors in tear with new ideas and opinions.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1487981"},"PeriodicalIF":3.1,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757256/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045439","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
Diagnostic accuracy of Bellavere's score in cardiac autonomic neuropathy among chronic kidney disease patients: a study of prevalence and dialysis impact.
IF 3.1 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-10 eCollection Date: 2024-01-01 DOI: 10.3389/fmed.2024.1514214
Saket Satyasham Toshniwal, Sunil Kumar, Sourya Acharya, Abhishek Ghali, Sarang Raut, Vinit Deolikar, Harshitha Reddy, Palash Kotak, Anil Wanjari, Shilpa Bawankule

Background: Cardiac autonomic neuropathy (CAN) is a significant complication in chronic kidney disease (CKD), leading to increased morbidity and mortality. Early detection is essential for managing CKD patients effectively, especially those on hemodialysis. This study evaluated the prevalence CAN in CKD and diagnostic accuracy of Bellavere's Score in predicting CAN in CKD patients, including those undergoing hemodialysis.

Methods: This prospective observational study included 200 CKD patients. Cardiac autonomic neuropathy was assessed using Bellavere's Score, calculated through a series of autonomic function tests including heart rate variability and blood pressure responses. Bellavere's Score was measured pre-and post-dialysis in hemodialysis patients. The diagnostic performance of the score was evaluated using receiver operating characteristic (ROC) curves to determine sensitivity, specificity, and likelihood ratios.

Results: Among the patients, 60% were diagnosed with CAN, with 35% having early CAN and 24% severe CAN. Bellavere's Score showed high diagnostic accuracy across CKD stages, with sensitivity ranging from 75 to 89.29% and specificity from 69.09 to 96%. In CKD stage III patients, the sensitivity was 78.57% and specificity 91.4%. In stage V, sensitivity increased to 89.29%, though specificity dropped to 69.09%. For hemodialysis patients, Bellavere's Score exhibited a sensitivity of 79.78% and specificity of 79.28%. The prevalence of CAN decreased significantly from 79.8% pre-dialysis to 64% post-dialysis (p < 0.01).

Conclusion: Bellavere's Score provides a reliable and non-invasive approach for diagnosing CAN in CKD patients, with strong diagnostic performance across different disease stages and in hemodialysis. Larger studies are warranted to further validate its utility.

{"title":"Diagnostic accuracy of Bellavere's score in cardiac autonomic neuropathy among chronic kidney disease patients: a study of prevalence and dialysis impact.","authors":"Saket Satyasham Toshniwal, Sunil Kumar, Sourya Acharya, Abhishek Ghali, Sarang Raut, Vinit Deolikar, Harshitha Reddy, Palash Kotak, Anil Wanjari, Shilpa Bawankule","doi":"10.3389/fmed.2024.1514214","DOIUrl":"https://doi.org/10.3389/fmed.2024.1514214","url":null,"abstract":"<p><strong>Background: </strong>Cardiac autonomic neuropathy (CAN) is a significant complication in chronic kidney disease (CKD), leading to increased morbidity and mortality. Early detection is essential for managing CKD patients effectively, especially those on hemodialysis. This study evaluated the prevalence CAN in CKD and diagnostic accuracy of Bellavere's Score in predicting CAN in CKD patients, including those undergoing hemodialysis.</p><p><strong>Methods: </strong>This prospective observational study included 200 CKD patients. Cardiac autonomic neuropathy was assessed using Bellavere's Score, calculated through a series of autonomic function tests including heart rate variability and blood pressure responses. Bellavere's Score was measured pre-and post-dialysis in hemodialysis patients. The diagnostic performance of the score was evaluated using receiver operating characteristic (ROC) curves to determine sensitivity, specificity, and likelihood ratios.</p><p><strong>Results: </strong>Among the patients, 60% were diagnosed with CAN, with 35% having early CAN and 24% severe CAN. Bellavere's Score showed high diagnostic accuracy across CKD stages, with sensitivity ranging from 75 to 89.29% and specificity from 69.09 to 96%. In CKD stage III patients, the sensitivity was 78.57% and specificity 91.4%. In stage V, sensitivity increased to 89.29%, though specificity dropped to 69.09%. For hemodialysis patients, Bellavere's Score exhibited a sensitivity of 79.78% and specificity of 79.28%. The prevalence of CAN decreased significantly from 79.8% pre-dialysis to 64% post-dialysis (<i>p</i> < 0.01).</p><p><strong>Conclusion: </strong>Bellavere's Score provides a reliable and non-invasive approach for diagnosing CAN in CKD patients, with strong diagnostic performance across different disease stages and in hemodialysis. Larger studies are warranted to further validate its utility.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1514214"},"PeriodicalIF":3.1,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757120/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143045769","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
Perceptions of final-year medical students and interns toward pursuing a career in critical care medicine.
IF 3.1 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2025-01-10 eCollection Date: 2024-01-01 DOI: 10.3389/fmed.2024.1502997
Mohammed Ageel

Background: Critical care medicine (CCM) faces challenges in attracting new physicians due to its demanding nature. Understanding medical students' and interns' perceptions of CCM is essential to address physician shortages and improve medical training.

Objective: To evaluate the factors influencing specialty selection and explore perceptions of final-year medical students and interns toward CCM at Jazan University.

Methods: A cross-sectional survey using convenience sampling was conducted. Participants completed questionnaire assessing factors influencing career choice and perceptions of CCM. Chi-squared tests analyzed the associations between demographic variables and perceptions.

Results: The study included 165 medical students (80% interns, 20% final-year students), primarily male (56.36%) and single (90.91%), with a mean age of 24.56 ± 1.46 years. The most influential career factors were job security (11.65%), enthusiasm/commitment (10.36%), and acceptable working hours (10.36%). Most students (81.82%) found CCM intellectually challenging, while 76.36% recognized its financial benefits. However, only 29.09% were considering a career in CCM, with concerns about work-life balance (34.54%) and family time (32.73%). Interns were more likely than final-year students to view limited working hours positively (p = 0.046), perceive greater colleague prestige (p = 0.035), expect private practice opportunities (p = 0.004), anticipate higher salaries (p < 0.001), and acknowledge the shortage of staff in CCM (p = 0.009).

Conclusion: There is a tension between the intellectual and financial benefits of CCM and its lifestyle demands. While students recognize its rewards, concerns about work-life balance and staffing challenges discourage many from pursuing the specialty. Tailored career counseling, mentorship, and addressing lifestyle concerns in medical curricula may improve interest in CCM.

{"title":"Perceptions of final-year medical students and interns toward pursuing a career in critical care medicine.","authors":"Mohammed Ageel","doi":"10.3389/fmed.2024.1502997","DOIUrl":"https://doi.org/10.3389/fmed.2024.1502997","url":null,"abstract":"<p><strong>Background: </strong>Critical care medicine (CCM) faces challenges in attracting new physicians due to its demanding nature. Understanding medical students' and interns' perceptions of CCM is essential to address physician shortages and improve medical training.</p><p><strong>Objective: </strong>To evaluate the factors influencing specialty selection and explore perceptions of final-year medical students and interns toward CCM at Jazan University.</p><p><strong>Methods: </strong>A cross-sectional survey using convenience sampling was conducted. Participants completed questionnaire assessing factors influencing career choice and perceptions of CCM. Chi-squared tests analyzed the associations between demographic variables and perceptions.</p><p><strong>Results: </strong>The study included 165 medical students (80% interns, 20% final-year students), primarily male (56.36%) and single (90.91%), with a mean age of 24.56 ± 1.46 years. The most influential career factors were job security (11.65%), enthusiasm/commitment (10.36%), and acceptable working hours (10.36%). Most students (81.82%) found CCM intellectually challenging, while 76.36% recognized its financial benefits. However, only 29.09% were considering a career in CCM, with concerns about work-life balance (34.54%) and family time (32.73%). Interns were more likely than final-year students to view limited working hours positively (<i>p</i> = 0.046), perceive greater colleague prestige (<i>p</i> = 0.035), expect private practice opportunities (<i>p</i> = 0.004), anticipate higher salaries (<i>p</i> < 0.001), and acknowledge the shortage of staff in CCM (<i>p</i> = 0.009).</p><p><strong>Conclusion: </strong>There is a tension between the intellectual and financial benefits of CCM and its lifestyle demands. While students recognize its rewards, concerns about work-life balance and staffing challenges discourage many from pursuing the specialty. Tailored career counseling, mentorship, and addressing lifestyle concerns in medical curricula may improve interest in CCM.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"11 ","pages":"1502997"},"PeriodicalIF":3.1,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757234/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143046038","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
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Frontiers in Medicine
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