A male in his early twenties, who participates in mixed martial arts (MMA) fighting with a past medical history of Hemophilia A but otherwise healthy, presented to the emergency room with a chief complaint of a two-day history of right lower extremity swelling, limiting his ability to walk. Of note, the patient had been self-administering recombinant Factor VIII (FVIII) for 12 years. His most recent self-injection had been the night before the onset of swelling and pain. On examination, his right calf was 2 inches in diameter wider than the left. Bilateral lower extremity venous doppler ultrasounds revealed bilateral acute non-obstructing popliteal vein thromboses.
{"title":"Bilateral DVTs in Hemophilia A, A Case Not Anticoagulated","authors":"Clarke Tr, Moas L","doi":"10.26502/aimr.0126","DOIUrl":"https://doi.org/10.26502/aimr.0126","url":null,"abstract":"A male in his early twenties, who participates in mixed martial arts (MMA) fighting with a past medical history of Hemophilia A but otherwise healthy, presented to the emergency room with a chief complaint of a two-day history of right lower extremity swelling, limiting his ability to walk. Of note, the patient had been self-administering recombinant Factor VIII (FVIII) for 12 years. His most recent self-injection had been the night before the onset of swelling and pain. On examination, his right calf was 2 inches in diameter wider than the left. Bilateral lower extremity venous doppler ultrasounds revealed bilateral acute non-obstructing popliteal vein thromboses.","PeriodicalId":8282,"journal":{"name":"Archives of Internal Medicine Research","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89498813","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jung Lee, Jainn Jim Lin, S. Hsia, Jing-Long Huang, C. Chiu, Mingqian Lin, Cheng-Keng Chuang
Background: We introduced high-fidelity simulation (HFS) using mannequins to teach pediatric residents about critical deterioration events (CDE; respiratory failure, circulatory shock, or both) in pediatric patients over a 1-year period. For an effective HFS program, a learning needs assessment is required. We assessed pediatric residents’ knowledge, attitudes, and perceptions of the new learning tool. Methods: A 20-item paper-based questionnaire survey was completed by pediatric residents of a tertiary medical center who participated in the HFS program. Results: Thirty-four (85%) of 40 pediatric residents responded to the survey. Their mean age was 29.35 ± 1.25 years, and 10 (29.4%) were male. The primary learning objective was the acquisition of technical skill. However, the residents considered HFS helpful for the acquisition of both technical and non-technical skills. A questionnaire with a seven-point Likert scale (1–7) was used to assess resident attitudes toward the HFS. The residents scored highly for active engagement with the HFS (mean score, 5.32 ± 1.45) and reported moderate stress levels (mean score, 4.35 ± 1.27). The residents ( n = 34) considered HFS training before encountering a real patient with a similar presentation helpful (mean score, 6.32 ±
{"title":"High-fidelity Simulation in Teaching Pediatric Critical Deterioration Events: A Learning Needs Assessment","authors":"Jung Lee, Jainn Jim Lin, S. Hsia, Jing-Long Huang, C. Chiu, Mingqian Lin, Cheng-Keng Chuang","doi":"10.26502/aimr.0115","DOIUrl":"https://doi.org/10.26502/aimr.0115","url":null,"abstract":"Background: We introduced high-fidelity simulation (HFS) using mannequins to teach pediatric residents about critical deterioration events (CDE; respiratory failure, circulatory shock, or both) in pediatric patients over a 1-year period. For an effective HFS program, a learning needs assessment is required. We assessed pediatric residents’ knowledge, attitudes, and perceptions of the new learning tool. Methods: A 20-item paper-based questionnaire survey was completed by pediatric residents of a tertiary medical center who participated in the HFS program. Results: Thirty-four (85%) of 40 pediatric residents responded to the survey. Their mean age was 29.35 ± 1.25 years, and 10 (29.4%) were male. The primary learning objective was the acquisition of technical skill. However, the residents considered HFS helpful for the acquisition of both technical and non-technical skills. A questionnaire with a seven-point Likert scale (1–7) was used to assess resident attitudes toward the HFS. The residents scored highly for active engagement with the HFS (mean score, 5.32 ± 1.45) and reported moderate stress levels (mean score, 4.35 ± 1.27). The residents ( n = 34) considered HFS training before encountering a real patient with a similar presentation helpful (mean score, 6.32 ±","PeriodicalId":8282,"journal":{"name":"Archives of Internal Medicine Research","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88047866","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Ashraf, M. Bannon, Matthew Nunley, P. Kaushik, Creticus Marak
A1c 12.9; urinalysis was negative for urinary tract infection. She was diagnosed with diabetic ketoacidosis (DKA), perineal abscesses, and candida vulvovaginitis and admitted to MICU for aggressive management and close monitoring. She was started on the hospital DKA protocol, oral fluconazole, IV vancomycin, and IV Piperacillin tazobactam (Zosyn). Incision and drainage of the bilateral perirectal abscesses was performed without complications. Multiple wound cultures, including anaerobic, grew only Candida krusei [Figures 4, 5], confirming C. krusei subcutaneous abscess. She completed 7 days of empiric therapy with IV vancomycin and IV Zosyn; Fluconazole was discontinued and switched to IV Micafungin. She completed 14 days of IV Micafungin with a good response. Post-discharge outpatient follow-up revealed adequate healing of the perineal wounds. Abstract Candida is considered a normal microbiota of the gastrointestinal and genitourinary systems with a tendency for an invasive disease if the predisposing conditions exist. Mucocutaneous manifestations of Candida infection include the commonly encountered oropharyngeal thrush, vulvovaginitis, balanitis, intertrigo, paronychia, diaper dermatitis, and the rare chronic mucocutaneous candidiasis. Subcutaneous abscess due to Candida (albicans and non-albicans) is rare, with the literature available only in case reports. We report the first case of a subcutaneous perineal abscess due to C. krusie in a patient with poorly controlled diabetes without immune compromised conditions or a hematologic malignancy.
{"title":"A Subcutaneous Abscess Caused by Candida Krusei Infection: A rare Manifestation","authors":"A. Ashraf, M. Bannon, Matthew Nunley, P. Kaushik, Creticus Marak","doi":"10.26502/aimr.0132","DOIUrl":"https://doi.org/10.26502/aimr.0132","url":null,"abstract":"A1c 12.9; urinalysis was negative for urinary tract infection. She was diagnosed with diabetic ketoacidosis (DKA), perineal abscesses, and candida vulvovaginitis and admitted to MICU for aggressive management and close monitoring. She was started on the hospital DKA protocol, oral fluconazole, IV vancomycin, and IV Piperacillin tazobactam (Zosyn). Incision and drainage of the bilateral perirectal abscesses was performed without complications. Multiple wound cultures, including anaerobic, grew only Candida krusei [Figures 4, 5], confirming C. krusei subcutaneous abscess. She completed 7 days of empiric therapy with IV vancomycin and IV Zosyn; Fluconazole was discontinued and switched to IV Micafungin. She completed 14 days of IV Micafungin with a good response. Post-discharge outpatient follow-up revealed adequate healing of the perineal wounds. Abstract Candida is considered a normal microbiota of the gastrointestinal and genitourinary systems with a tendency for an invasive disease if the predisposing conditions exist. Mucocutaneous manifestations of Candida infection include the commonly encountered oropharyngeal thrush, vulvovaginitis, balanitis, intertrigo, paronychia, diaper dermatitis, and the rare chronic mucocutaneous candidiasis. Subcutaneous abscess due to Candida (albicans and non-albicans) is rare, with the literature available only in case reports. We report the first case of a subcutaneous perineal abscess due to C. krusie in a patient with poorly controlled diabetes without immune compromised conditions or a hematologic malignancy.","PeriodicalId":8282,"journal":{"name":"Archives of Internal Medicine Research","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87099279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Matthew Nunley, Adrian Renaldi, R. Turner, M. Bannon, A. Ashraf, Creticus Marak, P. Kaushik
A thyroid storm is an acute, life-threatening complication in patients with inadequately controlled hyperthyroidism. Fortunately, this condition is rare and occurs mainly in patients with poorly controlled hyperthyroidism with additional risk factors. Commonly cited risk factors include abrupt discontinuation of antithyroid medicines, emergent thyroid and nonthyroid surgeries, trauma, infections, medications (amiodarone, salicylates), parturition, and use of iodinated contrast medium. There have also been reports of methamphetamine use precipitating a thyroid storm, albeit only a few. We are reporting a case of thyroid storm in a patient with untreated hyperthyroidism that we believe was precipitated by recent methamphetamine use. Arch Intern Med Res 2022; 5 (2): 199-202 DOI: 10.26502/aimr.0102 Archives of Internal Medicine Research 200
甲状腺风暴是控制不充分的甲亢患者的急性、危及生命的并发症。幸运的是，这种情况是罕见的，主要发生在控制不佳的甲亢患者和其他危险因素。常见的危险因素包括突然停用抗甲状腺药物、紧急甲状腺和非甲状腺手术、创伤、感染、药物(胺碘酮、水杨酸盐)、分娩和使用碘化造影剂。也有报告称，甲基苯丙胺的使用引发了甲状腺风暴，尽管只有少数。我们报告一例甲状腺风暴在患者未经治疗的甲亢，我们认为是沉淀最近甲基苯丙胺的使用。Arch Intern Med Res 2022;5 (2): 199-202 DOI: 10.26502/aimr.0102内科学研究文献2008
{"title":"A Fatal Case of Thyroid Storm Precipitated by Methamphetamine Use","authors":"Matthew Nunley, Adrian Renaldi, R. Turner, M. Bannon, A. Ashraf, Creticus Marak, P. Kaushik","doi":"10.26502/aimr.0102","DOIUrl":"https://doi.org/10.26502/aimr.0102","url":null,"abstract":"A thyroid storm is an acute, life-threatening complication in patients with inadequately controlled hyperthyroidism. Fortunately, this condition is rare and occurs mainly in patients with poorly controlled hyperthyroidism with additional risk factors. Commonly cited risk factors include abrupt discontinuation of antithyroid medicines, emergent thyroid and nonthyroid surgeries, trauma, infections, medications (amiodarone, salicylates), parturition, and use of iodinated contrast medium. There have also been reports of methamphetamine use precipitating a thyroid storm, albeit only a few. We are reporting a case of thyroid storm in a patient with untreated hyperthyroidism that we believe was precipitated by recent methamphetamine use. Arch Intern Med Res 2022; 5 (2): 199-202 DOI: 10.26502/aimr.0102 Archives of Internal Medicine Research 200","PeriodicalId":8282,"journal":{"name":"Archives of Internal Medicine Research","volume":"115 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76845090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
D. Desai, S. Singhal, Oladimeji Lanade, A. Khosla, Rashmika R. Potdar
Cemiplimab is a human immunoglobulin G4 monoclonal antibody directed against programmed cell death protein 1 (PD1). It is the treatment of choice in locally advanced or metastatic cutaneous squamous cell carcinoma (mCSCC). This popular and lifesaving drug also has many known adverse events, most of which are immune mediated. The most common adverse events include hepatotoxicity, rash, colitis, pneumonitis, and infusion related reactions. Although minimally hematotoxic, anemia is common and deranged coagulation cascades can be seen, albeit rare with Cemiplimab therapy [LD1]. We present a highly unusual case of an 84-year-old gentleman who developed an unexplained pancytopenia and was found to have novel Non-Hodgkin’s Lymphoma after receiving Cemiplimab therapy for mCSCC. Although the exact mechanism is unknown, it is likely that immune checkpoint inhibitor therapy led to stimulation of B cells and uncontrolled proliferation leading to development of low-grade B cell lymphoma. We aim to highlight this rare yet significant manifestation of this new therapy, and the need for further research to better understand the exact pathogenesis of this unique outcome
{"title":"The Tale of Unexplained pancytopenia: The Unusual Instance of Cemiplimab-Associated Non-Hodgkin’s Lymphoma","authors":"D. Desai, S. Singhal, Oladimeji Lanade, A. Khosla, Rashmika R. Potdar","doi":"10.26502/aimr.0092","DOIUrl":"https://doi.org/10.26502/aimr.0092","url":null,"abstract":"Cemiplimab is a human immunoglobulin G4 monoclonal antibody directed against programmed cell death protein 1 (PD1). It is the treatment of choice in locally advanced or metastatic cutaneous squamous cell carcinoma (mCSCC). This popular and lifesaving drug also has many known adverse events, most of which are immune mediated. The most common adverse events include hepatotoxicity, rash, colitis, pneumonitis, and infusion related reactions. Although minimally hematotoxic, anemia is common and deranged coagulation cascades can be seen, albeit rare with Cemiplimab therapy [LD1]. We present a highly unusual case of an 84-year-old gentleman who developed an unexplained pancytopenia and was found to have novel Non-Hodgkin’s Lymphoma after receiving Cemiplimab therapy for mCSCC. Although the exact mechanism is unknown, it is likely that immune checkpoint inhibitor therapy led to stimulation of B cells and uncontrolled proliferation leading to development of low-grade B cell lymphoma. We aim to highlight this rare yet significant manifestation of this new therapy, and the need for further research to better understand the exact pathogenesis of this unique outcome","PeriodicalId":8282,"journal":{"name":"Archives of Internal Medicine Research","volume":"35 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85850763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-28DOI: 10.21203/rs.3.rs-1158318/v1
Thiri Thazin Khine, Y. Sawangdee
Background – The maternal mortality ratio of Rakhine State is cited as being the highest level among the states of Myanmar. In contrast, the usage of healthcare providers for the delivery process is at the lowest rate in the Union. Therefore, this study sought to discover the factors influencing women from Rakhine State in receiving postpartum care from healthcare providers.Methodology – All in all, 278 women from the 15- to 49-year-old age group collected from the Myanmar Demographic Health Survey (2015-2016) were used for this study. Binary logistic regression was likewise employed. Results –Among the 104 cases receiving postpartum care, only 42 cases were home deliveries. Maternal health knowledge status, the role of healthcare providers, and places of delivery, rather than socioeconomic status and social structure, were the most essential factors in promoting postpartum care status. The occupation status of women also influenced their postpartum care receiving status.Conclusion – By strengthening the health care system setting and promoting the job efficacy of women, the postdelivery care status of Rakhine state can be increased and the maternal death after child birth can be reduced to reach the SDGs.
{"title":"Determinants for Postpartum Care of Women in Rakhine State, Myanmar: A Descriptive Cross- sectional Study","authors":"Thiri Thazin Khine, Y. Sawangdee","doi":"10.21203/rs.3.rs-1158318/v1","DOIUrl":"https://doi.org/10.21203/rs.3.rs-1158318/v1","url":null,"abstract":"\u0000 Background – The maternal mortality ratio of Rakhine State is cited as being the highest level among the states of Myanmar. In contrast, the usage of healthcare providers for the delivery process is at the lowest rate in the Union. Therefore, this study sought to discover the factors influencing women from Rakhine State in receiving postpartum care from healthcare providers.Methodology – All in all, 278 women from the 15- to 49-year-old age group collected from the Myanmar Demographic Health Survey (2015-2016) were used for this study. Binary logistic regression was likewise employed. Results –Among the 104 cases receiving postpartum care, only 42 cases were home deliveries. Maternal health knowledge status, the role of healthcare providers, and places of delivery, rather than socioeconomic status and social structure, were the most essential factors in promoting postpartum care status. The occupation status of women also influenced their postpartum care receiving status.Conclusion – By strengthening the health care system setting and promoting the job efficacy of women, the postdelivery care status of Rakhine state can be increased and the maternal death after child birth can be reduced to reach the SDGs.","PeriodicalId":8282,"journal":{"name":"Archives of Internal Medicine Research","volume":"83 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81078521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-28DOI: 10.1101/2021.11.26.21265946
N. Lelie, M. Koppelman, H. van Drimmelen, S. Bruisten
We prepared severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) working standards and reference panels from a pool of swab fluid samples before and after inactivation by beta-propiolactone and quantified viral load in nucleic acid amplification technology (NAT) detectable RNA copies/mL using limiting dilution analysis. The following 50% lower limits of detection (LOD) were estimated by probit analysis as compared to detection limits of rapid antigen tests on 1.5 fold dilutions of the native material: Roche cobas PCR 1.8 (1.0-3.3), Hologic Aptima TMA 6.6 (4.4-9.9), DRW SAMBA 15 (7-30), Molgen LAMP 23 (13-42), Fluorecare antigen 50,000, Abbott Panbio antigen 75,000 and Roche antigen 100,000 copies/mL. One 50% Tissue Culture Infectious Dose (TCID50)/mL of culture fluid was estimated to be equivalent to approximately 1000 RNA copies/mL (2700- 4300 International Units) in our working standard. When assuming this level as start of contagiousness in a log-linear ramp up viremia model with 10-fold rise of viral load per day for the B.1 (Wuhan) type we estimated relative time points of first detectability of early infection by the different SARS-CoV-2 assays from the LODs mentioned above. The four NAT assays would be able to detect early viremia 40-66 hours earlier than the 1000 copies/mL infectivity threshold, whereas the three antigen tests would become positive 41-48 hours later. Our modeling of analytical sensitivity data was found to be compatible with clinical sensitivity data of rapid antigen tests and confirms that NAT assays are more reliable than antigen assays for identifying early infected asymptomatic individuals who are potentially infectious.
{"title":"Analytical sensitivity and effectiveness of different SARS-CoV-2 testing options","authors":"N. Lelie, M. Koppelman, H. van Drimmelen, S. Bruisten","doi":"10.1101/2021.11.26.21265946","DOIUrl":"https://doi.org/10.1101/2021.11.26.21265946","url":null,"abstract":"We prepared severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) working standards and reference panels from a pool of swab fluid samples before and after inactivation by beta-propiolactone and quantified viral load in nucleic acid amplification technology (NAT) detectable RNA copies/mL using limiting dilution analysis. The following 50% lower limits of detection (LOD) were estimated by probit analysis as compared to detection limits of rapid antigen tests on 1.5 fold dilutions of the native material: Roche cobas PCR 1.8 (1.0-3.3), Hologic Aptima TMA 6.6 (4.4-9.9), DRW SAMBA 15 (7-30), Molgen LAMP 23 (13-42), Fluorecare antigen 50,000, Abbott Panbio antigen 75,000 and Roche antigen 100,000 copies/mL. One 50% Tissue Culture Infectious Dose (TCID50)/mL of culture fluid was estimated to be equivalent to approximately 1000 RNA copies/mL (2700- 4300 International Units) in our working standard. When assuming this level as start of contagiousness in a log-linear ramp up viremia model with 10-fold rise of viral load per day for the B.1 (Wuhan) type we estimated relative time points of first detectability of early infection by the different SARS-CoV-2 assays from the LODs mentioned above. The four NAT assays would be able to detect early viremia 40-66 hours earlier than the 1000 copies/mL infectivity threshold, whereas the three antigen tests would become positive 41-48 hours later. Our modeling of analytical sensitivity data was found to be compatible with clinical sensitivity data of rapid antigen tests and confirms that NAT assays are more reliable than antigen assays for identifying early infected asymptomatic individuals who are potentially infectious.","PeriodicalId":8282,"journal":{"name":"Archives of Internal Medicine Research","volume":"55 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85822701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-16DOI: 10.1101/2021.11.16.21266324
Y. Ayar, O. Deniz, B. Doner, İ. Kiliç, C. Demi̇r, A. Şahin
Objective: Coronavirus disease 2019 (Covid 19) started in China in December 2019 and spread all over the world, is more progressive in patients who are elderly and with chronic diseases. Especially kidney involvement affects the survival of patients. In this study, we analyzed Covid 19 patients who developed acute kidney injury treated in our unit, retrospectively. Matherials: The clinical and laboratory data of 610 patients who hospitalized due to Covid 19 pandemic between 01.06.2020 and 30.06.2021 in the intensive care and other clinics of our hospital evaluated from the records, retrospectively. One hundred-fourty patients diagnosed with AKI according to the criteria of KDIGO (Kidney Disease Global Outcomes). The patients divided into two groups as KDIGO stage 1 and 2, 3. Results: The median age in both groups was 70 (35-92) and 73 (35-90) years. Approximately seventy percent of them were over 65 years old. Almost all of the patients had hypertension. Most of the patients were using angiotensin converting enzyme inhibitors (ACE inh) or angiotensin receptor blockers (ARB) (84%). AKI was present at the time of admission (61.9%) in the KDIGO 1 group and at the time of hospitalization (64.3%) in the KDIGO 2, 3 group. The mortality rate was higher in stage 2-3 AKI patients (35.7%). Ferritin and fibrinogen levels were high in the KDIGO 2, 3 group, while lymphocyte levels were low. Conclusion: AKI can be seen at the time of admission and during treatment in patients who are hospitalized and treated due to Covid 19. Covid 19 is more mortal in patients with advanced AKI.
{"title":"COVID-19 in Elderly Patients with Acute Kidney Injury","authors":"Y. Ayar, O. Deniz, B. Doner, İ. Kiliç, C. Demi̇r, A. Şahin","doi":"10.1101/2021.11.16.21266324","DOIUrl":"https://doi.org/10.1101/2021.11.16.21266324","url":null,"abstract":"Objective: Coronavirus disease 2019 (Covid 19) started in China in December 2019 and spread all over the world, is more progressive in patients who are elderly and with chronic diseases. Especially kidney involvement affects the survival of patients. In this study, we analyzed Covid 19 patients who developed acute kidney injury treated in our unit, retrospectively. Matherials: The clinical and laboratory data of 610 patients who hospitalized due to Covid 19 pandemic between 01.06.2020 and 30.06.2021 in the intensive care and other clinics of our hospital evaluated from the records, retrospectively. One hundred-fourty patients diagnosed with AKI according to the criteria of KDIGO (Kidney Disease Global Outcomes). The patients divided into two groups as KDIGO stage 1 and 2, 3. Results: The median age in both groups was 70 (35-92) and 73 (35-90) years. Approximately seventy percent of them were over 65 years old. Almost all of the patients had hypertension. Most of the patients were using angiotensin converting enzyme inhibitors (ACE inh) or angiotensin receptor blockers (ARB) (84%). AKI was present at the time of admission (61.9%) in the KDIGO 1 group and at the time of hospitalization (64.3%) in the KDIGO 2, 3 group. The mortality rate was higher in stage 2-3 AKI patients (35.7%). Ferritin and fibrinogen levels were high in the KDIGO 2, 3 group, while lymphocyte levels were low. Conclusion: AKI can be seen at the time of admission and during treatment in patients who are hospitalized and treated due to Covid 19. Covid 19 is more mortal in patients with advanced AKI.","PeriodicalId":8282,"journal":{"name":"Archives of Internal Medicine Research","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89269123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-09-27DOI: 10.21203/rs.3.rs-929867/v1
L. Cooper, Emily Wo, Irene Lee
Objectives Despite wide use of PRO tools in clinical development, resulting data is rarely incorporated into the US label. This study reviewed oncology product labels approved by the Food and Drug Administration (FDA) between 2006 and 2020 to determine if the number of PRO included in labeling has meaningfully changed. Sponsors were assessed to identify demographic trends in achieving PRO label success. Methods FDA-approved drugs were searched utilizing the Drugs@FDA database by month from January 2015 to December 2020 for novel drug and biologic approvals. Products approved between 2006-2014 were identified utilizing the Gnansakthy et al., 2012 and 2016 publications. Labels were reviewed for inclusion of PRO data in the label and product summary basis of approval (SBA). Sponsor size and experience were measured for each year of product approval. Results 155 oncology products received initial approval between 2006-2020, of which only 7 contained PRO data in the label. More than half (53.5%) of products had PRO data described in the SBA. Over time, PRO information has increasingly been included in the product marketing application. Sponsors utilizing PRO data tend to be experienced in oncology development and larger in size. Conclusions There has been a small increase in inclusion of PRO data in oncology product labeling over the past 15 years. Utilization and analysis of appropriate PRO tools and data remains a challenge to sponsors. Further collaboration with FDA is needed for the development of disease specific PRO tools that provide meaningful data to the targeted patient population.
{"title":"A 15 Year Review (2006-2020) of Patient-Reported Outcome (PRO) in United States Oncology Product Labeling and Trends in Sponsor Size and Oncology Experience.","authors":"L. Cooper, Emily Wo, Irene Lee","doi":"10.21203/rs.3.rs-929867/v1","DOIUrl":"https://doi.org/10.21203/rs.3.rs-929867/v1","url":null,"abstract":"Objectives\u0000Despite wide use of PRO tools in clinical development, resulting data is rarely incorporated into the US label. This study reviewed oncology product labels approved by the Food and Drug Administration (FDA) between 2006 and 2020 to determine if the number of PRO included in labeling has meaningfully changed. Sponsors were assessed to identify demographic trends in achieving PRO label success.\u0000\u0000\u0000Methods\u0000FDA-approved drugs were searched utilizing the Drugs@FDA database by month from January 2015 to December 2020 for novel drug and biologic approvals. Products approved between 2006-2014 were identified utilizing the Gnansakthy et al., 2012 and 2016 publications. Labels were reviewed for inclusion of PRO data in the label and product summary basis of approval (SBA). Sponsor size and experience were measured for each year of product approval.\u0000\u0000\u0000Results\u0000155 oncology products received initial approval between 2006-2020, of which only 7 contained PRO data in the label. More than half (53.5%) of products had PRO data described in the SBA. Over time, PRO information has increasingly been included in the product marketing application. Sponsors utilizing PRO data tend to be experienced in oncology development and larger in size.\u0000\u0000\u0000Conclusions\u0000There has been a small increase in inclusion of PRO data in oncology product labeling over the past 15 years. Utilization and analysis of appropriate PRO tools and data remains a challenge to sponsors. Further collaboration with FDA is needed for the development of disease specific PRO tools that provide meaningful data to the targeted patient population.","PeriodicalId":8282,"journal":{"name":"Archives of Internal Medicine Research","volume":"236 1","pages":"412-419"},"PeriodicalIF":0.0,"publicationDate":"2021-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81828079","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-08-26DOI: 10.1101/2021.08.24.21262535
W. Basha, Z. Nazzal, Y. El-Hamshary, A. Odeh, L. Hijjawi, M. Doden, A. Musa, S. Ruzzeh
COVID-19 was characterized by cytokine storm and endothelial dysfunction in severely ill patients. As the severity of the infection was corelated with ethnicity, this study aimed to assess the correlation of proinflammatory cytokine serum level and COVID-19 symptoms within the Palestinian population. In cross-sectional study, serum samples of 27 non-hospitalized patients and 63 hospitalized patients SARS-CoV-2 infected patients, were tested for total antibodies, IL-6, TNF-, IFN-{beta} and IL-1{beta} using the ELISA test. Results showed that most common symptoms within patients were Joint pain, cough, and fever (73.3%, 69.7% and 50% respectively). Serum total antibodies (IGs) levels in non-hospitalized patients were higher than hospitalized patients ((44.7 COI and 9.2 COI). TNF- and IL-6 were lower in non-hospitalized patients compared to hospitalized patients (48 ± 17.9 pg/ml, 193.3 ± 350.5 pg/ml respectively). On the other hand, IFN-, in non-hospitalized patients (1 ± 2 IU/ml) was significantly higher than hospitalized patients (0.4 ± 0.26 IU/ml). IL-1{beta} was slightly lower in hospitalized patients (8.8 ± 13.6 pg/ml ) compared to non-hospitalized patients (12.5 ± 24.5 pg/ml). Common mild symptoms of COVID-10 were negatively associated with proinflammatory cytokines serum level. In conclusion as it with other populations worldwide, IL-6 and TNF- are playing a major role in the complications of SARS-CoV-2 infection. Monitoring the two cytokines is crucial for management and treatment of complicated consequence of COVID-19.
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