scholarly journals Bamlanivimab Use in a Military Treatment Facility

2021 ◽  
Author(s):  
Eric Karr ◽  
Theodore Chung ◽  
Kathryn Burtson ◽  
Ronald Markert ◽  
Devin Kelly

ABSTRACT Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19), was first identified in 2019 in Wuhan, China, and has rapidly spread across the world. As of April 2021, SARS-CoV-2 has infected more than 140,000,000 and caused more than 3,000,000 deaths globally. In November 2020, the monoclonal antibody bamlanivimab was approved by the FDA for non-hospitalized patients with SARS-CoV-2 (COVID-19) who possessed risk factors for progression to severe COVID-19. This provided a treatment option that may help prevent hospitalization. Methods Patients who regularly received ambulatory care at a military treatment facility and who were diagnosed with mild-to-moderate COVID-19 and possessed risk factors for progression to severe COVID-19 were treated with a single, intravenous infusion (700 mg) of the virus-neutralizing monoclonal antibody bamlanivimab. The primary outcome was improvement of self-reported symptoms within 24 to 72 hours of receiving the infusion. The secondary outcome was prevention of disease progression requiring emergency department (ED) utilization or hospitalization related to COVID-19 within 30 days of infusion. Bamlanivimab was administered in accordance with the FDA’s approval and Defense Health Agency’s guidance, including follow-up within 72 hours of administration. Institutional Review Board (IRB) approval was obtained. Results Of the COVID-19 patients who were given the option of a bamlanivimab infusion, 40 accepted and 6 did not (40/46, 86.9%). Thirty-six of 40 patients in the treatment group were contacted within 72 hours. ED/hospitalization information was available for all 46 patients. In the treatment group, 94.4% (34/36) reported global improvement. Three of 40 (7.5%) patients in the treatment group required inpatient admission, and 2 of 40 patients (5%) required ED evaluation within 30 days of infusion. Therefore, 5 of 40 (12.5%) patients required evaluation shortly after infusion, while 2 of 6 (33.3%) patients who declined treatment required hospital evaluation or admission related to COVID-19 within 30 days of infusion (P = .15). Conclusions Global improvement of symptoms within 24 to 72 hours of infusion was reported by 94.4% of patients receiving bamlanivimab; however, statistical significance could not be determined due to the small sample size and lack of placebo group due to study design. Furthermore, ED visits and hospital admissions were analyzed, but with only six patients in the comparison group, the relative risk was not statistically significant and could not be precisely estimated. In the future, this study can be replicated with both larger control/treatment arms to validate the initial results of this small, retrospective, cohort study.

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Alper Bilgic ◽  
Laurent Kodjikian ◽  
Jay Chhablani ◽  
Anand Sudhalkar ◽  
Megha Trivedi ◽  
...  

Purpose. To determine the risk factors associated with sustained intraocular pressure (IOP) rise in patients enrolled in the treat and extend (T&E) protocol receiving aflibercept/ranibizumab therapy for 3 years. Design. Retrospective, observational chart review. Setting. Multicentric. Patients. 789 patients (1021 eyes; 602 males) enrolled in T&E using aflibercept/ranibizumab for diabetic macular edema (DME), wet age-related macular degeneration (AMD), or macular edema in retinal vein occlusion (RVO). Intervention. The history, examination (clinical and special investigations), and treatment records were thoroughly scrutinized. Sustained IOP rise was defined as a rise in IOP above baseline by ≥6 mmHg and/or >24 mmHg on 2 or more consecutive visits. The Wilk–Shapiro test was used for confirming normality of data. The Mantel–Haenszel test and generalized estimating equations were used to analyse multicentric data as well as to analyse data from both eyes of the same patients in the event that both eyes were under therapy. The relative risk, chi-square test (with and without Yates’ correction), and univariate and multivariate analysis were used wherever appropriate. Statistical significance was set at P<0.05. The primary outcome measure was the determination of risk factors for sustained IOP rise with ranibizumab/aflibercept therapy. Secondary outcome measures included determining the incidence of IOP rise (short term and sustained), visual field, and retinal nerve fibre layer (RNFL) changes. Results. The mean follow-up was 42.4 months. Male gender, South Asian ethnicity, older age, presence of AMD and vein occlusion, use of ranibizumab, higher number of injections, narrow angles, switch to bevacizumab/ranibizumab, and preexisting glaucoma were associated with sustained IOP rise. No significant visual field and RNFL changes were seen. The overall incidence was 8.91%. No patient required filtering surgery. No patient with IOP rise returned to baseline. Conclusion. IOP rise is an important consideration as the chronicity of the condition can eventually lead to glaucomatous changes in eyes with already compromised vision. Follow-ups and use of appropriate therapy can be determined correspondingly.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1220-1220
Author(s):  
Adam Stepanovic ◽  
Lauren Gabriele Banaszak ◽  
Erica Reinig ◽  
Jens Eickhoff ◽  
Ryan J. Mattison

Abstract INTRODUCTION: Venous thromboembolism (VTE) is an important complication of many cancers. Although more widely recognized in solid tumors, VTE is still an appreciable cause of morbidity and mortality among patients with hematologic malignancies. For example, acute promyelocytic leukemia (APL) is a well-recognized risk factor for disseminated intravascular coagulation (DIC), which can lead to thrombosis. Patients with non-APL AML are also at increased risk for VTE, though the exact mechanisms are currently unclear. Thus, we sought to explore how patient demographics, comorbidities, hematologic factors, coagulation parameters, and cytogenetic and molecular profiles impact the incidence of VTE in patients with non-APL AML. METHODS: This was a retrospective observational case-control study of 120 non-APL AML patients treated at the University of Wisconsin-Madison. The electronic health record was manually reviewed for extraction of the relevant clinical information. Coagulation parameters assessed included INR, PTT, fibrinogen, D-dimer, and fibrin monomer. Coagulation data were collected both at diagnosis and during the first 7 days of induction, if applicable. Cytogenetics was categorized based on the presence of a normal karyotype or not. Genomic data were subdivided into eight different functional categories of genes that are commonly mutated in AML. Other factors that could potentially increase the risk of thrombosis were also analyzed, including age, sex, BMI, baseline blood counts, baseline bone marrow blast percentage, previous history of VTE, use of antifibrinolytic agents, and whether blood products were transfused during the early treatment period. The variables of interest between VTE cases and non-VTE cases were compared using the nonparametric Wilcoxon rank sum test. RESULTS: Across the entire cohort (n=120), VTE developed in 25 patients (20.8%) and did not develop in 95 patients (79.2%). Table 1 and Table 2 show comparisons between VTE cases and patients without VTE for both quantitative and categorical variables. Median INR values at diagnosis and across the first 7 days of induction tended to be lower in patients with VTE and reached significance on days 3-5 (p=0.032 for INR-Day 3, p=0.046 for INR-Day 4, p=0.014 for INR-Day 5). Patients with VTE had a median BMI of 30, while patients without VTE had a median BMI of 28, which approached statistical significance (p=0.055). 8% of patients with VTE (2/25) had a history of VTE prior to the diagnosis of AML, while 3% without VTE (3/95) had a history of previous VTE (OR 2.7, p=0.281). Mutation in genes involved in DNA methylation also conferred an increased risk of VTE, with the association approaching statistical significance (p=0.083). There were no other variables that were significantly different between the two groups. CONCLUSIONS: In this cohort of patients with non-APL AML, there was a trend towards lower INR correlating with an increased incidence of VTE. Additionally, higher BMI, previous history of VTE, and mutation in DNA methylation genes were associated with increased incidence of VTE, though these trends did not reach statistical significance. The pathophysiology of VTE in this setting is likely complex and multifactorial. The shorter INR in those who developed VTE suggests a mechanism independent of the development of DIC, which is distinct from APL. The finding that obesity and personal history of VTE, both known risk factors for thrombosis, were associated with an increased incidence of VTE is also consistent with a non-DIC mechanism. Mutations in DNA methylation genes may have contributed to increased risk of VTE in this cohort; while this association is compelling, further studies with larger sample sizes are needed to confirm this finding. This study was limited by small sample size and missing data, especially regarding available data on coagulation tests. However, this analysis uncovers interesting associations that shed light on the pathophysiology of VTE in AML. More research is needed to further elucidate risk factors for VTE in order to provide optimal supportive care for this patient population. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.


2020 ◽  
pp. 194187442097259
Author(s):  
William Hoffman ◽  
James Aden ◽  
Randall Bossler ◽  
Joshua Luster ◽  
Morgan Jordan

Status migrainosus (SM) is a subtype of migraine defined by migraine lasting >72 hours and is difficult to treat in clinical practice. Magnesium is commonly used in the treatment of migraine. We conducted a retrospective cohort study to determine if length of admission was associated with IV magnesium therapy in patients with SM. We reviewed the charts of all patients admitted to a large military treatment facility from October 2013 to December 2018 with the admission diagnosis of migraine. There were 333 patients that were reviewed and 141 met the inclusion criteria. Nearly half of patients received IV magnesium therapy with routine care (46.8%, n = 66). IV magnesium therapy was not associated with length of admission (58 hours (IQR 25.5, 86) compared to 42 hours (IQR 25.5, 80.5) respectively, p = 0.47). Of the cases without Neurology consultation, patients who received magnesium therapy (n = 5) had numerically shorter admission but this difference did not meet statistical significance (n = 12) (17 hours (IQR 13.75, 31.25) versus 24.5 hours (IQR 15.25, 58.75), p = 0.0534). This study contributes to the limited pool of available data on the treatment of SM. Prospective research is needed to study magnesium therapy in patients with prolonged migraine.


2021 ◽  
Vol 14 (2) ◽  
pp. 426-436
Author(s):  
Sumit Sharma ◽  
Peter D. Fowler ◽  
Dhan Kumar Pant ◽  
Subir Singh ◽  
Melinda J. Wilkins

Background and Aim: Poultry is becoming an increasingly important source of protein in the Nepalese diet. The Chitwan region of Nepal is the hub of the emerging poultry industry. Little is known about the prevalence of non-typhoidal Salmonella (NTS) on poultry farms or the role of farm management practices that may contribute to the presence of NTS on farms. The role of poultry in the transmission of Salmonella enterica to humans is also poorly defined. This descriptive study seeks establish baseline data through estimation of the prevalence of NTS on broiler and layer operations in various farms of the Chitwan district of Nepal. Materials and Methods: Based on district documents on poultry production and meat marketing, a purposive sampling of 18 commercial poultry farms comprising ten broilers farms and eight layers farms was conducted. Environmental samples including water, litter, feces, feed, farm, and eggshell swabs were randomly collected from each farm. Samples were cultured and tested for the presence of NTS; positives were serotyped, and antimicrobial susceptibility determined. A comprehensive farm and practice questionnaire was administered to each farm manager. Results: The farm level point prevalence rate was 55% (10 of 18 farms) for S. enterica. Of the total 288 farm environmental samples collected, 26 samples (9%) were positive. The rate of isolation varied according to the origin of samples: Water (27.5%), feces (10.6%), litter (8.6%), farm swabs (5%), feed (1.8%), and eggshells (0%). Farm management variables/risk factors are summarized and categorized as non-modifiable and modifiable for analysis. Broiler operations were more likely to be positive than layer operations as were poultry houses with two or less open sides. All-in/all-out management style was found to be protective. Due to the small sample size (18 farms), no associations reached statistical significance. Conclusion: Based on environmental sampling results, NTS is highly prevalent on the poultry farms in the Chitwan district of Nepal. Certain risk factors are associated with finding NTS on farms. Our findings are generally in agreement with other studies in similar countries with rapidly emerging poultry industries. The identification of risk factors provides owners, technicians, and veterinarians with some guidance to help reduce the prevalence of NTS on farms. This baseline data are critical to understanding the epidemiology of zoonotic strain of NTS in the region and are necessary for the design of future studies and mitigation plans and underlines the need for a one-health approach to protect public health-related to Salmonella spp. from poultry farms.


2020 ◽  
Author(s):  
Iñigo Alberdi-Paramo ◽  
Germán Montero-Hernández ◽  
María Dolores Sáiz-González ◽  
Marina Díaz-Marsá ◽  
José Luis Carrasco-Perera

Abstract Background:Suicidal behavior (SB) is nuclear in Borderline Personality Disorder (BPD). It is considered a symptom clinically relevant and with an important prognostic value. The literature describes different variables related to SB in BPD such as impulsivity, aggressiveness or hopelessness. There are not hardly any studies focused on the role of sociodemographic variables and their specific relationship with SB in BPD. The objective of this work is to identify which clinical and sociodemographic parameters could act as markers of suicide risk in BPD.Methods:A cross-sectional, observational, and retrospective study was conducted of a sample of 134 patients diagnosed with BPD. The analysis of the association between variables was carried out with a multivariate negative binomial logistic regression model.Results:SB is related to the number of siblings with statistical significance. Likewise, a greater number of suicide attempts is significantly associated with female gender, parenthood, permanent work, sick leaves and the number of previous hospital admissions. Both the presence of SB and a greater number of suicide attempts are significantly related to history of trauma in childhood and to the score in Hamilton Anxiety Rating Scale.Conclusions: These parameters could act as risk factors for SB in BPD. The role of these variables could be the subject of further research projects in order to identify them in clinical practice.


2020 ◽  
Vol 29 (2) ◽  
pp. 175-179
Author(s):  
Melania Macarie ◽  
Simona Bataga ◽  
Simona Mocan ◽  
Monica Pantea ◽  
Razvan Opaschi ◽  
...  

Background and Aims: The importance of sessile serrated lesions (SSLs) in the pathogenesis of colorectal carcinoma has been recently established. These are supposed to cause the so-called “interval cancer”, having a rapidly progressive growth and being difficult to detect and to obtain an endoscopic complete resection. We aimed to establish the most important metabolic risk factors for sessile serrated lesions. Methods: We performed a retrospective case-control study, on a series of 2918 consecutive patients who underwent colonoscopy in Gastroenterology and Endoscopy Unit, County Clinical Emergency Hospital, Târgu-Mureș, Romania between 1 st of January 2015-31 th of December 2017. In order to evaluate the metabolic risk factors for polyps’ development, enrolled participants were stratified in two groups, a study group, 33 patients with SSLs lesions, and a control group, 138 patients with adenomatous polyps, selected by systematic sampling for age and anatomical site. Independent variables investigated were: gender, smoking, alcohol consumption, obesity, arterial hypertension, diabetes, hypercholesterolemia, hypertriglyceridemia, hyperuricemia, nonalcoholic liver disease. Results: For SSLs the most common encountered localization was the right colon in 30.55% of cases. By comparative bivariate analysis between SSLs group and control group, it was observed that hypertension (p=0.03, OR 2.33, 95 %CI 1.03-5.24), obesity (p=0.03, OR 2.61, 95 %CI 1.08-6.30), hyperuricemia (p=0.04, OR 2.72, 95 %CI 1.28-7.55), high cholesterol (p=0.002, OR 3.42; 95 %CI 1.48-7.87), and high triglycerides level (p=0.0006, OR 5.75; 95 %CI 1.92-17.2) were statistically associated with SSLs development. By multivariate analysis hypertension and hypertriglyceridemia retained statistical significance. Conclusions: Our study showed that the highest prevalence of SSLs was in the right colon and hypertension and increased triglycerides levels were associated with the risk of SSLs development. These risk factors are easy to detect in clinical practice and may help identifying groups with high risk for colorectal cancer, where screening is recommended.


2020 ◽  
Vol 66 (1) ◽  
pp. 19-22
Author(s):  
Melania Macarie ◽  
Simona Maria Bataga ◽  
Monica Pantea ◽  
Razvan Opaschi ◽  
Simona Mocan ◽  
...  

AbstractObjective: This study aims to determine the correlation between risk factors and erosive esophagitis development.Methods: We conducted a retrospective observational study on a consecutive series of 19.672 patients who underwent upper gastrointestinal endoscopy between 01.01.2011-31.12.2017. A total of 3005 patients, diagnosed with erosive esophagitis, were included in the present study and stratified according to Los Angeles classification.Results: During the studied period we found 3005 patients with erosive esophagitis, sex ratio male to female was 1.3/1, the most common forms of esophagitis being grade A and B: 74.54% patients with esophagitis grade A, 14.80% patients with grade B; 5.29% patients were with grade C and 5.35% patients with esophagitis grade D. In severe esophagitis the male predominance was more prevalent (249 males, 71 female), with a sex ratio 3.50/1. The correlation of male gender with severe esophagitis was highly statistically significant (p < 0.0001, OR 2.97; 95% CI 2.25-3.91). Hiatal hernia was diagnosed in 1171 patients, the presence of large hiatal hernias, being an important predictor, with statistical significance (p < 0.0001, OR 3.41; 95% CI 2.22-5.21), for severe esophagitis development. Incidence of Helicobacter pylori infection was 11.51%, in the entire study group, with no statistical significant difference between patients with mild or severe esophagitis (12.02% vs 7.18%).Conclusion: Erosive esophagitis is a frequent disease, the most common forms being grade A and B. Male gender and the presence of hiatal hernia are the most important risk factors for erosive esophagitis development, in our study group.


Author(s):  
Abdullah Aldamigh ◽  
Afaf Alnefisah ◽  
Abdulrahman Almutairi ◽  
Fatima Alturki ◽  
Suhailah Alhtlany ◽  
...  

Author(s):  
Ruihuan Pan ◽  
Shanshan Ling ◽  
Haodong Yang ◽  
Yan Huang ◽  
Lechang Zhan ◽  
...  

Background: Shoulder-hand syndrome (SHS) refers to a syndrome causing sudden edema, shoulder pain and limited hand function. Qingpeng ointment, a kind of Tibetan medicine, can reduce swelling, relieve pain, tonify stagnation and clear the meridians, which is consistent with the pathological mechanism of SHS after stroke. Therefore, if clinical trials can be used to explore the effectiveness of Qingpeng ointment for treatment of poststroke SHS and promote its application in clinical medicine, this is of specific significance for the treatment of poststroke SHS. Objective: To investigate the clinical efficacy and safety of Qingpeng ointment in the treatment of poststroke SHS. To provide an objective basis for a better therapeutic treatment for poststroke SHS. Method: A prospective, randomized, controlled study was conducted. This study recruited 120 patients with poststroke SHS who met the inclusion criteria. They were randomized into the treatment group and the control group, with 60 patients allocated to each group. The treatment group received routine medical treatment and rehabilitative care after using the Qingpeng ointment, while the patients in the control group received only routine treatment without the ointment. All patients received clinical assessment with the Visual Analogue Scale (VAS), measurement of the range of motion (ROM) of the upper-limb joints, the Fugl-Meyer Assessment of Upper Extremity (FMA-U) and the Modified Barthel Index Score (MBI) before and after the whole treatment. Results: After 4 weeks of treatment, the VAS scores of both groups were decreased significantly (P<0.05), and the difference between the two groups was statistically significant (P < 0.05). There is no statistical significance for the difference between the treatment group and control group in terms of the FMA-U and MBI scores and the forward bend, backward, outstretch, external rotation and pronation angles after treatment. The increases in the values of VAS, FMA-M and MBI in the treatment group were greater than those in the control group, and the difference was statistically significant (P < 0.05). The increases in the values of the forward bend, outreach and external rotation angles in the treatment group were greater than those in the control group, and the difference was statistically significant (P < 0.05). Conclusion: The treatment group showed better results than the control group in terms of the relief of pain symptoms, the improvement of motor function and the improvement of the activities of daily living for patients with shoulder-hand syndrome after cerebral hemorrhage. Qingpeng ointment is effective and safe in treating poststroke SHS.


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