Inadequate Therapy Research Articles

GASTROPLEURAL FISTULA: AN UNCOMMON ETIOLOGY OF VANCOMYCIN RESISTANT ENTEROCOCCUS FAECIUM EMPYEMA

TOPIC: Chest Infections TYPE: Medical Student/Resident Case Reports INTRODUCTION: Empyema is an infection of the pleural space. Inadequate drainage or antimicrobial therapy results in increased morbidity and mortality and a 20%-30% fatality rate [1-3]. Streptococcal and Staphylococcal species are the frequent cause of community-acquired empyema. In comparison, Enterobacteriaceae and Staphylococcus Aureus have been implicated in healthcare-associated empyema CASE PRESENTATION: A 58-year-old female came in with right-sided chest discomfort and acute onset hypoxic respiratory failure with a history of diabetes mellitus, chronic obstructive pulmonary disease, and Roux-en Y surgery (requiring multiple revisions). Examination revealed acute respiratory distress and diminished right-sided breath sounds, and she underwent emergent intubation. Chest x-ray showed right pleural effusion and pneumomediastinum (Figure A). A complex right pleural effusion with a extensive pneumomediastinum surrounding the distal esophagus was displayed by chest computed tomography (CT) (Figure B). CT chest with oral contrast revealed no esophageal perforation (Figure C). A 20 French chest tube insertion returned feculent fluid. Pleural fluid analysis revealed: pH 6.88, protein: 3.9 g/dL, LDH >2500 U/L, amylase 655 U/L. Pleural fluid stain was positive for gram-positive cocci and culture grew vancomycin-resistant Enterococcus faecium (VRE) sensitive to daptomycin and linezolid. She was treated with daptomycin and meropenem. Pan-endoscopy was performed to evaluate the pneumomediastinum, and esophagogastroduodenoscopy revealed gastro-pleural fistula. She was diagnosed with VRE empyema due to a gastro-pleural fistula from gastric limb perforation. Unfortunately, her clinical course worsened, and she was transitioned to comfort care DISCUSSION: Among the infrequent enterococcal empyema's, VRE is rare. A literature review revealed only two VRE empyema cases. Both cases occurred in immunocompromised hosts (Asplenia and HIV) [4-5]. The presented patient's empyema was due to the perforation of her residual gastric limb with bile reflux, resulting in her pleural cavity VRE seeding. Enterococci are commensals in the gastrointestinal tract (GI) but typically only represent a small portion of the gut microbiome [6]. As with the above patient, in individuals with multiple hospitalizations and courses of antibiotics, VRE can flourish due to significant shifts in the gut microbiota [7] CONCLUSIONS: Enterococcus infections are a rare cause of empyema and correlates with increased mortality and morbidity without prompt identification and treatment. When VRE is identified in the pleural space, a GI source should be considered and evaluated with pan-endoscopy. It should be preceded promptly with thoracic drainage and broad antimicrobial coverage REFERENCE #1: Grijalva CG, Zhu Y, Nuorti JP, Griffin MR. Emergence of parapneumonic empyema in the USA. Thorax. 2011;66(8):663-668. doi:10.1136/thx.2010.156406 REFERENCE #2: Nielsen J, Meyer CN, Rosenlund S. Outcome and clinical characteristics in pleural empyema: a retrospective study. Scand J Infect Dis. 2011;43(6-7):430-435. doi:10.3109/00365548.2011.562527 REFERENCE #3: Maskell NA, Batt S, Hedley EL, Davies CWH, Gillespie SH, Davies RJO. The bacteriology of pleural infection by genetic and standard methods and its mortality significance. Am J Respir Crit Care Med. 2006;174(7):817-823. doi:10.1164/rccm.200601-074OC DISCLOSURES: No relevant relationships by Cliff Chen, source=Web Response No relevant relationships by Yuji Oba, source=Web Response No relevant relationships by Tarang Patel, source=Web Response No relevant relationships by SACHIN PATIL, source=Web Response No relevant relationships by Blaine Winterton, source=Web Response

Dissociative Visual Loss in Children and Adolescents.

Psychogenic vision disorders in children and adolescents are a common disorder primarily encountered by ophthalmologists at the onset because, as with other disorders of dissociation, the presentation suggests a neurologic or other somatic condition. Loss of visual acuity, blurred vision and visual field restriction-often described as tunnel vision-appears to be typical. The onset may be sudden, frequently related to a wide range of stressful life events (school failure, family conflicts, accidents). While the majority of these children quickly recover from their symptoms, a substantial percentage experience persistent symptoms or a fluctuating course. Due to the lack of efficacy studies of specific treatment protocols, diagnostic work-up and treatment suffer from a high degree of uncertainty. Differentiating dissociative visual loss from physical illness requires special expertise. The uncertainty of ophthalmologists and the other specialists involved in dealing with this clinical condition often delays the specialised treatment and may also trigger inadequate therapy with the iatrogenic risk of harming the patient. This article primarily describes the disorder-specific psychiatric diagnostic as well as the somatic differential diagnostic work-up and outlines the therapeutic principles of dissociative visual loss.

Risk Factors for Relapse in Acute Bacterial Prostatitis: the Impact of Antibiotic Regimens.

ABSTRACTThe aim of the study was to analyze the risk factors for relapse in patients with acute bacterial prostatitis (ABP), focusing on the impact of different antibiotic regimens. We conducted an observational study of all patients diagnosed with ABP (irritative and/or obstructive urinary symptoms, temperature of >37.8°C, and the presence of bacteriuria in urine culture, in the absence of data suggesting pyelonephritis) from January 2017 to December 2018. The main outcome was relapse. We performed a multivariate analysis to identify the risk factors associated with relapse. A propensity score with inverse weighting was applied to attenuate antibiotic selection bias. We included 410 patients. The mean age was 68 years; 28.8% had diabetes mellitus, and 61.1% benign prostatic hyperplasia. The most common isolated bacteria were Escherichia coli (62.4%) and Klebsiella spp. (10%). The overall resistance rate was 39.5% to quinolones. The mortality rate was 1.2%, and the relapse rate was 6.3%. The only independent risk factor for relapse was inadequate antibiotic therapy (odds ratio [OR] 12.3; 95% confidence interval [95% CI], 3.5 to 43.1). When the antibiotic was modified according to the susceptibility pattern, the rates of relapse were 1.8% in those treated with ciprofloxacin, 3.6% with intravenous beta-lactam, 9.3% with co-trimoxazole, and 9.8% with oral (p.o.) beta-lactam (P = 0.03). Treatment with oral beta-lactam (OR, 5.3; 95% CI, 1.2 to 23.3) and co-trimoxazole (OR, 4.9; 95% CI, 1.1 to 23.2) were associated with a risk of relapse. In this large real-life observational study, a significantly higher relapse rate was observed when antibiotic treatment was inadequate. When the antibiotic was tailored, quinolones and intravenous beta-lactams had a lower relapse rate than co-trimoxazole and oral beta-lactams.IMPORTANCE In the manuscript, we report a large series of acute bacterial prostatitis cases and describe data about the etiology, antibiotic resistance rate, and outcome, specially focused on the risk factors for relapse. We found high rates of resistance to the most frequently used antibiotics and a high relapse rate in patients whose treatment was not adjusted according to their microbiological susceptibility. We did not observe differences, though, in mortality or relapse according to appropriate or inappropriate empirical treatment. What is new in this article is the different relapse rates observed depending upon the definitive adequate antibiotic used. Quinolones and intravenous (i.v.) beta-lactam have lower rates of relapse (1.8% and 3.6%, respectively) compared to co-trimoxazole and oral (p.o.) beta-lactam (3.3% and 9.8%, respectively). Clinicians should carefully choose an adequate antibiotic for definitive ABP treatment depending on the results of microbiological isolation, using quinolones as the first option. Whenever quinolones cannot be administered, i.v. beta-lactams seem to be the second-best option.

The power of lipid registries for cardiovascular disease prevention.

Lipid registry-based research is a valuable tool for assessing current lipid management in patients at risk of cardiovascular disease (CVD). Results of several registries are useful for improving clinical practice highlight gaps between guidelines and their implementation and potential impact on population health. We summarize recent clinical studies based on lipid registries. Current guidelines for lipid management recommend high-intensity statins and concomitant therapies such as ezetimibe and proprotein convertase subtilisin-kexin type 9 inhibitors for high-risk patients. However, recent observational studies show that the majority of patients received inadequate lipid-lowering therapy (LLT), and the low-density lipoprotein-cholesterol (LDL-C) goal attainment rates are still unsatisfactory. There is a clear gap between lipid guidelines and lipid management in clinical practice. Clinical studies based on registry databases represent real-world conditions, as opposed to clinical trials. Contemporary registry data reveal that only half of the patients received high-intensity statins, and less than half achieve the LDL-C <70 mg/dL in secondary prevention. In addition, the major reasons for insufficient therapy have been shown to be not only side effects of LLT, but poor adherence by patients to medication regimens and low use of combination therapies by physicians. The real-world evidence from lipid registries clarifies gaps, areas for focus for implementation, to improve CVD prevention.

Case Report:clinical experience of bilateral giant pediatric Testicular adrenal rest tumors with 3 Beta-Hydroxysteroid Dehydrogenase-2 family history

BackgroundWe reported a patient with Testicular adrenal rest tumors(TARTs) caused by congenital adrenal hyperplasia(CAH). TARTs occur frequently in CAH population with 21-hydroxylase deficiency(21-OHD). There are few reports of TARTs with 3β-hydroxysteroid dehydrogenase deficiency-2 (3β-2HSD).Furthermore,gaint TARTs are rarely mentioned in reported cases involving affected siblings.Case presentationA 14-year-old male patient was admitted by congenital adrenal hyperplasia with progressively increasing bilateral testicular masses.The Patient and his elder brother had been performed mutational and chromosome analysis and biopsy. Hormonal and anthropometric measurements were performed during endocrine treatments. We successfully performed surgery and excised two 83mm×46mm×44mm and 74mm×49mm×31mm tumors. Our pathology and immunochemistry tests have proven TARTs in patient. At first, both siblings received regular doses of hydrocortisone and fludrocortisones and tumor size regressed. During the one-year irregular intake due to Covid-19 pandemic, endocrine treatment became insensitive and tumor size slowly increased. The gene analysis reported two novel mutations C.776 C>T and C.674 T>A. The C.776 C>T is from father and has been reported. The C.674 T>A inherited from mother and cannot found in gene library and may related to TARTs.ConclusionsThis case illustrates inadequate hormone therapy could cause tumor enlargement. It is essential to seek for ultrasound examination once suspected scrotal mass occurred.It is necessary to adjust endocrine medicine or adopt surgery in refractory gaint TARTs. And presence of tunica vaginalis cavity may indicate the severity of TARTs in surgery.

Specificities of acute cholangitis in patients with cancer: a retrospective comparative study of 130 episodes.

Pancreatic and biliary duct cancers are increasing causes of acute cholangitis (AC). We retrospectively characterize 81 cancer-associated cholangitis (CAC) compared to 49 non-cancer-associated cholangitis (NCAC). Clinical and biological presentations were similar. However, in CAC, antibiotic resistance and inadequate empirical antibiotic therapy were more frequent; more patients required ≥ 2 biliary drainages; and mortality at day 28 was higher than in NCAC. Death was associated with initial severity and CAC in a multivariate analysis. Cholangitis associated with pancreatic or biliary duct cancers requires specific empirical antimicrobial therapy; early use of biliary drainage may improve outcomes.

Analysis of antithrombotic therapy in elderly patients with nonvalvular atrial fibrillation in the Kyrgyz Republic and ways to increase treatment adherencе

Aim. To analyze anticoagulant therapy in elderly patients with non-valvular atrial fibrillation and ways to increase adherence in the work of a specialized team.&#x0D; Methods. The study followed 250 patients with non-valvular atrial fibrillation aged 65 to 74 years (mean age 70.74.39 years). The patients were divided into three groups: the first group included 105 people, who were prescribed warfarin in a retrospective study; the second group 57 people treated with rivaroxaban, and the third group 88 people treated with warfarin. The second and third groups were prospective study groups which were supervised by a specialized team of physicians. The groups were matched on sex and age, comorbidities. Statistical data analysis and mathematical processing were performed by using the methods of descriptive and variational statistics. Most parameters reported as absolute values and percentages, while quantitative data the 25th and 75th percentiles.&#x0D; Results. All patients included in the study had a high risk of developing thromboembolic complications by their CHA2DS2-VASc score (2) and a low risk of developing hemorrhagic complications on the HAS-BLED scale (average score 1.490.04). They were prescribed anticoagulant therapy. By the end of the year follow-up from the start of anticoagulant therapy, only 9.5% of patients were treatment adherent, in the second group 43.8%, in the third group 70.5% of patients. The reason for refusing to take warfarin in the vast majority of cases was the inability to control the international normalized ratio, medical contraindications, and the high cost of the drug in prescribing rivaroxaban. The results showed that the majority of patients with atrial fibrillation (90.5%) receive inadequate antithrombotic therapy in routine outpatient clinical practice. At the same time, in a very small number of patients (9.5%) receiving warfarin, this type of therapy can be considered adequate (60% or more of the stay time in the therapeutic range of international normalized ratio of 2.0 to 3.0).&#x0D; Conclusion. Anticoagulant therapy prescription under the supervision of a specialized team contributes to a significant improvement in treatment adherence (from 43.8 to 70.5%); promising in the future is the use of drugs from the group of new oral anticoagulants that do not require routine monitoring of coagulogram.

Frequency of Fits in Pregnant Women with Previously Controlled Epilepsy

Background: Epilepsy drug therapy advancements have resulted in an increasing number of childbearing age well-controlled epileptic women. It is not surprising then, that the impact of pregnancy on the progression of epilepsy has sparked renewed interest. Aim: The aim of current study was to evaluate the frequency of fits or seizure in pregnant women with previously controlled epilepsy. Materials and Methods: This cross-sectional study was carried out on 98 pregnancies of 84 epileptic women during the period between August 2019 and August 2021in the department of neurology and gynaecology of Ayub Teaching Hospital, Abbottabad. All the pregnant women with less than three verified epileptic fits, pregnancy ended with abortion and incomplete seizure or fit frequency were excluded. All the patients were referred to Gynaecology and Neurology department for early pregnancy and planning by a neurologist and gynaecologist. Data analysis was done with SPSS version 23 with p&lt;0.05 as statistical significance. Results: The association of fits frequency on pregnancy was studied and monitored in 84 epileptic women out of 98pregnancies. About 49 (50%) pregnancies were not affected by fits frequency. The fits frequency was increased in 36 (37%) pregnancies or puerperium while decreased in 13 (13%) pregnancies. Sleep deprivation or drug regimen on-compliances associated was increased in 30 (30.6%) pregnancies. Out of 19pregnancies, eight (42%) had improvement with sleep deprivation correction during none months pre-gestation. Antiepileptic drugs with low plasma concentration of uncontrolled epilepsy during pregnancy were found in 47%. Conclusion: Sleep deprivation, Non-compliance during pregnancy, and before and after pregnancy inadequate therapy all have a significant impact on the course of epilepsy during pregnancy. With proper medical care, pregnancy appears to have only a minor impact on the course of epilepsy. Keywords: Epilepsy, Frequency fits, Sleep Deprivation.

The Effect of Immunosuppressant Therapy Adherence on the Comfort of Liver Transplant Recipients.

Inadequate immunosuppressive therapy causes rejection, whereas an overdose may lead to infections or malignancy to affect a patient's life and comfort. This study used a descriptive correlational design to determine how compliance with immunosuppressive therapy affected the well-being of liver transplant patients. The study was conducted in the liver transplant unit of a university hospital with 103 patients who underwent liver transplant surgery. The target population included patients who received treatment in liver transplant clinics between July 2016 and August 2017. Mean age of the patients in the study was 44.66 ± 14.86 years and the time after transplant was 15.48 ± 16.90 months on the average. A significant difference was found between mean General Comfort Scale scores according to the variable of adherence status (t = 6.898, p < .05). Simple linear regression analysis showed a positive moderate, significant correlation between the adherence variable and mean General Comfort Scale scores (R = 0.543, p < .001). It was found that the patients who adhered to immunosuppressive therapy experienced higher levels of comfort. Therefore, arrangements to improve patient adherence to therapy, hence comfort, are recommended, as well as periodic evaluations of patient comfort levels.

Risk Factors Associated With 30-Day Mortality Among Neonates With A. baumannii Sepsis.

Acinetobacter baumannii sepsis constitutes an extreme threat with a poor prognosis and is a difficult infection to control, especially in Asia. Moreover, a knowledge gap in the risk of mortality in neonatal A. baumannii sepsis still exists. This study aimed to identify the risk factors of mortality in neonates with A. baumannii sepsis in Thailand from 1996 to 2019. A multivariable logistic regression model was analyzed for nonsurvivors and survivors of neonatal A. baumannii sepsis. In a 24-year period, 91 neonates with A. baumannii sepsis were reviewed. The median (interquartile range) gestational age and birth weight were 33 (28.5, 37.5) weeks and 1740 (987.5, 2730.0) g, respectively. The 30-day case fatality rate was 36.3% (33/91). In univariable analysis, nonsurvivors of neonatal A. baumannii sepsis was associated with smaller neonates, lower Apgar scores, septic shock, mechanical ventilation, umbilical catheterization, neutropenia, severe thrombocytopenia, carbapenem-resistant A. baumannii sepsis, inadequate empiric antimicrobial therapy, and acute kidney injury. In multivariable analysis, nonsurvivors of neonatal A. baumannii sepsis were associated with septic shock (adjusted odds ratio [OR] = 41.38; 95% confidence intervals [CI]: 3.42-501.13; P = 0.003), severe thrombocytopenia (adjusted OR = 33.70; 95% CI: 3.44-330.55; P = 0.002), and inadequate empiric antimicrobial therapy (adjusted OR = 10.05; 95% CI: 1.40-71.98; P = 0.02). In high multidrug-resistant areas, empiric treatment with broader spectrum antimicrobials should be considered in neonates with sepsis shock or severe thrombocytopenia.

Low Total Lymphocyte Count as the Risk of Hospital Acquired Malnutrition in Children

Background: Hospital Acquired Malnutrition (HAM) is characterized by inadequate nutritional therapy and the risk of developing malnutrition during the hospital stay. In clinical practice, there are many measurements to determine nutritional status. Total lymphocyte count (TLC) is associated with impaired function of immune system in malnutrition. The purpose of this study was to evaluate the prognostic value of TLC to the occurrence of HAM in pediatric patients.Materials and Methods: This an observational study with a prospective cohort design. Subjects were assessed for weight at the first day of hospitalization, then the subjects were followed until they were discharged. Body weight was re-measured on discharge to determine the presence or absence of HAM. This research was conducted at Sanglah Hospital from May-December 2019. Subjects who met the inclusion and exclusion criteria were enrolled in the study.Results: Among 120 subjects, 55 subjects or 45.8% were malnourished on admission. Subjects with a low TLC compared to a normal TLC had a 3.9-fold risk of experiencing hospital acquired malnutrition (95% Confidence Interval: 1.59 to 7.19, p=0.001). Subjects who had a low TLC had HAM of 61.8%, while subjects who had a normal TLC had HAM of 32.3%. In multivariate analysis, low TLC was the only risk factor for HAM in this research.Conclusion: This study proved that low TLC is the risk of HAM. Total lymphocyte count could be used as predictor of the risk of HAM in hospitalization children.Keywords: hospital malnutrition, total lymphocyte, children

Prospective Audit for Antimicrobial Use and Stewardship Practices in Intensive Care Unit at a Tertiary-Care Center in India

Background: Antimicrobial decision making in the ICU is challenging. Injudicious use of antimicrobials contributes to the development of resistant pathogens and drug-related adverse events. However, inadequate antimicrobial therapy is associated with mortality in critically ill patients. Antimicrobial stewardship programs are increasingly being implemented to improve prescribing. Methods: This prospective study was conducted over 11 months, during which the pharmacist used a standardized survey form to collect data on antibiotic use. Evaluation of antimicrobial use and stewardship practices in a 12-bed polytrauma ICU and a 20-bed neurosurgery ICU of the 248-bed AIIMS Trauma Center in Delhi, India. Antimicrobial consumption was measured using WHO-recommended defined daily dose (DDD) of given antimicrobials and days of therapy (DOT). Results: Antibiotics were ranked by frequency of use over the 11-month period based on empirical therapy and culture-based therapy. The 11-month DDD and DOT averages when empiric antibiotics were used were 532 of 1,000 patient days and 484 per 1,000 patient days, respectively (Figure 1). When cultures were available, DDD was 486 per 1,000 patient days and DOT was 442 per 1,000 patient days (Figure). Conclusions: The quantity and frequency of antibiotics used in the ICUs allowed the AMSP to identify areas to optimize antibiotic use such as educational initiatives, early specimen collection, and audit and feedback opportunities.Funding: NoDisclosures: None

Congenital adrenal hyperplasia in men: classical form. Clinical case

Recently, in the foreign scientific literature there have been reports that boys and young men with the classic virile form of congenital adrenal hyperplasia or congenital dysfunction of the adrenal cortex as a result of inadequate glucocorticoid therapy in 21–28% of cases have testicular adrenal rest tumors, which increases under the influence of excessive production of adrenocorticotropic hormone (ACTH). This benign formation up to 2 cm in diameter and larger is detected by palpation and ultrasound. The formations can press on the testicular tissue and lead to hypogonadism. Such individuals may have low testosterone levels due to decreased Leydig cell function. Testicular adrenal rest tumors usually decrease after treatment optimization. Unreasonable surgery is sometimes performed in suspected cancer. A clinical case is presented of the classic form of congenital adrenal hyperplasia, manifested itself in isosexual precocious puberty, cryptorchidism and testicular adrenal rest tumors rare, increased under the influence of excessive ACTH production as a result of inadequate glucocorticoid replacement therapy. Formations detected during ultrasound decrease when treatment is optimized. Observation of the patient in the dynamics showed that ones of the main diagnostic hormonal tests are blood levels of ACTH and 17-hydroxyprogesterone, which at the time of disease detection were excessively high. Continuous glucocorticoid replacement therapy maintains the level of these indicators within the reference values. Timely diagnosis of the nature of the pathology, constant corrective hormone therapy ensured the patient’s ability to adapt to life and society in accordance with his status. Clinical manifestations of hypocorticism and/or hyperandrogenism in the parents of our patient were not detected, which indicates autosomal recessive inheritance of congenital adrenal hyperplasia. In the future, it is important to provide genetic counseling to expectant parents, especially with manifestations of hyperandrogenism, to assess the possible development of such pathology in their offspring.

Clinical characteristics and risk factors for mortality in children with Pseudomonas aeruginosa bacteraemia: A retrospective review at a paediatric tertiary centre.

The objective of this study was to describe clinical features and to assess the risk factors associated with mortality in Pseudomonas aeruginosa bacteraemia in a tertiary Japanese paediatric care hospital. Patients diagnosed with P. aeruginosa bacteraemia at our hospital between 2007 and 2018 were analysed in a retrospective case series. Inadequate initial therapy for P. aeruginosa bacteraemia was defined as initial treatment without antipseudomonal antibiotics or an administration of antipseudomonal agent to which the causative strain was resistant. Bacteraemia-related death was defined as all deaths occurring within 7 days after the onset of bacteraemia. Overall, 41 patients with 42 P. aeruginosa bacteraemia episodes were identified. The most common underlying condition was malignancy (27%), followed by congenital heart disease (20%) and preterm birth (17%). Among the 42 P. aeruginosa clinical isolates, 24% were resistant to at least one of the antipseudomonal agents and 10% were resistant to more than one agent. The susceptibility levels for piperacillin, fourth-generation cephalosporins and ciprofloxacin were higher than that for carbapenems. Bacteraemia-related death was observed in 43% of episodes. The 30-day all-cause mortality was 50% (standard error 8%). Neonates, intensive care, mechanical ventilation, afebrile episodes, septic shock, hypoxia, renal injury and inadequate initial therapy were associated with bacteraemia-related death episodes. We found that childhood P. aeruginosa bacteraemia is still a high mortality disease. Our results imply the importance of the identification of high-risk patients and the establishment of adequate empirical antibiotic therapy.

Safety of Deferiprone in Individuals with Sickle Cell Disease

Background: Deferiprone (Ferriprox®) is an oral iron chelator approved by the US Food and Drug Administration in 2011 for the treatment of transfusional iron overload in patients with thalassemia syndromes with inadequate chelation therapy. It has been used off-label for the treatment of transfusional iron overload in some patients with conditions other than thalassemia. Utilizing a comprehensive deferiprone patient registry, we sought to assess the safety profile of deferiprone use in patients with SCD.Methods: Since 2011, a patient registry has been maintained for all US patients who receive deferiprone, through a comprehensive support program, “Ferriprox Total Care” run by a central pharmacy. At registry entry, patient information is collected, including age, sex, and ICD-10 code for disease classification. The registry also collects all adverse effects (AEs) reported during deferiprone use through a detailed active drug surveillance program. Prior to initial drug shipment, patients are counseled by a pharmacist about the drug, invited to ask questions, and encouraged to contact the program with questions or safety concerns. Thereafter, the patient/family is contacted monthly to inquire about general well-being, which includes questions on dose adjustments, amount of drug left, hospitalizations, and side effects. Any patient reporting an AE is referred to a pharmacist, who collects additional information on the AE. All AEs are de-identified and reported to the Medical Safety department at ApoPharma. For each AE, the pharmacist and/or ApoPharma assigns causality to deferiprone, and the most conservative assessment prevails. This study reviewed all registry data through March 2016 to determine real-world use safety profile of deferiprone in patients with SCD.Results: A total of 291 patients with SCD, 43% male, received deferiprone. The mean age at drug initiation was 29.5 (SD 15.7) years (y) and 79 (27%) were younger than 18y. The mean drug exposure per patient was 1.3y (SD 1; range 0 to 4.1y). At the time of analysis, 117 (40%) remained on drug, 162 (56%) had discontinued treatment, and 12 (4%) were on hold in the registry for various reasons. 10% discontinued for AEs; AEs most commonly associated with discontinuation were nausea (48%), vomiting (31%), and sickle cell crisis (14%). Eighteen percent discontinued due to physician discretion and 10% due to switching to another chelator. Nine (3%) deaths were reported. All four deaths with follow-up information were deemed unrelated to Ferriprox use. Cause of death in the other five cases was not provided. Overall, a total of 275 AEs assessed as at least possibly related to deferiprone occurred in 112 patients (38.5%). These AEs are referred to as adverse drug reactions (ADRs). Gastrointestinal ADRs were most common including nausea (11%), vomiting (7%), and abdominal discomfort (6%). Arthralgia occurred in 6 patients (2%). Elevation in hepatic enzymes was noted in 6 patients (2.1%). In 61 patients (21%) 133 episodes of sickle cell crisis (36.44 events/100 pt years) were reported as serious AEs; five of these episodes were assessed as possibly related to deferiprone. Agranulocytosis (ANC <0.5 x109/L) developed in 2 (0.7%) patients (0.55 per 100 pt years) and milder neutropenia (ANC <1.5 x 109/L, but ≥ 0.5 x 109/L) in 3 (1%; 0.82 per 100 pt years).Conclusions: Deferiprone is frequently prescribed for patients with SCD. Agranulocytosis occurred in 0.7%, comparable to the rate of 1.7% seen in thalassemia. Overall, the adverse effect profile in patients with SCD is consistent with its known safety profile in thalassemia. DisclosuresKwiatkowski:Bluebird Bio: Research Funding; Apopharma: Research Funding; Novartis: Research Funding; Agios: Consultancy, Honoraria; Ionis: Consultancy, Honoraria. Tricta:ApoPharma: Employment. Rozova:ApoPharma: Employment.

Antithrombotic Therapy in Elderly Patients with Atrial Fibrillation: The State of the Problem in the Real Clinical Practice of a Family Medicine Doctor

Introduction. The research aimed at studying the efficacy and safety of anticoagulant therapy in patients with atrial fibrillation (AF), especially in older age groups, is now increasingly relevant.The aim of the study is to analyze the situation with prescribing anticoagulant therapy in elderly and senile persons with atrial fibrillation in real clinical practice and to demonstrate the possibility of improving the quality of observation and management of a group of patients as part of the work of a specialized team.Materials and methods. A total of 2,770 medical records of outpatient patients with atrial fibrillation were studied for the period from 2017 to 2019. Of this number, 320 patients with AF of nonvalvular etiology were selected, the average age of which was 70.3 ± 8.15 years. There were 270 women and 50 men. An observational prospective study in 45 elderly and senile patients with AF of non-valvular etiology was carried out by a team of specialized doctors for 12 months.Results. Of the 301 patients, anticoagulant therapy was prescribed to 166 (55.1 %), of which only 17 (10.2 %) people received proper anticoagulant therapy. The excessive activity was observed in 114 (37.9 %) patients, who underwent antiplatelet therapy with aspirin, and 21 (7.0 %) patients remained without any treatment with anticoagulants nor antiplatelet agents. Although, in the case of both, prescribing aspirin and not prescribing, anticoagulants have been indicated. In the prospective part of the study (for 12 months), all 45 patients continued to take anticoagulants and were systematically monitored. The INR in the target range over 60 % of the time was achieved in 37 % of patients receiving warfarin therapy.Conclusion. In the actual clinical practice of Kyrgyzstan family medicine centers, older patients with atrial fibrillation receive inadequate antithrombotic therapy. The main drug of choice for specialists remains warfarin, a therapy that can be recognized as adequate only in a small number (16 %) of patients. The ability to improve the quality of surveillance and management of a group of patients with AF and high adherence to treatment was demonstrated by the work of a specialized team of doctors.

Contextualising evidence-based recommendations for the second wave of the COVID-19 pandemic in India

Contextualising evidence-based recommendations for the second wave of the COVID-19 pandemic in India

Risk factors in total hip arthroplasty and hemiarthroplasty: Infection and mortality

BackgroundSurveillance systems make it possible to analyze the trends of infections associated with hip arthroplasty. The aim of this study is to determine risk factors associated with surgical site infection (SSI) and mortality following total hip arthroplasty (THA) or hemiarthroplasty (HHA). MethodsObservational study including individuals ≥18 years who underwent THA or HHA between January 2007 and December 2017. Incidences of SSI were compared with the national rates according to NNIS indexes. Risk factors for SSI and mortality were evaluated using multiple logistic regression model. ResultsIn THA, an association with a higher risk of SSI was found with hospital stay (OR 1.08; 95% CI: 1.02–1.15; p=.007).In HHA, hospital stay was associated with a higher risk of SSI (OR 1.05; 95% CI: 1.02–1.08; p=.001), as also happened with obesity (OR 13.28; 95% CI: 2.68–65.74; p=.002), while inadequate antibiotic prophylaxis was associated with a higher risk of mortality (OR 4.69; 95% CI: 1.01–21.74; p=.048). ConclusionIn THA, hospital stay was associated with an increased risk of SSI. In HHA this association is found with hospital stay and obesity, while inadequate antibiotic therapy was associated with mortality.

Asymptomatic Barrett’s Oesophagus-Complicated Gastroesophageal Reflux Disease at Ineffective Antisecretory Therapy

Aim. A clinical description of gastroesophageal reflux disease (GERD) complicated by Barrett’s oesophagus (BO) at inadequate antisecretory therapy and the assessment of functional tests in control of conservative treatment.Key points. A 63-yo patient with no complaints in a proton pump inhibitor (PPI) therapy was admitted for a follow-up examination for BO-complicated GERD using oesophagogastroduodenoscopy (OGDS) with biopsy, high-resolution oesophageal manometry and 24-h pH-impedance. Endoscopy revealed signs of BO (long segment C1M3), erosive reflux oesophagitis (grade B in Los Angeles classification). Non-contractile oesophagus in manometry. Antisecretory therapy was stated ineffective and subject to correction in 24-h pH-impedance.Conclusion. Asymptomatic BO-complicated GERD patients comprise a special cohort. The main challenge to prevent progression into oesophageal adenocarcinoma is an adequate personalised patient management leveraging the modern diagnostic techniques, control of antisecretory treatment and its correction a situ.

P187 Change in Urgency Status Among Ulcerative Colitis Patients: Understanding the Impact of Treatment Changes from the Corrona Inflammatory Bowel Disease Registry

Abstract Background Stooling urgency (also known as urgency to defecate) is one of the most common symptoms among Ulcerative Colitis (UC) patients (pts). Understanding factors associated with changes in urgency status, such as the association between timing of treatment changes and subsequent onset or resolution of urgency symptoms, are essential in addressing unmet pts needs. Our aim was to explore treatment frequency and persistence among UC pts stratified by a change in urgency status from enrollment to the 6-month follow-up (6M) visit. Methods Participants included UC pts in the Corrona Inflammatory Bowel Disease Registry between 5/3/17–9/1/20. Stooling urgency was defined as no urgency or urgency using the categories, none and hurry/immediate, from the Simple Clinical Colitis Activity Index (SCCAI). Urgency status groups were formed by urgency at enrollment and the 6M visit: no persistent urgency (NPU), i.e., no urgency at both visits; change from urgency to no urgency (UN); change from no urgency to urgency (NU); and persistent urgency at both visits (PU). Chi-square tests were conducted to compare treatment use and change between urgency status groups (NPU=reference group). Kaplan Meier curves and log-rank tests were used to assess time to first treatment change between urgency status groups. Results The urgency status groups (n=400) included: 44% NPU (n=175), 21% UN (n=86), 14% NU (n=56), and 21% PU (n=83). A higher proportion of UN (47%, p=0.03) and PU (51%, p=0.01) pts received two or more treatments compared to NPU (33%) pts. Compared to NPU pts, pts in all three groups, UN (52% vs. 27%, p&amp;lt; 0.001), NU (45% vs. 27%, p=0.02), and PU (53% vs. 27%, p&amp;lt; 0.001) were more likely to change treatment between enrollment and the 6M visit. Similarly, a higher proportion of pts on a biologic at enrollment, UN (24% vs. 11%, p=0.01), NU (23% vs. 11%, p=0.03), and PU (35% vs 11%, p&amp;lt; 0.001), changed treatment between enrollment and the 6M visit vs. NPU pts. The time to first treatment change was shorter for all other urgency status groups when compared to NPU pts (log-rank tests, all p&amp;lt;0.02) (Figure 1). Among pts without urgency at enrollment, the time to first treatment change was shorter for NU vs. NPU pts (p=0.01) whereas it was similar for pts with urgency at enrollment, UN vs. PU pts (p=0.93) (Figure 1). Conclusion Among UC pts in a real-world setting, there were significant differences in change of treatment and time to treatment change between pts who experienced urgency either at their enrollment visit, 6M, or both, compared to those without urgency. Urgency at any time point is a symptom of great concern to UC pts and is a sign of inadequate therapy, and often is an indication to switch treatment therapy.