Changes In Laboratory Parameters Research Articles

Analysis of epidemiological and clinical manifestations of foodborne botulism in the Volgograd region

Aim. To analyze the situation regarding manifestations of foodborne botulism in the Volgograd region in the 2005–2023 period.Materials and methods. A retrospective analysis of 158 records of hospital patients with a diagnosis of foodborne botulism was carried out. The epidemiological data under analysis included transmission factors and outcomes. The clinical data under analysis were duration of the incubation period, severity of clinical manifestations at the time of admission and during the course of the disease, severity of changes in laboratory parameters, studies of biological material for the presence of botulinum toxin. Statistical data were processed using the MS Excel and Stastica 10.0 MS Office software packages. Results. Predominant sporadic cases of botulism were identified. The leading factors of infection transmission and the predominant type of botulinum toxin in the Volgograd region in the period from 2005 to 2023 were determined.Conclusion. Physicians and other specialists working in outpatient facilities and hospital emergency departments should maintain updated knowledge about this severe food bacterial poisoning.

CHARACTERISTICS AND OUTCOME OF LEFT MAIN STEM PCI AMONG WOMEN

Left main stem disease is a severe condition affecting a major coronary artery, traditionally treated with coronary artery bypass grafting. Recent advancements in percutaneous coronary intervention have made it a viable option, particularly for women who face unique risks and outcomes compared to men. Objective: This study aims to evaluate the characteristics and outcomes of percutaneous coronary intervention for left main stem disease in female patients, focusing on procedural outcomes and changes in laboratory parameters before and after the intervention. Methods: A prospective observational study was conducted from January to July 2024 with 68 female patients, aged 18 and above, from Fauji Foundation Hospital Rawalpindi. Various percutaneous coronary intervention techniques were used, and data on ejection fractions, access methods, and procedural specifics were collected. Pre- and post-procedural laboratory outcomes including haemoglobin, creatinine, platelet counts, and alanine aminotransferase levels were analyzed. Results: The mean age of participants was 63.6 years. Diabetes, hypertension, and dyslipidemia were common comorbidities. Laboratory results showed stable haemoglobin levels, slight increases in creatinine, and consistent platelet counts and ALT levels post-procedure. Statistical analysis revealed no significant changes in these parameters, indicating minimal impact on anaemia, renal function, and platelet or liver function. Conclusion: percutaneous coronary intervention for the left main stem in females generally results in stable laboratory outcomes with minimal impact on anaemia, renal function, and platelet or liver function. The procedure is safe with a low mortality rate. Continuous monitoring is recommended to manage any potential complications effectively.

The Effect of Corticosteroids on the Progression and Outcomes of Polytrauma in Children

Polytrauma in children are among the most common causes of death in the pediatric intensive care unit (ICU).The aim of this study was to evaluate the effect of systemic corticosteroids (SCS) on the progression, laboratory parameters, and outcomes of severe multiple injuries in children requiring ICU.Materials and methods. A retrospective, observational, multicenter (case-control and cross-sectional) study included 203 patients from pediatric ICUs across the Russian Federation. The Abbreviated Injury Scale (AIS) score was 36.81 (25–48), and the Pediatric Trauma Score (PTS) was 5.2 (2–8). SCS were administered to 113 (55.7%) children, 19 (9.36%) of whom died.Results. The most severe changes in laboratory parameters, such as an increase in amylase (35.3 vs. 18.3; P0.001) and activated partial thromboplastin time (APTT) (28.9 vs. 25.8; P0.001), were documented upon admission of children with multiple traumatic injuries to the hospital compared with subsequent days of treatment in the ICU. The average fluid volume (as a percentage of age-related fluid requirements) on the first day of treatment in the ICU was 118.53% and did not exceed 84.42% on subsequent days (P0.001). Higher systolic blood pressure (SBP) during the first three days of ICU treatment was observed in children treated without SCS. SBP tended to decrease by day 5, and then a tendency toward arterial hypertension emerged on days 6–7. In children treated with SCS, blood pressure remained stable during the first seven days in the ICU, contributing to a favorable outcome.Conclusion. The use of SCS in children with severe polytrauma from the first day of ICU treatment contributed to the stabilization of hemodynamic parameters and improved control of shock signs. A positive response to SCS in these patients can be considered a marker for a favorable disease course during ICU treatment.

Impact of Etonogestrel-releasing contraceptive implant use in cisgender women with Sickle cell disease

BackgroundSickle cell disease is a hereditary hemolytic anemia that exposes women to increased health risks especially in pregnancy, with serious implications for the woman and fetus. Acute pain episodes can occur multiple times per month and result in reduction of quality of life and disruption of her life. ObjectiveTo assess the clinical, including pain and metabolic parameters of women with sickle cell disease using etonogestrel-releasing contraceptive implants. MethodsWomen with sickle cell disease, aged 18–40 years, with reports of pain crises in the preceding 3 months were included and followed up for 12 months. Blood samples were collected to evaluate the blood count, reticulocytes, liver profile (alkaline phosphatase, gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and total bilirubin and its fractions), lipid profile, and lactate dehydrogenase levels before and 6 and 12 months after implant insertion. The following clinical variables were analyzed every 3 months: bleeding pattern, blood pressure, weight, body mass index, pain intensity (assessed using a visual analogic scale (VAS) from 0 to 10), and frequency of pain crises. ResultsTwenty-three women completed the study. There were no differences in laboratory variables between baseline and 6 and 12 months after implant insertion. Similarly, clinical variables did not differ, except for pain intensity (VAS pre-insertion = 8 vs. VAS 12 months post insertion = 4; p = 0.005) and frequency of pain crises (pre-insertion = 6 vs. 12 days/month post insertion = 0; p = 0.000). ConclusionsEtonogestrel-releasing contraceptive implants were associated with a reduction in the intensity and frequency of pain crises in women with sickle cell disease. Moreover, it was safety among these population due to no changes in laboratory parameters during the first 12 months of use.

Exploring variations in dengue symptoms: a comparative study of 2013, 2019, and 2023 in a tertiary care hospital of Bangladesh

Background: Dengue fever remains a major public health issue in Bangladesh, with repeated outbreaks. This study compares dengue symptoms in a tertiary care hospital during 2013, 2019, and 2023. The purpose of this study is to evaluate the variations in dengue symptoms among Bangladeshi dengue patients from 2013 and 2019 to 2023. Methods: This was a cross-sectional study, conducted on 100 dengue positive patients, admitted between 1st January to 7th August 2023, to the Medicine Department, Holy Family Red Crescent Medical College and Hospital, Dhaka. Demographic data, sign and symptoms and laboratory investigation reports were collected. These data were compared with a previously published study from the same institute comparing dengue symptoms between 2013 and 2019 among admitted dengue patients. The study employed a convenience sampling method for participant selection, and data analysis was carried out using SPSS version 26. Results: Analysis of 100 sero-positive dengue cases reveals a predominant occurrence in the 20 to 40 age group (51%), with the mean age of patients being 34.5 years. Among these cases, a higher prevalence is observed in males (62%) compared to females (38%). Symptomatology exhibits variations over time, with fever being consistently present. Other symptoms such as headache (90%, 23% and 12%), retroorbital pain (45%, 3% and 16%), skin rash (16%, 4% and 1%) and constipation (32%, 1% and 5%) showing fluctuations, respectively in 2013, 2019 and 2023. Notably, a significant proportion of patients in 2023 exhibit normal ultrasound findings (53%). Conclusions: In conclusion, our study provides a comprehensive analysis of Dengue infection dynamics over a decade, highlighting significant variations in clinical manifestations, laboratory findings, and abdominal ultrasound results among Bangladeshi patients. The findings suggest that Dengue remains a considerable public health concern, with fluctuations observed in symptomatology, including fever and other associated symptoms, and changes in laboratory parameters over time. BIRDEM Med J 2024; 14(3): 131-136

Experience of abrocitinib in atopic dermatitis

Atopic dermatitis is an autoinflammatory, genetically determined, itchy disease characterized by a long, relapsing course and a sharp decrease in the patient’s quality of life. Atopic dermatitis is caused by a complex interaction of immune dysregulation, epidermal gene mutations, and multi-environmental factors that affect the skin, causing intense itchy rashes. The disease often occurs among young children and subsequently has age-related clinical features. Currently, the treatment of atopic dermatitis has a wide range of options, including drugs from the group of small molecules recently registered in the Russian Federation. The drugs are intended for patients with moderate to severe atopic dermatitis. Baricitinib, abrocitinib and upadacitinib as Janus kinase inhibitors from the small molecule group have already demonstrated good tolerability, safety and a pronounced clinical effect in the vast majority of patients with atopic dermatitis in available clinical trials. The first clinical experience with the use of abrocitinib in adult patients with atopic dermatitis is presented. The interest of the presented clinical cases lies in the demonstration of high clinical efficacy and safety of mono- and combination therapy with the Janus kinase inhibitor abrocitinib. Despite the short period of treatment and observation (4 weeks), objective severity of atopic dermatitis manifestations (SCORAD index 60 points) and sharp decrease in the patients' quality of life (DLQI index 20 points), a reduction of clinical parameters exceeding 60% was achieved at a dose of 200 mg daily. During the whole observation period no adverse clinical reactions or changes in laboratory parameters were registered against the background of abrocitinib administration. The pilot results of abrocitinib use are encouraging and provide grounds for conducting longer and larger-scale studies to investigate the efficacy of the drug for its inclusion in the combination therapy of patients with moderate to severe atopic dermatitis.

Bariatric Surgery and Metabolic Status.

Background and Objectives: Obesity is associated with numerous co-morbidities, including dyslipidemia, insulin resistance and diabetes mellitus. Bariatric surgery is the mainstay of treatment for obesity as the only method with confirmed long-term effects in weight reduction and the remission of comorbidities. Postoperative recommendations leading to changes in dietary habits and changes in digestion and absorption in the gastrointestinal tract after bariatric surgery may additionally influence the levels of laboratory parameters that reflect the metabolic and nutritional status. The purpose of the study was to analyze the possible influence of changes in dietary habits after bariatric surgery on those laboratory results that reflect the metabolic and nutritional status. Materials and Methods: This was a retrospective study of 88 patients with a history of bariatric surgery. Data were gathered from before the surgery and at 6 months after the surgery and included diet structure and selected laboratory parameters reflecting the metabolic and nutritional status, i.e., levels of fasting glucose, glycated hemoglobin, cholesterol, low- and high-density lipoproteins, triglycerides, alanine and aspartate aminotransferases, proteins, ferrum, ferritin, vitamin B12, folic acid, vitamin D and calcium, the red blood cell count and the hematocrit. Results: Postoperative festive glucose levels were reduced by 14% and were more significant in patients after Roux-en-Y gastric bypass. There was an increase of 22% in concentrations of high-density lipoproteins. Triglyceride concentrations were reduced by 32%. Aminotransferase levels decreased by 43% for alanine aminotransferase and by 14% for aspartate aminotransferase. Among the changes in dietary habits, post-bariatric patients had a reduced consumption of red meat and an increased consumption of fish, milk and dairy products and wholegrain products. Vitamin D and ferrum levels were higher after the surgery, whereas vitamin B12 and folic acid levels remained unchanged. Conclusions: Improved dietary habits of patients after bariatric surgery may lead to changes in laboratory parameters that reflect the ameliorated metabolic and nutritional status of patients after bariatric surgery.

The influence of rehabilitation on the quality of life after radical treatment of endometrial cancer and atypical endometrial hyperplasia

Background. Gynecological cancers in women are a widespread type of oncology. Among them, endometrial cancer (EC) is often highlighted as one of the most common diseases in this group. The analysis of publications showed insufficient effectiveness of rehabilitation in patients with EC and recurrent atypical endometrial hyperplasia (rAEH).Objective: to compare the state of patients with rAEH or EC after hysterectomy with bilateral salpingo-oophorectomy, depending on the recovery tactics.Material and methods. The study included 119 patients diagnosed with rAEH (n=58) or stage IA EC (n=61) after hysterectomy with bilateral salpingo-oophorectomy. The group of women with rAEH was divided into two subgroups: 1A (“active” rehabilitation, n=27) and 1B (“passive” rehabilitation, n=31); two subgroups were also formed from the cohort of EC patients: 2A (“active” rehabilitation, n=29) and 2B (“passive” rehabilitation, n=32). “Active’ rehabilitation included a comprehensive, personalized program, “passive” one was based on standard rehabilitation protocols. Apart from standard clinical examination of patients, their quality of life (QoL), physical condition as well as the levels of cytokines and other biochemical blood parameters were assessed.Results. An analysis of the overall picture showed a high incidence of rAEH or EC in women aged 40–49 years. Comorbid pathologies, low QoL level and a number of significant changes in laboratory parameters were often observed. Regardless of the approach to rehabilitation, the patients' health improved over the course of 12 months. “Active” rehabilitation significantly improved psychological well-being, sexual function, overall QoL and a number of other objective health indicators of patients with rAEH or EC compared to standard rehabilitation course.Conclusion. The overall picture of rAEH or EC patients was presented, the main factors that reduce QoL in women with these diseases were identified. A system of integral QoL assessment in patients with rAEH or stage IA EC was developed including subjective and objective parameters obtained during general clinical examination, laboratory tests and analysis of questionnairing results, which should be used to adequately monitor the state of patients after surgery and the effectiveness of rehabilitation. The advantage of comprehensive rehabilitation over standard protocols in terms of efficiency and speed of recovery was shown.

Course and complications of influenza A in seniors over 65 years of age.

Influenza A and B viruses cause epidemics every year, with approximately 3-5 million serious cases and about 290,000 to 650,000 deaths worldwide. Most patients die from bacterial complications of influenza. The aim of our study was to describe the clinical pictures of influenza and the development of the complications in seniors over 65 years of age, who were treated in University Hospital Pilsen. The course of the disease and changes in laboratory parameters were evaluated with regard to the method of treatment performed. A descriptive retrospective study was performed. Clinical and laboratory data of seniors with the diagnosis of influenza were extracted from electronic medical records and later analysed. The data were processed with Excel 2016 and Statistica. A collection of 261 seniors, of whom 218 were hospitalized and 43 treated in an outpatient setting, has been studied. Patients who later developed complications had elevated values of CRP, procalcitonin, urea, and creatinine. The antiviral drug oseltamivir was administered to 226 of 261 seniors. Forty-seven seniors (18.0%) died from influenza and its complications (severe pneumonia with acute respiratory insufficiency or heart failure). The course of influenza in seniors was usually more severe and required hospitalization along with antiviral treatment. The mortality rate in the monitored group exceeded 18%. Annual timely vaccination, but also other preventive measures, and maybe considering other risk groups are methods to prevent severe or even fatal cases of influenza.

Unraveling Postoperative Bleeding Dynamics in Laparoscopic Roux-en-Y Gastric Bypass: Insights from a Single-Center Tranexamic Acid Study.

The efficacy of postoperative tranexamic acid (TXA) administration in mitigating bleeding after primary laparoscopic Roux-en-Y gastric bypass (RYGB), a prevalent complication associated with significant morbidities and mortality, and the use of sequential laboratory parameter changes in bleeding screening and TXA impact tracking were investigated. This retrospective analysis included RYGB patients (aged 18-65years, with a body mass index of 35-50kg/m2) over 5years who were categorized into three groups by evolving treatment regimens: Group A (n = 42) received standard pre- and postoperative enoxaparin (30mg) every 12h; Group B (n = 160) received enoxaparin and postoperative TXA (250mg every 6h); and Group C (n = 73) received TXA alone. Postoperative bleeding-related adverse events, vital signs, and laboratory changes were compared. Postoperative hemorrhage occurred in 3.6% (10/275) of patients, with no significant intergroup differences. Patients who experienced bleeding had greater decreases in hemoglobin (∆Hb) (2.1 vs. 1.4; p = 0.003), greater ∆Hb > 2 (50% vs. 15%; p = 0.013), and greater use of staples than did those who did not experience bleeding (8 vs. 7; p = 0.001). The ∆Hb values were lower in Groups B (1.4) and C (1.3) than in Group A (1.7, p = 0.011). No significant difference was noted between Groups C and B. This study emphasizes the potential of TXA to mitigate postoperative bleeding after RYGB, with no added benefit from excluding enoxaparin. Monitoring patients with a ∆Hb > 2mg/dl and increased stapler usage is crucial. Further research is needed to validate routine TXA use across different procedures.

Establishing the Interrelations of the Laboratory Parameters in the Gut-Kidney Axis in Cats with Signs of Triple Phosphate Urolithiasis

Introduction. Efficient treatment of the feline urolithiasis much depends on the early diagnosis of the disease, however, the diagnostic algorithm of this type of pathology is extremely poor due to the various reasons, in particular, it does not take into account the interrelations in the gut-kidney axis. Analysis of the state of gastrointestinal tract functioning and the composition of the gut microbiota can improve the potential of diagnosing the urolithiasis, predict the risk, improve the prognosis and choose the correct treatment strategy. The aim of this publication is to establish the interrelations of the laboratory parameters in the gut-kidney axis in cats with struvite urolithiasis with the signs of cystolithiasis.Materials and Methods. The objects of the research were the outbred cats with the triple phosphate urolithiasis with the signs of cystolithiasis: 1st experimental group — females; 2nd experimental group — neutered males; the control group — clinically healthy animals of both sexes. The laboratory and clinical examinations of sick animals included: ultrasonography of abdominal organs; macroscopic and biochemical urine tests; microscopy of urine sediment and urine culture test without determination of antibiotic sensitivity; macroscopic, microscopic and simple chemical examinations of freshly excreted feces; bacteriological culture test of rectal flushes without determination of antibiotic sensitivity.Results. In the urine of cats of the experimental groups, under the activity of gram-negative microorganisms Escherichia coli (0.03±0.01×106 CFU (colony forming units) and 1.00±0.03×106 CFU) and gram-positive microorganisms Staphilococcus intermedius (1.05±0.07×106 CFU and 1.00±0.08×107 CFU) there were recorded within the microscope field of view: alkalization, development of hypersthenuria, proteinuria, hypercalciuria, hematuria, including microhematuria and leukocyturia, crystalluria. The results of coprological examinations in sick cats indicated the presence of stercobilin, well-digested muscle fibres, undigested and digested cellulose, extracellular and intracellular starch, as well as impurities of non-food origin (wool). The data of microbiological examinations of feces indicated the growth of Escherichia coli (1.00±0.05×105 CFU and 1.04±0.08×107 CFU). Along with the cystolytiasis, the acoustic shadowing of the gastrointestinal tract organs in the experimental animals revealed the hyperechogenicity of liver capsule and parenchyma and heterogeneity of the pattern.Discussion and Conclusion. The revealed character of the laboratory parameter changes in the experimental animals, such as the increase of protein and creatinine levels in urine and growth of Escherichia coli in feces, proved the existence of the pathogenetic relationship between the urogenital tract lesion caused by the gram-negative microorganisms and the gut microbiota in the gut-kidney axis. The results of our study of the sick animals’ urine indicated on the infection of the urogenital tract with the urease-producing microorganisms, which led to the alkalization of urine and formation of the infection struvite stones. Urolithiasis, in turn, had an impact on the gut microbiome due to the topographic proximity of the urogenital and gastrointestinal tracts: examination of feces in cats of the experimental group had confirmed the disorder of gastrointestinal tract functioning due to dysbiotic processes in the large intestine.

Analysis of the Perioperative Course of Cardiac Surgery Patients with Coronary Artery Disease and Heart Valve Dysfunction

The aim. To analyze the perioperative course of cardiac surgery patients with coronary artery disease (CAD) and heart valve dysfunction. Materials and methods. Retrospective analysis of 41 consecutive cardiac surgery patients (mean age 61.6 ± 7.8 years) with CAD and heart valve dysfunction who were operated on and discharged from the National Amosov Institute of Cardiovascular Surgery of the National Academy of Medical Sciences of Ukraine. All the patients underwent standard clinical and laboratory examinations, coronary angiography, on-pump cardiosurgical intervention. Results. The patients were divided into three subgroups: patients with post-infarction left ventricular aneurysm (LVA) combined with insufficiency of atrioventricular valves, n = 15 (36.6%); those with ischemic mitral insufficiency (MI), n = 11 (26.8%); and patients with CAD combined with aortic valve disease, n = 15 (36.6%). During echocardiographic study, decreased left ventricular ejection fraction was found in patients with LVA and with ischemic MI: 33 ± 6.4% and 39.4 ± 7.8%, respectively, and in patients with aortic valve disease, left ventricular ejection fraction averaged 48.2 ± 9.9% (p < 0.0001). According to the EuroSCORE II scale, the average risk was 11.8 ± 7.3%. All the patients were discussed by the heart team to choose the optimal method of cardiosurgical correction. In order to reduce the ischemic time, off-pump coronary bypass surgery was performed at the first stage, and the second stage was on-pump correction of valvular dysfunction. The average number of grafts was 2.8 ± 1.4, but the largest number of grafts was in the subgroup of ischemic MI: 4 ± 0.9 (p < 0.005). Mitral valve replacement in patients with LVA was performed through LVA in 12 patients. Acute heart failure, acute renal failure often developed in patients after correction of ischemic MI (p < 0.005). On the 1st day after the operation, there was an increase in average glucose values from 6.6 ± 2.8 to 10.3 ± 2.9 mmol/L (p < 0.0001), a decrease in glomerular filtration rate from 72.1 ± 15.3 to 57 ± 18.8 mL/min/1.73 m2 (p = 0.0001), the above indicators returned to the initial level at discharge (p < 0.0001). Conclusions. Off-pump myocardial revascularization in patients with CAD and dysfunction of the heart valves can significantly reduce the ischemic time. The method of mitral valve replacement through LVA developed in the department allowed to reduce the perfusion time (p = 0.0023) and the duration of the operation (p < 0.005). Preoperative discussion of examination data of patients by the heart team, thorough preparation for cardiac surgery, timely response to changes in laboratory parameters with correction of drug treatment avoid complications.

549 - Laboratory parameters in adolescent patients aged 12–17 with moderate-to-severe atopic dermatitis treated with tralokinumab up to week 52: results from the phase 3 ECZTRA 6 trial

Abstract Introduction/Background Tralokinumab, a high-affinity, monoclonal antibody that targets IL-13, is approved in the EU and Canada for adolescents (aged ≥12 years) with inadequately controlled moderate-to-severe atopic dermatitis (AD), and it does not require laboratory monitoring. The phase 3 ECZTRA 6 (NCT03526861) clinical trial demonstrated efficacy and safety up to 52 weeks in that population. Objectives To further characterize the safety profile of tralokinumab by evaluating laboratory parameters of adolescents in the ECZTRA 6 trial. Methods ECZTRA 6 subjects received tralokinumab 150mg (n=98), 300mg (n=97) or placebo (n=94) every 2 weeks (Q2W) from week 0–16 after a loading dose at week 0 (twice the subsequent dose), and then randomized to maintenance [original tralokinumab dose either Q2W or every 4 weeks (Q4W) or placebo Q2W] or open-label (tralokinumab 300mg Q2W) until week 52. Laboratory parameters included hematology, serum biochemistry, and urinalysis throughout the trial (weeks 0, 8, 16, 28, and 52). Results Overall (n= 289 subjects), laboratory baseline parameters were similar across treatment groups. Mean and median changes of most hematology parameters showed minor fluctuations within the normal ranges through week 52, except for eosinophils. At baseline, elevated mean eosinophil counts (>0.5 109/L) were observed for 40.8% (tralokinumab 150mg), 48.5% (tralokinumab 300mg), and 43.6% (placebo) of subjects in each respective treatment group. Some tralokinumab-treated patients had small transient increases in eosinophils (maximum mean change from baseline 0.2×109/L) before week 16. Continued treatment with tralokinumab or placebo did not correspond with further increase in eosinophil levels over time, and no adverse events of eosinophilia were reported. Mean levels of most biochemistry parameters, including electrolytes, renal and liver function parameters, and lipid panel, were within normal range at baseline, and mean and median changes showed minor fluctuations within normal ranges in all treatment arms. Mean lactate dehydrogenase levels were around or above the upper limit of normal at baseline and decreased to within the normal ranges during the trial across all groups. Overall, no clinically meaningful differences were observed in hematology, biochemistry, or urinalysis parameters between active treatment groups or placebo. Conclusions Similar to findings in adult trials, no meaningful changes in laboratory parameters were observed in adolescents through week 52 with tralokinumab treatment. No routine laboratory monitoring is needed for adult or adolescent AD patients treated with tralokinumab.

The Gallstone Ileus, a Retrospective Study and Review of the Literature

Introduction: Gallstone ileus (GI) is a rare complication of cholelithiasis and is one of the most irregular forms of all mechanical bowel obstructions. It is, however, a more common cause of non-strangulating mechanical small bowel obstruction, accounting for 1% to 4% of all patients and up to 25% in the elderly.
 The diagnosis is often delayed since symptoms may be intermittent, and investigations may fail to identify the cause of the obstruction. As a result, gallstone ileus continues to be associated with relatively high rates of morbidity and mortality.
 The cornerstone of healing is the removal of the stone that represents obstruction. As is the case with cholelithiasis, women are more frequently affected.
 Material and Methods: This article aims to review the incidence of gallstone ileus in our country in the literature, addressing the pathophysiology, clinical presentation, radiological findings, and treatment options. A literature search was done on gallstone ileus for 2005-2018.
 Results: The patients in the study presentation were both genders and older. They all came to INP because of abdominal pain and general nausea. All had CRP elevation present. Leukocytosis was present in only 2/3 of patients. AST was elevated in one patient and ALT in 2. All changes in laboratory parameters indicate the instability of marker changes and, consequently, the unreliability of use alone without other diagnostic methods. A CT scan was performed on all three patients, but one still needed to be uploaded to the system at the time of writing.
 Conclusions: Ileus due to gallstones is a rare disease. It is an uncommon cause of mechanical small bowel obstruction. It is a rare complication of chronic cholecystitis and occurs when a gallstone passes through a fistula between the gallbladder and small bowel before becoming impacted at the ileocecal valve. The use of radiological imaging is invaluable in the diagnosis of gallstone ileus. These authors recommend a low threshold for investigation. There is evidence for using AXR as a quick first-line investigation; however, CT scanning is a powerful and gold-standard tool to diagnose the condition and guide its management.

Laboratory Parameters in Adolescent Patients Aged 12–17 with Moderate-to-Severe Atopic Dermatitis Treated with Tralokinumab Up to Week 52: Results from the Phase 3 ECZTRA 6 Trial

Introduction: Tralokinumab, a high-affinity, monoclonal antibody that targets IL-13, is approved in the EU and Canada for adolescents (aged ≥12 years) with inadequately controlled moderate-to-severe atopic dermatitis (AD), and it does not require laboratory monitoring. The phase 3 ECZTRA 6 (NCT03526861) clinical trial demonstrated efficacy and safety up to 52 weeks in that population.
 Objective/Purpose: To further characterize the safety profile of tralokinumab by evaluating laboratory parameters of adolescents in the ECZTRA 6 trial.
 Methods: ECZTRA 6 subjects received tralokinumab 150mg (n=98), 300mg (n=97) or placebo (n=94) every 2 weeks (Q2W) from week 0–16 after a loading dose at week 0 (twice the subsequent dose), and then randomized to maintenance [original tralokinumab dose either Q2W or every 4 weeks (Q4W) or placebo Q2W] or open-label (tralokinumab 300mg Q2W) until week 52. Laboratory parameters included hematology, serum biochemistry, and urinalysis throughout the trial (weeks 0, 8, 16, 28, and 52).
 Results: Overall (n= 289 subjects), laboratory baseline parameters were similar across treatment groups. Mean and median changes of most hematology parameters showed minor fluctuations within the normal ranges through week 52, except for eosinophils. At baseline, elevated mean eosinophil counts (>0.5 109/L) were observed for 40.8% (tralokinumab 150mg), 48.5% (tralokinumab 300mg), and 43.6% (placebo) of subjects in each respective treatment group. Some tralokinumab-treated patients had small transient increases in eosinophils (maximum mean change from baseline 0.2×109/L) before week 16. Continued treatment with tralokinumab or placebo did not correspond with further increase in eosinophil levels over time, and no adverse events of eosinophilia were reported. Mean levels of most biochemistry parameters, including electrolytes, renal and liver function parameters, and lipid panel, were within normal range at baseline, and mean and median changes showed minor fluctuations within normal ranges in all treatment arms. Mean lactate dehydrogenase levels were around or above the upper limit of normal at baseline and decreased to within the normal ranges during the trial across all groups. Overall, no clinically meaningful differences were observed in hematology, biochemistry, or urinalysis parameters between active treatment groups or placebo.
 Conclusions: Similar to findings in adult trials, no meaningful changes in laboratory parameters were observed in adolescents through week 52 with tralokinumab treatment. No routine laboratory monitoring is needed for adult or adolescent AD patients treated with tralokinumab.

Efficacy and Safety of Upadacitinib in Rheumatoid Arthritis: Real-Life Experience from a Prospective Longitudinal Multicentric Study.

We provide the first prospective longitudinal multicenter experience on Upadacitinib efficacy and safety profile in Rheumatoid Arthritis (RA) in a real-life context, focusing on clinimetric and ultrasonographic (US) data. RA patients referred to three Italian tertiary Centers who started Upadacitinib were enrolled as per ACR/EULAR classification criteria and prospectively reviewed. The primary aim of this study was to assess changes in clinimetric and ultrasonographic scores through time (at baseline, after 1 month, 3 months, and 6 months from the beginning of the therapy). Secondary aims were to: (i) estimate the impact of biologic lines of treatment and concomitant therapies on response to therapy; (ii) explore changes in laboratory parameters; and (iii) find potential predictive factors associated with response to therapy. Seventy-one patients (49 Females and 22 Males) were included. Clinimetric scores, including the Disease Activity Score (DAS28-CRP) and Simplified Clinical Disease Activity Index (SDAI), and US findings (synovial hypertrophy and power Doppler) significantly improved (p = 0.029, p = 0.001, p = 0.001, p = 0.001, respectively). Regression analysis revealed a significant association between the concomitant csDMARDs therapy at baseline and the lack of improvement in synovial hypertrophy [OR -4.824, p = 0.010] as well as with DAS28-CRP [OR -0.690, p = 0.045], whereas the presence of increased ESR or CRP at baseline was able to predict a significant improvement in SDAI [OR 8.481, p = 0.003]. No adverse events, such as deep venous thrombosis, pulmonary embolism, or herpes zoster virus infection, were reported during this study observation. Our real-life experience confirms the efficacy of Upadacitinib in terms of clinical and ultrasonographic improvement, as well as displaying a good safety profile.

Compatible co-administration of BioThrax® vaccine and ciprofloxacin—Results of a randomized open-label drug-vaccine interaction trial

The recommended treatment for post-exposure prophylaxis (PEP) following known/suspected exposure to Bacillus anthracis involves immunization with anthrax vaccine adsorbed (AVA, i.e., BioThrax® vaccine) and a course of antimicrobial therapy. A drug-vaccine interaction clinical trial was conducted to determine whether this combined treatment might modify antimicrobial exposure or vaccine immunogenicity.A Phase 2, randomized, open-label, multi-center trial involving 154 healthy adult participants was completed to evaluate the effect of AVA immunization (three doses administered subcutaneously (SC) at weeks 0, 2 and 4) on the pharmacokinetics (PK) of ciprofloxacin, as well as the effect of ciprofloxacin administration (500 mg po bid) on the immunogenicity of AVA. PK parameters were derived using noncompartmental analysis of ciprofloxacin serum concentrations. Immunogenicity was assessed using a toxin neutralizing antibody (TNA) assay resulting in 50 % neutralization factor (NF50) values. Safety was assessed via reports of adverse events (AEs), clinically significant changes in laboratory parameters and vital signs, and collection of solicited local and systemic reactogenicity reactions.Statistical analyses of the steady state (SS) and single dose PK parameters Cmax and AUC0-–12h indicated that the AVA PEP regimen did not significantly modify ciprofloxacin exposure. Comparison of the geometric mean TNA NF50 values between participants receiving AVA + ciprofloxacin and those receiving AVA alone showed that the combined treatment was non-inferior to AVA alone. The trial met all prospectively defined success criteria for the primary PK endpoint and for the secondary PK and immunogenicity endpoints. There were no deaths, SAEs or AEs leading to drug discontinuation or study withdrawal during the trial.Overall, concomitant administration of ciprofloxacin and AVA produced no significant changes in the PK profile of ciprofloxacin nor in the immunogenicity of AVA. Furthermore, this trial demonstrated that the co-administration of ciprofloxacin and AVA was well tolerated in healthy adult participants.

Impact of Upadacitinib on Laboratory Parameters and Related Adverse Events in Patients with RA: Integrated Data Up to 6.5 Years.

Upadacitinib (UPA) is a Janus kinase inhibitor that has demonstrated efficacy in moderate-to-severe rheumatoid arthritis (RA) with an acceptable safety profile. We investigated laboratory parameter changes in UPA RA clinical trials. Pooled data from six randomized trials in the SELECT phase 3 program were included. Key laboratory parameters and safety data were measured for UPA 15 and 30mg once daily (QD), adalimumab (ADA) 40mg every other week + methotrexate (MTX), and MTX monotherapy. Exposure-adjusted event rates (EAERs) of adverse events were calculated. A total of 3209 patients receiving UPA 15 mg QD (10 782.7 patient-years [PY]), 1204 patients receiving UPA 30mg QD (3162.5 PY), 579 patients receiving ADA + MTX (1573.2 PY), and 314 patients receiving MTX monotherapy (865.1 PY) were included, representing up to 6.5years of total exposure. Decreases in mean levels of hemoglobin, neutrophils, and lymphocytes, and increases in mean levels of liver enzymes and creatinine phosphokinase were observed with UPA, with grade 3 or 4 changes observed in some patients. Mean low- and high-density lipoprotein cholesterol ratios remained stable for patients receiving UPA 15 mg QD. EAERs of anemia and neutropenia occurred at generally consistent rates between UPA and active comparators (3.1-4.3 and 1.7-5.0 events [E]/100 PY across treatment groups, respectively). Rates of hepatic disorder were higher with MTX monotherapy, UPA 15mg and UPA 30mg (10.8, 9.7, and 11.0 E/100 PY, respectively) versus ADA + MTX (6.4 E/100 PY). Rates of lymphopenia were highest with MTX monotherapy (3.2 E/100 PY). Treatment discontinuations due to laboratory-related events were rare, occurring in 1.1% and 2.2% of patients treated with UPA 15 and 30mg QD, respectively. The results of this integrated long-term analysis of laboratory parameters continue to support an acceptable safety profile of UPA 15 mg QD for moderate-to-severe RA.

No evidence of pathogenicity of Dientamoeba fragilis following detection in stools: A case-control study.

Dientamoeba fragilis is a ubiquitous intestinal parasite with detection in the stools that has become increasingly frequent following the advent of PCR as a routine screening tool. However, the pathogenicity of this parasite is still much debated. In order to assess the potentially pathogenic nature of this protozoan, a retrospective case-control study was carried out between January and December 2020 on patients from Toulouse University Hospital, with the aim of evaluating the potential clinical effects and changes in laboratory parameters linked to the presence and load of D. fragilis in stools. After matching age, sex and mode of care (consultation or hospitalisation), no significant difference was observed in the frequency of clinical signs between the 36 patients who tested positive for Dientamoeba fragilis PCR in their stools and the 72 control patients who were PCR negative for this protozoan. The presence of D. fragilis in the faeces was not associated with changes in laboratory parameters. Furthermore, a high digestive load of D. fragilis had no identifiable impact on clinical and laboratory parameters. Only the concomitant presence of Blastocystis sp. in stools was significantly more frequent in the D. fragilis group (uni- and multivariate analysis). Finally, this study showed no significant difference in clinical or laboratory signs between patients carrying Dientamoeba fragilis and the control group, regardless of the intestinal parasite load, suggesting that D. fragilis could be considered a commensal of the digestive tract.

Hematological Parameters and Comorbidities in COVID-19: Insights into Clinical Profiles and Outcome Predictors.

The global pandemic, known as the coronavirus disease 2019 (COVID-19) and caused by the severe acute respiratory syndrome, coronavirus 2 (SARS-CoV-2), poses a significant threat, particularly to individuals with comorbidities such as hypertension, chronic obstructive pulmonary disease (COPD), diabetes, HIV, cardiovascular disease (CVD), and cancer. This descriptive retrospective study investigates the impact of comorbidities on COVID-19-positive patients. The study includes individuals that were tested positive for SARS-CoV-2 via polymerase chain reaction at the Security Forces Hospital, Makkah, KSA, between February, 2022, and June, 2022. A total of 208 patients (107 males, 101 females) were examined, and the laboratory results revealed normal parameters. An analysis indicates that 86.5% of the patients were discharged, 2.9% remained hospitalized, and 10.6% succumbed to the disease, indicating a 10.6% mortality rate among comorbid COVID-19-positive patients. Notably, the study identifies specific comorbidities (chronic kidney disease, diabetes mellitus, hypertension) and changes in laboratory parameters (red blood cells, hemoglobin, C-reactive protein, white blood cells, ferritin, D-dimer, ALT, troponin, LDH, neutrophils) associated with ICU admission during hospitalization. This study underscores the critical impact of comorbidities, such as chronic kidney disease, diabetes, and hypertension, on the clinical outcomes of COVID-19-positive patients. The identification of specific laboratory parameters linked with ICU admission provides valuable insights for risk stratification and tailored management strategies.