Abnormal Blood Tests Research Articles

Serological characteristics and clinical implications of IgG subclasses in visceral leishmaniasis.

Visceral leishmaniasis (VL) represents the most severe form of Leishmaniasis infection, often resulting in fatality without timely treatment. Previous studies have found that immunosuppression increases the risk of VL disease progression and mortality, and the total immunoglobulin G (IgG) levels in peripheral blood vary before and after treatment. However, the distinct levels and roles of IgG subclasses in VL have not been documented yet. This study aims to elucidate the characteristics and clinical significance of IgG subclasses in VL. A total of 43 cases newly-diagnosed with VL were enrolled in the cohort. We measured the levels of IgG subclasses before and after standard treatment and conducted assessments of bone marrow features. In addition, we analysed other haematological indices and examined the variations in IgG subclasses, as well as their correlation with clinical and laboratory factors. The levels of total IgG, IgG1, and the ratios of both IgG1/IgG and IgG1/IgG2 decreased significantly after treatment, whereas the ratios of IgG2/ IgG showed an obvious increase. The VL patients without hyperglobulinemia displayed significant lower IgG1/IgG2 ratios, but higher IgG2/IgG ratios compared with those with hyperglobulinemia. In addition, VL patients with positive bone marrow amastigotes had significant higher IgG1/IgG and IgG1/IgG2 ratios, but lower IgG2/IgG ratios. IgG subclasses were correlated with abnormal blood test results, particularly immunological elements including IgM and Complement 4 (C4). IgG1 and IgG2 exhibited contrasting changes after treatment in VL patients. The features of bone marrow and laboratory tests indicated that IgG1 and IgG2 serve different roles in the progression of VL. The ratios of IgG subclasses may be more precise indicators to evaluate immune reaction in VL than traditional total IgG.

Monoclonal Gammopathy of Undetermined Significance in General Practice

Background: In addition to progression to lymphoproliferative diseases, patients with monoclonal gammopathy of undetermined significance (MGUS) appear to suffer from other types of comorbidities although the extent to which MGUS contributes to these comorbidities is unclear. The aim of this study is to evaluate the presence of patients with MGUS who attend general practice (GP) in our healthcare area, as well as to describe the comorbidities and abnormal blood test results associated with these patients.Methods: A retrospective study was carried out, where demographic data, comorbidities, and results of some analytical parameters were collected from 1201 patients who visited their general practice physician: 201 patients with a monoclonal protein detected, and 1000 patients without presence of monoclonal protein.Main findings: Out of the 6307 proteinograms performed on patients from GP, 201 presented an M-protein (3.2%). The presence of MGUS increased with age and was significantly higher in men than in women (55.7% vs 44.3%, p<0.05). We found that the most frequently associated comorbidities with MGUS are renal and cardiovascular diseases, osteoporosis and bone lesions, anemia, and hyperlipidemia. There was a significant association between MGUS and the following blood parameters: hemoglobin, leukocytes, neutrophils, monocytes, proteins, albumin, globulin and creatinine; as well as for the indices neutrophil-to-lymphocyte, monocyte-to-lymphocyte and albumin-to-globulin ratio.Principal conclusions: We conclude that MGUS is a common premalignant plasma cell disorder in general practice patients, the prevalence of which increases with age. Likewise, a series of blood parameters and comorbidities associated with MGUS that support the need to implement a program for early detection and monitoring of MGUS was described.Key words: MGUS, paraprotein, general practice, comorbidities

The incidence and risk factors for abnormal postoperative blood tests following primary total joint replacement.

We aim to evaluate the usefulness of postoperative blood tests by investigating the incidence of abnormal results following total joint replacement (TJR), as well as identifying preoperative risk factors for abnormal blood test results postoperatively, especially pertaining to anaemia and acute kidney injury (AKI). This is a retrospective cohort study of patients who had elective TJR between January and December 2019 at a tertiary centre. Data gathered included age at time of surgery, sex, BMI, American Society of Anesthesiologists (ASA) grade, preoperative and postoperative laboratory test results, haemoglobin (Hgb), white blood count (WBC), haematocrit (Hct), platelets (Plts), sodium (Na+), potassium (K+), creatinine (Cr), estimated glomerular filtration rate (eGFR), and Ferritin (ug/l). Abnormal blood tests, AKI, electrolyte imbalance, anaemia, transfusion, reoperation, and readmission within one year were reported. The study included 2,721 patients with a mean age of 69 years, of whom 1,266 (46.6%) were male. Abnormal postoperative bloods were identified in 444 (16.3%) patients. We identified age (≥ 65 years), female sex, and ASA grade ≥ III as risk factors for developing abnormal postoperative blood tests. Preoperative haemoglobin (≤ 127 g/dl) and packed cell volume (≤ 0.395 l/l) were noted to be significant risk factors for postoperative anaemia, and potassium (≤ 3.7 mmol/l) was noted to be a significant risk factor for AKI. The costs outweigh the benefits of ordering routine postoperative blood tests in TJR patients. Clinicians should risk-stratify their patients and have a lower threshold for ordering blood tests in patients with abnormal preoperative haemoglobin (≤ 127 g/l), blood loss > 300 ml, chronic kidney disease, ASA grade ≥ III, and clinical concern.

Epidemiological, Clinical, and Laboratory Findings of 235 Hospitalized COVID-19 Adult Patients (Survivors and Non-Survivors) at Sohar Hospital in Oman.

The aim of this study was to describe the epidemiological and clinical characteristics and laboratory findings of coronavirus disease 2019 (COVID-19) patients at the Sohar Hospital, Sohar, Oman. This retrospective study of admitted COVID-19 patients at Sohar Hospital in Oman was carried out from March to October 2020. Demographics and laboratory data of 19 tests for 235 COVID-19 patients, of which 202 were survivors and 33 were non-survivors, were collected from the hospital information system after ethics approval. Thirteen factors were significantly correlated with in-hospital mortality, including older age, having chronic disease, high neutrophil count, high troponin T, high creatinine, low albumin (p < 0.0001), high white blood cell (WBC) count, low hemoglobin, high D-dimer (p < 0.001), high C-reactive protein (CRP) (p < 0.002), low lymphocyte count (p < 0.003), high alkaline phosphatase (ALP) enzyme (p < 0.007) and high ferritin (p < 0.045). The most common laboratory blood test abnormalities that were highly correlated with mortality were increased values of CRP (100% of non-survivors), D-dimer (94.1% of non-survivors), ferritin (88.2% of non-survivors), and troponin T (85% of non-survivors) and reduced lymphocyte count (73.9% of non-survivors). These findings could help in categorizing COVID-19 patients for risk-based assessment and early identification of patients with poor prognosis.

Discontinuation of anti-tumour necrosis factor alphatreatment owing to blood test abnormalities, and cost-effectiveness of alternate blood monitoring strategies.

There is no evidence base to support the use of 6-monthly monitoring blood tests for the early detection of liver, blood and renal toxicity during established anti-tumour necrosis factor alpha (TNFα) treatment. To evaluate the incidence and risk factors of anti-TNFα treatment cessation owing to liver, blood and renal side-effects, and to estimate the cost-effectiveness of alternate intervals between monitoring blood tests. A secondary care-based retrospective cohort study was performed. Data from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR) were used. Patients with at least moderate psoriasis prescribed their first anti-TNFα treatment were included. Treatment discontinuation due to a monitoring blood test abnormality was the primary outcome. Patients were followed-up from start of treatment to the outcome of interest, drug discontinuation, death, 31 July 2021 or up to 5 years, whichever came first. The incidence rate (IR) and 95% confidence intervals (CIs) of anti-TNFα discontinuation with monitoring blood test abnormality was calculated. Multivariate Cox regression was used to examine the association between risk factors and outcome. A mathematical model evaluated costs and quality-adjusted life years (QALYs) associated with increasing the length of time between monitoring blood tests during anti-TNFα treatment. The cohort included 8819 participants [3710 (42.1%) female, mean (SD) age 44.76 (13.20) years] that contributed 25 058 person-years (PY) of follow-up and experienced 125 treatment discontinuations owing to a monitoring blood test abnormality at an IR of 5.85 (95% CI 4.91-6.97)/1000 PY. Of these, 64 and 61 discontinuations occurred within the first year and after the first year of treatment start, at IRs of 8.62 (95% CI 6.74-11.01) and 3.44 (95% CI 2.67-4.42)/1000 PY, respectively. Increasing age (in years), diabetes and liver disease were associated with anti-TNFα discontinuation after a monitoring blood test abnormality [adjusted hazard ratios of 1.02 (95% CI 1.01-1.04), 1.68 (95% CI 1.00-2.81) and 2.27 (95% CI 1.26-4.07), respectively]. Assuming a threshold of £20 000 per QALY gained, no monitoring was most cost-effective, but all extended periods were cost-effective vs. 3- or 6-monthly monitoring. Anti-TNFα drugs were uncommonly discontinued owing to abnormal monitoring blood tests after the first year of treatment. Extending the duration between monitoring blood tests was cost-effective. Our results produce evidence for specialist society guidance to reduce patient monitoring burden and healthcare costs.

Gluten Sensitivity Underlying Resistant “Laryngopharyngeal Reflux” Symptoms and Signs

Laryngopharyngeal reflux (LPR) is one of the most common conditions encountered in otolaryngology. Gluten sensitivity may mimic the signs and symptoms of LPR or act as an aggravating cofactor with LPR. Gluten sensitivity and food intolerance also have been implicated as conditions that may be associated specifically with LPR symptoms and signs resistant to traditional medical treatment. Medical management of LPR may be insufficient to control symptoms and laryngeal signs of reflux, constituting resistant LPR. Eliminating gluten from the diet could provide symptomatic relief to patients with gluten sensitivity and LPR that is not controlled adequately by current regimens. The purpose of our study was to investigate the relationship between gluten sensitivity and LPR. We aimed to evaluate reflux finding score (RFS) improvement following elimination of gluten from the diet in patients with resistant LPR who had positive blood tests associated with gluten sensitivity. Symptom improvement was also assessed following dietary gluten elimination. Lastly, we aimed to identify predictors for a positive response to a gluten-free diet. Adult patients who underwent gluten sensitivity testing for treatment-resistant LPR symptoms and/or signs were included. Patients with ≥1 positive test were advised to begin a therapeutic trial of a gluten-free diet. Subjects who chose not to trial a gluten-free diet or tested negative for gluten sensitivity markers served as controls. RFS was the primary outcome measure. One hundred ninety-seven patients were included; 81 trialed a gluten-free diet. Subjects who trialed the gluten-free diet were significantly more likely to demonstrate objective improvement in RFS (77.14% vs 43.88%), and report subjective improvement (55.41% vs 25.77%) than those who did not. RFS had decreased significantly from baseline at 1-3, 3-6, 6-12, and >12-month interval follow-up examinations in subjects who trialed a gluten-free diet. Comparison between subjects who trialed the gluten-free diet, tested positive for a gluten sensitivity marker but did not trial the gluten-free diet, and subjects who were negative for all gluten sensitivity markers revealed that a gluten-free diet was associated with a significantly greater percent improvement in RFS compared to controls at 1-3, 6-12, and >12-months. Gluten sensitivity can mimic or aggravate LPR. A gluten-free diet should be considered for patients with resistant LPR, especially if blood test abnormalities that suggest gluten sensitivity are identified. The diet should be maintained for a minimum of three months to demonstrate objective improvement using RFS.

Elective surgery cancellations in pediatric surgery: rate and reasons

IntroductionCanceling pediatric elective surgery leads to multiple disturbances regarding the inefficient operating room (OR) management, the financial repercussions, and the psychological impact on the patient and his family. This study aims to identify the reasons for cancellations among the pediatric population in our setting and suggest some convenient solutions.MethodsWe carried out a prospective and descriptive study over 12 months in the pediatric surgery department of Fattouma Bourguiba University Hospital.ResultsOne thousand four hundred twenty-six patients were scheduled for surgery at the pediatric surgery department, of whom 131 (9.2%) were canceled. Medical and anesthesia-related reasons accounted for 62.5% of all cancellations, followed by surgical reasons at 16%, organizational or administrative issues at 11.5%, and patient-related reasons at 10%. The most significant causes were upper respiratory tract infections (URTIs) in 36.6%, abnormal blood test results in 16%, and non-adherence to preoperative fasting in 9.2%.ConclusionsThe rate of pediatric elective surgery cancellations at Fattouma Bourguiba University Hospital was higher than the accepted average rate (5%). Therefore, to prevent these cancellations as much as possible, efforts should be made to promote children’s medical care, operation scheduling, and efficient institution resource utilization.

Retrospective analyses of routine preoperative blood testing in a tertiary eye hospital: could Choosing Wisely work in China?

AimsTo explore the possibility of implementing Choosing Wisely on ocular patients in China by investigating the prevalence of abnormalities in routine preoperative blood tests (RPBTs) and its turnaround time (TAT).MethodsData...

A multicentre study on the clinical characteristics of newborns infected with coronavirus disease 2019 during the omicron wave.

To investigate the clinical characteristics and outcomes of newborns infected with coronavirus disease 2019 (COVID-19) during the Omicron wave. From December 1, 2022, to January 4, 2023, clinical data were collected from neonates with COVID-19 who were admitted to 10 hospitals in Foshan City, China. Their epidemiological histories, clinical manifestations and outcomes were analysed. The neonates were divided into symptomatic and asymptomatic groups. The t test or χ2 test was used for comparisons between groups. A total of 286 children were diagnosed, including 166 males, 120 females, 273 full-term infants and 13 premature infants. They were 5.5 (0-30) days old on average when they were admitted to the hospital. These children had contact with patients who tested positive for COVID-19 and were infected through horizontal transmission. This study included 33 asymptomatic and 253 symptomatic patients, among whom 143 were diagnosed with upper respiratory tract infections and 110 were diagnosed with pneumonia. There were no severe or critical patients. Fever (220 patients) was the most common clinical manifestation, with a duration of 1.1 (1-6) days. The next most common clinical manifestations were cough with nasal congestion or runny nose (4 patients), cough (34 patients), poor appetite (7 patients), shortness of breath (15 patients), and poor general status (1 patient). There were no significant abnormalities in routine blood tests among the neonates infected with COVID-19 except for mononucleosis. However, compared with the asymptomatic group, in the symptomatic group, the leukocyte and neutrophil granulocyte counts were significantly decreased, and the monocyte count was significantly increased. C-reactive protein (CRP) levels were significantly increased (≥10 mg/L) in 9 patients. Myocardial enzyme, liver function, kidney function and other tests showed no obvious abnormalities. In this study, neonates infected with the Omicron variant were asymptomatic or had mild disease. Symptomatic patients had lower leucocyte and neutrophil levels than asymptomatic patients.

Possible Ameliorative Role of Spirulina platensis on Coagulation Factors, Lymphocytopenia, and Malnutrition in ICU Patients with COVID-19.

Considering the anti-viral effects of Spirulina platensis (Sp), this study investigated the impact of Sp on impaired blood biomarkers of patients hospitalized in the intensive care unit (ICU) with COVID-19. Therefore, 104 patients (aged 48-66; 61.5% male) were randomly assigned to the Sp (daily consumption of 5 g) or placebo group for two weeks. Linear regression analysis was employed to assess the differences in blood test results between the control and intervention groups among patients with COVID-19. Our results showed significant differences in certain hematological tests, including a higher level of hematocrit (HCT) and a lower platelet count (PLT) in the intervention group (p<0.05). The percentage of lymphocytes (Lym%) in serology testing was significantly different between the control and intervention groups (p=0.03). In terms of biochemical test analyses, Sp supplementation was associated with reduced levels of both blood urea nitrogen (BUN) and lactate dehydrogenase (LDH) (p=0.01). Furthermore, on day 14, the intervention group displayed significantly higher medians of serum protein, albumin, and zinc compared to the control group (p<0.05). Additionally, patients supplemented with Sp had a lower BUN-albumin ratio (BAR) (p=0.01). No immunological and hormonal differences were observed between groups following two weeks. Our analysis indicates that Sp supplementation may be effective in regulating some blood test abnormalities associated with COVID-19. This study was registered at ISRCTN as IRCT20200720048139N1.

THE INCIDENCE AND RISK FACTORS FOR ABNORMAL POSTOPERATIVE BLOOD TESTS FOLLOWING PRIMARY TOTAL JOINT REPLACEMENT: A SINGLE-CENTRE RETROSPECTIVE COHORT STUDY

Primary total joint arthroplasty (TJA) is an increasingly common and safe way of treating joint disease. Robust preoperative assessment improved intraoperative techniques and holistic rehabilitation contribute to an uneventful postoperative period. Despite there being evidence against the utility of postoperative blood tests, it is still often part of routine practice. We aim to evaluate the usefulness of these tests by investigating their incidence following TJA as well as identifying preoperative risk factors for abnormal blood test results postoperatively especially pertaining to anaemia and acute kidney injury (AKI).This is a retrospective cohort study of patients who had elective TJA between January and December 2019 at a tertiary centre. An independent student's t-test and Fisher's exact test was used to compare variables between the normal and abnormal postoperative results groups. An analysis of variance (ANOVA) was performed to identify risk factors for an abnormal blood test result. Analyses of receiver operating characteristic (ROC) curves and the area under the curve (AUC) were used to determine cut off values that could be suggestive of abnormal test results postoperatively.The study included 2721 patients with a mean age of 69 of which 46.6% were males. Abnormal postoperative bloods were identified in 444 (16.3%) patients. We identified age (≥65 years), female gender, ASA ≥ 3 as risk factors for developing abnormal postoperative blood tests. Preoperative haemoglobin (≤ 127 g/dL), haematocrit (≤ 0.395L/L) and potassium (≤ 3.7 mmol/L) were noted as cut-offs that could be predictive of postoperative anaemia or AKI respectively.The costs outweigh the benefits of ordering routine postoperative blood tests in TJA patients. Clinicians should risk stratify their patients and have a lower threshold for ordering blood tests in patients with one or more of the risk factors we have identified. These risk factors are age (≥65 years), females, ASA ≥ 3, preoperative haemoglobin (≤ 127 g/L), haematocrit (≤ 0.395L/L), and potassium (≤ 3.7 mmol/L).

Outpatient parenteral antimicrobial therapy (OPAT) in a safety-net hospital: Opportunities for improvement

Background: Parkland Health is a 900-bed safety-net hospital that serves Dallas County, Texas. It has an OPAT program in which patients are managed via self-administration (S-OPAT), home-health/hemodialysis (H-OPAT), and skilled nursing facilities (SNF-OPAT). We evaluated the reasons for unscheduled emergency department (ED) visits by patients in these groups to identify strategies to decrease unexpected healthcare utilization and to improve safety. Methods: We performed a retrospective chart review of all adult patients discharged from Parkland Health on OPAT between April and June 2021. Demographic, medical, and healthcare utilization information, including the date and reason of first unscheduled ED visit after discharge, was collected utilizing a standardized instrument. The institutional review board approved this study. Results: In total, 184 patients were discharged with OPAT. Among them, 32% were female and 55% identified as Hispanic; 41% were non-English speakers, and 45% were treated for a musculoskeletal infection. Among all OPAT models of care, 43.4% were S-OPAT patients, 31.5% were H-OPAT patients, and 25% were SNF-OPAT patients (Table 1). The groups differed, and fewer African Americans received H-OPAT. Also, 45% were being treated for musculoskeletal infections and were more likely to be discharged with H- or SNF-OPAT. In addition, 41% were being treated for endovascular infections and 21.7% were being treated for genitourinary infections. The total length of stay in the hospital was longer for SNF-OPAT patients and shorter for S-OPAT patients (Table 2). Among 184 OPAT patients, 41 patients (22.2%) had an ED visit: 17.3% SNF-OPAT patients, 27.6% H-OPAT patients, and 21.3% S-OPAT patients (Table 2). ED visits were attributed to intravenous (IV) access–related problems (12 of 41, 29.0%), worsening of known infection (3 of 41, 7.3%), and abnormal blood test results (2 of 41, 4.9%). Also, 24 ED visits (58%) were not related to underlying infection or OPAT. However, when examined by the OPAT care model, 41% of ED visits among S-OPAT patients, 20% among H-OPAT visits, and 25% among SNF-OPAT visits were related to IV access issues. Among S-OPAT ED visits pertaining to IV access, 71% were for minor issues such as dressing changes or line occlusion or malfunction. Conclusions: One-fifth of OPAT patients had an unscheduled ED visit, of whom 20%–41% had issues with IV access. Many of these visits could be avoided with enhanced outreach to patients discharged with OPAT and improved ambulatory capabilities to provide standard services related to maintenance of IV access.Disclosures: None

Risk stratified monitoring for methotrexate toxicity in immune mediated inflammatory diseases: prognostic model development and validation using primary care data from the UK

ObjectiveTo develop and validate a prognostic model to inform risk stratified decisions on frequency of monitoring blood tests during long term methotrexate treatment.DesignRetrospective cohort study.SettingElectronic health records within the UK’s...

The clinical significance of macrolide resistance in pediatric Mycoplasma pneumoniae infection during COVID-19 pandemic.

Mycoplasma pneumoniae (MP) is a commonly occurring pathogen causing community-acquired pneumonia (CAP) in children. The global prevalence of macrolide-resistant MP (MRMP) infection, especially in Asian regions, is increasing rapidly. However, the prevalence of MRMP and its clinical significance during the COVID-19 pandemic is not clear. This study enrolled children with molecularly confirmed macrolide-susceptible MP (MSMP) and MRMP CAP from Beijing Children's Hospital Baoding Hospital, Capital Medical University between August 2021 and July 2022. The clinical characteristics, laboratory findings, chest imaging presentations, and strain genotypes were compared between patients with MSMP and MRMP CAP. A total of 520 hospitalized children with MP-CAP were enrolled in the study, with a macrolide resistance rate of 92.7%. Patients with MRMP infection exhibited more severe clinical manifestations (such as dyspnea and pleural effusion) and had a longer hospital stay than the MSMP group. Furthermore, abnormal blood test results (including increased LDH and D-dimer) were more common in the MRMP group (P<0.05). Multilocus variable-number tandem-repeat analysis (MLVA) was performed on 304 samples based on four loci (Mpn13-16), and M3562 and M4572 were the major types, accounting for 74.0% and 16.8% of the strains, respectively. The macrolide resistance rate of M3562 strains was up to 95.1%. The prevalence of MRMP strains in hospitalized CAP patients was extremely high in the Baoding area, and patients infected with MRMP strains exhibited more severe clinical features and increased LDH and D-dimer. M3562 was the predominant resistant clone.

E030 Rheumatologists beware! Digital ischaemia as a presenting feature in metastatic ovarian cancer

Abstract Background/Aims Digital ischaemia is an umbrella term to describe the spectrum of acral vascular phenomena irrespective of aetiology, ranging from temporary (as in Raynaud’s phenomenon) to permanent (necrosis). It can be the presenting feature in multiple cancer types, and can be present with or without other features of connective tissue disease. Methods A 54-year-old woman was referred to Rheumatology with a four-day history of acute pain and ischaemic discolouration of all her fingertips bilaterally. There was no history of Raynaud’s phenomenon and no other clinical features of connective tissue disease. She had never smoked. There was a family history of breast cancer in her maternal aunt. She was admitted under vascular surgery for urgent review. All ten fingertips were ischaemic, with a capillary refill time of greater than five seconds. The history was otherwise significant for abdominal bloating, altered bowel habit and fatigue. Examination revealed normal peripheral pulses with no bruits, normal heart sounds and chest sounds. Her abdomen was soft with a mildly enlarged liver. Results FBC, U&amp;E, and LFTs showed no abnormalities. CRP, ESR, ANA, serum protein electrophoresis and complement levels were all normal. Blood tests for ANCA, rheumatoid factor and anti-CCP were also negative. Lupus anticoagulant, anti-cardiolipin and anti-B2-glycoprotein were all negative. The tumour marker CA125 was markedly elevated at 837kU/L (0.0-35.0kU/L). A CT abdomen &amp; pelvis showed a large right-sided adnexal mass with multiple enhancing peritoneal and omental nodules and moderate ascites. Biopsy of a metastatic deposit in the omentum revealed high grade serous ovarian adenocarcinoma. Partial improvement in digital ischaemia was achieved with iloprost and maintenance apixaban and sildenafil. Four cycles of carboplatin and paclitaxel chemotherapy produced near-complete resolution of digital ischaemia symptoms, corresponding to a fall in her CA125 level and reduction in the size of the ovarian mass and intra-abdominal metastases on CT. Ten cases of digital ischaemia associated with ovarian cancer have been described prior to this. The age of onset ranged from 45 to 71, with a median age of 56. Most patients had digital ischaemia without features of connective tissue disease. Four had no blood test abnormalities other than a raised tumour marker CA125. The time from onset of digital ischaemia to diagnosis of ovarian cancer ranged from less than one week to 2 years, with a median time of four months. Conclusion This case study supports previous findings that patients with digital ischaemia associated with ovarian cancer may have normal markers of inflammatory or rheumatological disease. Marked therapeutic responses can be achieved with systemic anti-cancer therapies. Therefore, underlying cancer should be suspected in patients with new-onset or worsening digital ischaemia over the age of 45. A high index of suspicion is required - rheumatologists beware! Disclosure J.H. Miller: None. P. Merry: None.

Variations in Biochemical Parameters in Diabetic and Non-Diabetic Patients of Septicemia

Septicemia is an infection caused by poisoning of blood by bacteria and is a prevalent disease in Pakistan. However, there is limited understanding of the pathogenesis of abnormal blood, liver and renal chemistry tests in septicemia. Objective: To determine variations in respective LFTs and RFTs and CBCs of diabetic and non-diabetic patients of septicemia. Methods: A descriptive, observational, cross-sectional research was directed, involving 101 participants diagnosed with septicemia. Study setting was Mayo Hospital Lahore. A specially designed Performa was used to record data, including liver function tests, renal function tests, and complete blood count for each patient. The data were analyzed using the latest version of SPSS. Results: In this study 45/101 patients of septicemia had diabetes. LFTs were also same for both non-diabetic and diabetic patients except Albumin which was low in diabetic patients but normal in non-diabetic patients. CBC were equally deranged in all diabetic and non-diabetic patients. Conclusions: This research provides important understandings into the variations of LFTs and RFTs and CBCs in diabetic and non-diabetic patients with septicemia. The findings suggest that while LFTs are similar between the two groups, there is a difference in albumin levels, highlighting the need for further investigation into the role of diabetes in septicemia.

P628 Tofacitinib in pediatric ulcerative colitis: a retrospective multi-center experience from the Paediatric IBD Porto group of ESPGHAN

Abstract Background Tofacitinib, a Janus kinase (JAK) inhibitor, has recently been approved for treatment of moderate to severe active ulcerative colitis (UC) in adults. Data on efficacy and safety in pediatrics are limited. In this multicenter study from the Paediatric IBD Porto group of ESPGHAN, we describe the short-term effectiveness and safety of tofacitinib in an international pediatric IBD cohort. Methods Retrospective review of children (2-18 years) diagnosed with UC treated with tofacitinib from 15 pediatric centers internationally. Primary outcome was corticosteroid-free clinical remission (PUCAI&amp;lt;10) at week 8, with secondary outcomes including clinical response (≥20 point decrease in PUCAI), colectomy rate and safety. Primary outcome was calculated utilizing non-response imputation (NRI), whereby drug cessation for any reason was considered treatment failure. Results 78 patients (43 (55%) female, mean age at diagnosis 12.5 (±2.7) years, median disease duration 20 months (IQR 10.3-38.8)), all with previous biologic failure, including 20/78 (26%) with previous failure of three biologic classes. 15/78 (19%) patients achieved corticosteroid-free clinical remission at week 8 with a further 18/78 (23%) demonstrating clinical response. 9/78 (12%) underwent colectomy by week 8, and 21/78 (27%) by week 24. Twelve adverse events were reported including five infective (three of which deemed possibly related to treatment – zoster, HSV-2 cheilitis and septic arthritis), one case of pancreatitis, and abnormal blood test results in 5 children (anemia, lymphopenia, elevated hepatic transaminases and hypercholesterolemia). Conclusion In this largest real-life cohort of tofacitinib in pediatric UC to date, tofacitinib seemed effective in at least 19% of highly refractory patients by week 8. Adverse reactions and safety were largely consistent with adult data.

Real-Life Effectiveness and Safety of Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: A Single-Center 16-Week Study.

The treatment of severe atopic dermatitis (AD) includes cyclosporine and recently approved biologics and small molecules. Among these, upadacitinib is a selective inhibitor of Janus kinase 1, approved for the treatment of severe AD in adolescents/adults. Upadacitinib has shown efficacy and safety in several phase 3 clinical trials, but data on real-life patients are still lacking. We conducted a retrospective real-life observational study to evaluate the effectiveness and safety of upadacitinib up to week 16 in a cohort of both bio-naïve and bio-experienced patients. This study was carried out by analyzing the AD database records of an Italian referral hospital. Thirty-eight patients were included in this study, and 35 completed 16weeks of treatment. At week 16, out of 35 patients, the percentages of Eczema Area and Severity Index (EASI) 50, EASI 75, EASI 90 and EASI 100 responses were 94.29, 91.43, 74.29, and 60%, respectively. A decrease of at least 4 points from baseline of itch-NRS was reported by 94.74 and 91.43% of patients at weeks 8 and 16. Regarding the safety of upadacitinib, 26.32% of patients experienced at least one adverse event (AE), and a total of 13 AEs were recorded, including blood test abnormalities and papulopustular acne. None of our patients interrupted the drug because of an AE. We observed higher rates of EASI75/EASI90/EASI100 responses at week 16, compared with data from clinical trials. The safety profile of upadacitinib was favorable, as no AEs leading to discontinuation were experienced by our patients up to week 16.

Efficacy of Kami Guibi-tang as an Add-On Therapy to Acetylcholinesterase Inhibitor for Cognitive Function in Mild Alzheimer's Disease: A Pilot Study.

Kami Guibi-tang (KGT), a traditional Korean herbal medicine is mainly used to treat insomnia and nervousness. Acetylcholinesterase inhibitors (AChEIs) are the main treatments for mild Alzheimer's disease (AD), a degenerative brain disease. However, currently no drug can fundamentally treat AD or reverse the advanced cognitive decline. This clinical study explored the efficacy and safety of adding KGT to AChEI for cognitive function in mild AD. This was a pilot study for a larger randomized, double-blind, placebo-controlled trial. Participants between 55-90 years diagnosed with mild AD were recruited from Kyung Hee University Hospital at Gangdong, Seoul, Korea. They were randomized to receive either KGT or placebo for 24 weeks, in addition to their regular AChEI. The primary outcome was treatment efficacy, as assessed by the relative amount of change over the study period in total scores on the Dementia version of the Seoul Neuropsychological Screening Battery (SNSB-D). Changes in SNSB subscores were assessed as secondary outcomes. Safety parameters, including adverse events and abnormalities in blood tests, electrocardiograms, and brain magnetic resonance imaging were also monitored. Between March 2018 and November 2020, seven participants each in the KGT group and the placebo group completed the 24-week trial. There were no significant changes in SNSB-D total or subindex scores for either group (p = 0.69 and 0.63, respectively), and no significant differences were observed between them (p=0.71). No adverse events related to KGT were reported. We also compared and analyzed the results of a previous pilot study conducted on amnestic mild cognitive impairment (aMCI) using protocol of this study. The aMCI group showed a significant improvement in the total SNSB-D score, especially in the memory domain, compared to the mild AD group (p = 0.04 and 0.02, respectively). The Korean Mini-Mental State Exam and Korean Instrumental Activities of Daily Living scores also significantly improved in the aMCI group (p = 0.01 and 0.02, respectively). Compared to placebo, adding KGT to AChEI did not significantly improve cognitive function in SNSB in patients with mild AD. We suggest that KGT would have a positive effect on patients with early stages of cognitive impairment such as aMCI. The findings could assist design larger, longer-term clinical trials of KGT use in elderly patients with mild AD. This study was registered in the Korean Clinical Trial Registry on December 26, 2017, with the CRIS approval number KCT0002904.

Efficacy and Safety of Adding Kami Guibi‐tang to Acetylcholinesterase Inhibitor for Cognitive Function in Mild Alzheimer’s Disease: A Pilot, Randomized, Double‐blind, Placebo‐controlled Trial

AbstractBackgroundThe main treatments for mild AD have been acetylcholinesterase inhibitors(AChEI). However, no current drugs can fundamentally treat AD or reverse advanced cognitive decline. This clinical study was conducted to explore the efficacy and safety of adding Kami Guibi‐tang(KGT) to AChEI for cognitive function in elderly patients with mild AD.MethodThis study was designed as the pilot for a larger randomized, double‐blind, placebo‐controlled study. Elderly participants aged 55 to 90 years diagnosed with mild AD. Subjects were randomized to receive either KGT or placebo for 24 weeks, in addition to their regular AChEI. The primary study outcome was treatment efficacy as assessed by the relative amount of change over the study period in total scores on the Dementia version of the Seoul Neuropsychologic Screening Battery(SNSB‐D). Changes in SNSB sub‐scores such as the Korean Mini‐Mental State Exam(K‐MMSE) and in scores on the Korean version of Quality of Life‐Alzheimer’s Disease(KQoL‐AD), and the Caregiver‐Administered Neuropsychiatric Inventory(CGA‐NPI) were assessed as secondary outcomes. We also monitored patient safety parameters including adverse events and abnormalities in blood tests, electrocardiogram, and brain magnetic resonance imaging tests.Result7 participants in the KGT group and 7 participants in the placebo group completed the 24‐week trial. There were no significant changes in SNSB‐D total/subindex scores, KQoL‐AD or CGA‐NPI scores for either group, and no significant differences were observed between the two groups. K‐MMSE scores were decreased significantly within each group, but were not significantly different between groups. No adverse events related to KGT were reported. In addition, we compared / analyzed the results of a previous pilot study conducted on amnestic mild cognitive impairment(aMCI) with the same protocol as this study. The aMCI group showed a significant improvement in the total SNSB‐D score(especially in the memory domain) and K‐MMSE and Korean Instrumental Activities of Daily Living scores compared with the mild AD group.ConclusionAdding KGT to AChEI did not significantly improve cognitive function in SNSB compared to placebo. Although KGT did not show cognitive improvement in the patients with mild AD in this study, we suggest that KGT would have a positive effect on the patients with early stages of cognitive impairment such as aMCI.