2nd Visit Research Articles

Myopia Progression Among School-Aged Children in the COVID-19 Distance-Learning Era.

To investigate the effect of online learning and other environmental factors on myopia progression during the Coronavirus pandemic (COVID-19). A retrospective cohort study from 2018 to 2021. Data from children aged 6-14 were gathered during three visits: pre-pandemic, at the beginning, and during the pandemic. Demographics (hours spent on screens for educational, recreational purposes, outdoors, and type of screen), best-corrected distance visual acuity (BCDVA), uncorrected distance visual acuity (UCDVA), and cycloplegic refraction were gathered. Of 150 patients, 70 [47%] were boys. The mean age was 11 (2.4) years. Participants mainly used mobile phones (62%) and had insufficient outdoor play (88%). Of the 300 eyes, 221 (74%) showed myopia progression. A significant difference in spherical equivalent (SE) was found between pre-pandemic and post-pandemic periods (-0.29 (0.23) D vs -0.40 (0.11) D; p =0.023). Additionally, UCDVA showed a difference between the initial and 1st follow-up visits (0.57 (0.37) vs 0.64 (0.36), p =0.001), and the first and 2nd follow-up visits (0.64 (0.36) vs 0.70 (0.36), p =0.001). Significant hazard ratio for change in SE in patients with higher age (>9 years), (HR [95% confidence interval (CI)], 0.71 [0.51-0.84]), greater recreational screen usage (HR [95% CI], 1.26 [1.15-1.66]), and insufficient outdoor time (HR [95% CI], 1.45 [1.35-1.67]). Myopia progression was accelerated during the COVID-19 pandemic. Younger age, prolonged screen use, and insufficient outdoor time contributed to increased myopia progression. However, the type of device used had no significant effect.

EFFECTIVENESS OF LIRAGLUTIDE IN REDUCING BODY WEIGHT AND IMPROVING GLYCEMIC CONTROL IN PATIENTS WITH T2DM

Objective: This study aimed to determine the effects of Liraglutide on glycosylated hemoglobin (HbA1c) and body weight in patients with type 2 diabetes. Material and Methods: A prospective observational study was conducted in a private tertiary healthcare setting. A total of 58 adult patients with T2DM using oral anti-diabetic agents with or without insulin were enrolled in the study from November 2020 to April 2022. Liraglutide was administered at a dose of 0.6 mg/day which was raised to 1.2 mg/day after 1 week and later to 1.8 mg/day depending upon patient preferences and tolerability. Patients were assessed for changes in their body weight, fasting blood glucose (FBG) level, random blood glucose (RBG) level, and HbA1c at the 1st and 2nd follow-up visits of the 8th and 16th week, respectively. Results: At the 16th week, the mean weight was 100.78±17.56 vs 102.74±17.26 and 104.11±17.95 at the 8th week and baseline visit, revealing a significant difference across three-time points [F(1.4, 36.45)=8.57, p=0.003]. A post hoc pairwise analysis showed that weight significantly decreased from baseline and 16th-week follow-up visits (p=0.011). Similarly, a significant decrease was observed in mean HbA1c across three-time points [F (2, 39.40) =8.81, p=0.001]. Mean HbA1c at 16th week was 6.61±1.13% vs 8.09±1.43% at baseline (P = 0.001). No significant reduction in FBG, RBG, blood pressure, and serum lipid profile were observed. Moreover, no major side effects occurred in any patient. Conclusion: Liraglutide is an effective and well-tolerable drug in improving glycemic control, causing significant weight loss in the study population when used as a monotherapy or in combination therapy. KEYWORDS: Liraglutide, Glucagon-like peptide-1 agonist, Type 2 diabetes mellitus, Glycemic control, Weight loss

Комбинированная терапия больных рецидивирующим циститом с применением комплекса природных антимикробных пептидов и цитокинов: первые результаты

Urinary tract infections (UTIs) remain an important problem in urology due to their high prevalence and tendency to relapse. The improvement of the treatment outcomes in chronic cystitis is still relevant.A total of 91 patients were included in prospective, multicenter, randomized, comparative, controlled study. They were randomized into three groups: in the comparison group 1 (n=32) basic therapy was administered for 5 days. In the comparison group 2 (n=28) basic therapy was combined with rectal suppositories Superlymph 25 IU once a day for 10 days. In the main group (n=31) basic therapy in combination with rectal suppositories Superlymph 10 IU once a day for 20 days were prescribed. The basic therapy included a combination of two antimicrobial drugs: fosfomycin trometamol 3.0 g at night once on the first day of therapy, and furazidin 100 mg three times a day after meals for 5 days. Pathogenetic treatment was not prescribed in comparison group 1, but administered for 10 days and 20 days in comparison group 2 and main group, respectively.After the completion of etiotropic therapy, a significant effect in all groups was shown. At the same time, at the 2nd visit, there was a significantly better results in patients who received Superlymph rectal suppositories, both at a dose of 10 U and at a dose of 25 U, without any differences between two schemes. The frequency and severity of cystitis symptoms at the end of etiopathogenetic therapy in the main group was less pronounced than in the comparison groups (p=0.0001), and a significant difference was found between comparison groups 1 and 2 (p=0.0001). The use of Superlymph significantly improved the parameters of microcirculation in the urethra, however, there was no difference between comparison group 2 and main group.Etiopathogenetic therapy, including Superlymph rectal suppositories at a dose of 10 IU and 25 IU in patients with chronic cystitis, can significantly improve the results of combination therapy. Analysis of the symptoms score of acute cystitis showed the superiority of longer-term use of Superlymph rectal suppositories at a reduced dosage (10 units). Peptide-cytokine therapy led to a significant improvement in local microcirculation in comparison group 2 and the main group.

A non-invasive risk score including skin autofluorescence predicts diabetes risk in the general population

Increased skin autofluorescence (SAF) predicts the development of diabetes-related complications and cardiovascular disease. We assessed the performance of a simple model which includes SAF to identify individuals at high risk for undiagnosed and incident type 2 diabetes, in 58,377 participants in the Lifelines Cohort Study without known diabetes. Newly-diagnosed diabetes was defined as fasting blood glucose ≥ 7.0 mmol/l and/or HbA1c ≥ 6.5% (≥ 48 mmol/mol) or self-reported diabetes at follow-up. We constructed predictive models based on age, body mass index (BMI), SAF, and parental history of diabetes, and compared to results with the concise FINDRISC model. At 2nd visit to Lifelines, 1113 (1.9%) participants were identified with undiagnosed diabetes and 1033 (1.8%) participants developed diabetes during follow-up. A model comprising age, BMI and SAF yielded an AUC of 0.783 and was non-inferior to the concise FINDRISC model, which had an AUC of 0.797 to predict new diabetes. At a score of 5.8, sensitivity was 78% and specificity of 66%. Model 2 which also incorporated parental diabetes history, had an AUC of 0.792, and a sensitivity of 74% and specificity of 70% at a score of 6.5. Net reclassification index (NRI) did not improve significantly (NRI 1.43% (− 0.50–3.37 p = 0.15). The combination of an easy to perform SAF measurement with age and BMI is a good alternative screening tool suitable for medical and non-medical settings. Parental history of diabetes did not significantly improve model performance in this homogeneous cohort.

Therapeutic effects of sialendoscopy for diagnosis and treatment of hyposalivation patients: a retrospective study

BackgroundHyposalivation is disease with multiple symptoms. This disease is hard to be diagnosed and to be treated, and there are not enough clinical protocols to cure the disease. In this study, we propose our own treatment protocols which aim not only to cure the disease but also to care for the disease-related symptoms.MethodsAt the 1st visit, we collect patient-related information. This procedure includes an intraoral exam, patient history taking, VAS value and unstimulated whole saliva (UWS) measurement, and salivary buffer test. Following the interview and oral examination, objective results are obtained by radiological image, CT, and sialoscintigraphy. At the 2nd visit, we analyze radiographic images including neck CT and salivary scintigraphy. These images can allow accurate diagnosis and help the patients to better understand the current condition. Depending on the severity of symptoms and patient’s discomfort, we try a surgical approach at the 3rd visit, sialendoscopy.ResultsWith treatment, we can manage the discomfort of patients in daily life. The VAS value of hyposalivation patients dropped gradually with the trial of sialendoscopy. In the case of Sjogren’s syndrome patients, the treatment efficacy has been decreased with low reactivity of treatment. The true meaning of this treatment is in not only curing the disease, but also caring for the disrupted patients. Overall, the amount of UWS increased with the progress after the procedure. Especially in the lower UWS at the 1st visit, there was a more significant increase after the procedure.ConclusionAlthough many factors that cause hyposalivation have not been identified, the efficacy of sialendoscopy to relieve discomfort in hyposalivation patients has been observed. However, treatment was more difficult and complicated in the group of patients with systemic disease. This study will not only present a treatment protocol for hyposalivation patients, but also consider methods for diagnosing more precisely and improving treatment efficacy. Hyposalivation is a curable and manageable disease in some cases, so interpretation between the clinician and the patient is important.

Building research capacity for sickle cell disease in Africa: Lessons and challenges from establishing a birth cohort in Tanzania.

Sickle Cell Disease (SCD) is a known public health burden in sub-Saharan Africa (SSA). The manifestation of SCD starts in early childhood and if not well-managed may lead to early death (before the age of 5 years). Understanding the underlying mechanisms that influence early SCD manifestation is of great importance for early disease and intervention management which will in turn, reduce both morbidity and mortality rates in children. One approach of achieving this is by establishing SCD birth cohorts that can be followed for a period of time (3–5 years) whilst documenting necessary information related to early childhood illnesses. To date, there are few SCD birth cohorts in Africa. To address this gap, we have established a birth cohort of babies with and without SCD (with sickle cell trait and healthy babies). These babies are followed up for 3 years with their study visits synchronized to the immunization schedule. During enrollment and follow-up visits, information on demographic, clinical, and laboratory parameters are collected. To date, we have enrolled a total of 341 babies with and without SCD. Out of these, a total of 311, 186, 133, 81, 44, and 16 babies have returned for their 1st, 2nd, 3rd, 4th, 5th, and 6th visits, respectively. We have collected both demographic and clinical information for these babies at enrollment and during follow-up. We have also utilized this platform to learn on the best approaches of establishing and maintaining a research birth cohort in an African context. We have analyzed the practical issues pertaining to the integration of the birth cohort with the immunization platform which seems to be the most effective and sustainable strategy for maintaining a birth cohort in our context.

Impact of time-of-day on judo-specific performance

In judo tournaments, matches for each weight category are held on the same day and athletes competing at the finals have to compete at different times of the day. This study aimed to investigate the effect of time-of-day on judo specific performance and the changes in physiological load following judo specific performance. Fourteen male judo athletes (age 19.1±1.4 years) voluntarily participated in the study. At the 1st visit, anthropometrical measurements and familiarization procedures were conducted and the athletes’ chronotype was determined. Athletes performed the Special Judo Fitness Test (SJFT) during 2nd and 3rd visits. Athletes randomly performed two consecutive SJFTs with 15 min intervals at 10:00h, which is the official start time of matches, and at 18:00h which is the time when the finals start. During SJFT applications, athletes heart rate (HR), blood lactate (bLA), body temperature and rate of perceived exertion (RPE) were monitored. The changes in total throw numbers (F1, 13= 1.32, p=0.27) and SJFT index (F1, 13= 0.30, p=0.59) were not different between morning and evening. There were similar changes in bLA (F4, 52=0.66, p=0.63), RPE (F1, 13=1.42, p=0.26) and body temperature (F1.4, 18.0=1.18, p=0.31) which were measured before and after the tests. However, HR measured in the evening were higher compared to morning measurement at all measurement times (F1, 13=10.28, p=0.01), but there was no difference in SJFT throws (F3.8, 48.8=0.49, p=0.74). In conclusion, different times of the day did not affect judo specific performance as well as physiological variables in judo athletes.

The impact of adenoid hypertrophy on pulmonary functions measured using impulse oscillometry in preschool-age children.

To assess pulmonary impedance [resistance (zR5, zR20, R5-20, Fres, and AX) and reactance (zX5 and zX20)] using impulse oscillometry (IOS) in children with adenoid hypertrophy (AH) and its association with the degree of AH, and to evaluate subsequent changes in pulmonary function 3 months after adenoidectomy. This prospective cross-sectional study was conducted with 170 preschool-age children [110 with AH and 60 sex- and age-matched healthy controls (HCs)]. Pulmonary function was analyzed using IOS at baseline (1st visit) in all participants and 3 months after adenoidectomy (2nd visit) in patients who underwent the operation. The IOS parameters of zR5, zR20, R5-20, Fres, and AX were higher, but zX20 was lower, in children with AH compared to the HCs (p < 0.05 for all). The parameters of zR5, Fres, and AX were higher in children with grade IV AH than in those with grade I (p < 0.001). zR5, zR20, R5-20, Fres, and AX decreased, but zX20 increased, after adenoidectomy (2nd visit) compared to baseline (1st visit) (p < 0.05). Post-adenoidectomy (2nd visit) zR5, AX, Fres values were higher in children with AH compared to baseline values in the HCs (1st visit) (p < 0.05). The area under the ROC curve (AUC) value for estimating adenoidectomy was 0.741 forzX20 (CI 0.648-0.834,p < 0.001) with a cut-off value of ≤ -3.21, sensitivity of 68.8%, and specificity of 70%. This study shows that IOS is a useful method for demonstrating subclinical bronchial obstruction in preschool-age children with AH with greater pulmonary impedance (resistance and reactance). Pulmonary impedance decreased 3 months after adenoidectomy, but remained higher than in the HCs. The IOS parameter of X20 may be predictive of adenoidectomy. This study evaluated the pulmonary functions of children with adenoid hypertrophy (AH) using impulse oscillometry (IOS) and the association with the scale of AH. Pulmonary functions were analyzed using IOS. The main IOS parameters include resistances (zR5 and zR20), reactance (zX5 and zX20), R5-20 (resistance at 5 Hz minus resistance at 20 Hz), resonant frequency (Fres), and AX. Fres is the point at which reactance is zero and is measured in Hz (1/s). The Reactance Area (AX - "Goldman Triangle") represents the integrated low-frequency respiratory reactance magnitude between 5 Hz and Fres. Faster frequencies of R (~ 20 Hz) reflect larger airways, regarded as resistance around the central airways. Lower frequencies of R (~ 5 Hz) providing information around the entire (small and large) airways. Peripheral (small) airway resistance is defined by R5-20. IOS parameters of zR5, zX20, Fres, and AX differed among AH grades I-IV and compared to the HCs (p < 0.001 for all).

Sleep Quality and New Onset Postpartum Hypertension

Background: Chronic sleep deficiency is a stressful situation which has an association with high blood pressure. After delivery, mothers have disrupted sleep due to frequent awakenings by their infants. What is not known is how significant this relationship is inwomen during the postpartum period as well as other factors that may affect their Sleep quality. Sleep quality is a measure of duration and disruption.Aim and Objectives: Study is aimed at determining the relationship between Sleep quality and new onset postpartum hypertension. The specific objectives are; to determine the Sleep quality of mothers in the postpartum period using the Pittsburgh Sleep quality index (PSQI), identify factors that affect Sleep quality of mothers in the post-partum period and determine blood pressure patterns of mothers in the postpartum period.Materials and Methods: This was a longitudinal study. Using systematic random sampling, a sample size of 126 women were recruited between June and August 2016 in the Postnatal clinic of the 37 Military Hospital. Written consent was obtained from participants. Sitting blood pressure was checked and recorded and a modified form of the Pittsburgh Sleep quality index (PSQI) was used to assign a global score for Sleep quality. A global score of more than 5 indicated poor Sleep quality in that mother. Clients were first recruited at the 1st postnatal visit with follow-up at the 2nd routine postnatal visit (6weeks). Only mothers whose blood pressures were normal during pregnancy and upon discharge from hospital were included. For categorical data, Pearson’s chisquare test was used for comparisons and logistic regression as used to determine significant factors that contribute to new onset hypertension in postpartum women. A P-value less than 0.05 was considered significant.Results: Majority of mothers (92.1% and 90.5% at first and second visits respectively) had poor Sleep quality. Mothers who slept away from their babies at the sixth week visit had better sleep. Mean global Sleep quality scores had no significant association with new onset hypertension but mean scores of some Age , p=0.001, OR =1.20 (C.I: 1.09-1.32) and some sleep components sleep disturbance, p=0.041, OR =1.86(C.I: 1.02-3.37), and use of sleep medicine, p=0.031, OR =1.54 (C.I:1.04- 2.29) were significantly associated with new onset postpartum hypertension.Conclusion: Global poor Sleep quality is not associated with increased odds of new onset hypertension but the Sleep quality components, sleep disturbance and increased use of sleep medicine, were significantly associated with new onset hypertension in mothers.

Effect and possible mechanisms of metformin as adjuvant therapy in the management of tuberculosis: A prospective study

ObjectiveTuberculosis (TB) is a deadly infectious ailment causing mortality and morbidity globally. The study objectives were to investigate the effect and possible mechanisms of metformin as adjuvant therapy in the management of tuberculosis. MethodsTB patients attending HAHC hospital, New Delhi (India) and had T2DM (Type-2 diabetes mellitus) comorbidity were enrolled. Study participants were categorized into metformin non-users and metformin users depending on the presence of metformin in their prescription. Whole blood was used for immunophenotyping of total T-Cells (CD45+CD3+), Helper T-Cells (Th) (CD45+CD3+ CD4+) and Cytotoxic T Cells (Tc) (CD45+CD3+CD8+) through flow cytometry. BD FACS Verse and BD LSR II were used for sample acquisition. ResultsEstimation of T-Cells (CD45+CD3+), Helper T-Cells (Th) (CD45+CD3+ CD4+) and Cytotoxic T Cells (Tc) (CD45+CD3+CD8+) levels at 2nd visit showed a larger T-Cells (CD45+CD3+) (p < 0.001), Helper T-Cells (Th) (CD45+CD3+ CD4+) (p = 0.004) and Cytotoxic T Cells (Tc) (CD45+CD3+CD8+) (p = 0.001) in metformin users in comparison with metformin non users. The use of metformin had significant effect on the conversion of sputum smear (p = 0.0318, unpaired t-test) in comparison with metformin non-users. ConclusionMetformin has potential to develop long-term immunity against TB infection and responsible for its protective impact in TB + T2DM comorbid patients. Metformin therapy improved T cells, Helper T cells and cytotoxic T cells in TB + T2DM comorbid patients and it can be prescribed as an adjuvant antitubercular medication unless contraindicated.

HOME-BASED PHYSIOTHERAPY PROGRAM FOR SHOULDER FUNCTION, QUALITY OF LIFE AND PHYSICAL CAPACITY IN FEMALE BREAST CANCER SURVIVORS

Breast cancer is one of the most common cancer which is prevalent in females worldwide. Mastectomy is a common surgical method used to treat breast cancer. Women may experience many complications post-surgery such as reduced range of motion, pain, lymphedema, shortening of muscles, fatigue and decreased functional capacity which affects the quality of life of the breast cancer survivors. Early physical therapy may benefit the patient in all these aspects. This study aimed to evaluate the effect of Home-based tailor-made protocol in breast cancer survivors. This interventional study was conducted in SDM Hospital, Dharwad, Karnataka. Convenient sampling was done. 40 eligible participants were included in the study. Duration of the study was 6 weeks. The participants were evaluated on EORTC scale for quality of life, SPADI for shoulder function and pain and 6MWT for functional capacity. Baseline evaluation was done on the day of discharge post mastectomy, 2nd visit was done after 4 weeks of discharge and 3rd evaluation session was done at 6th week. The participant received a call on weekly basis. Data was statistically analyzed. There was a significance in effect size and the p-values. Physical therapy improved shoulder function, quality of life and functional capacity post 6 weeks of home-based intervention. Home-based Physiotherapy Program for 6 weeks improves shoulder range of motion, quality of life and physical capacity in Female Breast Cancer Survivors and prevents breast cancer related lymphedema, shortening of muscles, pain at the operated site and chest complications.

Retinopathy of Prematurity –Recent Screening Status in a Tertiary Care Hospital of Bangladesh

Retinopathy of prematurity (ROP) results in severe visual impairment and blindness in newborns. In the recent days with development of the technology to save preterm infants, it’s incidence is increasing in both developed and developing countries. Only appropriate and timely screening program can prevent ROP and reduce the functional impairment of eyes. The aim of this study was to see the recent screening status of the hospital so that future plan of ROP treatment and prevention can be taken more appropriately. This prospective study was conducted from January 2018 to December 2018 in neonatology department of Dhaka Shishu (Children) Hospital. Neonates with gestational age &lt; 34wks or birth weight, &lt;1800gms were screened for ROP. First screening was done at 4 wks chronological age or 32 wks postmenstrual age of neonate which comes later. Then subsequent screening was done according to the findings upto 45 wks of postmenstrual age. The findings regarding incidence of ROP, types of ROP and treatment modalities of ROP along with other variables were recorded. Data were analyzed with SPSS version 17. Total 116 cases were screened for ROP. Mean gestational age was 30.7±2.4 wks and mean weight was 1420.9±313.8 gms. According to gestational age, 14 (12%) neonates with gestational age &lt; 28 wks had ROP. Nine (7.8%) cases had ROP in both gestational age groups of 29-30wks and 31-32wks. Only 5(4.3%) cases with gestational age&#x0D; 33-34wks had ROP. According to birth weight, neonates with birth weight &lt;1000 gms had ROP in 1(0.9%). Twenty four (20.7%) and 12(10.3%) cases had ROP in weight groups of 1000-1499gms and 1500-1800 gms consequently. Thirty one (26.8%) cases were found ROP in their first visit. In 6(5.1%) cases ROP were found in 2nd and subsequent visits. Among the neonates, A-P ROP was present in 15(12.9%) cases, type -1 in 9 (7.7%), type- 2 in 11 (9.6%) and RD in 2(1.7%) cases. Three (2.6%) cases of type 2 ROP turned into type- 1 ROP in subsequent visits. Among the ROP cases, total 29(78%) needed treatment. Laser therapy was given in 7(24%) cases, both laser and intravitreal bivacizumab in 17 (59%) cases, only intravitreal bivacizumab in 2(7%) cases and surgery along with medical treatment was advised for 3(10%) cases. Thirty four (92%) cases had good outcome and 3 (8%) infant had no vision.The incidence of ROP was 31.9% in this study. Most of cases were A-P ROP then Z2S3 ROP. Laser plus intravitreal bivacizumab were given in most of the cases with ROP. The more number of advanced stages of ROP and a large number of babies required treatment indicates that these babies came to us in advanced stages due to irregularity and missing of follow-up.

P-221 Prognostic value of CD3+CD8+ T lymphocytes in advanced and metastatic PDAC

T cells traffic into the tumor microenvironment, and exhibit cytotoxicity against tumor cells. Infiltration by cytotoxic CD3+CD8+ lymphocytes is associated with increased OS and DFS in PDAC (Orhan, 2020). There are some studies reflecting the prognostic value of circulating CD3+CD8+ cells in other cancer localisations. The proliferation potential of circulating CD8+ T cells was found to be a significant predictor for PFS in small cell lung cancer (An, 2019). The positive correlation between high CD3+CD8+ T cells and clinical results indicated the role in the prognosis of gastric cancer patients (He, 2017). We conduct one institution clinical trial to evaluate the prognostic and predictive value of different T lymphocyte subsets and other cells in the peripheral blood in patients with PDAC. A cohort of 105 pts with advanced inoperable and metastatic PDAC was evaluated in this analysis. All patients undergoing systemic treatment in our institution and who signed informed consent were enrolled in the study. All patients were treated with mFOLFIRINOX or gemcitabine regimen for the 1st line. Blood samples were collected for analysis of T cell subsets, including CD19, CD3+ CD56+, CD8+ CD57+, CD3+ CD57+, CD3, CD3+ CD4+, CD3+ CD8+, CD3+ CD4- CD8, CD3- CD56+ CD16+, CD3- CD56+ CD16-, CD4+ CD25+ CD127+/-, CD4+ FOXP3+, CD8+ CD25+ CD127+/-, CD8+ FOXP3+ T cells by flow cytometry at initial diagnosis before chemotherapy. Results were estimated according to the age, sex, differentiation grade, presence of distant metastasis, number of metastatic sites, presence of ascites, body mass index, CA 19-9 values, chemotherapy regimen received, number of lines given after disease progression. Univariate Cox regression was used and survival curves were analyzed using the Kaplan–Meier method. There was a strong relationship between the presence of distant metastasis, the number of metastatic sites with PFS in our cohort. OS in addition to that was strongly associated with age, CA 19-9 level, number of following treatment lines. A quantity of circulating CD3+CD8+ cytotoxic T lymphocytes measured before treatment was found to be of prognostic value for both PFS (p=0.046) and OS (p= 0.031). Patients with higher than median 424,19 cells/MCL value demonstrated significantly better PFS and/or OS in the whole cohort as well as in the mFOLFIRINOX arm (p=0.037 for OS), in staging groups 4 (p=0,04 for PFS p=0.016 for OS) and 3 (p=0,049 for PFS) and G2 differentiation (p=0.03 for OS) arm. In gemcitabine arm and G3 tumors, low and high CD3+CD8+ survival differences didn‘t stand out. Lymphocyte count and CD3- CD56+CD16- T lymphocyte values before treatment also impact PFS but not OS. No other subset values at 1st visit and changes in means between 1st visit and 2nd visit 2 months later revealed an impact on PFS and OS. The positive correlation between high CD3+CD8+ T cells and clinical outcome may show its‘ prognostic significance in advanced and metastatic pancreatic cancer patients and together with other well-known biomarkers, it could help in clinical decision making.

Diurnal variation on tear stability and correlation with tear cytokine concentration

PurposeTo investigate the effect of time of day on tear evaporation rate (TER) and tear break-up time, and its possible relationship with the concentration of inflammatory tear molecules (cytokines) in healthy subjects. MethodsParticipants with healthy ocular surfaces attended 3 visits, including the screening visit (V0), the 2nd visit (V1) and the 3rd visit (V2). There were 7-day intervals between visits. Participants with Dry Eye Disease (DED) were excluded by using appropriate clinical tests during V0. Clinical evaluation (TER and Non-Invasive Tear Break-Up Time (NITBUT)) and tear collection were performed during V1 and V2, between 9 and 10AM and 3-4PM. The relative humidity and temperature of the examination room were also measured. The tear fluid concentrations of 15 cytokines were measured by multiplex bead analysis. ResultsSeven men and 10 women (mean age ± S.D; 25.1 ± 6.63 years old) participated in the study. There were no differences in neither the TER and NITBUT outcomes, nor humidity and temperature among times or visits. Eleven out of the 15 cytokines measured were detectable in tear fluids in > 50% of the participants. In the tear levels, no significant (p > 0.05) inter- and/or intra-day differences were detected for EGF, fractalkine, IL-1RA, IL-1β and IP-10. However, significant inter-day differences were found in the tear levels of IL-10 (p = 0.027), IFN-γ (p = 0.035) and TNF-α(p = 0.04) and intra-day differences in the tear levels of IL-8/CXCL8 (p = 0.034) and MCP-1 (p = 0.002). A significant correlation between TER and IL1-β, IL-2, and Fractalkine (p = 0.03, p = 0.03 and p = 0.046, respectively) was found at V1. ConclusionsNITBUT and TER values had no significant variability over the course of a day (AM versus PM), or on different days in healthy participants when humidity and temperature were constant. However, some tear molecule levels did show inter- and intra-day variability, having an inconsistent and moderate correlation with TER diurnal variation.

MP35-09 LINEAR RELATIONSHIP BETWEEN THE TIME OF DOSING AND 24-HOUR AVERAGE CONCENTRATION OF TOTAL TESTOSTERONE IN MEN TREATED WITH AN ORAL TESTOSTERONE UNDECANOATE CAPSULE (JATENZO®)

You have accessJournal of UrologyCME1 May 2022MP35-09 LINEAR RELATIONSHIP BETWEEN THE TIME OF DOSING AND 24-HOUR AVERAGE CONCENTRATION OF TOTAL TESTOSTERONE IN MEN TREATED WITH AN ORAL TESTOSTERONE UNDECANOATE CAPSULE (JATENZO®) Ronald Swerdloff, Jason Kovac, Christina Wang, Marc Gittelman, B. Woun Seo, Jay Newmark, Nestor Rohowsky, and Robert Dudley Ronald SwerdloffRonald Swerdloff More articles by this author , Jason KovacJason Kovac More articles by this author , Christina WangChristina Wang More articles by this author , Marc GittelmanMarc Gittelman More articles by this author , B. Woun SeoB. Woun Seo More articles by this author , Jay NewmarkJay Newmark More articles by this author , Nestor RohowskyNestor Rohowsky More articles by this author , and Robert DudleyRobert Dudley More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002589.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In 2019, a novel, first-in-class testosterone (T) replacement therapy (TRT), oral testosterone undecanoate (TU) was approved by the US FDA for the treatment of male hypogonadism. Concordance studies have shown that total T at 6 hrs after the morning TU dose best corresponds to the total T 24-hr average concentration (Cavg). Hence, product labeling directs clinicians to measure serum T 6 hrs after a morning TU dose. However, testing at 6 hrs may pose scheduling difficulties for some men. Therefore, the relationship between other T assay time points and Cavg was examined to see if a conversion factor could be derived to convert T values collected at earlier or later times than directed in product labeling (i.e., 6 hrs) into values that reflect true Cavg. METHODS: Hypogonadal men, age 18–65 y/o, were recruited into a randomized, open-label, multicenter, dose-titration trial. Dose titration was based on Cavg calculated from serial pharmacokinetic (PK) samples. Patients had two dose adjustments based Cavg. Because of the need for titration, there were three different PK visits. Ratio between the different timepoints and Cavg were determined for the oral TU PK samples following morning drug administration. RESULTS: With the values from all three PK days pooled, there was a linear relationship between T concentrations at 4, 6, and 9 hrs and Cavg (r2=0.35). The r2 for the three visits were similar: 1st PK visit, r2=0.33; 2nd PK visit, r2=0.36; final PK visit, r2=0.35. A factor based on the following equation was derived to enable conversion of T values assessed at a times other than 6 hrs (i.e., time of blood draw) into a close approximation of Cavg: (1.870−0.14)×(hours after AM dose). Table summarizes the conversion factors to normalize T to Cavg at various T assay time points. To illustrate, for a serum T value drawn at either 4 or 8 hrs after the morning oral TU dose, the normalized (or corrected) Cavg concentration would be approximately 75% or 133% of the drawn value, respectively. CONCLUSIONS: While dose titration for this novel oral TRT is based on a serum T level drawn at 6 hours after the AM dose, the T level can be estimated from samples obtained at other timepoints using a conversion factor. Source of Funding: Clarus Therapeutics © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e590 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ronald Swerdloff More articles by this author Jason Kovac More articles by this author Christina Wang More articles by this author Marc Gittelman More articles by this author B. Woun Seo More articles by this author Jay Newmark More articles by this author Nestor Rohowsky More articles by this author Robert Dudley More articles by this author Expand All Advertisement PDF DownloadLoading ...

Association between smoking cessation and alterations in forced expiratory volume in one second (FEV1). A Follow-Up Study from a Greek Tobacco Cessation Clinic.

Cigarette smoking is the most important preventable cause of several diseases such as malignancies, pulmonary and cardiovascular diseases. Smoking cessation is now supported by both behavioral counseling and medical pharmacotherapy and is the only effective approach for slowing down an accelerated decline in forced expiratory volume in one second (FEV1). Our study aims to examine changes in forced expiratory volume in one second (FEV1) after smoking cessation for smokers attending our smoking cessation clinic their correlation to smokers' demographic characteristics. 114 smokers (48 males and 66 females), with a mean age of 48.36±10.49 years, were enrolled. They were classified in 4 groups, according to their age; <40 years (Group Α), 41-50 years (Group Β), 51-60 years (Group C), >60 years (Group D) and underwent Spirometry on the 1st day of visit, one month (2nd visit) and, 3 months later (3rd visit). Statistically significant increase in FEV1 values at the 2nd and 3rd visit compared to the 1st visit was observed in smokers who quit smoking in Group Α, B and C (p<0.05). In addition, a statistically significant decrease in FEV1 values at the 2nd and 3rd visit compared to the 1st visit was noticed in smokers who continued smoking in Group B, C and D (p<0.05). Smoking cessation achieved through smoking cessation support led to the improvement of FEV1 values within 3 months. The greatest benefit was observed in smokers under the age of 60.

IDF21-0517 Fast eGFR Decline is Associated With a Considerable Reduction of Hemoglobin A1c in Patients with Type 2 Diabetes

Background: Chronic kidney disease (CKD) is diagnosed by the persistent presence of elevated urinary albumin excretion (albuminuria), low estimated glomerular filtration rate (eGFR), or other manifestations of kidney damage. The slope of eGFR changes over time varied widely among individuals with type 1 diabetes and had been shown as very fast, fast, moderate, or slow decline; however, less evidence was found in participants with T2D. Aim: To explore the factors related to eGFR changes during 3–12 month follow-ups in patients with T2D and an eGFR≥30 mL/min per 1.73 m2 after multivariable adjustments, including the effect of hyperglycemia and hyperfiltration. Method: This was an observational, multicenter, longitudinal, retrospective study based on medical records included in the diabetes Share-care system database of Ruijing Diabetes Chain Hospitals (RDCH), five primary care medical institutes of China. Patients with T2D, aged 18–75 years, and had 2 or 3 HbA1c and eGFR measurements in 12 months were enrolled. According to the change of serum creatinine or eGFR from 2nd or 3rd visit to baseline, patients were categorized into five groups, relatively stable (RS, control group): eGFR change –3.49–3.49 mL/min per 1.73 m2; fast decline (FD): eGFR change >–10.00 mL/min per 1.73 m2; moderate decline (MD): eGFR change –10.00– –3.50 mL/min per 1.73 m2; moderate increase (MI): eGFR change 3.50–10.00mL/min per 1.73 m2 and fast increase (FI): eGFR change >10.00 mL/min per 1.73 m2. Results: The final analytic cohort consisted of 4,020 individuals with T2D. The age-adjusted prevalence of hyperfiltration were 48.43, 41.31, 39.57, and 40.21% for patients aged 18–49, 50–59, 60–69, and 70–75 years. The hyperfiltration rate was significantly higher in patients with higher baseline HbA1c of ≥10.0 (53.05%), 9.0–9.9 (49.17%), 8.0–8.9 (44.21%), and 7.0–7.9% (39.65%) than in patients with a baseline HbA1c<7.0% (32.15%). The median eGFR changes from baseline were 0.00, –20.13, –6.41, 6.68, and 19.43 mL/min per 1.73 m2, respectively, from the RS group (16.67%) to FD (29.65%), MD (12.54%), MI (13.91%), and FI (27.24%) groups. Compared with the RS group, significantly more participants in the FD group had a higher baseline HbA1c and a larger HbA1c change from baseline. Multinomial logistical regression analysis showed an HbA1c decrease of ≥–3.00% (OR: 2.509), –2.99 to 2.00% (OR: 1.758), −1.99 to 1.00% (OR: 1.590), hyperfiltration (OR: 1.913), micro-(OR: 1.338) and macroalbuminuria (OR: 1.736) were associated with a higher chance for developing FD (P < 0.05). Discussion: Hyperfiltration was common in patients with suboptimal glycemic control shown as HbA1c ≥ 7.0%. HbA1c decreases were associated with a higher chance of developing FD, despite the coexisting effect of hyperfiltration, microalbuminuria or macroalbuminuria. The implication of creatinine-based GFR estimates is limited in hyperglycemia status and may lead to excessive optimism about renal function. The eGFR value after glycemic control would be more clinically meaningful.

Quality of knee strengthening exercises performed at home deteriorates after one week

BackgroundTo compare the performance (as determined by lower extremity kinematics) of knee exercises in healthy middle-aged and older individuals immediately after instruction and one week later.MethodsThis is a cross-sectional study in a laboratory setting. Nineteen healthy volunteers (age [y] 63.1 ± 8.6, mass [kg] 76.3 ± 14.7, height [m] 1.7 ± 0.1) participated in this study. High speed video and reflective markers were used to track motion during four exercises. The exercises were knee flexion, straight leg raise, and “V “in supine position, and hip abduction in side lying position. All participants received verbal and tactile cues during the training phase and the therapist observed and, if necessary, corrected the exercises. Upon return a week later the participants performed the same exercises without any further instructions. Knee and hip sagittal and rotational angles were extracted from the motion capture. A repeated measures t-test was used to compare the motions between two visits.ResultsParticipants demonstrated more knee flexion during straight leg raise and “V in” exercises at the 2nd visit compared to the 1st visit (both p < 0.05). During the “V out” exercise, they performed more external rotation (p < 0.05) while they showed more internal rotation during the “V in” exercise at the 2nd visit compared to the 1st visit.ConclusionsExercise performance declined significantly in healthy middle-aged and older individuals one week after instruction. This decline occurred despite an instructional exercise sheet being given to every participant. Other approaches designed to help individuals retain the ability to perform rehabilitative exercises correctly need to be explored.

Effect of Rivaroxaban in Stroke Prevention in Patient with Atrial Fibrillation due to Valvular Heart Disease

Objective: To observe the effect of rivaroxaban in patients with atrial fibrillation due to valvular heart diseases for proper anticoagulation to avoid stroke. Methodology: An observational follow up study was carried out in Cardiology Department of Aziz Fatimah Hospital, Faisalabad from February to August 2021. The study included 36 patients of valvular heart disease with atrial fibrillation on warfarin, whose INR was not tested during the last 4 months due to lack of facility nearby. All patients with non valvular atrial fibrillation were excluded .All patients were given rivaroxaban to replace warfarin. These patients were followed up for 6 months in the OPD of the same hospital to observe the end points including stroke and bleeding episodes and ischemic changes on ECG. Results: Total of 36 patients of mean age and SD of 56±7.00 years were followed up. Out of which 20 were male and 16 were female subjects.Not a single incident of stroke or bleeding episode or bruises was observed during the 6 month follow up. On echocardiographic examination, none of the patients showed clot in the left atrium. Left atrium size and LV ejection fraction remained the same, during next visit. LA size 44±5 and 44±6 on 1st and second visit respectively (p value =0.059) No other ischemic changes found in the ECG of any patient. International normalization ratio (INR) mean and SD was 2.1± 0.9, 2.2± 0.8, on 1st and 2nd visit of follow up respectively and no significant difference was noted between INR values. Conclusion: Rivaroxaban can be given safely to the patients with valvular heart disease with atrial fibrillation, particularly in patients who cannot get the INR checked on regular basis.

Prevalence and predictors for high blood pressure during covid-19 vaccination in Thailand

Funding AcknowledgementsType of funding sources: None.BackgroundThe Thai government mandates BP measurement prior to COVID-19 vaccination to ensure safety for all vaccinees. However, there is neither large study regarding the prevalence of high BP nor CV complication during COVID-19 vaccination. Purpose To describe the prevalence of high BP defined as SBP≥140 or DBP≥90 mmHg, predictors for high BP and outcome during vaccination day. Methods We enrolled all vaccinees at a Thai hospital, during June 2021. We reviewed medical records and compared vaccination day BP with BP from prior 2 visits extracted from the computer database. We used a fully automated non-invasive sphygmomanometers. Diagnosis of hypertension were extracted from the past records using ICD-10 code (I1-). Grade of hypertension were defined according to the ESC guideline 2018. Prior well-controlled BP was defined as SBP < 130 and DBP < 80 mmHg in the 2nd prior visit. Results There were 2308 vaccinees during the period and 2307 with complete data for analysis. Female accounted for 57%. The mean age was 49.69 ± 17.44 years old. Body mass index were 25.77 ± 14.10 kg/m2. Prime COVID-19 vaccines shot accounted for 73.6%. All vaccinees were pre-assigned to receive either ChAdOx1 nCoV-19 or CoronaVac: 54.2% and 45.8%, respectively. Essential hypertension was previously diagnosed in 21.5%, and 0.3% for secondary hypertension. The vaccination day mean SBP and DBP were 135.23 ± 17.97 and 76.14 ± 12.06 mmHg. There were 56%, 33%, 10.3% and 0.4% classified as normotension, gradeI, II and III hypertension, respectively. Estimated prevalence for any hypertension and grade II or III hypertension were 44% (95% CI 41.9-46.0) and 11% (95% CI 9.7-12.3), respectively. There were 1,335 participants with at least 2 previous BP measurements prior to the vaccination day. We compared BP change between group of 142 vaccinees who had grade II or III hypertension and group of 1193 vaccinees with normotension or grade I hypertension at vaccination day. There was a significant increase in SBP and DBP at vaccination day in both groups, and significantly higher BP from prior visits in grade II or III hypertension group (Figure 1). After adjusting for age, gender, type of vaccine, dose, previous diagnosis of hypertension and prior well-controlled BP, we found that the previous diagnosis of hypertension and prior well-controlled BP were independent predictors for grade II or III hypertension at vaccination day: OR 2.93 (95% CI 1.97 – 4.36) and 0.47 (95% CI 0.23 – 0.96), respectively. There were 3.38% who required on-site medical attention due to high BP, resulting in a delay to vaccination of 1 hour (IQR, 0.5- 2). Vaccination was postponed in 0.56%. All were diagnosed with hypertensive urgency by the onsite physicians. ConclusionsPrevalence of high BP was relatively high among Thai vaccinees but without CV event at vaccination day. BP measurement may be unnecessary in asymptomatic vaccinees with previously well-controlled BP. Figure. SBP change between two groups Figure. DBP change between two groups