Body Surface Research Articles

Short- and long-term reproducibility of body surface gastric mapping using the Gastric Alimetry® system.

Many diagnostic tests for gastroduodenal symptoms, such as gastric emptying scintigraphy (GES), gastric emptying breath tests (GEBT), and electrogastrography (EGG) show variable intra-individual reproducibility over time. This study investigated the short- and long-term reproducibility of body surface gastric mapping (BSGM), a non-invasive test for assessing gastric function, in controls and patients with chronic gastroduodenal disorders. Participants completed three standardized BSGM tests using Gastric Alimetry® (Alimetry, New Zealand). The test encompassed a fasting baseline (30 min), a 482 kCal standard meal, and a 4 h postprandial recording. The first two tests were >6 months apart and the last occurred ~1 week after the second test, to evaluate long and short-term reproducibility. Fourteen patients with upper gastrointestinal symptoms and 14 healthy controls were recruited. There were no significant differences in any BSGM metrics between the tests at short and long term (all p > 0.180). Lin's concordance correlation coefficients (CCC) for the primary metrics were high, ranging from 0.58 to 0.96, with intra-individual coefficients of variance (CVintra) ranging from 0.2% to 1.9%. Reproducibility was higher, and intra-individual variation lower, than in previous studies of GES (CCC = 0.54-0.83, CVintra = 3%-77%), GEBT (CVintra = 8%-11%), and EGG (CVintra = 3%-78%). BSGM spectral metrics demonstrate high reproducibility and low intra-individual variation at both short and long term, with superior results to comparable tests. The high reproducibility of Gastric Alimetry supports its role as a diagnostic aid for gastric dysfunction and a reliable tool for evaluating treatment outcomes and disease progression over time.

Using laparoscope to remove an ectopic intrauterine device in the anterior wall of urinary bladder: A case report

BACKGROUND An intrauterine device (IUD) is a contraceptive device placed in the uterine cavity and is a common contraceptive method for Chinese women. However, an IUD may cause complications due to placement time, intrauterine pressure and other factors. Ectopic IUDs are among the most serious complications. Ectopic IUDs are common in the myometrium and periuterine organs, and there are few reports of ectopic IUDs in the urinary bladder, especially in the anterior wall. CASE SUMMARY A 52-year-old woman was hospitalized due to a urinary bladder foreign body found via abdominal ultrasound and computed tomography (CT) examination. The patient had a 2-year history of recurrent abdominal distension and lower abdominal pain, accompanied by frequent urination, urgency, dysuria and other discomfort. Ultrasound examination revealed foreign bodies in the bladder cavity, with calculus on the surface of the foreign bodies. CT revealed a circular foreign body on the anterior wall of the urinary bladder, suggesting the possibility of an ectopic IUD. After laparoscopic exploration, an annular IUD was found in the anterior wall of urinary bladder, and an oval calculus with a diameter of approximately 2 cm was attached to the surface of the bladder cavity. The IUD and calculus were successfully and completely removed. The patient recovered well after surgery. CONCLUSION Abdominal ultrasound and CT are effective methods for detecting ectopic IUDs. The IUD is located in the urinary bladder and requires early surgical treatment. The choice of surgical method is determined by comprehensively considering the depth of the IUD in the bladder muscle layer, the situation of complicated calculus, the situation of intravesical inflammation and medical technology and equipment.

A rare case of extensive hydrofluoric acid burn.

Hydrofluoric acid (HF) is a strongly corrosive, highly toxic, and highly dangerous mineral acid. Burns with over 1% total body surface area (TBSA) caused by anhydrous HF can lead to deep tissue damage, hypocalcaemia, poisoning, even death. In recent years, HF has become one of the most common substances causing chemical burns and ranks as the leading cause of death from chemical burns. Herein, we report a rare case with 91% TBSA burns caused by 35% HF. The patient developed complications such as shock, severe hypocalcaemia, metabolic acidosis, and respiratory failure. Multidisciplinary team consultation (burns, respiratory medicine, nephrology, infectious disease, and pharmacy) was performed immediately after admission. An individualized diagnosis and treatment plan was developed for the patient. The patient was given intensive care, blood volume monitoring, tracheotomy, fluid resuscitation, continuous blood purification, anti-infective and analgesic treatments, intravenous and percutaneous calcium supplementation, early rehabilitation training, psychological rehabilitation and other treatments. To prevent the wound from deepening, large-area debridement and skin grafting were performed early after injury. A large dose of 10% calcium gluconate was injected into the patient in divided doses, and the wound was continuously treated with wet dressings. Multiple surgical debridements, negative pressure wound treatment, biological dressings, and Meek skin grafting were performed. After most of the wounds (approximately 85% TBSA) healed, the patient was discharged from the hospital and continued to undergo dressing changes at a local hospital. The patient was followed up 3 months after discharge. All the wounds healed well, and the patient basically regained functional independence in daily life.

A seismic ambient noise data classification method based on waveform and frequency-wavenumber analysis: Application to reliable geological interpretation adjacent to Well Songke-2, Northeast China

Passive seismic interferometry techniques enable the retrieval of virtual shot gathers at receiver locations. However, it is difficult to distinguish body waves from surface waves in seismic ambient noise data, which leads to failed dispersion measurements, artificial deep reflections, and misleading geologic interpretations. We develop a new method that uses the waveforms and their corresponding f- k spectra to identify body waves and surface waves. Our technique functions as a data classification procedure before wavefield retrieval and subsequent imaging. A field data example is conducted to test the feasibility of this technique. The field data results demonstrate that our technique can reconstruct satisfactory high signal-to-noise-ratio wavefields for reliable imaging and interpretation purposes. The method can also serve as a validation tool for identifying surface wave-related artificial events in the obtained virtual source reflection image. The marker boundaries of the Songliao Basin in Northeast China are interpreted in the obtained profile and are in agreement with the well-logging data. In addition, two normal faults are detected, which correspond to the extensional rift environment during the early Cretaceous.

Precision Medicine Approach Using Triple Combination Antifungal Therapy for Fusarium Brain Abscesses and Endocarditis in an Adult Burn Patient.

We report a management strategy for disseminated Fusarium solani fungal infection in an adult 35% total body surface area burn patient with brain abscesses and concomitant pulmonic valve endocarditis resulting in the longest survival reported in a burn patient. Early in his hospital course, the patient was diagnosed with a Fusarium burn wound infection with concomitant fungemia and was treated with a prolonged course of intravenous (IV) antifungal monotherapy. Shortly thereafter, he developed focal neurologic deficits and was found to have brain abscesses on MRI. He underwent emergent craniotomy with debridement, and triple antifungal therapy was initiated. Transesophageal echocardiography demonstrated pulmonic valve vegetations, which resolved with triple antifungal therapy. Disseminated Fusarium solani infection is quite rare with mortality approaching 100%. Given the rarity of this disease process, there are no established antifungal treatment guidelines. However, this patient survived for approximately 1 year after diagnosis with treatment including source control via craniotomy and debridement coupled with prolonged courses of combination antifungal therapy (given the near pan-resistance of his fungal infection). Pharmacogenomic testing was utilized to establish the patient's metabolism of voriconazole and dosing adjusted accordingly to improve the efficacy of the combination therapy. To our knowledge, an adult burn patient surviving this length of time after Fusarium brain abscesses with disseminated infection has not been previously described.

Self-expandable transcatheter valve is a potentially useful option for a failing small surgical aortic bioprosthetic valve.

Trans-catheter aortic valve implantation inside a failing surgical aortic valve bio-prosthesis has become an alternative for patients at high risk for redo surgical aortic valve replacement. However, the correlation between the size of the failing surgical aortic valve and the occurrence of prosthesis-patient mismatch after trans-catheter implantation is still controversial. The aim of this study is to analyze and report the results in Japanese patients. Thirty patients who underwent trans-catheter aortic valve implantation inside a failing surgical aortic valve at our hospital were retrospectively reviewed with results from echocardiography and computed tomography. The patients' mean age was 84.5 ± 4.8years. The mean body surface area was 1.42 ± 0.13 m2. The cohort was divided into two groups according to the size of the failing bio-prosthesis: small (≦19mm) and large (> 19mm). There were no significant differences in mean pressure gradient (12.2 ± 4.0mmHg vs. 11.1 ± 1.2mmHg; p = 0.54) and effective orifice area index (1.00 ± 0.26cm2/m2 vs. 0.99 ± 0.25cm2/m2; p = 0.92) between the groups at 6months after trans-catheter implantation. The incidence of moderate (38.5% vs. 28.6%; p = 0.59) and severe (0% vs. 7.1%; p = 0.33) prosthesis-patient mismatch was equivalent. There was no significant difference in survival between the two groups (log-rank test p-value = 0.08). Trans-catheter implantation inside a failing small aortic valve did not increase the frequency of prosthesis-patient mismatch in this Japanese cohort.

Advanced age worsens respiratory function and pulmonary inflammation after burn injury and this correlates with changes in the fecal microbiome in mice.

Cutaneous burn injury in the elderly is associated with poor clinical outcomes and increased pulmonary-related complications. We and others have shown that burn injury triggers a cascade of inflammatory mediators which increase gut permeability and dysbiosis of the fecal microbiota and this is more dramatic in the aged. Since cross-talk between intestinal microbes and the lung, termed the "gut-lung axis," impacts immunity and homeostasis in the airway, we hypothesized that the increased intestinal dysbiosis in age and burn injury may contribute to excessive pulmonary inflammation and poor prognosis after injury. To explore this hypothesis, we used a clinically relevant murine model of burn injury in which young and aged mice are subjected to a 12% total body surface area dorsal scald burn or sham injury. 24 hours after injury, lung function was assessed and lungs and feces were collected for analysis of inflammatory mediators and fecal microbial species. The results show that, when compared to younger mice, burn injury in aged mice triggers a decline in respiratory function and exacerbates pulmonary inflammation. In addition to heightened levels of the neutrophil recruiting chemokine CXCL1, aged mice displayed a profound increase in the pro-inflammatory protein, calprotectin, in the lung after burn injury. Comparison of the fecal microbiome and inflammatory markers in the lung revealed unique, age-dependent, correlation patterns between individual taxa and pulmonary inflammation. Taken together, these findings suggest that the post-burn dysbiosis of the gut flora in aged mice may contribute to the changes in pulmonary inflammatory profiles.

Predicting Reduction Mammaplasty Total Resection Weight With Machine Learning.

Machine learning (ML) is a form of artificial intelligence that has been used to create better predictive models in medicine. Using ML algorithms, we sought to create a predictive model for breast resection weight based on anthropometric measurements. We analyzed 237 patients (474 individual breasts) who underwent reduction mammoplasty at our institution. Anthropometric variables included body surface area (BSA), body mass index, sternal notch-to-nipple (SN-N), and nipple-to-inframammary fold values. Four different ML algorithms (linear regression, ridge regression, support vector regression, and random forest regression) either including or excluding the Schnur Scale prediction for the same data were trained and tested on their ability to recognize the relationship between the anthropometric variables and total resection weights. Resection weight prediction accuracy for each model and the Schnur scale alone were evaluated based on using mean absolute error (MAE). In our cohort, mean age was 40.36 years. Most patients (71.61%) were African American. Mean BSA was 2.0 m2, mean body mass index was 33.045 kg/m2, mean SN-N was 35.0 cm, and mean nipple-to-inframammary fold was 16.0 cm. Mean SN-N was found to have the greatest variable importance. All 4 models made resection weight predictions with MAE lower than that of the Schnur Scale alone in both the training and testing datasets. Overall, the random forest regression model without Schnur scale weight had the lowest MAE at 186.20. Our ML resection weight prediction model represents an accurate and promising alternative to the Schnur Scale in the setting of reduction mammaplasty consultations.

Comparison of eGFR Equations to Guide Dosing of Medications for Kidney Transplant Recipients.

Clinicians caring for kidney transplant recipients (KTRs) most commonly use estimated glomerular filtration rate (eGFR) to guide medication dosing as it is the most readily available measure of kidney function. Which eGFR equations provide the most accurate medication dosing guidance for KTRs remains uncertain. We studied 415 stable KTRs in Canada and New Zealand. Participants completed same-day measurements of creatinine and cystatin C and measured GFR (diethylenetriaminepentaacetic acid). Chronic Kidney Disease Epidemiology Collaboration, European Kidney Function Consortium, and transplant-specific eGFR equations were compared with both Cockcroft-Gault creatinine clearance (CrCl) and measured GFR. eGFR equations were assessed both indexed to a standardized body surface area (BSA) of 1.73 m2 (milliliter per minute per 1.73 m2, as is conventional reporting from most clinical laboratories) and nonindexed (milliliter per minute) accounting for actual BSA. The primary outcome was the proportion of medication dosing discordance relative to Cockcroft-Gault CrCl or measured GFR for 8 commonly prescribed medications. Stratified analyses were performed on the basis of obesity status. Nonindexed eGFR equations (milliliter per minute) resulted in substantially lower medication dosing discordance compared with indexed eGFR equations (milliliter per minute per 1.73 m2). These findings were most pronounced among KTRs with obesity, in whom underdosing was frequent. When compared with Cockcroft-Gault CrCl, the lowest proportion of discordance was found with the nonindexed 2023 transplant-specific equation. When compared with measured GFR, the lowest proportion of discordance was found with the nonindexed 2021 Chronic Kidney Disease Epidemiology CollaborationCr/CysC equation. Nonindexed eGFR values accounting for actual BSA should be used by clinicians for medication dosing in KTRs. These findings may inform KT providers about which eGFR equations provide the safest, most accurate medication dosing guidance for KTRs.

Clinical and instrumental characteristics of psoriatic arthritis in men and women. Data from a cohort observational study

To study and compare the clinical and imaging characteristics of psoriatic arthritis (PsA) in men and women. The study included 956 PsA patients observed in the Russian register, 411 (43%) men and 545 (57%) women. The average age of men/women was 46.0±16.50/50.7±17.20 years (p<0.001), the duration of PsA was 9.9±6.4/10.3±7.6 years (p>0.05), the age at the time of PsA establishment was 37.1±12.30/41.8±13.5 years (p<0.001). Rheumatological examination, X-ray of the pelvis, hands, feet were performed, the LEI, plantar fascia tenderness, body surface area (BSA), body mass index (BMI), CRP, HLA-B27 were determined. Patients filled out assessment scales of pain (Pain), disease activity (patient global assessment of disease activity - PGA), questionnaires HAQ-DI. The indices of Disease Activity in PSoriatic Arthritis (DAPSA), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), criteria of minimal disease activity (MDA) were evaluated. The following differences in the course of PsA in men/women were revealed: X-ray sacroiliitis was detected in 175 (42.6%)/153 (28.1%); p<0.001; the presence of erosions of the joints of the hands and feet - 138 (33.6%)/170 (31.2%); p=0.435; LEI≥3 - 34 (11.4%)/78 (20.9%); p=0.001; Pain - at 48.5±22.60/51.5±22.80 mm VAS; p=0.043; PGA - 50.2±23.07/54.0±21.91 mm VAS; p=0.010; moderate and severe functional disorders (HAQ-DI) were more often observed in women (p=0.002 and p<0.001, respectively); the average value of DAPSA is 26.4±16.8/31.9±22.58; p<0.001; average BASDAI value: 2.7±2.83/1.8±2.78; p<0.001; MDA was achieved in 13 (3.2%)/22 (4.1%); p=0.486; BSA>10% - 54 (13.1%)/102 (18.7%); p=0.021; comorbid diseases - 154 (37%)/277 (51%); p<0.001. At the time of inclusion in the register, the proportion of patients receiving biologic disease-modifying anti-rheumatic drugs was higher in the group of men. Our data, based on a large cohort study, demonstrate that PsA debuts in women at a later age than in men, the course of the disease is characterized by higher activity of peripheral arthritis, more pronounced functional disorders and a high prevalence of comorbid diseases. This creates a heavier burden of PsA in women and indicates that gender is an important characteristic of the patient that should be used to predict the course, therapeutic response and progression of the disease.

Pulsatile corticoid therapy reduces interictal epileptic activity burden in children with genetic drug-resistant epilepsy.

Corticosteroids and adrenocorticotropic hormone (ACTH) are the therapy of choice to treat infantile spasms. However, systematic studies about their use in other types of childhood epilepsies remain rare and ACTH can have serious side effects. This study compares the interictal epileptic activity (IEA) burden (% of electroencephalography (EEG) time with IEDs) in children with genetic drug-resistant epilepsy before and after a standardized treatment with pulsatile corticoid therapy (PCT). Children with drug-resistant epilepsy underwent a standardized protocol for PCT with cycles of high-dose dexamethasone (20 mg/m2 body surface) intravenously. Patients were hospitalized for 3 days per PCT cycle and EEGs were obtained before initiation of treatment (baseline) and during the hospitalization around the time of every second cycle. EEG recordings during sleep and wakefulness were obtained. IEA burden was compared before and after PCT. Secondary outcome measures included the sleep spindle rate, the seizure frequency and subjective evaluation in a standardized interview. In the cohort of 24 children (10 female, 6.2 ± 3.4 years), IEA burden was lower in the EEG after PCT compared to the baseline (baseline: 5.4% [0.7-97.3] vs. after PCT: 1.5% [0-96.9], p = 0.001, d = -0.41). Sleep physiology expressed by sleep spindles improved after PCT with enhanced fast spindle rates (0.8/min [0-2.2] vs. 1.5/min [0.2-3.4], p = 0.045, d = 0.36). Seizure frequency was decreased in 17 of the 24 patients (70.8%) with one patient achieving seizure freedom. The majority of patients improved in quality of life (79.2%), and sleep (81.3%). No serious adverse effects were documented. This study systematically assessed the effect of PCT in children with genetic / suspected genetic drug-resistant epilepsy. PCT was found to not only reduce the IEA burden but also increase sleep spindle rates, which are important for cognitive functioning. In this study, children with a form of epilepsy, which is resistant against antiseizure medication, received a systematic treatment with corticosteroids over multiple cycles in the hospital. It was found that not only the epileptic activity was reduced but also the sleep of the patients was improved after the treatment. These findings could provide the basis for extending the use of corticosteroids in children with epilepsy.

Food Security: An Unmet Need in Outpatient Burn Care.

Nutrition is paramount for wound healing after burn injury. With rising food prices and time off work due to burn injuries, access to adequate nutrition may be a significant financial stressor. We asked patients at an outpatient burn clinic to complete the Household Food Security Module, which queries about food security over the preceding 12 months. Demographics and burn characteristics were abstracted from the medical record. We assessed the overall prevalence of food insecurity, risk factors for food insecurity, and potential effects of food insecurity on nutritional status and wound healing time. Wound healing time was assessed via Cox regression while adjusting for burn depth, total body surface area burned, and diabetes. Over 40% of participants reported experiencing food insecurity; it was more common in patients who preferred Spanish language (p=0.014) or were unemployed (p=0.049). Just over half of participants experiencing food insecurity were using any food assistance resources. Among patients more than 30 days from burn injury, patients who were food insecure had larger burns (p=0.01). Experience of food insecurity was not associated presence of malnutrition on nutrition-focused physical exam (p=0.47). Wound healing time for burns managed in the outpatient setting was associated with burn depth (p<0.001), but not food insecurity (p=0.95), burn size (p=0.17), or diabetes (p=0.14). Although food insecurity did not result in malnutrition or negatively impact wound healing time, it is important for providers to routinely screen for food insecurity due to increased nutritional requirements and loss of wages after burn injury.

Phase 3 Trial of Crinecerfont in Pediatric Congenital Adrenal Hyperplasia.

Children with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency require treatment with glucocorticoids, usually at supraphysiologic doses, to address cortisol insufficiency and reduce excess adrenal androgens. However, such treatment confers a predisposition to glucocorticoid-related complications. In 2-week phase 2 trials, patients with CAH who received crinecerfont, a new oral corticotropin-releasing factor type 1 receptor antagonist, had decreases in androstenedione levels. In this phase 3, multinational, randomized trial, we assigned pediatric participants with CAH, in a 2:1 ratio, to receive crinecerfont or placebo for 28 weeks. A stable glucocorticoid dose was maintained for 4 weeks, and the dose was then adjusted to a target of 8.0 to 10.0 mg per square meter of body-surface area per day (hydrocortisone dose equivalents), provided that the androstenedione level was controlled (≤120% of the baseline level or within the reference range). The primary efficacy end point was the change in the androstenedione level from baseline to week 4. A key secondary end point was the percent change in the glucocorticoid dose from baseline to week 28 while androstenedione control was maintained. A total of 103 participants underwent randomization, of whom 69 were assigned to the crinecerfont group and 34 to the placebo group; 100 (97%) remained in the trial at 28 weeks. At baseline, the mean glucocorticoid dose was 16.4 mg per square meter per day, and the mean androstenedione level was 431 ng per deciliter (15.0 nmol per liter). At week 4, the androstenedione level was substantially reduced in the crinecerfont group (-197 ng per deciliter [-6.9 nmol per liter]) but increased in the placebo group (71 ng per deciliter [2.5 nmol per liter]) (least-squares mean difference, -268 ng per deciliter [-9.3 nmol per liter]; P<0.001); the observed mean androstenedione value, obtained before the morning glucocorticoid dose, was 208 ng per deciliter (7.3 nmol per liter) in the crinecerfont group, as compared with 545 ng per deciliter (19.0 nmol per liter) in the placebo group. At week 28, the mean glucocorticoid dose had decreased (while androstenedione control was maintained) by 18.0% with crinecerfont but increased by 5.6% with placebo (least-squares mean difference, -23.5 percentage points; P<0.001). Headache, pyrexia, and vomiting were the most common adverse events. In this phase 3 trial, crinecerfont was superior to placebo in reducing elevated androstenedione levels in pediatric participants with CAH and was also associated with a decrease in the glucocorticoid dose from supraphysiologic to physiologic levels while androstenedione control was maintained. (Funded by Neurocrine Biosciences; CAHtalyst Pediatric ClinicalTrials.gov number, NCT04806451.).

Vincristine (VCR) pharmacokinetics (PK) in infants dosed using a body surface area (BSA) banded dosing table and in older children dosed based on BSA: A pediatric early phase clinical trial network study (PEPN22P1).

10015 Background: The Children’s Oncology Group developed and implemented a unified method of dosing anticancer drugs in infants and small children with a BSA &lt; 0.6 m2. The dosing tables use BSA-based dose banding and account for deliverable doses/volumes of the drugs. We studied the PK of VCR (1.5 mg/m2 dose level) in infants and children to determine whether this new infant dosing method achieves uniform drug exposures across the pediatric age span. Methods: We designed a sampling strategy to limit the blood volume required by focusing on the elimination (β) phase of the VCR concentration-time curve, which accounts for &gt; 80% of the total area-under the curve (AUC). Duplicate samples to detect contamination were drawn at 3 post-infusion time points (2, 6-8 and 18-24 hr) through a central venous catheter (CVC) after a 90 min flush. VCR concentrations were measured at the Children’s Hospital of Philadelphia using a validated high-pressure liquid chromatography/tandem mass spectrometry method with a lower limit of quantitation (LLQ) of 0.25 ng/mL. A one-compartment model was fit to the concentration-time data using population PK methods (Phoenix NLME). The AUCβ was derived from the dose and clearance for each patient. Patients were accrued in 4 age groups (≤6 mo, goal n = 20); &gt; 6 mo to ≤12 mo, goal n = 10; &gt; 12 mo to ≤36 mo, goal n = 10; and &gt; 36 mo to ≤12 yr, goal n = 10) to focus on infants and ensure representation across the pediatric age range. Results: 52 eligible patients have been enrolled and 39 are evaluable for PK analysis, including 9 ≤6 mo, 8 &gt; 6 mo and ≤12 mo, 12 &gt; 12 mo and ≤36 mo, and 10 &gt; 36 mo and ≤12 y,. The median (range) age is 13.5 mo (1.15-112 mo). VCR was quantifiable in all samples, and there was no evidence of contamination in the duplicate samples drawn through the CVC. The mean ± SD AUCβ in the 39 evaluable patients was 54.7 ± 19.8 ng⋅h/mL. As shown in the Table, the AUCβ is similar in patients with a BSA &lt; 0.6 m2 dosed according to the BSA-banded infant dosing table and patients with a BSA ≥0.6 m2 dosed by multiplying their BSA times 1.5 mg/m2 (p = 0.53, Mann Whitney test). Conclusions: The VCR BSA-banded infant dosing table appears to provide uniform VCR exposure for infants and young children compared to conventional BSA-based dosing in older children. The study design and sampling strategy facilitated rapid accrual of a young population and generated more VCR PK data in infants within a year than has been published since the drug was approved in 1963. This study demonstrates the feasibility of systematically studying other anticancer drugs in infants and other special populations to ensure they are receiving safe and effective doses. VCR AUCβ by dosing method. Clinical trial information: NCT05359237 . [Table: see text]

Health-Related Quality of Life Burden Among Adults with Vitiligo: Relationship to Disease Severity and Disease Location.

Vitiligo was historically regarded as a cosmetic disorder; however, it is an autoimmune disease. As a visible condition, it affects patient well-being. We assessed the impact of disease severity, lesion location, and body surface area (BSA) affected on patient health-related quality of life (HRQoL). Retrospective data were from the Adelphi Real World Vitiligo Disease Specific Programme: a cross-sectional survey of physicians and their patients with vitiligo (10/2021-07/2022). Patient-reported outcomes were assessed by the Vitiligo-Specific Quality of Life Instrument (VitiQoL), Hospital Anxiety and Depression Scale (HADS), and EQ-5D-5L. The Work Productivity and Impairment Questionnaire (WPAI) questionnaire was used to assess disease-related impairment of daily activities. Data were stratified by physician-reported disease severity, presence/absence of vitiligo on the face, and BSA percentage affected. In total, 1388 patients were included. Mean (SD) VitiQoL, HADS depression, and anxiety scores were higher for those with severe disease [40.5(26.1), 5.2(4.4), and 6.8(4.7)] than those with mild [24.8(18.8), 3.6(3.8), 4.2(3.8)] or moderate [27.1(22.6), 3.8(4.5), 4.3(4.4)] disease. Patients with face affected reported higher VitiQoL [30.0(22.3) versus 23.2(19.3)], and HADS scores [depression, 4.3(4.3) versus 3.2(3.9); anxiety, 5.0(4.3) versus 3.8 (3.9)] than those without. Patients with ≥ 5% BSA affected had higher VitiQoL, depression and anxiety scores [27.9(21.8), 4.0(4.4), and 4.5(4.2)] than those with 0-5% [24.6(19.7), 3.4(3.7), and 4.3(4.1)]. Patients with severe vitiligo, facial lesions, or ≥ 5% BSA reported higher activity impairment. Mean EQ-5D-5L-utility score was approximately 0.9 regardless of disease severity or total BSA affected. These data demonstrate the impact disease severity can have on HRQoL and daily activities for patients with vitiligo. Lesions that are more severe, on the face, or covering a greater BSA are more often associated with poorer outcomes and activity impairment. These data also highlight the potential insensitivity of commonly used HRQoL measures and a need for more sensitive disease-specific measures.

Possibilities of long-term atezolizumab immunotherapy in patients with metastatic urothelial cancer.

e14628 Background: Results from various studies have indicated that atezolizumab can be an effective and well-tolerated treatment option for patients with advanced and metastatic urothelial cancer. However, the landscape of oncological practices in Uzbekistan reflects a scarcity of experience and data concerning the utilization of atezolizumab in the treatment of patients afflicted with urothelial cancer. This research endeavors to bridge this gap by contributing. Methods: In our retrospective study, a total of 44 patients were selected, with a mean age of 64.5±7.6 years, diagnosed with stage IV urothelial cancer and the presence of distant metastases in the lungs, bones, and liver. There were 28 (63.6%) males and 16 (36.4%) females. Group 1 included 18 (40.9%) patients with elevated PD-L1 levels SP142 – IC 2/3, receiving atezolizumab at 1200 mg intravenously (IV) on day 1 of each 21-day cycle + cisplatin at a dose of 70 mg/m2 body surface area (BSA), IV, on day 1 of each cycle, and gemcitabine at a dose of 1000 mg/m2 BSA, IV, on days 1 and 8 of each cycle. Group 2 included 26 (59.1%) patients receiving standard chemotherapy (cisplatin + gemcitabine) in the same regimens. Immunohistochemical analysis was performed using the Ventana Bench Mark Ultra automated stainer with Ventana PD-L1 SP142 monoclonal antibodies. Results: The research was conducted from September 2019 to May 2023, and the administered treatment was the first line for these patients. Treatment was administered until disease progression was registered or until the development of unacceptable toxicity. Grade I toxicity was not observed in both groups. Grade II toxicity in Group 1 was noted in 3 (16.7%), and in Group 2 - in 4 (15.4%). Grade III toxicity was identified in 9 patients (50.0%) in Group 1 and 14 patients (53.8%) in Group 2. Grade IV toxicity was encountered in 6 patients (33.3%) in Group 1 and 8 patients (30.8%) in Group 2. Hematological toxicity, regardless of atezolizumab use, predominated among the III and IV degrees of toxicity. The median overall survival in Group 1 was 14.8 months (95% CI: 12.8-16.2), while in Group 2, it was 11.9 months (95% CI: 9.3-13.5). Progression-free survival in Group 1 was 6.8 months (95% CI: 5.1-7.4), and in Group 2, it was 4.3 months (95% CI: 3.8-5.7). The objective response rate in Group 1 was 44.5%, and in Group 2, it was 38.5%. Conclusions: Atezolizumab, used in combination with standard platinum-based chemotherapy in the first line, improves treatment outcomes for metastatic urothelial cancer by increasing overall survival and progression-free survival without causing an increase in the toxicity of the administered therapy.

Maternal poor glycemic control increases risk of neonatal left ventricular hypertrophy.

Left ventricular hypertrophy (LVH) is an important complication of infants of diabetic mothers (IDMs). However, the defined factors, such as the influence of glycemic control, insulin administration of diabetic mothers and large for gestational age (LGA) in infants, are largely unknown on the incidence of LVH. Therefore, this study aimed to evaluate the prevalence of maternal and neonatal risk factors associated with LVH in IDMs. This prospective analytic study was conducted at tertiary care hospitals in a 1-year period. Inborn IDMs were enrolled, and ventricular hypertrophy was identified by 2D echocardiography in the first 72 hours after birth. A total of 160 IDMs met the inclusion criteria, 33 (20.6%) of which had LVH. The incidence of infants with LVH born to mothers with poor glycemic control (fasting blood sugar >95 mg/dL) was significantly elevated than those with good glycemic control (45.5% vs. 14.4%, P<0.001). Twelve IDMs (12/33, 36.5%) of LVH and 17 IDMs (17/127, 13.4%) of non-LVH were LGA. IDMs with LVH, compared those with non-LVH, had significantly increased left ventricular (LV) geometry; IVSd (6.5±0.8 vs. 4.0±0, 7 mm), LV IDd (16.8±3.3 mm vs. 18.4±1.1), left ventricular ejection fraction (LVEF) (68.3±8.5% vs. 62.9±17.5%), left ventricular fraction shortening (LVFS) (35.9±6.6% vs. 32.2±5.5%), LV mass (15.3±11.6 vs. 9.3±2.5 g) and LV mass index (66.2±17.5 vs. 46.6±9.7 g/m2), all with P<0.001. There was significant correlation in LV mass with infants' weight, height and body surface area (BSA) (r=0.408, 0.337 and 0.424, respectively; P<0.001). The prevalence of neonatal ventricular hypertrophy in IDMs was 20.6%. Maternal poor glycemic control and LGA status in IDMs were dominant risk factors of LVH.

THE OCCURRENCE OF CONTRACTURE AND THE SEVERITY OF BURN INJURIES AMONG BURN PATIENTS TREATED AT DR. SOETOMO GENERAL ACADEMIC HOSPITAL, SURABAYA, INDONESIA (2020-20220)

Highlights: A robust association was observed between total body surface area (TBSA) and burn injuries, except in the case of elderly individuals. The duration of hospitalization is significantly associated with the occurrence of contracture. Abstract: Introduction: Burn injuries are a worldwide issue and can happen for many reasons, often causing skin damage that leads to deformities and movement difficulties. Many burn patients, up to 50%, experience contractures, which limit movement in areas such as the shoulders, wrists, and torso. Proper management through medicine, surgery, and therapy is crucial for helping these patients. Research at Dr. Soetomo General Academic Hospital is focused on studying the frequency of contractures after burn injuries to improve treatment and prevention methods. Methods: The research used descriptive analytics and gathered data from the Burn Unit at Gedung Bedah Pusat Terpadu (GBPT) and the Plastic Surgery Polyclinic at Dr. Soetomo General Academic Hospital in Surabaya. The study examined 40 eligible patients and assessed variables including burn severity, affected body area, and hospitalization duration. Results: The results showed that the average age of patients was 26.30 years, with 70% of them being male. Only 5% of patients had other health problems, mainly related to hormones. Most burns were caused by fire (37.5%), and many were second-degree burns (42.5%). The percentage of the body affected by burns varied by age: children had around 9.86%, adolescents had around 15.96%, and adults had around 5.25%. Most injuries were on the left arm (67.5%), and many patients stayed in the hospital for a long time (67.5%). Conclusion: All patients developed contractures following burns, irrespective of burn severity. There was a correlation between burn size and severity, except among older patients. Additionally, a notable association was observed between contracture occurrence and prolonged hospitalization.

Racial differences in degrees of side effects to taxane based chemotherapy in patients with breast cancer.

e13726 Background: Taxane-based chemotherapy is well-established as a backbone of treatment for patients with breast cancer. While highly effective, all taxanes are known to cause peripheral neuropathy, with a high prevalence in obese patients. Other risk factors to developing peripheral neuropathy include older age, smoking, and hyperglycemia. Prior studies have shown that obesity is more prevalent in Black women compared with other racial group in the United States. Obese women have higher body surface areas and thus, tend to receive higher doses of chemotherapy. The higher total doses of taxanes received by obese women puts them at higher risks for developing peripheral neuropathy. We sought to evaluate the racial and BMI differences in rates of neuropathy in patients with breast cancer receiving taxanes. Methods: We created a 2-year database (2021-2022) of women diagnosed with breast cancer who received a taxane across a single health system. Data collected included age at diagnosis, self-identified race, breast cancer subtype, BMI, type of taxane, neuropathy, smoking and diabetes. Stratification analysis was performed using SAS Software 9.4. Results: The rate of neuropathy was 65.2% in White patients and 71.01% in Black patients (p=0.4649). The risk ratio between Black patients with neuropathy to White patients with was 1.26, 95% Cl (0.73-2.17), p=0.6525. In the total cohort of patients, regardless of neuropathy, 60.6% of Black patients had a BMI &gt;30 compared with only 39.5% of White patients. Of those who had neuropathy, obesity was present in 64% of White patients and 65% of Black patients. Conclusions: The data presented here suggest that in a population of breast cancer patients treated with taxanes, there was a trend towards increased neuropathy in Black patients, but no increase in neuropathy based on BMI. Black women were more obese, which suggests that they are at increased risk for developing neuropathy. Factors such as universal effects of chemotherapy across races, comorbid conditions and insufficient sample size could have masked potential significant differences. Further research is needed to understand the complex elements influencing treatment responses in a diverse population. [Table: see text]

Phase 3 Trial of Crinecerfont in Adult Congenital Adrenal Hyperplasia.

Adrenal insufficiency in patients with classic 21-hydroxylase deficiency congenital adrenal hyperplasia (CAH) is treated with glucocorticoid replacement therapy. Control of adrenal-derived androgen excess usually requires supraphysiologic glucocorticoid dosing, which predisposes patients to glucocorticoid-related complications. Crinecerfont, an oral corticotropin-releasing factor type 1 receptor antagonist, lowered androstenedione levels in phase 2 trials involving patients with CAH. In this phase 3 trial, we randomly assigned adults with CAH in a 2:1 ratio to receive crinecerfont or placebo for 24 weeks. Glucocorticoid treatment was maintained at a stable level for 4 weeks to evaluate androstenedione values, followed by glucocorticoid dose reduction and optimization over 20 weeks to achieve the lowest glucocorticoid dose that maintained androstenedione control (≤120% of the baseline value or within the reference range). The primary efficacy end point was the percent change in the daily glucocorticoid dose from baseline to week 24 with maintenance of androstenedione control. All 182 patients who underwent randomization (122 to the crinecerfont group and 60 to the placebo group) were included in the 24-week analysis, with imputation of missing values; 176 patients (97%) remained in the trial at week 24. The mean glucocorticoid dose at baseline was 17.6 mg per square meter of body-surface area per day of hydrocortisone equivalents; the mean androstenedione level was elevated at 620 ng per deciliter. At week 24, the change in the glucocorticoid dose (with androstenedione control) was -27.3% in the crinecerfont group and -10.3% in the placebo group (least-squares mean difference, -17.0 percentage points; P<0.001). A physiologic glucocorticoid dose (with androstenedione control) was reported in 63% of the patients in the crinecerfont group and in 18% in the placebo group (P<0.001). At week 4, androstenedione levels decreased with crinecerfont (-299 ng per deciliter) but increased with placebo (45.5 ng per deciliter) (least-squares mean difference, -345 ng per deciliter; P<0.001). Fatigue and headache were the most common adverse events in the two trial groups. Among patients with CAH, the use of crinecerfont resulted in a greater decrease from baseline in the mean daily glucocorticoid dose, including a reduction to the physiologic range, than placebo following evaluation of adrenal androgen levels. (Funded by Neurocrine Biosciences; CAHtalyst ClinicalTrials.gov number, NCT04490915.).