Mean Pretreatment Research Articles

Proliferative Diabetic Retinopathy in Nigerians: Treatment Methods, Visual Outcomes, and Predictors of Poor Outcomes

Abstract Objective: To investigate demographics, treatment methods, pre- and post-treatment vision of proliferative diabetic retinopathy (PDR) patients, and predictors of poor visual outcomes. Materials and Methods: This is a multicentre chart review of consecutive PDR eyes, investigating vision, presence of vitreous haemorrhage (VH), tractional retinal detachment (TRD), diabetic macular edema (DME), and rubeosis. Rates of good vision (6/60+) and poor vision (< 6/60) and rates of worse, same, or improved vision were the primary outcomes. The secondary outcome was the number of eyes in each treatment category. Results: A total of 640 PDR eyes/473 patients were evaluated [334 bilateral eyes (52.2%)/167 patients (35.3%)]. Mean age: 58.9/SD 10.97 years (17–95). Mean symptom duration: 12.8 months. Rates of DME, TRD, VH, TRD with VH , and rubeosis were 12%, 3%, 25.6%, 2.5%, and 15%, respectively. The five treatment categories include intravitreal antivascular endothelial growth factor injections (IVI) alone (392 eyes/61.25%), IVI + retinal laser photocoagulation (86 eyes/13.45%), IVI + cataract surgery (CS) (24 eyes/3.76%), IVI + vitrectomy (V) (109 eyes/17.0%), and IVI + CS + vitrectomy (29 eyes/4.54%). IVI + CS had the highest mean number of intravitreal anti-VEGF use (2.96/SD 4.56) and highest rate of improved vision (62.5%). IVI + vitrectomy had the highest worse vision (29%). IVI alone and IVI + CS had the highest pre- and post-treatment best corrected visual acuity (BCVA). TRD, rubeosis, VH, and no DME eyes had poor mean pretreatment BCVA (< 6/60). Post-treatment mean BCVA improved significantly in VH and DME. Poor pretreatment BCVA, TRD, TRD with VH, and rubeosis were predictors of poor outcomes. Conclusion: PDR is a cause of poor vision and associated poor treatment outcomes in Nigerians. Systematic, effective DR screening and retinal laser treatment of high-risk eyes is urgently needed.

Efficacy, safety and DNA methylation analysis of cadonilimab combined with taxane and cisplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Updated results from an open-label, multicenter phase II trial (AK104-IIT-014).

463 Background: Immune checkpoint inhibitors combined with chemotherapy had become the first-line standard treatment for advanced ESCC and cadonilimab, as a bispecific antibody simultaneously targeting PD-1 and CTLA-4, may further boost anti-tumor activity with a satisfied safety profile. Here, we present the updated data for the safety and efficacy of cadonilimab combination therapy as the first-line treatment in advanced ESCC. The correlation between DNA methylation and clinical response was also investigated. Methods: Treatment-naïve patients (pts) with unresectable locally advanced or metastatic ESCC were enrolled. Cadonilimab (10mg/kg, iv, d1, q3w) combined with paclitaxel or nab-paclitaxel (175 mg/m 2 , iv, d1, q3w) and cisplatin (65 to 75 mg/m 2 , iv, d1, q3w) were administrated for up to 6 cycles, then Cadonilimab (10mg/kg, iv, d1, q3w) monotherapy continued as maintenance until progressive disease or unacceptable toxicity, with a maximum of 24 months. The primary endpoint was objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and safety. Plasma cell-free DNA samples were collected before and after treatment and prepared for methylation level sequencing. Results: As of September 20, 2024, 43 pts were enrolled with a median age of 61 years (range 44-75), 81.4% were male, 39.5% had PD-L1 CPS≥10 and 95.3% had metastatic diseases. All pts were evaluable for safety and efficacy. The ORR was 81.4% (95%Cl: 66.1%-91.1%) and DCR was 97.7% (95%Cl: 86.2%-99.9%). The median PFS (mPFS) was 7.05 months (mo) (95%Cl: 5.86-8.24) and OS analysis was immature. In the PD-L1 CPS≥10 pts, the ORR was 100.0% (95%Cl: 77.1%-100.0%) and mPFS was 7.05 mo (95%Cl: 5.19-8.91). In the PD-L1 CPS＜10 pts, the ORR was 77.3% (95%Cl: 54.2%-91.3%) and mPFS was 7.05 mo (95%Cl: 5.87-8.24). Six hyper-methylated CpG sites, EPTIN9、PKNOX2、DLEU7、SOX7、CNRIP1 and LINC00554 might be the candidate biomarkers as the mean pretreatment methylation levels were significantly higher in the PR pts than those in the non-PR pts (p=7.8×10 -7 ). Grade 3-4 treatment-related adverse events (TRAEs) were reported in 44.2% (19/43) pts, mainly including neutropenia (25.6%), leukopenia (9.3%) and hyponatremia (7.0%). The infusion-related reactions (IRR) occurred in 14.0% (6/43) and grade ≥3 IRR occurred in 4.7% (2/43) pts. 7 pts discontinued cadonilimab administration due to TRAEs. Conclusions: The updated results suggested that bispecific antibody cadonilimab combined with taxane and cisplatin as first-line treatment continued to show encouraging anti-tumor activity and manageable safety in pts with advanced ESCC. DNA methylation level might be a potential biomarker for guiding patient outcomes. Clinical trial information: NCT05522894 .

Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials

Background: Tapinarof cream 1% once daily (QD) demonstrated significant efficacy in patients down to age 2 years with atopic dermatitis (AD) in the ADORING 1 and 2 phase 3 trials. We report local tolerability outcomes. Methods: Patients received Tapinarof or vehicle cream QD for 8 weeks. Tolerability was evaluated using patient/parent/caregiver and investigator 5-point Local Tolerability Scales (LTS). Investigators assessed tolerability for sensitive skin areas, including face/neck. Results: 813 patients were randomized (∼80% pediatric). Mean pretreatment baseline overall LTS scores were similar across groups and trials: 1.0–1.9 (patient-assessed) indicating slight burning/stinging and itching; and 0.3–0.6 (investigator-assessed) indicating no-to-minimal irritation. Tapinarof was well tolerated with improvement from pretreatment baseline and no-to-minimal burning/stinging and itching from first application through Week 8 (patient-reported): mean Week 8 LTS scores were 0.2–0.4 (burning/stinging) and 0.6–0.8 (itching). Investigators reported improvement from pretreatment baseline with no-to-minimal irritation (dryness/erythema/peeling) from first Tapinarof application through Week 8 (mean LTS scores: 0.2 and 0.1 in ADORING 1 and 2, respectively). Across sensitive skin, investigators reported no-to-minimal irritation from first application through Week 8 (mean scores [Tapinarof versus vehicle]: 0–0.3 versus 0–1.0). Conclusion: Tapinarof was well tolerated locally from first application through Week 8, including on sensitive skin areas. Clinicaltrials.gov numbers NCT05014568, NCT05032859

Efficacy of tamsulosin in patients with lower urinary tract symptoms due to benign prostate enlargement and having intravesical prostate protrusion.

Objective: To study the efficacy of Tamsulosin in patients with IPP due to BPE. Study Design: Descriptive study. Setting: Department of Urology, Madinah Teaching Hospital Faisalabad. Period: Oct 2020 to April 2021. Methods: After approval from ethical review comity and informed consent a total of 96 male patients between the ages 50-90 years who had LUTS due to benign prostate enlargement of ≥30g were included in the study. Patients with no IPP or having uncontrolled hypertension / diabetes were excluded from the study as well as those having LUTS due to any other etiology e.g. neurogenic bladder or bladder stone. IPSS was calculated for all the patients and entry was made in the research pro forma. All patients received Cap. Tamsulosin 0.4 mg at bedtime for 2 weeks. On follow up in outpatient department, IPSS was calculated again and any improvement of 3 points of the IPSS score was taken as significant and as an evidence of efficacy of Tamsulosin. All the data including any complication was collected and secured on the pro forma. Results: Pretreatment and post treatment mean IPSS was calculated to be 19.54 ± 5.87 and 17.27 ± 4.29 respectively. Frequency of efficacy of Tamsulosin in patients with Intravesical prostatic protrusion due to benign prostatic enlargement was recorded in 42.71% (n=41) whereas 57.29% (n=55) had no efficacy. Stratification with regards to grade of IPP shows that 12 of 25 cases of grade I, 19 of 40 cases in grade II and 10 of 31 cases in grade III had efficacy, p value was 0.23. Conclusion: We concluded that tamsulosin is effective in patients with intravesical prostatic protrusion due to benign prostatic enlargement, however, further trials are required to validate our results.

Apparent diffusion coefficient and magnetic resonance imaging characteristics in predicting response to radiosurgery in patients with vestibular schwannomas.

Predicting treatment response in patients with vestibular schwannomas (VSs) remains challenging. This study aimed to evaluate the use of pre-treatment normalized apparent diffusion coefficient (nADC) values and magnetic resonance (MR) imaging characteristics in predicting treatment outcomes in patients with VSs undergoing radiosurgery. The MR images of 44 patients with VSs who underwent radiosurgery at our institution were retrospectively reviewed, and the patients were categorized into tumor control (n = 28) and progression (n = 16) groups based on treatment response after treatment initiation, with a median follow-up duration of 29.5 (13-115)months. Pre-treatment nADC values for the whole tumor and solid portion of the tumor were assessed for predictive significance. MRI characteristics were analyzed, including hemorrhage status, tumor morphology, and post-treatment loss of central enhancement. Interobserver reliability was also evaluated. Early post-treatment enlargement was associated with tumor progression (p = .024). The mean pre-treatment nADC values for the solid part of the tumor were significantly higher in the tumor control group than in tumor progression group (1.32 vs 1.05, p = .005). The receiver operating characteristic curve analysis revealed a mean nADC of 1.18 as an optimal cutoff, with sensitivity and specificity of 76.2% and 86.7%, respectively, in predicting treatment response. The mean nADC values for the solid part of the tumor demonstrated predictive value for treatment response, with implications for treatment planning. Notably, early post-treatment enlargement was correlated with tumor progression. Incorporating these findings into clinical practice may refine treatment strategies for patients with VSs undergoing radiosurgery.

Estimation of Intraoral Volume Change in Patients Undergoing Orthodontic Treatment by Extraction Correction in Bidentoalveolar Protrusion Cases using CBCT—A Cross-sectional Comparative Study

Objective To estimate the change in intraoral volume following orthodontic extraction correction in bidentoalveolar protrusion cases and to establish whether there is a significant change in intraoral volume associated with the above treatment. Materials and Methods This study was conducted on 15 patients with bidentoalveolar protrusion. Data were collected using cone beam computed tomography before and after orthodontic extraction correction. Pretreatment and post-treatment intraoral volume were determined for each patient from multiplanar reconstructions using Planmeca Romexis viewer software. Results The mean pretreatment and post-treatment intraoral volume was 43.055 ± 2.55205 cm3 and 38.4958 ± 2.42266 cm3, respectively. The mean change in intraoral volume was 4.5592 ± 0.72272 cm3. Conclusion There was a significant reduction in intraoral volume after orthodontic retraction in bidentoalveolar protrusion cases.

Vonoprazan Fumarate: A Promising Therapeutic Option for the Rapid Relief of Laryngopharyngeal Reflux Disease.

The aim is to examine the Reflux Symptom Score-12 (RSS-12) and assess the effectiveness of vonoprazan fumarate in managing laryngopharyngeal reflux disease (LPRD) among the Chinese population. A total of 140 patients with LPRD who were treated at our otorhinolaryngology outpatient clinic were included. The patients were randomly divided into the vonoprazan treatment group and the esomeprazole treatment group. The outcome indicators were the pretreatment and post treatment values of the Reflux Symptom Index (RSI), RSS-12, and reflux finding score. The mean pretreatment RSS-12 and RSI values were 55.79±11.94 and 18.67±3.60 in the vonoprazan treatment group and 54.91±11.95 and 18.44±3.66 in the esomeprazole treatment group, respectively. Furthermore, both groups showed a significant decrease in the RSI and RSS-12 values after 4, 8, and 12weeks of acid suppression therapy. In particular, 12weeks of treatment led to a good treatment response in 91.4% and 87.1% of the patients in the vonoprazan treatment and esomeprazole treatment groups, respectively, based on their RSI values, and a favorable treatment response in 82.9% and 77.1% of those in the vonoprazan treatment and esomeprazole treatment groups, respectively, according to their RSS-12 values. More importantly, after 4 and 8weeks of acid-suppressive therapy, the relative baseline change in RSS-12 scores in the vonoprazan treatment group was considerably larger than that in the omeprazole treatment group. Compared to proton pump inhibitors (PPIs), vonoprazan fumarate has demonstrated superior early therapeutic efficacy, resulting in a notable improvement in laryngopharyngeal reflux symptoms at the start of treatment. When we extended acid-suppressive medication for 12weeks, we saw a treatment effect comparable to that ofPPIs.

Pulsed dye laser in jellyfish-induced keloids

ABSTRACT Jellyfish stings can cause acute inflammatory skin lesions that may hesitate in keloids. Pulsed dye laser (PDL) represents one of the most effective treatments for newly developed keloids. Aim of this study was to evaluate the efficacy of PDL on newly developed keloids specifically induced by jellyfish stings in pediatric patients.We conducted a retrospective observational study on pediatric patients with newly developed keloids from jellyfish stings, treated in the last two years with 595 nm wavelength PDL with a duration of 0.45–1.5 msec, spot-size 7 mm and fluence 8.5–9.5 J/cm2. PDL therapy was administered for a mean of 7.4 treatment sessions, every 1–3 months. Two expert dermatologists evaluated the vascularity, pigmentation, height, and pliability of keloids, according to the Vancouver Scar Scale (VSS), pre-and-post treatment. A total of 17 patients (7 males, 10 females) were included in the study, mean age of 11 years. Overall, mean pre-treatment global VSS was 11.0 ± 1.50. After treatment, global VSS was 3.88 ± 1.87. At paired t-test, the difference between pre-treatment and post-treatment was highly statistically significant (p < .0001). Commonly, manipulation and therapeutic intervention on jellyfish scars and keloids is feared. The present study supports the use of PDL in keloids secondary to jellyfish stings, though conducted on a limited number of patients.

The role of saroglitazar in the treatment of metabolic dysfunction-associated steatohepatitis in non-diabetic patients: A prospective observational study

Metabolic dysfunction-associated steatohepatitis (MASH) is a metabolic disease characterized by hepatic fat accumulation and significant inflammation. Patients with hepatic steatosis who also have at least one of the five cardiometabolic risk markers are considered to have metabolic dysfunction-associated steatotic liver disease. MASH is diagnosed when a microscopic examination of liver tissue reveals fat accumulation in hepatocytes along with inflammation and destruction of liver cells. This study aims to assess the role of saroglitazar, a dual proliferator peroxisome-activated receptor agonist, in the medical therapy of MASH in non-diabetic patients. A prospective observational study was carried out in a tertiary care facility in north India. A total of 51 non-diabetic MASH patients (males and females, 18 &amp;ndash; 75 years of age, body mass index &amp;ge;18.5 kg/m2) were included in this study. Diagnosis of MASH was based on liver FibroScan (controlled attenuation parameter [CAP] score &gt;238, liver stiffness measurement [LSM] value &gt;7kPa) along with raised liver enzymes (serum glutamic-oxaloacetic transaminase [SGOT], serum glutamic-pyruvic transaminase [SGPT] &gt; upper value of normal limits). All these 51 patients received 4 mg once-daily dose of saroglitazar for the treatment of MASH for 24 weeks. In this study, a standard treatment protocol was used. The percentage changes in aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, triglyceride, low-density lipoprotein (LDL), and LSM with CAP were evaluated using an analysis of variance test and multiple regression analysis. About 72.5% of these patients were male and 27.5% were female (male: female ratio of 2.6). The mean age of patients was 51 &amp;plusmn; 13.13 years. Pre- and post-treatment values of different parameters were compared. Pre-treatment mean values of ALT and AST were 93.83 &amp;plusmn; 6.16 U/L and 76.13 &amp;plusmn; 4.1 U/L, respectively, while their post-treatment mean values were 32.97 &amp;plusmn; 2.15 U/L and 34.57 &amp;plusmn; 1.65 U/L, respectively (P-value for AST and ALT &lt;0.001). In conclusion, saroglitazar is effective in the medical management of MASH by reducing liver stiffness and suppressing elevated liver enzymes (SGOT/SGPT) as well as serum LDL levels over 6 months.

The Use of Intralesional Corticosteroids in Idiopathic Granulomatous Mastitis: A Systematic Review.

Idiopathic granulomatous mastitis (IGM) is a debilitating, chronic, inflammatory condition of the breast. Several studies have emerged evaluating intralesional steroid (ILS) injection and topical steroid administration as a treatment for IGM. However, there is a dearth of international consensuses with regards to the management of IGM. Therefore, we have systematically reviewed the effectiveness of ILS in the management of IGM. A systematic search was conducted in PubMed and Cochrane Library databases, the Google Scholar website and by citation searching up to June 15th, 2023. Eight articles were selected and analyzed. A total of 397 IGM patients were included in the review. The mean patient age was 35.7 years, ranging from 23-62 years. The mean pre-treatment diameter of lesions was 27.5 mm. A total of 184 patients were treated with ILS. The mean complete clinical response time was 2.6 months. The overall complete response rate was 92.8%. Complications following ILS were minor, with hematoma, skin atrophy and hyperemia being commonly described, while avoiding the systemic side effects of oral steroid use, such as weight gain and hirsutism, which were the most commonly reported side effects with oral steroids. The recurrence rates in the ILS group (6.6%) appear to be lower than in the oral steroid group (25.8%) and surgery group (26.3%). ILS seem to show a favorable outcome in terms of complete response rate, complete clinical response time and has a lower recurrence rate and complication rate when compared to other intervention strategies. However, more comparative studies with standardized protocols are necessary to ascertain the optimum type, dosage and frequency of ILS regimens.

Modified Transepithelial Phototherapeutic Keratectomy for Band Keratopathy.

Objectives: To report the outcomes of novel modified transepithelial phototherapeutic keratectomy (PTK) in treating band keratopathy (BK). Methods: A retrospective analysis was performed on patients who underwent PTK for BK at the Sussex Eye Laser Clinic, Nuffield Health, Brighton. Patients with BK obscuring the visual axis, affecting visual acuity, or causing discomfort were considered for PTK. All the patients underwent preoperative evaluation, including preoperative corneal topography and optical coherence tomography. Modified transepithelial PTK was performed without using EDTA for chelation or alcohol for epithelium debridement. Patients were followed up for one week and then every two weeks after that until two months. Preoperative and postoperative best corrected visual acuities (BCVA) were compared using a paired t-test. Results: We studied 15 eyes of nine patients undergoing novel PTK for BK. The mean age was 80 ± 5.73 years. The mean pre-treatment visual acuity was 0.68 ± 0.17 logMAR (range: 0.6 logMAR to 1 logMAR) and improved to 0.22 ± 0.09 logMAR (p < 0.05), ranging from 0.18 to 0.48 logMAR at two months following PTK. None of the patients complained of ocular discomfort following the procedure. A repeat procedure was not required for any of these patients. Conclusions: Modified transepithelial PTK is an effective procedure for improving visual outcomes in patients with band keratopathy and should be considered for the treatment of band keratopathy.

Revisiting the etiology and clinical characteristics of hemorrhagic polyps of the vocal fold.

Benign phonotraumatic lesions of the vocal folds (BVFLs) are typically seen in younger female patients with high vocal loads. Hemorrhagic polyps (HPs) do not fit the classic paradigm of most BVFLs, as they tend to occur in an older population, have a male predominance, and report to result from a vocal accident. We present one of the largest cohorts of HPs, to reexamine their etiology and clinical features. Retrospective cohort study, inclusive of all patients with HP managed by the senior authors between the years 2016 through 2023. Demographic data, management, phonotraumatic risk factors, pre- and post-treatment VHI-10 were reviewed. We examined patient videostroboscopy, categorized the size of the lesion, and identified any concurrent mucosal abnormality. One hundred and eleven patients had confirmed HP, 84 males (75.7%). Thirty-five patients were size category 1; pinpoint (28.9%), 57 were category 2; less than 1/3rd the vocal fold (45.5%), and 26 were category 3; greater than 1/3rd the vocal fold (21.5%). Ten patients (9%) had bilateral HPs. Thirty-five patients had an additional 40 mucosal lesions in addition to the HP(s). The onset of symptoms was gradual in 60% of patients. The mean pretreatment VHI-10 was 18.0 (SD 10.7), compared to 6.0 (SD 10.5) post-treatment, (p < .001). 57/111 patients reported high voice demand professions or recreational activities. The average self-reported talkative scale score was 7.6/10. Patients were managed with operative microdirect laryngoscopy and microflap excision (53.1%), in-office clinic potassium titanyl phosphate (KTP) laser (24.3%), voice therapy alone (7.2%), and KTP in the operating room (6.3%). In our cohort, most patients were male, had high vocal demands, reported gradual symptom onset, and almost a third of patients had additional BVFLs. Level 3: Retrospective cohort study.

Examination of Excessive Mind-Wandering Following Attention-Deficit and Hyperactivity Disorder Treatment in Adults.

Although mind-wandering (MW) is a part of attention deficit and hyperactivity disorder (ADHD), the impact of psychostimulants on excessive MW remains unclear. We aimed to elucidate how psychostimulants impact the MW of adult ADHD patients post treatment. This cross-sectional cohort study consisted of 54 randomly selected ADHD patients who applied to our psychiatry outpatient clinic and 40 healthy controls. The ADHD patients were administered methylphenidate or atomoxetine. A Semi-Structured Sociodemographic and Clinical Data Form, the Adult ADHD Self-Report Scale (ASRS), and the Mind Excessively Wandering Scale (MEWS) were applied. Routine psychiatric assessments in the 1st, 2nd, and 3rd months of pharmacological treatment were carried out by a psychiatrist. The pre-treatment MEWS score of the ADHD patients was 26.09 ± 1.92, which significantly decreased to 12.78 ± 2.54 post-treatment (F = 715.250, p < .001). A statistically significant difference was identified between the mean pre-treatment ASRS total score (44.07 ± 10.09) and post-treatment score (27.34 ± 11.22; F = 50.364, p < .001). A lifetime history of alcohol/substance use was positively associated with the MEWS score. ADHD pharmacotherapy led to significant reductions in MW. Recognizing the interaction between MW and ADHD could help in the design of more specific and comprehensive interventions.

Predictive value of changes in basal myocardial 18F-fluorodeoxyglucose uptake for cardiotoxicity in locally advanced esophageal cancer patients receiving definitive radiotherapy

To investigate the predictive value of changes in segmental myocardial 18F-fluorodeoxyglucose (FDG) uptake for major adverse cardiac events (MACEs) in patients with locally advanced esophageal cancer undergoing definitive radiation therapy (RT). Between August 2012 and January 2019, 482 patients with stages II and III esophageal cancer from 2 institutions were enrolled and divided into the training (n = 285) and external validation (n = 197) cohorts. All patients underwent 18F-FDG positron emission tomography within 1 week before treatment and within 3 months of treatment. Myocardial delineation was performed using the Carimas software based on the American Heart Association 17-segment model and was automatically divided into basal, middle, and apical regions. The main endpoint was the occurrence of MACEs, including unstable angina, myocardial infarction, coronary revascularization, hospitalization for heart failure or urgent visits, and cardiac death. Analyses included competing risk and Cox regression. Model performance was assessed using the area under the receiver operating characteristic curve and Brier score. Thirty-four patients (11.9%) developed MACEs at a median follow-up of 78 months. The basal region (median, 19.44 Gy) of the myocardium received the highest radiation dose, followed by the middle (median, 13.02 Gy) and apical regions (median, 9.32 Gy). Multivariate analysis showed that the change ratio in pretreatment and posttreatment basal myocardial mean standardized uptake value (SUV) remained significant after adjusting for age, pre-existing cardiac disease, and dosimetric parameters. The area under the receiver operating characteristic curves and Brier scores demonstrated favorable predictive accuracies of models integrating variables with significant differences in the multivariate analysis when predicting MACEs in the training and validation cohorts. The basal change ratio of mean SUV was an independent predictor of MACEs in patients with locally advanced esophageal cancer receiving definitive RT. Changes in basal myocardial FDG uptake are promising biomarkers for predicting radiation-induced cardiotoxicity.

(034) COMPARATIVE OUTCOMES OF PHOSPHODIESTERASE 5 INHIBITORS AND COLLAGENASE CLOSTRIDIUM HISTOLYTICUM VS. COLLAGENASE CLOSTRIDIUM HISTOLYTICUM ALONE FOR MANAGEMENT OF PEYRONIE’S DISEASE: A MULTICENTER RETROSPECTIVE CHART REVIEW

Abstract Introduction Collagenase C. histolyticum (CCH) is currently the only intralesional medication approved by the Food and Drug Administration for Peyronie’s disease (PD), effectively reducing penile curvature through the digestion of collagen. Phosphodiesterase 5 inhibitors (PDE5i) have demonstrated antifibrotic effects by decreasing collagen deposits, profibrotic factors, oxidative stress, and myofibroblast count. However, the clinical application of PDE5i for PD remains unclear. Objective To date, there are no large, multi-institutional studies assessing the long-term outcomes of CCH in combination with PDE5i for PD. This study aims to determine outcomes in reducing penile curvature and side effects when combining PDE5i with CCH for PD. Methods We conducted multi-institutional retrospective chart review on men aged ≥18 who underwent CCH for PD between January 1, 2013, and December 31, 2023. Data collection consisted of patient demographics, erectile dysfunction diagnosis, medications (including PDE5i), baseline penile Doppler ultrasound, pain and International Index of Erectile Function (IIEF) scores, as well as treatment protocols. Patients were categorized into two groups: those treated with PDE5i and CCH (Group A), and those treated with CCH alone (Group B). Outcomes were assessed by changes in penile curvature, pain reduction, improvement in IIEF scores, patient satisfaction, and incidence of adverse events. Statistical analysis was performed to compare the efficacy and safety between the two treatment groups, with significance set at a p-value of &amp;lt;0.05. Additionally, we reviewed how frequently PDE5i is prescribed for PD. Results Of the 574 patients, the mean pre-treatment curvature for both groups was 45.9 degrees (Table 1). There was no significant difference in curvature improvement between Group A and Group B (15.9% for Group A and 16.7% for Group B). Patient-reported subjective improvement was 40% in both groups, and there was no difference in incidence of adverse events. 5 patients from each group experienced a penile fracture following CCH injection (Table 2). Additionally, PDE5i was only prescribed if patients reported erectile dysfunction and is not typically combined with CCH as a standard of care. Conclusions The combination of PDE5i with CCH does not appear to improve outcomes compared to CCH alone in men with PD. Both groups exhibited comparable curvature improvements and subjective outcomes. Additionally, incidence of adverse events, including penile fractures, was similar between groups, indicating that the use of PDE5 inhibitors does not affect the safety profile of CCH. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Endopharmaceuticals.

Y90 Radiation Segmentectomy versus Microwave Ablation for Hepatocellular Carcinoma in Locations Suboptimal for Percutaneous Ablation

Abstract Purpose The purpose of our study was to evaluate outcomes following percutaneous microwave ablation (MWA) versus yttrium-90 (Y90) radiation segmentectomy (RS) for tumors in suboptimal locations for ablation. Materials and Methods Retrospective review (January 2014–July 2019) was performed on patients who underwent Y90-RS or MWA (with or without prior transarterial chemoembolization [TACE]) with curative intent for early-stage hepatocellular carcinoma (HCC) lesions in suboptimal locations for percutaneous ablation, defined as locations in which needle placement is within 5 mm of critical structures (liver dome, liver capsule, gallbladder, and hilum). The primary endpoints were treatment response as per the modified Response Evaluation Criteria in Solid Tumors criteria and complications. Statistical Analysis Fischer's exact test was performed for categorical variables, and Student's t-tests for nominal variables. Results Twenty-three lesions in 20 patients (13 male, 67 ± 8.8 years) and 30 lesions in 30 patients (18 male, 62.5 ± 10.6 years) were treated with Y90-RS and MWA (19 with prior TACE), respectively. There were no differences in demographics (p &gt; 0.05). Mean tumor diameter was 2.9 ± 1.0 in those treated with Y90-RS and 2.3 ± 0.9 for MWA (p &lt; 0.05). Lesions were located adjacent to the following structures: dome (n = 22), capsule (n = 16), hilum (n = 9), and gallbladder (n = 6). All patients were Eastern Cooperative Oncology Group performance status 0 to 1. Of the MWA cohort, 19 were Child-Pugh class A, 5 were B, and 6 were C and the mean pretreatment laboratory values were as follows: Model for End-stage Liver Disease sodium (MELD-Na) 12.7 ± 4.6, alpha-fetoprotein (AFP) 848 ± 3168.0, aspartate aminotransferase (AST) 71.9 ± 49.1, alanine aminotransferase (ALT) 48.0 ± 32.4, and total bilirubin 2.4 ± 2.7. Of the Y90-RS cohort, 15 were Child-Pugh class A, 4 were B, and 1 was C and pretreatment laboratory values were as follows: MELD-Na 10.5 ± 3.3 (Y90-RS), AFP 762.2 ± 1793.8 (Y90), AST 50.3 ± 30.5 (Y90), ALT 30.1 ± 16.9 (Y90), and total bilirubin 1.6 ± 1.1 (Y90). Complete response rate following Y90 was 96 versus 76% for MWA, with no disease progression after Y90-RS within the follow-up period. Three (13%) lesions demonstrated progression of disease (time to progression 6.3 months) after MWA. No grade &gt; 2 toxicities or procedure-related complications were noted following Y90-RS. There were 7 major (arterioportal fistula with hemoperitoneum, pneumothorax, liver infarction, and capsular burn) and 3 minor complications following MWA. Conclusion Y90-RS is a valuable alternative to percutaneous MWA as a first-line therapy for early-stage HCC for tumors in suboptimal locations for ablation, offering a favorable treatment response and safety profile.

The Assessment of Patient-Reported Outcomes in the Medical Management of Patients With Benign Prostatic Hyperplasia.

Background Benign prostatic hyperplasia (BPH) is a prevalent condition that a large portion of the male population develops with aging, in which the prostate gland enlarges and results in urinary symptoms. Objective The objective of this article is to assess patient-reported outcomes (PRO) of medical management of benign prostate hyperplasia in terms of international prostate symptoms score (IPSS), BPH impact index (BPHII), and treatment satisfaction score (TSS). Methods This descriptive study included 114 patients who received medical management for BPH during the period 5th May 2021 till 30th December 2023, at the Department of Urology, Institute of Kidney Disease Peshawar. Patient-reported outcomes were measured in terms of IPSS, BPHII, and TSS. Readings were recorded at the start of treatment and at three months of treatment and then compared. Data was analyzed using SPSS v.25 (IBM Inc., Armonk, New York). Results The mean age of the patients was 64.33 ± 6.12 years. The mean prostate size was 77.35 ± 12.83 ml. Overall mean pre-treatment and post-treatment IPSS was 24.82 ± 4.90 versus 15.57 ± 5.15, respectively (p-value 0.00). Mean pre-treatment and post-treatment BPHII were 11.98 ± 1.02 and 7.12 ± 2.46, respectively (p-value 0.000). The overall mean treatment satisfaction score was 6.89 ± 1.44. Conclusion Medical management improved symptomatology in BPH patients. This study is a step in the direction of the development of larger and longer-term PRO studies in BPH management.

Meibomian gland dysfunction treated with a novel device: A case series

Abstract The effectiveness of a novel device, the MGrX (OcuSci), in treating meibomian gland dysfunction (MGD), is reviewed in this case series. The case series follows the ocular surface evaluation of 12 patients; all evaluated using the ocular surface disease index and infrared meibography with the Me-Check meibography device (Espansione, Italy). Evaluations were performed before and 4–6 weeks after therapy. The mean pretreatment OSDI score was 26.89 (±9.14). The mean posttreatment OSDI score was 13.29 (±14.04). The MGrX device appears to be a safe, effective, and quick way of treating MGD in patients of a wide range of ages and with different dry eye disease severity.

Recovery of cranial nerve neuropathies after LINAC-based stereotactic radiosurgery for benign cavernous sinus meningioma

PurposeCranial Nerve Neuropathies (CNNs) often accompany Cavernous Sinus Meningioma (CSM), for which Stereotactic Radiosurgery (SRS) or fractionated stereotactic radiotherapy (FSR) are established treatments. This study assesses CNNs recovery in CSM patients treated with LINAC, offering insight into treatment effectiveness.MethodsThis study was conducted on 128 patients with CSM treated with LINAC-based SRS/FSR between 2005 and 2020 at a single institution. 46 patients presented with CNNs. The study analyzed patients’ demographics, clinical parameters, SRS/FSR treatment characteristics, post-treatment CNNs recovery duration, status, and radiological control on their last follow-up.ResultsThe median follow-up duration was 53.4 months. Patients were treated with SRS (n = 25) or FSR (n = 21). The mean pretreatment tumor volume was 9.5 cc decreasing to a mean end-of-follow-up tumor volume was 5.1 cc. Radiological tumor control was achieved in all cases. CNN recovery was observed in 80.4% of patients, with specific nerve recoveries documented as follows: extra-ocular nerves (43.2%), trigeminal nerve (32.4%), and optic nerve (10.8%). A higher CNNs recovery rate was associated with a smaller pre-treatment tumor volume (p < 0.001), and the median time-to-improvement was 3.7 months. Patients with tumor volumes exceeding 6.8 cc and those treated with FSR exhibited prolonged time-to-improvement (P < 0.03 and P < 0.04 respectively).ConclusionsThis study suggests that SRS/FSR for CSM provides good and sustainable CNNs recovery outcomes with excellent long-term radiological control. A higher CNNs recovery rate was associated with a smaller pre-treatment tumor volume. while shorter time-to-improvement was identified in patients treated with SRS compared to FSR, particularly in those with small pre-treatment tumor volume.

Transcranial static magnetic stimulation for amyotrophic lateral sclerosis: a bicentric, randomised, double-blind placebo-controlled phase 2 trial

BackgroundEnhanced glutamatergic transmission leading to motor neuron death is considered the major pathophysiological mechanism of amyotrophic lateral sclerosis (ALS). Motor cortex excitability can be suppressed by transcranial static magnetic stimulation (tSMS), thus tSMS can be evaluated as a potential treatment for ALS. The aim of present study was to investigate the efficacy and safety of tSMS in ALS. MethodsIn this phase 2 trial, we randomly assigned ALS patients to receive daily tSMS or placebo stimulation over a period of 6 months. For each participant we calculated mean disease monthly progression rate (MPR) as the variation of the total ALS Functional Rating Scale-Revised (ALSRFS-R) score, before the beginning of the treatment (over a period of at least three months) and over the six-month treatment period. The primary efficacy outcome was the difference in MPR before and after the beginning of treatment. Secondary outcomes included safety and tolerability, compliance, and changes in corticospinal output. A long-term follow-up of 18 months was performed in all patients who completed the six-month treatment considering a composite endpoint event (tracheostomy or death). Trial registered at ClinicalTrials.gov, ID: NCT04393467, status: closed. FindingsForty participants were randomly assigned to real (n=21) or placebo stimulation (n=19). Thirty-two participants (18 real and 14 placebo) completed the 6-month treatment. The MPR did not show statistically significant differences between the two arms during the pre-treatment (mean ± Standard deviation; Real: 1.02 ± 0.62, Sham: 1.02 ± 0.57, p-value = 1.00) and treatment period (Real: 0.90 ± 0.55, Sham: 0.94 ± 0.55, p-value = 0.83). Results for secondary clinical endpoints showed that the treatment is feasible and safe and compliance with tSMS is high. The change in corticospinal output did not differ significantly between the two groups.At the end of the long-term follow-up of 18 months, patients of real group had a statistically significant higher tracheostomy-free survival compared with patients of placebo group (Hazard Ratio = 0.27 95% Confidence interval 0.09 to 0.80, p-value = 0.019) . InterpretationTSMS did not modify disease progression during the 6 months of treatment. However, long-term follow-up, revealed a substantial increase in tracheostomy free survival in patients treated with real stimulation supporting the evaluation of tSMS in larger and more prolonged studies. FundingThe “Fondazione 'Nicola Irti' per le opere di carità e di cultura”, Rome, Italy, supported present study.