OBJECTIVE: To evaluate the real-world efficacy and safety of iStent implanted standalone or combined with phacoemulsification in open-angle glaucoma (OAG) patients.
METHODS: This is a retrospective observational study of OAG patients who underwent standalone or combined iStent procedures were reviewed. Inclusion criteria included age over 18 years and open angle on gonioscopy. Exclusion criteria were prior incisional glaucoma surgeries, missing data, or follow-up shorter than 6 months. The primary outcome was surgical success between the two groups after one year. Secondary outcomes included differences in IOP reduction and medication use.
RESULTS: We included 48 eyes with primary (n = 44) and secondary OAG (n = 4). Nineteen eyes had standalone while 29 eyes had combined procedures. Kaplan-Meier analysis revealed overall surgical success in 31.3% of eyes after one year. Qualified success was higher in the combined group than the standalone group [62.5% (10 eyes) vs 27.3% (3 eyes), p = 0.239]. At 24 months, mean IOP reduced by 2.2 ± 2.5 mmHg vs 3.3 ± 2.9 mmHg, p = 0.333), and the number of medications reduced by 1.1 ± 1.2 vs 1.3 ± 0.1, p < 0.001) in the standalone and combined group, respectively. Stent occlusion occurred in two eyes.
CONCLUSIONS: While both standalone and combined iStent procedures provide safe IOP reduction throughout 12 months, there was no statistically significant difference in surgical success between them.

High-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (HDC/ASCT) has been useful in relapsed or refractory classic Hodgkin lymphoma (RRcHL). Furthermore, a ranimustine, cytarabine, etoposide, and cyclophosphamide (MCVAC) conditioning regimen has been effective in diffuse large B-cell lymphoma. However, limited data are available regarding this conditioning regimen for cHL. In this study, we investigated the efficacy and toxicity of MCVAC for RRcHL. We retrospectively analyzed 10 patients with RRcHL who underwent ASCT preceded by the MCVAC conditioning regimen between January 2009 and December 2021 at our institution. A total of 10 patients (median [range] age, 36 [23-64] years), including 5 (50%) men and 5 (50%) women, were treated with the MCVAC regimen followed by ASCT. The median follow-up duration of the 10 patients was 25.0 months. The 36-month PFS and OS rates were 43.8% (95% CI, 11.9%-72.6%) and 64.0% (95% CI, 22.6%-87.5%), respectively. Two patients died because of treatment-related factors, and one patient died because of disease progression. Based on our findings, recognizing the risk factors for adverse events (AEs) associated with this treatment, MCVAC may be a valid treatment option for the management of RRcHL.

BACKGROUND: Difamilast is the first selective phosphodiesterase 4 inhibitor approved for atopic dermatitis (AD) in Japan. A phase 3, 52-week, open-label study is ongoing to establish efficacy and safety of difamilast ointments in infants with AD aged 3 to < 24 months because a clinical study has not been conducted in this population.
METHODS: This study consisted of a 4-week primary evaluation period in which difamilast 0.3% ointment was applied twice daily to Japanese infants aged 3 to < 24 months (n = 41) and an ongoing 48-week long-term extension period in which difamilast 0.3% or 1% ointment was applied based on existing symptoms. The data on efficacy and safety of difamilast were obtained as of an interim report in the study period.
RESULTS: The response rate in Investigator\'s Global Assessment score was 45.0% at week 1, which was maintained at 56.1% at week 4 and 63.4% at the interim report. Infants achieved the response rate in Eczema Area and Severity Index 75 (improvement of ≥ 75%) of 47.5% at week 1, which further improved to 82.9% at week 4 and 78.1% at the interim report. Adverse events (AEs) were reported in 22 (53.7%) infants in the primary evaluation period: of those the most frequent AE was nasopharyngitis (19.5%) followed by dermatitis contact (7.3%). As of the interim report, 36 (87.8%) infants experienced AEs: of those, nasopharyngitis (70.7%) and gastroenteritis (22.0%) were most frequently observed. The total AEs were mostly mild or moderate in severity. No investigational medicinal product-related AEs and no AEs leading to discontinuation were reported.
CONCLUSIONS: Difamilast ointments applied twice daily to Japanese infants with AD aged 3 to < 24 months is effective and well tolerated as of the interim report in the study period. The final results will be reported in the near future.
BACKGROUND: Clinical Trials. gov identifier: NCT05372653.

UNASSIGNED: The flow diverter (FD) has emerged as a promising treatment option for intracranial aneurysms. Recently, a novel flow-diverting stent, the Choydar FD device, has been developed within our nation.
UNASSIGNED: To introduce the newly developed Choydar FD device and present our preliminary clinical experience with its application in the treatment of intracranial aneurysms.
UNASSIGNED: A total of 23 patients with 23 unruptured intracranial aneurysms, comprising 20 (87.0%) aneurysms located at the internal carotid artery and 3 (13.0%) at the vertebral artery, were treated with the Choydar FD device between December 2021 and April 2022. Patient baseline data, clinical and angiographic outcomes were collected and analyzed.
UNASSIGNED: The Choydar FD device was successfully deployed in all patients (100%), with 18 aneurysms (78.3%) additionally treated with coils. One patient experienced an ischemic event with sensory disturbance during the perioperative period. At the 1-year follow-up, all patients demonstrated good clinical outcomes. Of the 23 aneurysms with available angiographic follow-up, 22 (95.7%) achieved complete occlusion, and one patient exhibited in-stent stenosis without neurological deficits.
UNASSIGNED: The initial clinical results of the Choydar FD device are encouraging, and it appears to be a useful option for treating intracranial aneurysms with acceptable efficacy and safety. Future studies with larger sample sizes and longer follow-up durations are warranted to validate these findings.

Gastrointestinal bleeding is the most common cause of iron deficiency in adult men and menstrual blood loss is the leading cause of iron insufficiency in women, anemia due to iron deficiency is mostly caused by blood loss. Ferric carboxymaltose (FCM) is a contemporary parenteral iron formulation that may be used therapeutically to treat anemia caused by an iron deficiency [iron-deficiency anemia (IDA)]. The main goal of the trial was to evaluate FCM\'s safety and efficacy in treating IDA. The Department of Hematology, Rajshahi Medical College Hospital, Rajshahi, Bangladesh participated in this quasi-experimental research, which comprised adult patients with IDA. Participants were given an intravenous (IV) infusion of 500 mg of FCM, diluted in 100 mL of 0.9% normal saline, throughout a 30-minute period after their participation. The second dosage of FCM was administered after a 7-day period of the first dose. The comparison of the outcomes [hemoglobin (Hb) level, serum ferritin level, and other hematological parameters] between the baseline and day 14 postintervention was done using a paired t-test. Compared to baseline, patients\' Hb levels rose considerably (p = 0.001) after FCM. Aside from serum ferritin level, additional hematological parameters that sharply increased were red blood cells (RBCs) count, mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width - coefficient of variation (RDW-CV), and iron indicators. The experiment recorded mild adverse effects such as fever, headaches, and gastrointestinal issues including vomiting, diarrhea, and constipation, but no significant adverse events. In summary, IDA may be effectively treated with FCM, a safe and secure IV medication that has no major negative effects.
UNASSIGNED: Miah MMZ, Pramanik MEA, Rafi A, et al. Iron-deficiency Anemia Treatment with Ferric Carboxymaltose: A Real-world Quasi-experimental Study from Bangladesh. Euroasian J Hepato-Gastroenterol 2024;14(1):12-15.

UNASSIGNED: The purpose of this study was to compare efficacy and side effects between oral propranolol combined with and without intralesional injection of lauromacrogol for infantile hemangioma (IH).
UNASSIGNED: This was a single center randomized controlled prospective study, all participants were firstly diagnosed with IH between August 2022 and January 2023 in our hospital and without any treatment before. Patients were randomized into two groups. PRO group: oral propranolol (2 mg/kg/day) continued for 6 months; PRO + LAU group: oral propranolol (2 mg/kg/day) for 6 months and intralesional injection of lauromacrogol for 2-4 times within 6 months. The dimensions, color, consistency, photographic documentation were well recorded based on Visual Analogue Scale (VAS) before and after starting treatment. According to the treatment response after 6 months, the results were classified into four levels: Grade 1, complete resolution achieved; Grade 2, with ≥50% reduction in size of IH; Grade 3, with <50% reduction in size of IH; Grade 4, no response or worsening of IH.
UNASSIGNED: A total of 67 patients were involved in the study (17 boys, 50 girls; mean age, 3.6 months, range, 1.1-7.2 months) and randomized to receive oral propranolol combined with or without intralesional injection of lauromacrogol (29 in PRO group, 38 in PRO + LAU group). All patients completed treatment. Eleven patients (37.9%) in PRO group were in Grade 1, 14 patients (48.3%) in Grade 2, 4 patients (13.8%) in Grade 3, compared with these in PRO + LAU group, 11 patients (28.9%) in Grade 1, 24 patients (63.2%) in Grade 2, and 3 patients (7.9%) in Grade 3. No patient was in Grade 4, and no severe side effects were observed in both group. In PRO group, it takes an average of 17.1 ± 5.4 weeks from the start of treatment to cure, and in PRO + LAU group, the average time is 13.7 ± 4.9 weeks.
UNASSIGNED: Oral propranolol with intralesional injection of lauromacrogol was a safety treatment strategy for IH. But it was not superior to oral propranolol in final cure rates (P = 0.45), moreover, it cannot certainly offer the benefits of shortening the duration of oral drug treatment (P = 0.24).

BACKGROUND: Although chemotherapy is effective for treating advanced gastric carcinoma (aGC), it may lead to an adverse prognosis. Establishing a highly effective and low-toxicity chemotherapy regimen is necessary for improving efficacy and outcomes in aGC patients.
OBJECTIVE: To determine the efficacy and safety of cetuximab (CET) combined with the FOLFOX4 regimen (infusional fluorouracil, folinic acid, and oxaliplatin) as first-line therapy for patients with aGC, who received evidence-based care (EBC).
METHODS: A total of 117 aGC patients who received EBC from March 2019 to March 2022 were enrolled. Of these, 60 in the research group (RG) received CET + FOLFOX4 as first-line therapy, whereas 57 in the control group (CG) received FOLFOX4. The efficacy [clinical response rate (RR) and disease control rate (DCR)], safety (liver and kidney dysfunction, leukopenia, thrombocytopenia, rash, and diarrhea), serum tumor marker expression [STMs; carbohydrate antigen (CA) 19-9, CA72-4, and carcinoembryonic antigen (CEA)], inflammatory indicators [interleukin (IL)-2 and IL-10], and quality of life (QOL) of the two groups were compared.
RESULTS: A markedly higher RR and DCR were observed in the RG compared with the CG, with an equivalent safety profile between the two groups. RG exhibited notably reduced CA19-9, CA72-4, CEA, and IL-2 levels following treatment, which were lower than the pre-treatment levels and those in the CG. Post-treatment IL-10 was statistically increased in RG, higher than the pre-treatment level and the CG. Moreover, a significantly improved QOL was evident in the RG.
CONCLUSIONS: The CET + FOLFOX4 regimen is highly effective as first-line treatment for aGC patients receiving EBC. It facilitates the suppression of STMs, ameliorates the serum inflammatory microenvironment, and enhances QOL, without increased adverse drug effects.

OBJECTIVE: The evidence of apatinib plus immune checkpoint inhibitors (ICIs) and transarterial chemoembolization (TACE) for treating advanced hepatocellular carcinoma (HCC) is limited. This study aimed to compare the treatment efficacy and safety of apatinib plus ICIs and TACE with apatinib plus TACE in these patients.
METHODS: This study retrospectively enrolled 90 patients with advanced HCC treated with apatinib plus TACE (A-TACE group, n = 52) or apatinib plus ICIs and TACE (IA-TACE group, n = 38).
RESULTS: The objective response rate was numerically higher in IA-TACE group compared with A-TACE group without statistical significance (57.9% vs. 36.5%, P = 0.055). Disease control rate was not different between groups (86.8% vs. 76.9%, P = 0.248). Progression-free survival (PFS) was improved in IA-TACE group compared with A-TACE group (P = 0.018). The median PFS (95% confidence interval) was 12.5 (8.7-16.3) months in IA-TACE group and 8.5 (5.6-11.4) months in A-TACE group. Overall survival (OS) was also prolonged in IA-TACE group compared with A-TACE group (P = 0.007). The median OS (95% confidence interval) was 21.1 (15.8-26.4) months in IA-TACE group and 14.3 (11.5-17.1) months in A-TACE group. By multivariate Cox regression model, IA-TACE was independently associated with prolonged PFS (hazard ratio = 0.539, P = 0.038) and OS (hazard ratio = 0.447, P = 0.025). Most adverse events were not different between groups. Only the incidence of reactive cutaneous capillary endothelial proliferation was higher in IA-TACE group compared with A-TACE group (10.5% vs. 0.0%, P = 0.029).
CONCLUSIONS: Apatinib plus ICIs and TACE may be an effective and safe treatment for patients with advanced HCC, but further large-scale studies are needed for verification.

OBJECTIVE: Immune checkpoint inhibitor (ICI) monotherapy and chemotherapy (CT) have been used to treat recurrent or metastatic nasopharyngeal carcinoma (R/M-NPC), with demonstrated survival benefits and good safety. However, whether combination therapy is superior to CT alone remains unclear. We summarized the existing evidence comparing the effectiveness and toxicities of ICI combined with CT versus CT alone.
METHODS: Online databases was conducted for eligible randomized controlled trials (RCTs) published up to November 1, 2023. Progression-free survival (PFS) and overall survival (OS) were the primary endpoint. Objective response rates (ORRs) and adverse events (AEs) were the secondary endpoint.
RESULTS: Three randomized controlled trials (Capture-1st, JUPITER-02, and RATIONALE-309) were included. First-line ICI therapy combined with CT showed significant improvement in PFS (hazard ratio[HR], 0.53; 95% confidence interval[CI]: 0.44-0.64), OS (HR, 0.63;95%CI: 0.49-0.81) and ORRs (odds ratio[OR], 1.79;95%CI: 1.30-2.46), when compared with CT alone. AEs ≥ grade 3 during treatment and treatment-related deaths were not significantly different between the two groups.
CONCLUSIONS: In patients with R/M-NPC, ICI therapy combined with CT showed improved ORRs, PFS, and OS, with similar safety as CT alone.

A meta-analysis of the clinical survival indicators, adverse reactions and safety of lenvatinib combined with programmed death-1 (PD-1) inhibitors in treating liver cancer was conducted, providing objective and effective evidence for clinical use. The present study is anticipated to guide the clinical application of lenvatinib. In the current meta-analysis, the PubMed, Embase and Cochrane Library databases were searched from inception to September 2023. Randomized controlled trials (RCTs), non-RCTs and single-arm trial studies related to the combined treatment of lenvatinib and PD-1/PD-ligand 1 (L1) inhibitors for hepatocellular carcinoma (HCC) were included, while published and unpublished literature on other study types, literature with incomplete or inadequate information, animal experiments, literature reviews and systematic studies were excluded. Data were processed using STATA 15.1. The pooled results showed that the objective response rate [ORR; odds ratio (OR), 3.36; 95% confidence interval (CI), 2.13-5.30; P<0.001], disease control rate (DCR; OR, 1.62; 95% CI, 1.03-2.57; P=0.038) and partial response (PR; OR, 3.81; 95% CI, 2.17-6.70; P<0.001) of combined lenvatinib and PD-1/PD-L1 inhibitor therapy were significantly higher than those of lenvatinib monotherapy. Additionally, subgroup analysis results showed that the DCR of combination therapy using lenvatinib and nivolumab was significantly higher than that of lenvatinib monotherapy (OR, 2.20; 95% CI; 1.07-4.51; P=0.032). The difference between combination therapy using lenvatinib and camrelizumab, and lenvatinib monotherapy was not significant. However, the complete response, stable disease, progression disease and incidence rate of adverse events between combination therapy and lenvatinib monotherapy were not significantly different. Compared with lenvatinib alone, lenvatinib combined with PD-1/PD-L1 inhibitors significantly improved ORR, mainly PR, and DCR in patients with HCC. At present, lenvatinib is mainly combined with nivolumab to increase the DCR of lenvatinib monotherapy for HCC. In addition, the incidence rate of adverse reactions between combination therapy and lenvatinib monotherapy was not significantly different for HCC.