nepafenac (Ilevro)

Clinical efficacy, safety evaluation, and mechanism of acetylcysteine in improving first-line anti-tuberculosis treatment of newly diagnosed pulmonary TB: an open-label, randomized, single-center trial.

Zhang Huan H, Liu Ming M, Shi Lu L, Wang Xianlei X et al.

To investigate the clinical efficacy, safety and mechanism of N-acetylcysteine combined with conventional antituberculosis drugs in the treatment of newly diagnosed pulmonary tuberculosis. A total of 90 newly diagnosed pulmonary tuberculosis patients were randomly assigned to a Control group (n = 30), Aerosol NAC group (n = 30), or Oral NAC group (n = 30). The Control group received standard HRZE therapy, whereas the Aerosol NAC and Oral NAC groups received additional nebulized N-acetylcysteine (300 mg twice daily) or oral N-acetylcysteine (600 mg once daily), respectively. Clinical efficacy, sputum conversion, St. George's Respiratory Questionnaire (SGRQ) scores, liver function indices, oxidative stress biomarkers, inflammatory markers, and adverse events were assessed over 3 months. Data were analyzed using one-way ANOVA, repeated-measures ANOVA, Chi-square tests, and Bonferroni-adjusted post hoc analyses. Treatment successful response rates were significantly higher in the Aerosol NAC group (96.67%) and Oral NAC group (93.33%) than in the Control group (70.00%) (p < 0.05). At 3 months, sputum conversion rates reached 93.33 and 96.67% in the Aerosol NAC and Oral NAC groups, respectively, compared with 73.33% in the Control group (p < 0.05). Both NAC groups demonstrated significantly lower SGRQ scores, improved liver function parameters (AST, ALT, TBIL, and GGT), higher antioxidant enzyme levels (SOD and GSH-Px), lower MDA concentrations, and reduced inflammatory markers (IFN-γ, PCT, and IL-4) compared with the Control group (all p < 0.05). The incidence of adverse reactions was lower in both NAC groups (10.0%) than in the Control group (40.0%) (p < 0.05). Adjunctive N-acetylcysteine, administered either by aerosol inhalation or orally, significantly improved treatment outcomes, accelerated sputum conversion, reduced oxidative stress and inflammation, protected liver function, and decreased adverse events in patients with newly diagnosed pulmonary tuberculosis.

Dose once, treat forever: drugs are being engineered to last much longer.

Deighton Ben B

Short Term Safety and Effectiveness of Valganciclovir Prophylactic Dosing for Cytomegalovirus in Solid Organ Transplant Recipients Requiring Intermittent Hemodialysis.

Edwards Megan M, Sturm Ashley A, Shulha Jenny J, Cole Kristin K et al.

Valganciclovir is the preferred antiviral agent for cytomegalovirus (CMV) prophylaxis in solid organ transplant (SOT) recipients; however, limited data exist to guide optimal dosing in patients requiring intermittent hemodialysis (iHD). This study evaluated the safety and efficacy of our institution's current dosing strategy of valganciclovir 450 mg three times weekly. In this single-center, retrospective study, adult liver, heart, lung, and kidney transplant recipients from January 2014 to November 2024 were included. Patients requiring ≥ 3 iHD sessions posttransplant and receiving valganciclovir 450 mg three times weekly were compared with recipients with normal renal function receiving 900 mg once daily. The primary outcomes were the risk of neutropenia, leukopenia, and thrombocytopenia within 3.5 months posttransplant. A total of 116 patients were included in the iHD cohort and were matched 1:2 to 232 patients in the normal renal function cohort. Rates of leukopenia and neutropenia were comparable between cohorts. However, thrombocytopenia occurred significantly more frequently in the iHD cohort (45.2% vs. 26.7%; p = 0.002). No significant differences were observed in rates of CMV infection between groups. Valganciclovir 450 mg three times weekly appears safe and effective for CMV prophylaxis in SOT recipients requiring iHD, though it may be associated with an increased risk of thrombocytopenia.

A centralized hybrid model for regulatory inspection readiness in a multi-site radiation oncology system.

Kalavagunta Chaitanya C, Simonson Dustin D, Guerrero Mariana M

State regulatory inspections of radiation-producing treatment equipment combine a review of quality assurance and regulatory records with direct verification of facility and safety systems. When these activities are performed entirely on-site across multiple facilities, real-time document retrieval can prolong visits and divert clinical staff. To develop and evaluate a centralized hybrid framework that separates advance document review from focused on-site verification during state-mandated annual inspections of photon linear accelerators. The framework was implemented across five photon treatment sites comprising 10 linear accelerators using an institutionally deployed cloud-based quality assurance platform (TotalQA, Image Owl Inc., Greenwich, NY). Site physicists uploaded machine- and site-specific records directly. A dedicated guest account allowed the inspector to review documents approximately 14 days before each visit. Document-verifiable items and photographs of required postings were reviewed remotely; audio/video monitoring systems, linac-on warning lights, staff access to applicable state regulatory requirements and personnel dosimetry records, written operating and emergency procedures, direct questions, and unresolved items remained on-site. A system-wide clinical deviation logbook containing protected health information was reviewed once in person at a central location. Operational outcomes included on-site duration, daily throughput, physicist support, schedule adherence, treatment impact, and inspection findings. Historical inspections required approximately 120 min of on-site time per facility, based on calendar records, prior schedules, and staff recollection. During the hybrid implementation, on-site inspection time was approximately 30 minutes per facility based on records documented at the time of each inspection, representing an estimated 75% reduction. Daily throughput increased from approximately three sites per day to four sites per day. The inspector estimated that advance review required 1 to 2 h per site, generally closer to 2 h during the first cycle. All visits remained within scheduled blocks, no inspection-related treatment delays or interruptions occurred, and no documentation-related citations were identified. A centralized hybrid model was feasible for state-mandated annual inspections of linear accelerators in a multi-site radiation oncology system. Advance review reduced on-site document-navigation demands while preserving direct verification of physical and safety-related elements. Because remote-review time was estimated retrospectively, the findings support reduced on-site duration rather than reduced total inspector effort.