Tolerance of Human Fibroblasts to Benfo-Oxythiamine In Vitro.

OBJECTIVES: To explore the potential application of B-OT in the aspiration tract. MATERIALS AND METHODS: We conceived and optimized an in vitro model simulating the mouth-washing process to assess tolerance to B-OT on primary human gingival fibroblasts. Cells derived from 4 unrelated donors were flushed with medium containing drugs of various concentration for one minute twice daily for 3 days. RESULTS: No effect was seen on the cells up to 1000 µM B-OT. In addition, we treated the cells with B-OT permanently in medium, corresponding to a systemic treatment. No effect was seen by 10 µM B-OT and only a slight reduction (approximately 10%) was seen by 100 µM B-OT. CONCLUSIONS: Our results suggest good tolerance of oral cells for B-OT, favoring the further development of this antiviral reagent as a mouth-washing solution and nasal spray.

Prophylaxis of Neutropenia with Lipegfilgrastim in Breast Cancer Patients with Dose-Dense Chemotherapy: Results of a Noninterventional Study on Therapeutic Routine in Germany (NADENS).

Introduction: Noninterventional study (NIS) on application and effectiveness of primary G-CSF prophylaxis with lipegfilgrastim in primary breast cancer patients undergoing dose-dense (dd) or intense-dose-dense (idd) chemotherapy (CTx) regimen in daily clinical practice. Methods: Prospective, multicenter, single-arm, NIS in 41 private practices and 27 hospitals in Germany. Results: Data analysis of 282 patients with a mean age of 49 years (93.6% of patients <65 years) was performed. Hormone receptor status was triple negative in 29.8% of patients, and 81.9% of patients were HER2 negative. A total of 73.8% of patients received "EC dd → taxane CTx." Patients received lipegfilgrastim prophylaxis in 97.5% of 1,121 documented dd/idd cycles. Overall, the study registered 275 events of SN (CTCAE grade 3 or 4) and 9 events of FN. During the first dd cycle, SN occurred in 33.3% and FN in 1.1% of patients. CTx delay or dose reduction due to neutropenia was required in 2.5% of patients during the 4 dd cycles with lipegfilgrastim support. Overall, 314 adverse events (AEs) were reported from 107 patients and 27 serious AEs from 21 patients. None of the SAEs was "fatal," and CTCAE grade was mostly (89.6%) assessed as "1" or "2." According to the treating physicians, 99.3% of all patients benefitted from lipegfilgrastim prophylaxis, and tolerability was mostly rated "very good" or "good." Conclusion: These results suggest that primary lipegfilgrastim prophylaxis is effective and safe in clinical routine and is beneficial in primary breast cancer patients undergoing dd/idd-ETC CTx.

Visual outcome after rhegmatogenous retinal detachment repair surgery in patients with multifocal vs monofocal intraocular lenses.

PURPOSE: To evaluate functional outcome after retinal detachment (RD) repair surgery in eyes with a multifocal intraocular lens (mIOL). SETTING: Ludwig-Maximilians-University, Munich, Germany. DESIGN: Single-center case control study. METHODS: 52 pseudophakic eyes with successful anatomical outcome after surgical RD repair were included. Retrospectively, 21 mIOL eyes were compared with a matched group of 21 monofocal eyes over 6 weeks. Prospectively, corrected distance visual acuity (CDVA) was evaluated over 12 months in these eyes. Furthermore, uncorrected distance, intermediate, and near visual acuity (UDVA, UIVA, and UNVA, respectively), defocus curves, and patient-reported outcomes were evaluated at 1 year in 24 mIOL eyes. RESULTS: 52 eyes of 48 patients comprised the study. The mean CDVA (logMAR) improved significantly from 1.35 ± 1.38 to 0.29 ± 0.37 at 6 weeks and remained stable at 12 months postoperatively in monofocal eyes (P = .001) and from 1.16 ± 1.2 to 0.37 ± 0.29 (6 weeks) and 0.20 ± 0.36 (12 months) in mIOL eyes (P = .001). Univariate factorial analysis of variance showed no statistically significant differences in CDVA at 6 weeks or 12 months postoperatively for IOL type or for preoperative macular status (P > .05). In the prospective cohort of 24 mIOL eyes, a mean CDVA of 0.13 ± 0.33 logMAR, UDVA of 0.21 ± 0.34 logMAR, UIVA of 0.17 ± 0.28 logMAR, and UNVA of 0.23 ± 0.32 logMAR was achieved. Macular status did not affect final outcome significantly (P > .05). Most patients stated they usually did not need spectacles; no patient wanted mIOL replacement. CONCLUSIONS: 1 year after successful anatomical repair after 23-gauge vitrectomy with gas tamponade, functionality of mIOL was restored, and CDVA was comparable with that of patients with monofocal IOL.