Background: Cyclosporine (CS) is widely used in various dermatological diseases, and its range of usage has been expanded to younger patients. However, data on the safety of CS in children and adolescents are limited. Objective: This study aimed to investigate the adverse events and safety of CS in pediatric and adolescent patients with dermatologic diseases. Methods: This retrospective study included 992 pediatric patients (≥12 and ＜19 years of age) having administered oral CS for dermatological reasons between 2010 and 2021. Results: Among the 992 patients, 57 (5.7%) reported adverse events at the clinic. Gastrointestinal symptoms were the most common adverse events (2.6%). Other adverse events included hypertrichosis (1.4%) and headaches (0.6%). During subgroup analysis, hypertrichosis was found more frequently in pediatric patients (age ＜12 years), and the cumulative dose of CS was higher (≥420 mg/kg). Of the 150 patients who underwent laboratory tests, 28 (18.7%) showed abnormal results, including an increase in serum creatinine (8.0%), hypercholesterolemia (6.7%), and urea (2.7%). Conclusion The use of CS in pediatric dermatoses resulted in a low frequency of adverse events, and all the patients showed reversible courses without serious complications. The study suggest that dermatologists should safely administer oral CS with detailed history taking and periodic laboratory tests.

Background: and Purpose: Blood pressure (BP) control is strongly recommended, but BP control rate has not been well studied in patients with stroke. We evaluated the BP control rate with fimasartan-based antihypertensive therapy initiated in patients with recent cerebral ischemia. Methods: This multicenter, prospective, single-arm trial involved 27 centers in South Korea. Key inclusion criteria were recent cerebral ischemia within 90 days and high BP [systolic blood pressure (SBP) >140 mm Hg or diastolic blood pressure (DBP) >90 mm Hg]. BP lowering was initiated with fimasartan. BP management during the follow-up was at the discretion of the responsible investigators. The primary endpoint was the target BP goal achievement rate (<140/90 mm Hg) at 24 weeks. Key secondary endpoints included achieved BP and BP changes at each visit, and clinical events (ClinicalTrials.gov Identifier: NCT03231293). Results: Of 1,035 patients enrolled, 1,026 were included in the safety analysis, and 951 in the efficacy analysis. Their mean age was 64.1 years, 33% were female, the median time interval from onset to enrollment was 10 days, and the baseline SBP and DBP were 162.3±16.0 and 92.2±12.4 mm Hg (mean±SD). During the study period, 55.5% of patients were maintained on fimasartan monotherapy, and 44.5% received antihypertensive therapies other than fimasartan monotherapy at at least one visit. The target BP goal achievement rate at 24-week was 67.3% (48.6% at 4-week and 61.4% at 12-week). The mean BP was 139.0/81.8±18.3/11.7, 133.8/79.2±16.4/11.0, and 132.8/78.5±15.6/10.9 mm Hg at 4-, 12-, and 24-week. The treatment-emergent adverse event rate was 5.4%, including one serious adverse event. Conclusions Fimasartan-based BP lowering achieved the target BP in two-thirds of patients at 24 weeks, and was generally well tolerated.

Background: and Purpose We aimed to develop a model predicting early recanalization after intravenous tissue plasminogen activator (t-PA) treatment in large-vessel occlusion. Methods: Using data from two different multicenter prospective cohorts, we determined the factors associated with early recanalization immediately after t-PA in stroke patients with large-vessel occlusion, and developed and validated a prediction model for early recanalization. Clot volume was semiautomatically measured on thin-section computed tomography using software, and the degree of collaterals was determined using the Tan score. Follow-up angiographic studies were performed immediately after t-PA treatment to assess early recanalization. Results: Early recanalization, assessed 61.0±44.7 minutes after t-PA bolus, was achieved in 15.5% (15/97) in the derivation cohort and in 10.5% (8/76) in the validation cohort. Clot volume (odds ratio [OR], 0.979; 95% confidence interval [CI], 0.961 to 0.997; P=0.020) and good collaterals (OR, 6.129; 95% CI, 1.592 to 23.594; P=0.008) were significant factors associated with early recanalization. The area under the curve (AUC) of the model including clot volume was 0.819 (95% CI, 0.720 to 0.917) and 0.842 (95% CI, 0.746 to 0.938) in the derivation and validation cohorts, respectively. The AUC improved when good collaterals were added (derivation cohort: AUC, 0.876; 95% CI, 0.802 to 0.950; P=0.164; validation cohort: AUC, 0.949; 95% CI, 0.886 to 1.000; P=0.036). The integrated discrimination improvement also showed significantly improved prediction (0.097; 95% CI, 0.009 to 0.185; P=0.032). Conclusions The model using clot volume and collaterals predicted early recanalization after intravenous t-PA and had a high performance. This model may aid in determining the recanalization treatment strategy in stroke patients with large-vessel occlusion.

Background: and Purpose: Blood pressure (BP) control is strongly recommended, but BP control rate has not been well studied in patients with stroke. We evaluated the BP control rate with fimasartan-based antihypertensive therapy initiated in patients with recent cerebral ischemia. Methods: This multicenter, prospective, single-arm trial involved 27 centers in South Korea. Key inclusion criteria were recent cerebral ischemia within 90 days and high BP [systolic blood pressure (SBP) >140 mm Hg or diastolic blood pressure (DBP) >90 mm Hg]. BP lowering was initiated with fimasartan. BP management during the follow-up was at the discretion of the responsible investigators. The primary endpoint was the target BP goal achievement rate (<140/90 mm Hg) at 24 weeks. Key secondary endpoints included achieved BP and BP changes at each visit, and clinical events (ClinicalTrials.gov Identifier: NCT03231293). Results: Of 1,035 patients enrolled, 1,026 were included in the safety analysis, and 951 in the efficacy analysis. Their mean age was 64.1 years, 33% were female, the median time interval from onset to enrollment was 10 days, and the baseline SBP and DBP were 162.3±16.0 and 92.2±12.4 mm Hg (mean±SD). During the study period, 55.5% of patients were maintained on fimasartan monotherapy, and 44.5% received antihypertensive therapies other than fimasartan monotherapy at at least one visit. The target BP goal achievement rate at 24-week was 67.3% (48.6% at 4-week and 61.4% at 12-week). The mean BP was 139.0/81.8±18.3/11.7, 133.8/79.2±16.4/11.0, and 132.8/78.5±15.6/10.9 mm Hg at 4-, 12-, and 24-week. The treatment-emergent adverse event rate was 5.4%, including one serious adverse event. Conclusions Fimasartan-based BP lowering achieved the target BP in two-thirds of patients at 24 weeks, and was generally well tolerated.

Background: and Purpose We aimed to develop a model predicting early recanalization after intravenous tissue plasminogen activator (t-PA) treatment in large-vessel occlusion. Methods: Using data from two different multicenter prospective cohorts, we determined the factors associated with early recanalization immediately after t-PA in stroke patients with large-vessel occlusion, and developed and validated a prediction model for early recanalization. Clot volume was semiautomatically measured on thin-section computed tomography using software, and the degree of collaterals was determined using the Tan score. Follow-up angiographic studies were performed immediately after t-PA treatment to assess early recanalization. Results: Early recanalization, assessed 61.0±44.7 minutes after t-PA bolus, was achieved in 15.5% (15/97) in the derivation cohort and in 10.5% (8/76) in the validation cohort. Clot volume (odds ratio [OR], 0.979; 95% confidence interval [CI], 0.961 to 0.997; P=0.020) and good collaterals (OR, 6.129; 95% CI, 1.592 to 23.594; P=0.008) were significant factors associated with early recanalization. The area under the curve (AUC) of the model including clot volume was 0.819 (95% CI, 0.720 to 0.917) and 0.842 (95% CI, 0.746 to 0.938) in the derivation and validation cohorts, respectively. The AUC improved when good collaterals were added (derivation cohort: AUC, 0.876; 95% CI, 0.802 to 0.950; P=0.164; validation cohort: AUC, 0.949; 95% CI, 0.886 to 1.000; P=0.036). The integrated discrimination improvement also showed significantly improved prediction (0.097; 95% CI, 0.009 to 0.185; P=0.032). Conclusions The model using clot volume and collaterals predicted early recanalization after intravenous t-PA and had a high performance. This model may aid in determining the recanalization treatment strategy in stroke patients with large-vessel occlusion.

PURPOSE: The aim of this animal study was to evaluate the safety and feasibility of a portable, ultrasonography-guided, high-intensity focused ultrasound (USg-HIFU) system to treat the pancreas. METHODS: Eight swine were included. Using a portable HIFU device (ALPIUS 900, Alpinion Medical Systems), ablations were performed on the pancreas in vivo. Different acoustic intensities were applied (1.7 kW/cm2 or 1.5 kW/cm2, n=2 [group A for a pilot study]; 1.5 kW/ cm2, n=3 [group B]; and 1.2 kW/cm2, n=3 [group C]). Magnetic resonance imaging (MRI) was performed immediately (group A) or 7 days (groups B and C) after HIFU treatment. In groups B and C, serum amylase and lipase levels were measured on days 0 and 7, and performance status was observed every day. Necropsy was performed on days 0 (group A) or 7 (groups B and C) to assess the presence of unintended injuries and to obtain pancreatic and peripancreatic tissue for histological analysis. RESULTS: Ablation was noted in the pancreas in all swine on MRI, and all pathologic specimens showed coagulation necrosis in the treated area. The mean ablation areas on MRI were 85.3±38.1 mm2, 90.7±21.2 mm2, and 54.4±30.6 mm2 in groups A, B, and C, respectively (P>0.05). No animals showed evidence of complications, except for one case of a pseudocyst in group B. CONCLUSION: This study showed that pancreas ablation using a portable USg-HIFU system may be safe and feasible, and that coagulation necrosis of the pancreas was successfully achieved with a range of acoustic intensities.
Acoustics ; Amylases ; Animal Experimentation ; Animals ; Lipase ; Magnetic Resonance Imaging ; Necrosis ; Pancreas* ; Swine* ; Ultrasonography*

OBJECTIVE: To evaluate transverse skeletal and dental changes, including those in the buccolingual dental axis, between patients with skeletal Class III malocclusion and facial asymmetry after bilateral intraoral vertical ramus osteotomy with and without presurgical orthodontic treatment. METHODS: This retrospective study included 29 patients with skeletal Class III malocclusion and facial asymmetry including menton deviation > 4 mm from the midsagittal plane. To evaluate changes in transverse skeletal and dental variables (i.e., buccolingual inclination of the upper and lower canines and first molars), the data for 16 patients who underwent conventional orthognathic surgery (CS) were compared with those for 13 patients who underwent preorthodontic orthognathic surgery (POGS), using three-dimensional computed tomography at initial examination, 1 month before surgery, and at 7 days and 1 year after surgery. RESULTS: The 1-year postsurgical examination revealed no significant changes in the postoperative transverse dental axis in the CS group. In the POGS group, the upper first molar inclined lingually on both sides (deviated side, −1.8°± 2.8°, p = 0.044; nondeviated side, −3.7°± 3.3°, p = 0.001) and the lower canine inclined lingually on the nondeviated side (4.0°± 5.4°, p = 0.022) during postsurgical orthodontic treatment. There were no significant differences in the skeletal and dental variables between the two groups at 1 year after surgery. CONCLUSIONS: POGS may be a clinically acceptable alternative to CS as a treatment to achieve stable transverse axes of the dentition in both arches in patients with skeletal Class III malocclusion and facial asymmetry.
Dentition ; Facial Asymmetry* ; Humans ; Malocclusion* ; Molar ; Orthognathic Surgery* ; Osteotomy ; Retrospective Studies

BACKGROUND/AIMS: This study was designed to evaluate the dose-effect relationship of statins in patients with ischemic congestive heart failure (CHF), since the role of statins in CHF remains unclear. METHODS: The South koreAn Pitavastatin Heart FaIluRE (SAPHIRE) study was designed to randomize patients with ischemic CHF into daily treatments of 10 mg pravastatin or 4 mg pitavastatin. RESULTS: The low density lipoprotein cholesterol level decreased by 30% in the pitavastatin group compared with 12% in the pravastatin (p < 0.05) group. Left ventricular systolic dimensions decreased significantly by 9% in the pitavastatin group and by 5% in the pravastatin group. Left ventricular ejection fraction (EF) improved significantly from 37% to 42% in the pitavastatin group and from 35% to 39% in the pravastatin group. Although the extent of the EF change was greater in the pitavastatin group (16% vs. 11%) than that in the pravastatin group, no significant difference was observed between the groups (p = 0.386). Exercise capacity, evaluated by the 6-min walking test, improved significantly in the pravastatin group (p < 0.001), but no change was observed in the pitavastatin group (p = 0.371). CONCLUSIONS: Very low dose/low potency pravastatin and high dose/high potency pitavastatin had a beneficial effect on cardiac reverse remodeling and improved systolic function in patients with ischemic CHF. However, only pravastatin significantly improved exercise capacity. These findings suggest that lowering cholesterol too much may not be beneficial for patients with CHF.
Aged ; Biological Markers/blood ; Cholesterol, LDL/*blood ; Down-Regulation ; Dyslipidemias/blood/diagnosis/*drug therapy/epidemiology ; Exercise Tolerance/drug effects ; Female ; Heart Failure/diagnosis/*drug therapy/epidemiology/physiopathology ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/*administration & dosage/adverse effects ; Male ; Middle Aged ; Myocardial Ischemia/diagnosis/*drug therapy/epidemiology/physiopathology ; Pravastatin/*administration & dosage/adverse effects ; Prospective Studies ; Quinolines/*administration & dosage/adverse effects ; Recovery of Function ; Republic of Korea ; Stroke Volume/drug effects ; Time Factors ; Treatment Outcome ; Ventricular Function, Left/drug effects ; Ventricular Remodeling/drug effects

PURPOSE: To compare the clinical results after implantation of three one-piece aspheric lenses, Acrysof IQ SN60WF, Tecnis 1-piece ZCB00 and the newly developed IOL HOYA AF-1 NY-60. METHODS: In total 66 eyes, one of three one-piece aspheric lenses, Acrysof IQ SN60WF, TECNIS 1-piece ZCB00 or HOYA AF-1 NY-60 was implanted after cataract extraction. Best corrected visual acuity (BCVA) and uncorrected visual acuity (UCVA) were assessed at postoperative 3 months. Total spherical aberration, high order aberration and modulation transfer function of 5.0 mm pupil size zone were evaluated. RESULTS: There were no significant differences of UCVA, BCVA, the accuracy of postoperative refractive power and modulation transfer function among three groups. High order aberrations of the entire eye and internal optics showed almost no significant differences except some aberration values. CONCLUSIONS: The newly developed intraocular lens, HOYA AF-1 NY-60 showed almost equal clinical results in comparison with Acrysof IQ SN60WF and TECNIS 1-piece ZCB00.
Cataract Extraction ; Eye ; Lenses, Intraocular ; Pupil ; Visual Acuity