Clinical safety of drug-eluting stents in the Korea acute myocardial infarction registry.

BACKGROUND: Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) may be useful in patients with acute myocardial infarction (AMI), but safety issues still need to be solved. This study was undertaken to investigate the incidence of major adverse cardiac events (MACE) and stent thrombosis in DES-implanted AMI patients in real-life clinical practice. METHODS AND RESULTS: On-line registry of AMI cases at the web site www.kamir.or.kr has been performed in 41 primary PCI centers in Korea and between November 2005 and September 2006, 1,541 surviving patients who had been implanted with either Cypher or Taxus stents were enrolled for analysis during a 6-month clinical follow-up. There were 2 groups: group I [834 patients, 61.9+/-11.9 years: sirolimus-eluting stent (Cypher)], group II [707 patients, 62.9+/-12.0 years: paclitaxel-eluting stent (Taxus)]. At both 1 and 6 months the incidence of MACE was not significantly different between the 2 groups. There were 17 cases of stent thrombosis, but the incidence of stent thrombosis was not significantly different between the 2 groups (group I:II=9 (1.1%):8 (1.1%), p=1.000). The stent type, length, number, lesion complexity and diabetes were not significant for the incidence of MACE or stent thrombosis after adjustment. CONCLUSION: MACE and stent thrombosis rates did not differ between 2 types of DES identified in Korea Acute Myocardial Infarction Registry (KAMIR). DES can be used in patients with AMI with a relatively low 6-month MACE rate.     

Near-complete photoluminescence retention and improved stability of InP quantum dots after silica embedding for their application to on-chip-packaged light-emitting diodes

Silica is the most commonly used oxide encapsulant for passivating fluorescent quantum dots (QDs) against degradable conditions. Such a silica encapsulation has been conventionally implemented via a Stöber or reverse microemulsion process, mostly targeting CdSe-based QDs to date. However, both routes encounter a critical issue of considerable loss in photoluminescence (PL) quantum yield (QY) compared to pristine QDs after silica growth. In this work, we explore the embedment of multishelled InP/ZnSeS/ZnS QDs, whose stability is quite inferior to CdSe counterparts, in a silica matrix by means of a tetramethyl orthosilicate-based, waterless, catalyst-free synthesis. It is revealed that the original QY (80%) of QDs is nearly completely retained in the course of the present silica embedding reaction. The resulting QD–silica composites are then placed in degradable conditions such UV irradiation, high temperature/high humidity, and operation of an on-chip-packaged light-emitting diode (LED) to attest to the efficacy of silica passivation on QD stability. Particularly, the promising results with regard to device efficiency and stability of the on-chip-packaged QD-LED firmly suggest the effectiveness of the present silica embedding strategy in not only maximally retaining QY of QDs but effectively passivating QDs, paving the way for the realization of a highly efficient, robust QD-LED platform.

Silica embedding strategy enabling a nearly full PL retention of the original QY of InP QDs is proposed for the realization of a highly efficient, robust QD-LED platform.     

Measurement properties of the Wheelchair Skills Test for scooters among experienced users

Purpose: To investigate the score distribution, reliability, and validity of the objective Wheelchair Skills Test (WST) for scooter users.

Method: A study using a test–retest design was conducted with 20 people who had mobility limitations that prevented them from ambulating more than one city block without a mobility aid, and who had owned a scooter for ≥3 months. Objective scooter skills, confidence, and physical accessibility were measured at both time points, while anxiety, depression, visual attention and task switching, functional independence, and visual acuity were measured only at baseline.

Results: The mean total WST scores at Time 1 and Time 2 were 86.3% and 87.5%. The WST ICC was 0.889. The WST had a SEM of 2.50 and a Cronbach’s alpha of 0.74. The total WST scores were significantly correlated with total subjective WST-Q scores (r?=?0.547, p?=?0.013), scooter confidence (r?=?0.466, p?=?0.038), and were affected by gender (p?=?0.005).

Conclusion: The WST for scooters has good test–retest reliability and generally varies as anticipated with other measures. Although further study is needed, the WST for scooters appears to have promise for use in research and clinical practice.

• Implications for Rehabilitation

• It is important to understand the measurement properties of the tools we use in rehabilitation so the results can be interpreted correctly.

• As scooter use increases, better measurement of skills is required.

     

Bone regeneration by means of a three‐dimensional printed scaffold in a rat cranial defect

Recently, computer‐designed three‐dimensional (3D) printing techniques have emerged as an active research area with almost unlimited possibilities. In this study, we used a computer‐designed 3D scaffold to drive new bone formation in a bone defect. Poly‐L‐lactide (PLLA) and bioactive β‐tricalcium phosphate (TCP) were simply mixed to prepare ink. PLLA + TCP showed good printability from the micronozzle and solidification within few seconds, indicating that it was indeed printable ink for layer‐by‐layer printing. In the images, TCP on the surface of (and/or inside) PLLA in the printed PLLA + TCP scaffold looked dispersed. MG‐63 cells (human osteoblastoma) adhered to and proliferated well on the printed PLLA + TCP scaffold. To assess new bone formation in vivo, the printed PLLA + TCP scaffold was implanted into a full‐thickness cranial bone defect in rats. The new bone formation was monitored by microcomputed tomography and histological analysis of the in vivo PLLA + TCP scaffold with or without MG‐63 cells. The bone defect was gradually spontaneously replaced with new bone tissues when we used both bioactive TCP and MG‐63 cells in the PLLA scaffold. Bone formation driven by the PLLA + TCP30 scaffold with MG‐63 cells was significantly greater than that in other experimental groups. Furthermore, the PLLA + TCP scaffold gradually degraded and matched well the extent of the gradual new bone formation on microcomputed tomography. In conclusion, the printed PLLA + TCP scaffold effectively supports new bone formation in a cranial bone defect.     

72-Week Safety and Tolerability of Dimethyl Fumarate in Japanese Patients with Relapsing-remitting Multiple Sclerosis: Analysis of the Randomised,Double Blind,Placebo-Controlled,Phase III APEX Study and its Open-Label Extension

Introduction

The long-term safety of dimethyl fumarate (DMF) in patients with relapsing-remitting multiple sclerosis (RRMS) has been studied in mainly Caucasian patients. The present interim analysis aimed to evaluate the 72-week safety of DMF in Japanese patients with RRMS.

Methods

Safety data of Japanese subjects enrolled in the 24-week randomised, double-blind, placebo-controlled APEX study (Part I) and its following open-label extension (Part II) were analysed at 72 weeks from the beginning of Part I. In Part I, subjects were randomised to DMF treatment or matching placebo while all subjects received DMF treatment during Part II. Adverse events (AEs) reported throughout the study period were recorded.

Results

Overall, 109 Japanese subjects completed 72 weeks of treatment. The incidence of AEs and serious AEs was 95% and 19%, respectively, in the DMF group compared with 84% and 18%, respectively, in the placebo group at 24 weeks. Common AEs (at least 5%) reported with treatment included nasopharyngitis, flushing, hot flush, gastrointestinal events, pruritus, rash, headache, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST). AEs led to discontinuation of DMF in 5% of patients and included MS relapse, flushing, abdominal pain, liver disorder and increased ALT/AST. After an initial decrease from baseline of 17% in the DMF group at week 24, the mean lymphocyte counts stabilised and were maintained until week 72. No opportunistic/serious infections nor malignancies were reported with DMF treatment. The incidences of AEs, serious AEs, and discontinuation due to AEs were similar between the DMF and the placebo groups.

Conclusion

The 72-week safety profile of DMF in Japanese patients with RRMS was consistent with previous studies that enrolled mostly Caucasian patients, with a lower incidence of flushing and related symptoms and a lower reduction in the lymphocyte count compared with previous reports.

Trial Registration

ClinicalTrials.gov identifier NCT01838668.

Funding

Biogen Japan Ltd.

     

Sex Differences Associated With Hepatitis B Virus Surface Antigen Seropositivity Unwareness in Hepatitis B Virus Surface Antigen-positive Adults: 2007-2012 Korea National Health and Nutrition Examination Survey

Objectives:

To examine the sex-specific factors associated with being unaware of one’s hepatitis B virus surface antigen (HBsAg) seropositivity status in a large, HBsAg-positive population of Koreans.

Methods:

In total, 1197 subjects aged 19 years or older who were HBsAg-positive according to data from the 2007-2012 Korea National Health and Nutrition Examination Survey were included. Subjects were considered unaware of their HBsAg seropositivity status if they answered that they had no knowledge of being previously infected by the hepatitis B virus (HBV) or diagnosed with HBV hepatitis. Multivariate Poisson regression models with robust variance estimate were used to assess the significance of the variables using weighted frequencies.

Results:

The majority (77.8%) of HbsAg-positive Korean adults (females, 81.9%; males, 74.6%) were unaware of their HBsAg seropositivity status. We found that sex (female: prevalence ratio [PR] 1.19), household income (low: PR, 1.15), marital status (never married: PR, 1.18), self-rated health (moderate: PR, 1.14; good: PR, 1.12), and alcohol use (at least 2-3 times/wk: PR, 1.21) were associated with being unaware. In females, age (50 to 59 years: PR, 1.29; ≥70 years: PR, 1.30), household income (low: PR, 1.37; middle–low: PR, 1.24), and marital status (never married: PR, 1.33) were associated with being unaware. In males, self-rated health (moderate: PR, 1.14; good: PR, 1.21) and alcohol use (at least 2–3 times/wk: PR, 1.21) were associated with being unaware.

Conclusions:

Factors related to the socioeconomic status of females and the health-related behaviors of males were found to be associated with being unaware of one’s HBsAg seropositivity status.     

Correlations Between the Incidence of National Notifiable Infectious Diseases and Public Open Data,Including Meteorological Factors and Medical Facility Resources

Objectives:

This study was performed to investigate the relationship between the incidence of national notifiable infectious diseases (NNIDs) and meteorological factors, air pollution levels, and hospital resources in Korea.

Methods:

We collected and stored 660 000 pieces of publicly available data associated with infectious diseases from public data portals and the Diseases Web Statistics System of Korea. We analyzed correlations between the monthly incidence of these diseases and monthly average temperatures and monthly average relative humidity, as well as vaccination rates, number of hospitals, and number of hospital beds by district in Seoul.

Results:

Of the 34 NNIDs, malaria showed the most significant correlation with temperature (r=0.949, p<0.01) and concentration of nitrogen dioxide (r=-0.884, p<0.01). We also found a strong correlation between the incidence of NNIDs and the number of hospital beds in 25 districts in Seoul (r=0.606, p<0.01). In particular, Geumcheon-gu was found to have the lowest incidence rate of NNIDs and the highest number of hospital beds per patient.

Conclusions:

In this study, we conducted a correlational analysis of public data from Korean government portals that can be used as parameters to forecast the spread of outbreaks.     

Comparison of Abdominal Visceral Adipose Tissue Area Measured by Computed Tomography with That Estimated by Bioelectrical Impedance Analysis Method in Korean Subjects

We evaluated the concordance between visceral fat area (VFA) estimated by bioelectrical impedance analysis (BIA) or computed tomography (CT) in Korean subjects with a wide range in age and body mass index (BMI). In 1006 individuals (mean age 55.2 ± 11.8 (19–87) years, mean BMI 26.0 ± 3.5 (17–46) kg/m², 48.9% men), VFA quantified by CT was compared with VFA using multifrequency BIA machines within 15 days. Concordance rates were compared by age or BMI using correlation analysis, Bland-Altman plots, and intraclass correlation coefficient (ICC). Using BIA data, we established a regression formula to reflect CT-VFA. The mean VFAs by CT and BIA were 131.9 ± 57.3 cm² and 110.5 ± 33.9 cm², respectively (r = 0.605, p < 0.001). The mean difference was 21.4 ± 45.6 cm², tending to increase with BMI. In women with BMI <25 kg/m² or age <50 years, the VFAs by BIA were similar to those by CT (ICC = 0.496 in BMI <25 kg/m² and ICC = 0.638 in age <50 years). However, the difference was greater in men with BMI ≥25 kg/m² or age ≥50 years. Applying our formula, the difference between estimations decreased to 0.2 ± 38.2cm². VFA estimated by BIA correlated well with that by CT, but a more accurate formula is needed to match CT data, particularly in older men or subjects with a high BMI.     

Polybenzimidazole/Nafion hybrid membrane with improved chemical stability for vanadium redox flow battery application

In order to increase the chemical stability of polybenzimidazole (PBI) membrane against the highly oxidizing environment of a vanadium redox flow battery (VRFB), PBI/Nafion hybrid membrane was developed by spray coating a Nafion ionomer onto one surface of the PBI membrane. The acid–base interaction between the sulfonic acid of the Nafion and the benzimidazole of the PBI created a stable interfacial adhesion between the Nafion layer and the PBI layer. The hybrid membrane showed an area resistance of 0.269 Ω cm² and a very low vanadium permeability of 1.95 × 10⁻⁹ cm² min⁻¹. The Nafion layer protected the PBI from chemical degradation under accelerated oxidizing conditions of 1 M VO₂⁺/5 M H₂SO₄, and this was subsequently examined in spectroscopic analysis. In the VRFB single cell performance test, the cell with the hybrid membrane showed better energy efficiency than the Nafion cell with 92.66% at 40 mA cm⁻² and 78.1% at 100 mA cm⁻² with no delamination observed between the Nafion layer and the PBI layer after the test was completed.

Novel polybenzimidazole (PBI)/Nafion hybrid membranes for the VRFB are made by spray coating a Nafion layer to protect PBI from chemical degradation.