Bayer (South Korea)

BACKGROUND: Activities of daily living (ADL) deficits are integral components of dementia disorders, and ADL measures are among the most robust markers of the course of Alzheimer's disease (AD). Despite this acknowledged importance, no clearly useful ADL instrument for cross-cultural application in pharmacologic trials in the early stages of AD had been available. METHOD: An international effort was launched to develop an ADL scale for pharmacologic trials in early AD. Steps taken from 1990 to the present included: (1) international scientific working group meetings and reviews, (2) reviews of existing measures, (3) collating of existent, nonredundant items, (4) querying experts for new items, (5) interviews with informants and subjects in the USA, France, and Germany, toward the identification of potential new items, (6) identification of an item pool based upon these procedures, (7) creation of a trial instrument, (8) piloting of this instrument, and (9) refinement of the scale based upon statistical analysis of the pilot data. Final item selection was based upon: (1) relevance for > or = 80% of subjects in severity-stratified USA and German samples; (2) absence of gender and national biases; (3) significant (p <.05) discrimination between (a) normal versus mildly impaired and (b) mildly impaired versus moderately to moderately severely impaired subjects; and (4) Global Deterioration Scale (GDS) scores accounting for > or = 12% of variance in the item after controlling for age and gender. RESULTS: An ADL scale consisting of 40 items that correlate with the global and cognitive progress of AD is developed for international usage in pharmacologic trials in incipient, mild, moderate, and moderately severe AD. The scale contains 40 items falling within 13 ADL categories. The 40-item scale is shown to have .81 correlation with GDS staging, .81 with mental status assessment (Mini-Mental State Examination), and .81 with a psychometric test (the SKT) (p values < .001). CONCLUSION: This scale can be used to measure therapeutic response in AD.

Some of the universal characteristics of pre-agricultural hominin diets are strikingly different from the modern human diet. Hominin dietary choices were limited to wild plant and wild animal foods, while the modern diet includes more than 70 % of energy consumed from refined sugars, refined vegetable oils, and highly processed cereals and dairy products. The modern diet, with higher intake of fat has also resulted in a higher ratio of omega-6 (n-6) to omega-3 (n-3) polyunsaturated fatty acids (PUFA), contributing to low-grade chronic inflammation (LGCI) and thus promoting the development of many chronic diseases, including obesity and osteoporosis. In this review, we describe the changes in modern diet, focusing on the kind and amount of consumed fat; explain the shortcomings of the modern diet with regard to inflammatory processes; and delineate the reciprocity between adiposity and inflammatory processes, with inflammation being a common link between obesity and osteoporosis. We present the evidence that overconsumption of n-6 PUFA coupled with under-consumption of n-3 PUFA results in LGCI and, along with the increased presence of reactive oxygen species, leads to a shift in mesenchymal stem cells (precursors for both osteoblasts and adipocytes) lineage commitment toward increased adipogenesis and suppressed osteoblastogenesis. In turn, high n-6 to n-3 PUFA ratios in the modern diet, coupled with increased synthesis of pro-inflammatory cytokines due to adiposity, propagate obesity and osteoporosis by increasing or maintaining LGCI.

In total, 39 clinical cases of fowl adenoviruses (FAdV) infection in chickens (28 broiler, 7 native, and 4 layer chickens) between 2007 and 2010 in Korea were investigated. The FAdV types 4, 8b, and 11 comprised 18, 9, and 12 clinical cases, respectively. All FAdV type 4 cases showed clinical hydropericardium (HPS) lesions as well as inclusion body hepatitis (IBH), whereas all FAdV types 8b and 11 cases exhibited IBH lesions without HPS. All 3 types were detected in broiler (9-30 d old) and layer chickens (23-112 d old), whereas most native chickens (14-65 d old) were affected only by FAdV type 4. Infectious bursal disease virus and chicken infectious anemia virus were complications in 51.3% of FAdV cases, with mortalities of 55% to <0.1%. Chicken infectious anemia virus was detected in all native chicken cases. These results indicate that preventive measures against FAdV infection and immunosuppressive diseases on poultry farms should be implemented.

We studied the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetes patients whose blood glucose levels were inadequately controlled with basal insulin alone or in combination with metformin (or a sulfonylurea). This study was a 24-week prospective, open-label, randomized, active-controlled multi-center study. Participants were randomized to receive either acarbose (n=59, 300 mg/day) or voglibose (n=62, 0.9 mg/day). The mean HbA1c at week 24 was significantly decreased approximately 0.7% from baseline in both acarbose (from 8.43% ± 0.71% to 7.71% ± 0.93%) and voglibose groups (from 8.38% ± 0.73% to 7.68% ± 0.94%). The mean fasting plasma glucose level and self-monitoring of blood glucose data from 1 hr before and after each meal were significantly decreased at week 24 in comparison to baseline in both groups. The levels 1 hr after dinner at week 24 were significantly decreased in the acarbose group (from 233.54 ± 69.38 to 176.80 ± 46.63 mg/dL) compared with the voglibose group (from 224.18 ± 70.07 to 193.01 ± 55.39 mg/dL). In conclusion, both acarbose and voglibose are efficacious and safe in patients with type 2 diabetes who are inadequately controlled with basal insulin. (ClinicalTrials.gov number, NCT00970528).

An analytical procedure using accelerated solvent extraction and gas chromatography with an electron capture detector has been optimized to simultaneously determine the residue of two insecticides (diazinon and EPN) and one fungicide (isoprothiolane) in polished rice and was confirmed by GC-mass spectrometry. Several parameters, including temperature, pressure, solvent ratio, cell size and cell cycle, were thoroughly investigated to find the optimal extraction conditions. The average recoveries of the three pesticides were between 82.7 and 126.4% at spiking levels of 0.1 and 0.5 ppm. The relative standard deviations were less than 7% for all of the recovery tests. The optimum accelerated solvent extraction operating conditions were 100 degrees C, 1500 atm, acetone-n-hexane (20:80 v/v) as the extraction solvent, two cycles, and a cell size of 33 ml. The total extraction time was approximately 20 min. The optimized procedure has also been applied to the determination of diazinon, isoprothiolane and EPN in real rice samples. In conclusion, accelerated solvent extraction was used for the first time for the analysis of diazinon, isoprothiolane and EPN in polished rice and offers the possibility of a fast and simple process for obtaining a quantitative extraction of the studied pesticides.

BACKGROUND: Dienogest has been shown to substantially improve endometriosis-associated symptoms such as debilitating chronic pelvic pain, and in turn, health-related quality of life (HRQoL). To date, there is no data on patient-reported outcomes reflecting the real-world practice in Asia where endometriosis is a relevant health, social and economic burden. This non-interventional, multi-center, prospective study aims to investigate the influence of dienogest on HRQoL. METHODS: Asian women received dienogest (2 mg/daily) and were followed for 24 months. The effectiveness of dienogest to improve HRQoL and endometriosis-associated pelvic pain (EAPP) was assessed by patient-reported outcomes. HRQoL, especially the "pain" domain as primary endpoint, was evaluated with the Endometriosis Health Profile-30 (EHP-30) questionnaire. The numeric rating scale served to determine changes in the severity of EAPP. Within the presented interim analysis (data cut-off: 2017-11-27), the mean changes in EHP-30 and EAPP scores from baseline to 6 months upon availability of the data were evaluated. Treatment-emergent adverse events (TEAEs) and bleeding profiles were documented. RESULTS: Dienogest therapy decreased EHP-30 scores in all assessed domains (score 0-100, lower scores indicate better HRQoL). Primarily, the "pain" domain was improved in 78.4% of patients. EAPP was reduced (score 0-10, lower scores reflect less pain), highlighted by a mean reduction of the pain score by - 4.5 points. Patients with a higher EAPP score at baseline had an increased response to dienogest (- 6.2 points mean change) compared to patients with low baseline EAPP severity (- 1.4 points mean change). Both surgically and clinically diagnosed patients described comparable pain reduction, as well as women with or without prior treatment. Drug-related TEAEs were documented for 31.5% of patients, with amenorrhoea (5.9%) and metrorrhagia (5.1%) being the most common events. The bleeding pattern was changed upon dienogest, characterized by decreased normal bleeding (84.2 to 28.8%) and increased amenorrhea (3.2 to 42.9%) at 6 months. CONCLUSION: The data indicate an amelioration of HRQoL and EAPP upon dienogest therapy. No new safety signals were observed. Therefore, its use as first-line therapy for long-term management of debilitating and chronic endometriosis-associated pain represents an interesting option that remains to be further investigated. TRIAL REGISTRATION: Name of registry: Clinical Trials Clinicaltrials.gov registration number: NCT02425462 Registration date: 2015-04-24. Registration timing: prospective.

Several clinical trials in women with endometriosis demonstrated that dienogest reduces endometrial lesions and improves health-related quality of life (HRQoL). To assess HRQoL in dienogest-treated patients in real-world setting, we conducted a prospective, non-interventional study in 6 Asian countries. Women aged ≥18 years with clinical or surgical diagnosis of endometriosis, presence of endometriosis-associated pelvic pain (EAPP) and initiating dienogest therapy were enrolled. The primary objective was to evaluate HRQoL using the Endometriosis Health Profile-30 (EHP-30) questionnaire. The secondary objectives included analysis of EAPP, satisfaction with dienogest, endometriosis symptoms and bleeding patterns. 887 patients started dienogest therapy. Scores for all EHP-30 scales improved with the largest mean changes at month 6 and 24 in scale pain (-28.9 ± 27.5 and - 34 ± 28.4) and control and powerlessness (-23.7 ± 28.2 and - 28.5 ± 26.2). Mean EAPP score change was -4.6 ± 3.0 for both month 6 and 24 assessments. EAPP decrease was similar in surgically and only clinically diagnosed patients. From baseline to month 24, rates of normal bleeding decreased (from 85.8% to 17.5%) while rates of amenorrhea increased (from 3.5% to 70.8%). Majority of patients and physicians were satisfied with dienogest. Over 80% of patients reported symptoms improvement. 39.9% of patients had drug-related treatment-emergent adverse events, including vaginal hemorrhage (10.4%), metrorrhagia (7.3%) and amenorrhea (6.4%). In conclusion, dienogest improves HRQoL and EAPP in the real-world setting in women with either clinical or surgical diagnosis of endometriosis. Dienogest might be a promising first-line treatment option for the long-term management of debilitating endometriosis-associated symptoms.NCT02425462, 24 April 2015.

PURPOSE: The purpose of this study is to report real life experiences of sorafenib therapy for hepatocellular carcinoma (HCC) in Korea, using a subset of data from GIDEON (Global Investigation of Therapeutic Decisions in HCC and of Its Treatment with Sorafenib; a large, prospective, observational study). MATERIALS AND METHODS: Between January 2009 and April 2012, a total of 497 patients were enrolled from 11 sites in Korea. Of these, 482 patients were evaluable for safety analyses. Case report forms of paper or electronic version were used to record safety and efficacy data from all patients. RESULTS: More patients of Child-Pugh A received sorafenib for > 8 weeks than did patients of Child-Pugh B (55.5% vs. 34.3%). Child-Pugh score did not appear to influence the starting dose of sorafenib, and approximately 70% of patients both in Child-Pugh A and B groups received the recommended initial daily dose of 800 mg (69.0% and 69.5%, respectively). The median overall survival (OS) and time to progression (TTP) were 8.5 months and 2.5 months. In Child-Pugh A patients, the median OS and TTP were 10.2 months and 2.5 months. The most frequent treatment-emergent drug-related adverse event was hand-foot skin reaction (31.7%), followed by diarrhea (18.0%). The incidence of treatment-emergent adverse events was similar in both Child-Pugh A (85.4%) and Child-Pugh B (84.8%) patients. CONCLUSION: Sorafenib was well tolerated by Korean HCC patients in clinical settings, and the safety profile did not appear to differ by Child-Pugh status. Survival benefit in Korean patients was in line with that of a previous pivotal phase III trial (SHARP).

Whole fat milk and dairy products (although providing more energy compared to low- or non-fat products), are good sources of α-linolenic acid (ALA), conjugated linoleic acid (CLA) and calcium, which may be favorable in modulating bone and adipose tissue metabolism. We examined individual and/or synergistic effects of ALA, CLA and calcium (at levels similar to those in whole milk/dairy products) in regulating bone and adipose cell growth. ST2 stromal, MC3T3-L1 adipocyte-like and MC3T3-E1 osteoblast-like cells were treated with: (a) linoleic acid (LNA):ALA ratios = 1-5:1; (b) individual/combined 80-90 % c9, t11 (9,11) and 5-10 % t10, c12 (10,12) CLA isomers; (c) 0.5-3.0 mM calcium; (d) combinations of (a), (b), (c); and (e) control. Local mediators, including eicosanoids and growth factors, were measured. (a) The optimal effect was found at the 4:1 LNA:ALA ratio where insulin-like growth factor-1 (IGF-1) and IGF binding protein-3 (IGFBP-3) production was the lowest in MC3T3-L1 cells. (b) All CLA isomer blends decreased MC3T3-L1 and increased MC3T3-E1 cell differentiation. (c) 1.5-2.5 mM calcium increased ST2 and MC3T3-E1, and decreased MC3T3-L1 cell proliferation. (d) Combination of 4:1 LNA:ALA + 90:10 % CLA + 2.0 mM calcium lowered MC3T3-L1 and increased MC3T3-E1 cell differentiation. Overall, the optimal LNA:ALA ratio to enhance osteoblastogenesis and inhibit adipogenesis was 4:1. This effect was enhanced by 90:10 % CLA + 2.0 mM calcium, indicating possible synergism of these dietary factors in promoting osteoblast and inhibiting adipocyte differentiation in cell cultures.

Salmonella enterica serovar Typhimurium (S. Typhimurium) isolated and identified from swine were subjected for the analysis of antibiotic resistance pattern and clinically important class 1 and 2 integrons. In addition, S. Typhimurium isolates exhibiting ampicillin, chloramphenicol, streptomycin, sulfamethoxazole, tetracycline and florfenicol (ACSSuTF) resistance pattern as described in most Salmonella enterica serotype Typhimurium definitive type 104 (DT104) were characterized by polymerase chain reaction. All the isolates were resistant to more than four antibiotics and showed the highest resistance to streptomycin (94.1%), followed by tetracycline (90.1%), ampicillin (64.7%), chloramphenicol (56.8%) and gentamicin (54.9%). MIC value for the ten isolates ranged between 0.125-2 mug/ml for ciprofloxacin. Among the beta-lactams used, only one of the isolate exhibited resistance to ceftiofur (MIC 8 microg/ml). Sixty eight percent of these multi drug resistance (MDR) S. Typhimurium isolates carried clinically important class 1 integron with 1kb (aadA) and/or 2kb (dhfrXII-orfF-aadA2) resistance gene cassettes. This study reports the increasing trend of multi drug resistance (MDR) S. Typhimurium with clinically important class 1 integron in pigs. In addition, emergence of the ACSSuTF-type resistance in S. Typhimurium PT other than DT104 may limit the use of resistance gene markers in its detection methods by PCR.

OBJECTIVE: To examine healthcare resource utilisation (HRU) and direct medical costs for patients with diabetic macular oedema (DME) treated with antivascular endothelial growth factor (anti-VEGF) in Korea by comparing with those for (1) patients with diabetes mellitus (DM) without retinopathy and (2) patients with neovascular age-related macular degeneration (nAMD) treated with anti-VEGF. DESIGN: Retrospective cohort study. SETTING: The Korean National Health Insurance (NHI) database from 1 January 2014 to 31 December 2016. PARTICIPANTS: We identified 1398 patients older than 30 years of age who received anti-VEGF treatment for DME in 2015 after excluding patients who had a diagnosis of nAMD in 2015 and any cancer in the preceding year. MAIN OUTCOME MEASURES: One-year healthcare resource use and direct medical costs of patients with DME treated with anti-VEGF. RESULTS: In total, 1398 patients with DME receiving anti-VEGF, 12 813 patients with DM without retinopathy and 12 222 patients with nAMD receiving anti-VEGF were identified. Hospital admissions and outpatient visits were highest in patients with DME, while the number of licensed anti-VEGF injections in those with DME was about half that of those with nAMD (2.1 vs 3.9 per patient per year). Mean 1-year medical costs were also higher in patients with DME (US$6723) than in those with DM without retinopathy (US$2687) and nAMD (US$4980). In a multivariable analysis with matched cohorts, DME was associated with 66% higher medical costs for comorbid diseases (adjusted OR (aOR), 1.66; 95% CI 1.45 to 1.90) and 50% lower anti-VEGF injections (aOR, 0.50; 95% CI 0.46 to 0.54) compared with nAMD. CONCLUSIONS: The overall HRU and economic burden for DME treated with anti-VEGF were higher than for DM without retinopathy or for nAMD treated with anti-VEGF. Meanwhile, the lower number of licensed anti-VEGF injections compared with nAMD may reflect a potential lack of ophthalmological treatment for DME supported by the NHI in Korea.

BACKGROUND: Atopic dermatitis (AD) is an inflammatory skin disease of multiple phenotypes and endotypes, and is highly prevalent in children. Many people of all ages, including active adolescents, pregnant women, and the elderly, suffer from AD, experiencing chronicity, flares, and unexpected relapse. Dexpanthenol has multiple pharmacological effects and has been employed to treat various skin disorders such as AD. We aimed to summarize the up-to-date evidence relating to dexpanthenol and to provide a consensus on how to use dexpanthenol effectively for the treatment of AD. METHODS: The evidence to date on the application and efficacy of dexpanthenol in AD was reviewed. The literature search focused on dexpanthenol use and the improvement of skin barrier function, the prevention of acute flares, and its topical corticosteroid (TCS) sparing effects. Evidence and recommendations for special groups such as pregnant women, and the effects of dexpanthenol and emollient plus in maintenance therapy, were also summarized. RESULTS: Dexpanthenol is effective and well-tolerated for the treatment of AD. Dexpanthenol improves skin barrier function, reduces acute and frequent flares, has a significant TCS sparing effect, and enhances wound healing for skin lesions. CONCLUSION: This review article provides helpful advice for clinicians and patients on the proper maintenance treatment of AD. Dexpanthenol, as an active ingredient in ointments or emollients, is suitable for the treatment and maintenance of AD. This paper will guide dermatologists and clinicians to consider dexpanthenol as a treatment option for mild to moderate AD.

Field trials have been carried out to determine the residues of the fungicide pyrimethanil in persimmon (Diospyros kaki Linn) after field treatment. Three treatments using pyrimethanil (PYR 30% WP) were carried out on persimmon trees at a recommended dose rate: the former was sprayed at two different times at 30 and 21 days prior to harvesting; the second was sprayed three times at 40, 30 and 21 days prior to harvesting; and the third was sprayed four times at 40, 30, 21 and 14 days prior to harvesting. The analysis was based on liquid-liquid extraction and solid-phase extraction followed by liquid chromatography with ultraviolet detection at 268 nm. Pyrimethanil was confirmed by high-performance liquid chromatography-mass spectrometry HPLC-MS in the selected ion monitoring mode. The method was validated with spiked fruit samples at concentrations of 0.1 and 0.4 ppm. Average recoveries (three replicates) ranged from 87.1 to 92.1% with relative standard deviations between 4.5 and 11.98%. The calculated limit of detection was 0.02 ppm and the limit of quantitation was 0.07 ppm. After two, three or four applications, pyrimethanil residues on persimmon averaged 0.44, 0.48 or 0.53 ppm, respectively; all of these values were below the maximum residue level established by the Korean Food and Drug Administration (5.0 ppm). This indicates that pyrimethanil residues declined to a level well below the maximum residue level within the 14 day period between the last application and harvesting.

We investigated the feasibility of free-breathing modified Look-Locker inversion recovery (MOLLI) sequence for measuring hepatic T1 values in children and young adults. To investigate the accuracy and the reproducibility of the T1 maps, a phantom study was performed with 12 different gadoterate meglumine concentrations and the T1 relaxation times of phantoms measured with the MOLLI sequence were compared against those measured with three different sequences: spin-echo inversion recovery, variable flip angle (VFA), and VFA with B1 correction. To evaluate the feasibility of free-breathing MOLLI sequence, hepatic T1 relaxation times obtained by free-breathing and breath-hold technique in twenty patients were compared. The phantom study revealed the excellent accuracy and reproducibility of MOLLI. In twenty patients, the mean value of hepatic T1 values obtained by free-breathing (606.7 ± 64.5 ms) and breath-hold (609.8 ± 64.0 ms) techniques showed no significant difference (p > 0.05). The Bland-Altman plot between the free-breathing and breath-hold revealed that the mean difference of T1 values was - 3.0 ms (- 0.5%). Therefore, T1 relaxation times obtained by MOLLI were comparable to the values obtained using the standard inversion recovery method. The hepatic T1 relaxation times measured by MOLLI technique with free-breathing were comparable to those obtained with breath-hold in children and young adults.

We combined the abbreviated and ultrafast magnetic resonance imaging (MRI) technique with the standard MRI protocol and compared lesion characterization quantitatively and qualitatively to the standard MRI protocol.Fifty-six patients with breast cancer who underwent MRI from June 2017 to May 2018 and fulfilled our inclusion criteria were included. Three radiologists measured the lesion sizes, described the MRI findings using BI-RADS lexicon, and demarcated the regions of interest to extract the volumetric quantitative and semi-quantitative parameters. We used Pearson's correlation analysis comparing the quantitative and semi-quantitative parameters. To evaluate the inter-observer variability, we calculated the intra-correlation coefficient (ICC). We also analysed the correlation in BI-RADS lexicon.There were 45 (80.4%) luminal and 11 (19.6%) non-luminal breast cancers, and the most common tumour subtype was invasive carcinoma (n = 48, 85.7%), followed by ductal carcinoma in situ (n = 8, 14.3%). Regarding correlation between the quantitative and semi-quantitative parameters, K significantly correlated with the wash-in factor (r, 0.862; P < .001) and AUC value (r, 0.951; P < .001). The lesion size measured by standard and combined abbreviated-ultrafast phases and that from the surgical pathological specimens showed moderate agreement (ICC range, 0.516-0.578). The ICCs among the 3 readers were excellent for lesion size measurement, BI-RADS lexicon regarding lesion type, mass shape, margin, internal enhancement, non-mass enhancement distribution, and internal enhancement by the standard and combined abbreviated-ultrafast protocols.The use of the modified and combined abbreviated-ultrafast MRI protocol provides a reliable measurement of the quantitative parameters and may aid in the screening of breast cancer.

Purpose: This regulatory post-marketing surveillance (PMS) study was performed to evaluate the safety and effectiveness of regorafenib on Korean patients with colorectal cancer (CRC), gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma (HCC) in a real-world clinical setting. Methods: This PMS was conducted as a multi-center, prospective, observational study at 34 centers in Korea from August 2013 to August 2019. The primary objective was to evaluate the safety of regorafenib in real-world practice, with the secondary objective to investigate its effectiveness, including its overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Results: In total, 301 patients were included in the analysis (254 patients with CRC, 14 patients with GIST, and 33 patients with HCC). The incidence rates of adverse events (AEs) were 85.0%, 78.6%, and 81.8% in patients with CRC, GIST, and HCC, respectively. The most frequent AE related to regorafenib in the three cancer types was palmar-plantar erythrodysesthesia syndrome (PPES). The ORRs of patients with CRC, GIST, and HCC were 4.7%, 0%, and 41.4%, respectively. The median PFS and OS were 2.1 and 6.1 months for CRC, respectively; 9.2 and 16.4 months for GIST, respectively; and 5.5 months and not estimated (NE) for HCC, respectively. Patients who experienced a dose modification or discontinuation of regorafenib showed significantly shorter median PFS and OS (2.2 vs. 2.6 months, respectively, P = 0.0335 for PFS; 5.3 vs. 8.5 months, respectively, P = 0.0010 for OS). Conclusion: This PMS study, which is the largest surveillance study of CRC in Korea, found no newly identified safety concerns for patients who received regorafenib in the real-world setting. Additionally, the results of this study were consisted with those previously reported in phase III trials.

Rhizoctonia solani와 Pythium ultimum에 의한 모잘록병은 대부분의 작물에서 전 세계적으로 발생하여 종자와 유묘에 심각한 피해를 주고 있다. Serenade 제제(1.34%, SC)의 Rhizoctonia 및 Pythium 모잘록병 방제 효과를 조사하기 위하여, 병원균 접종 토양에 파종된 고추와 오이에 Serenade 제형 9배, 19배 및 39배 희석액을 관주 처리하였다. Serenade 제제를 9배 및 19배 희석액으로 처리하였을 때, 고추의 Rhizoctonia 모잘록병에 대한 Serenade 제제의 방제효과는 각각 58%와 29%이었다. 그리고 오이에서도 고추의 Rhizoctonia 모잘록병과 유사한 각각 54%와 28%의 방제효과를 보였다. 반면에 오이 Pythium 모잘록병에 대한 Serenade 제형의 방제효과는 Rhizoctonia 모잘록병에 비하여 아주 낮은 방제효과를 나타내었고, Serenade 9배 희석액으로 처리한 고추의 Pythium 모잘록병에 대해서만 무처리구와 유의성 있는 발병도 차이를 보였다. 이상의 결과로부터 Serenade 제형은 Rhizoctonia 및 Pythium 모잘록병을 효과적으로 방제할 수 있을 것으로 생각되었다. Damping-off, caused by Rhizoctonia solani and Pythium ultimum, is a very important plant disease and affects seeds and seedlings of many plant species worldwide. To investigate control efficacy of Serenade formulation (1.34%, SC) against Rhizoctonia and Pythium damping-off diseases, seeds of chili pepper and cucumber were sown in soils inoculated with R. solani and P. ultimum and Serenade formulation was applied by soil-drenching with 9-, 19-, and 39-fold dilutions. Control values of Serenade formulation on Rhizoctonia damping-off of chili pepper was 58% and 29% for 9- and 19-fold dilutions, respectively. In the case of cucumber Rhizoctonia damping-off, Serenade treatments showed similar control efficacy with damping-off of chili pepper. On the other hand, control efficacy of Serenade formulation on Pythium damping-off of cucumber was less than control effects on Rhizoctonia damping-off. Only Pythium damping-off of chili pepper treated with 9-fold dilution Serenade was statistically different with untreated control. This result suggest that Serenade formulation could be effectively used for controlling Rhizoctonia and Pythium damping-off diseases.

PURPOSE: To investigate the efficacy and safety of intravitreal aflibercept (IVT-AFL) in Asian patients with neovascular age-related macular degeneration (nAMD) in a real-world clinical setting. PATIENTS AND METHODS: In this analysis of a prospective, regulatory, postmarketing surveillance study for IVT-AFL, 3115 patients with nAMD were included and followed for 8 months. The mean changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were analyzed using last observation carried forward method. A post hoc subgroup analysis and a multivariate logistic regression analysis were also performed to assess factors related to treatment outcomes. RESULTS: Mean BCVA improved from 0.62 to 0.51 logarithm of minimum angle resolution and mean CRT decreased from 383.3 to 289.7 μm, with a mean of 3.4 injections during the 8-month follow-up. In the subgroup analysis, patients who had received 3 initial monthly doses had significantly better anatomical improvements than those treated as needed. Patients with confirmed polypoidal choroidal vasculopathy (PCV) had significantly better anatomical improvements and better visual recovery than those with other types of nAMD. The multivariate regression analysis demonstrated that age, injection number, PCV, and baseline BCVA were significantly associated with higher odds of gaining 3 lines at 8 months, and sex, injection number, PCV, and baseline CRT were associated with CRT ≤250 µm at 8 months. No new safety findings were identified. CONCLUSION: IVT-AFL was effective and well tolerated in a real-world setting with a large number of Asian patients with nAMD. Number of injections and PCV were important determinants for improved treatment outcomes.

4628 Background: Previous studies with sorafenib in Asian patients with advanced RCC were relatively small and used strict entry criteria. Here we investigated safety and efficacy in a large subset of Asian patients in the prospective, non-interventional PREDICT study of sorafenib in routine practice (NCT 00895674). Methods: Patients were eligible based on a diagnosis of advanced RCC and the decision by the investigator to prescribe sorafenib under compliance of the local product label. Tumor status, patients’ performance and physician assessment of efficacy and tolerability were collected up to 12 months. Results: Between Jan 2007 and June 2010, 1092 patients were enrolled in China (n=1033), South Korea (n=55), the Philippines (n=3) and Indonesia (n=1). In the efficacy population (n=909), baseline characteristics were: 71% male; 89% &lt;70 years old; 89% clear cell histology; 78% prior nephrectomy; 56% prior systemic therapy; 16% high MSKCC risk; 35% ECOG PS ≥2; 5% brain metastases. Overall, 19% of patients had ≥1 concomitant disease at baseline; the most frequent concomitant diseases were hypertension (14%) and diabetes (6%). Initial sorafenib dose was 800 mg daily in 97% of patients, of whom 91% were also receiving 800 mg daily as last dose. Median duration of sorafenib treatment was 9.7 months (range 0.2–24.1), and in clinically relevant subgroups was as follows: treatment-naïve, 9.7 months; high MSKCC risk, 9.3 months; brain metastases, 8.4 months; age ≥70 years, 7.6 months; ECOG PS 2, 9.7 months; ECOG PS 3, 6.1 months. At last follow up, 63% of physicians reported good/very good efficacy and 59% good/very good tolerability. Sorafenib was well tolerated; &lt;2% of the safety population (n=1022) reported serious drug-related adverse events (SDRAEs) and only 3% discontinued due to DRAEs. In all, 35% of patients reported a DRAE, with the most frequent being hand-foot skin reaction (21%), diarrhea (7%), rash (7%), alopecia (5%), hypertension (3%). Conclusions: In this large subset of Asian patients with advanced RCC treated in daily practice settings, sorafenib was well tolerated and provided benefit, including in clinically relevant patient subgroups.

Vibrio harveyi is one of the most serious pathogens causing vibriosis in larval and grow-out shrimp culture. This study was performed to investigate the bactericidal effect of a monopersulfate compound against V. harveyi and its toxicity in Litopenaeus vannamei. The monopersulfate compound was prepared at 0, 0.15, 0.3, 0.6, 1.2, and 2.4 ppm for the bactericidal efficacy study, and then V. harveyi was added at a rate of 1&#xD7;10⁶ CFU/mL. Subsequently, five shrimps/dose were added to the water bath. The other groups of shrimp were exposed to monopersulfate, but not to the bacterium. None of the shrimps exposed to any of the monopersulfate treatment doses without bacteria died, and no changes in their movement were detected for 7 days. However, shrimps exposed to bacteria without monopersulfate showed decreased movement and lethargy, but no death. The total number of other bacteria and V. harveyi at the different concentrations decreased significantly by 4-6 log values compared to that in the bacterial control group. The monopersulfate compound completely inhibited V. harveyi growth beginning 1 h after exposure to 2.4 ppm. These results show that the monopersulfate compound is an efficient disinfectant against naturally occurring marine bacteria and V. harveyi without being toxic to shrimp.