• Korean Journal of Clinical Pharmacy
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• v.30 no.2
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• pp.102-112
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• 2020

Objective: To analyze the prescription patterns for the treatment of ulcerative colitis (UC) and to investigate factors co-occurring with systemic corticosteroid use. Methods: We used patient-level data from Korean National Health Insurance claims database to identify patients diagnosed with UC (ICD-10 code : K51) and their medications prescribed for UC between January 1 and Decemeber 31, 2017. We found that medications for UC treatment were 5-aminosalicylic acid (5-ASA), immunomodulators, biologics, and corticosteroids. We presented the prescription pattern according to the sex, age group, type of health insurance, site of UC, type of medical institution, and concomitant medication. To evaluate factors associated with prescription of systemic corticosteroids for UC, we used a multivariate logistic regression model to estimate adjusted odds ratios (aORs) and their 95% confidence intervals (CIs). Results: Of 1,469 UC patients, 74.5% used 5-ASA and 15.2% used systemic corticosteroids. 5-ASA constituted 77.5% of all prescriptions and systemic corticosteroids accounted for 13.1%. The most widely used therapy was 5-ASA monotherapy (54.8%), followed by a double therapy with 5-ASA and immunomodulators (8.2%) or 5-ASA and systemic corticosteroids (7.2%). Systemic corticosteroids were more likely to be prescribed with immunomodulators (aOR=1.88, 95% CI=1.54-2.28) and biologics (aOR=2.82, 95% CI=2.28-3.50) than without them. Conclusions: We found that 15.2% of UC patients were prescribed with a systemic corticosteroid, which is less than reported previously. Systemic corticosteroids were more likely to be prescribed with immunomodulators and biologics.

• Journal of Microbiology and Biotechnology
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• v.29 no.7
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• pp.1117-1123
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• 2019

Control of pine wilt disease, which is caused by pine wilt nematode Bursaphelenchus xylophilus, is heavily dependent on the use of chemicals such as abamectin. Although such chemicals are highly effective, demands for alternatives that are derived preferentially from natural sources, are increasing out of environmental concerns. One of the challenges to discovery of alternative control agents is lack of fast and efficient screening method that can be used in a high-throughput manner. Here we described the development of colorimetric assay for the rapid and accurate screening of candidate nematicidal compounds/biologics targeting B. xylophilus. Contrary to the conventional method, which relies on laborious visual inspection and counting of nematode population under microscope, our method utilizes a redox dye that changes its color in response to metabolic activity of nematode population in a given sample. In this work, we optimized parameters of our colorimetric assay including number of nematodes and amount of redox dye, and tested applicability of our assay for screening of chemicals and biologics. We demonstrated that our colorimetric assay can be applied to rapid and accurate quantification of nematode viability/mortality in a nematode population treated with candidate chemicals/biologics. Application of our method would facilitate high-throughput endeavors aiming at finding environment-friendly control agents for deadly disease of pine trees.

• Journal of Veterinary Science
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• v.22 no.5
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• pp.47.1-47.10
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• 2021

Background: Due to multiple similarities in the structure and physiology of human and pig skin, the pig model is extremely useful for biological drug testing after subcutaneous administration. Knowledge of the differences between subcutaneous injection sites could have a significant impact on the absorption phase and pharmacokinetic profiles of biological drugs. Objectives: This study aimed to analyze the impact of administration site on pharmacokinetics and selected biochemical and hematological parameters after a single subcutaneous administration of ustekinumab in pigs. Drug concentrations in blood plasma were analyzed by enzyme-linked immunosorbent assay. Pharmacokinetic analyses were performed based on raw data using Phoenix WinNonlin 8.1 software and ThothPro v 4.1. Methods: The study included 12 healthy, female, large white piglets. Each group received a single dose of ustekinumab given as a 1 mg/kg subcutaneous injection into the internal part of the inguinal fold or the external part of the inguinal fold. Results: The differences in absorption rate between the internal and external parts of the inguinal fold were not significant. However, the time of maximal concentration, clearance, area under the curve calculated between zero and mean residence time and mean residence time between groups were substantially different (p > 0.05). The relative bioavailability after administration of ustekinumab into the external part of the inguinal fold was 40.36% lower than after administration of ustekinumab into the internal part of the inguinal fold. Conclusions: Healthy breeding pigs are a relevant model to study the pharmacokinetic profile of subcutaneously administered ustekinumab.

• KSBB Journal
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• v.23 no.4
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• pp.303-310
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• 2008

Bovine blood, cell, tissue, and organ are used as raw materials for manufacturing biologics such as biopharmaceuticals, tissue-engineered products, and cell therapy. Manufacturing processes for the biologics have the risk of viral contamination. Therefore viral validation is essential in ensuring the safety of the products. Bovine parainfluenza virus type 3 (BPIV3) is one of the common bovine pathogens and has widely been known as a contaminant of biologics. In order to establish the validation system for the BPIV3 safety of biologics, a real-time RT-PCR method was developed for quantitative detection of BPIV3 contamination in raw materials, manufacturing processes, and final products. Specific primers for amplification of BPIV3 RNA was selected, and BPIV3 RNA was quantified by use of SYBR Green I. The sensitivity of the assay was calculated to be 2.8 $TCID_{50}/mL$. The real-time RT-PCR method was validated to be reproducible and very specific to BPIV3. The established real-time RT-PCR assay was successfully applied to the validation of Chinese hamster ovary (CHO) cell artificially infected with BPIV3. BPIV3 RNA could be quantified in CHO cell as well as culture supernatant. Also the real-time RT-PCR assay could detect 7.8 $TCID_{50}/mL$ of BPIV3 artificially contaminated in bovine collagen. The overall results indicated that this rapid, specific, sensitive, and robust assay can be reliably used for quantitative detection of BPIV3 contamination during the manufacture of biologics.

• Korean journal of dermatology
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• v.56 no.9
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• pp.548-551
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• 2018

Biologics are the most advanced treatment for psoriasis. Ustekinumab, one of the biologics for psoriasis, is a human monoclonal antibody that binds to the p40 subunit of interleukin-12 and interleukin-23. A 41-year-old woman with a 17-year history of plaque psoriasis and psoriatic arthritis presented with worsening lesions. The patient had previously been treated with a number of topical and systemic medications and narrow band ultraviolet B. However, none of the treatments consistently controlled her disease. Thus, treatment with ustekinumab 45 mg via subcutaneous injection was initiated. Approximately 7 days after the first treatment, she experienced a flare with generalized pustules in her whole body. The condition was controlled with systemic steroid treatment. The patient was subsequently treated with adalimumab, and improvement in her plaque and pustular lesions was noted. Herein, we report a case of psoriasis that flared up after ustekinumab therapy, which was accompanied by a morphological change from plaque to pustular lesions.

• Proceedings of the PSK Conference
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• 2003.10b
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• pp.100.2-101
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• 2003

To satisfy the increasing medical demanding especially for sever burn patients to regenerate full thickness wound cure, this study developed dermis with gelatin based scaffold and perform the biocompatibility tests. To prepare scaffold 30% of gelatin was mixed with sieved salt and dried in the mold to shape then, cross linked with a water-soluble cross-linker, EDAC. Preparing the cell for seeding from a rabbit skin, the fibroblast and keratinocyte were successfully isolated and cultured in vitro. After cell and scaffold were ready, the fibroblast was seeded to the scaffold (∼10$\^$6/ cell/cm ) for preparing dermis and keratinocyte was cultured until forming the sheet. (omitted)

• Korean Journal of Poultry Science
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• v.43 no.2
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• pp.111-118
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• 2016

Mycotoxins are secondary metabolites produced by molds, such as Aspergillus, Fusarium and Penicillium, that have adverse effects on animals and humans. Aflatoxin, ochratoxin, zearalenone, fumonisin and deoxynivalenol are the mycotoxins of greatest agro-economic importance and cause acute disease called mycotoxicoses. Mycotoxicosis in poultry birds results in decreased meat/egg production, immunosuppressant, and hepatotoxicosis. Some of toxins or their metabolites may be retained in animal or human tissues and induce health problems. This study was designed to develop a sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) method for the simultaneous detection and quantification of mycotoxins, such as aflatoxin $B_1$, aflatoxin $M_1$, ochratoxin A, zearalenone, fumonisin B and deoxynivalenol, in chicken liver and kidney tissues. The mycotoxins were extracted and purified using modified QUECHERS methods, separated by LC and detected by an electrospray ionisation interface (ESI) and tandem MS. Good precision and linearity were observed for most of six mycotoxins. The recovery test for each mycotoxin in liver and kidney tissues mostly indicated good average recovery rates between 80.94% and 98.10% and the coefficient of variation mostly under 13.78%, except for aflatoxin $M_1$ and fumonisin $B_1$. The limit of detection (LOD) for six mycotoxins was $7.6{\sim}145.79{\mu}g/kg$ in liver tissues and $6.07{\sim}197.20{\mu}g/kg$ in kidney tissues. The quantification limits (LOQ) for 6 mycotoxins were in the range $23.04{\sim}441.78{\mu}g/kg$ in liver tissues and $18.40{\sim}597.59{\mu}g/kg$ in kidney tissues, respectively. The developed multi-mycotoxin method in this study permits simultaneous, simple, and rapid determination of several co-existing mycotoxins in chicken liver and kidney tissues.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.24 no.4
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• pp.357-365
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• 2021

Purpose: A change in diagnosis from ulcerative colitis (UC) to Crohn's disease (CD) has been reported in pediatric inflammatory bowel disease; however, only a few clinical characteristics and predictors of this diagnostic change have been reported. We aimed to describe the clinical characteristics of patients with UC who underwent a change in diagnosis to CD and identify variables associated with the change. Methods: The medical records of pediatric patients with UC who were followed up at the National Center for Child Health and Development between 2006 and 2019 were retrospectively reviewed. Clinical data on disease phenotype, laboratory parameters, endoscopic findings, and treatment of patients whose diagnosis changed to CD (cCD) were compared to those of patients whose diagnosis remained UC (rUC). Results: Among the 111 patients initially diagnosed with UC, 11 (9.9%) patients were subsequently diagnosed with CD during follow-up. There was no significant difference between the cCD and rUC groups in terms of sex, age at initial diagnosis, and the extent and severity of disease at initial diagnosis. Albumin and hemoglobin levels were significantly lower in the cCD group than in the rUC group. The proportion of patients who required biologics was significantly higher in the cCD group than in the rUC group (p<0.05). Conclusion: Approximately 10% children initially diagnosed with UC were subsequently diagnosed with CD. Hypoalbuminemia and anemia at initial diagnosis and use of biologics could be predictors of this diagnostic change.

• Journal of Veterinary Science
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• v.21 no.5
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• pp.80.1-80.13
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• 2020

Background: In suckling piglets, transmissible gastroenteritis virus (TGEV) causes lethal diarrhea accompanied by high infection and mortality rates, leading to considerable economic losses. This study explored methods of preventing or inhibiting their production. Bovine antimicrobial peptide-13 (APB-13) has antibacterial, antiviral, and immune functions. Objectives: This study analyzed the efficacy of APB-13 against TGEV through in vivo and in vitro experiments. Methods: The effects of APB-13 toxicity and virus inhibition rate on swine testicular (ST) cells were detected using 3-(4,5-dimethylthiazol-2-yl)-2, 5-diphenyl tetrazolium bromide (MTT). The impact of APB-13 on virus replication was examined through the 50% tissue culture infective dose (TCID₅₀). The mRNA and protein levels were investigated by real-time quantitative polymerase chain reaction and western blot (WB). Tissue sections were used to detect intestinal morphological development. Results: The safe and effective concentration range of APB-13 on ST cells ranged from 0 to 62.5 ㎍/mL, and the highest viral inhibitory rate of APB-13 was 74.1%. The log₁₀TCID₅₀ of 62.5 ㎍/mL APB-13 was 3.63 lower than that of the virus control. The mRNA and protein expression at 62.5 ㎍/mL APB-13 was significantly lower than that of the virus control at 24 hpi. Piglets in the APB-13 group showed significantly lower viral shedding than that in the virus control group, and the pathological tissue sections of the jejunum morphology revealed significant differences between the groups. Conclusions: APB-13 exhibited good antiviral effects on TGEV in vivo and in vitro.

• International Commerce and Information Review
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• v.18 no.4
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• pp.165-193
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• 2016

This paper conducts a comparative analysis of the KORUS FTA and the TPP Agreement to assess the current state of affairs in international trade rules for the pharmaceutical industry. Intellectual property rights as well as public health related regulations have evolved to strengthen the position of innovator drug companies. In particular, the TPP Agreement which adopted data exclusivity for biologics for the first time, will set the standard for the future. Apart from this however, the TPP Agreement has not gone further than the KORUS FTA and in some respects, even contains greater policy flexibilities and provisions for market access than the KORUS FTA. Korea should take advantage of such differences when and if she must engage in negotiations to join the TPP Agreement or a renegotiation of the KORUS FTA.