• 한국임상약학회지
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• 제30권2호
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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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• 제29권7호
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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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• 제22권5호
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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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• 제23권4호
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• pp.303-310
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• 2008

소의 혈액, 세포, 조직, 기관 등 소유래 물질을 원료로 사용한 생물의약품, 조직공학제제, 세포치료제의 경우 소유래 원료물질에 다양한 바이러스가 오염된 사례가 있기 때문에 바이러스 안전성 검증이 필수적이다. BPIV3는 동물 세포주, 우혈청 등에 가장 흔하게 오염되는 바이러스이다. 소유래 물질을 원료로 하는 생물의약품, 조직공학제제, 세포치료제 등에서 BPIV3 안전성을 확보하기 위해, 원료물질, 제조공정, 완제품에서 BPIV3를 정량적으로 검출하고, 제조공정에서 BPIV3 제거 검증을 위한 시험법으로 활용이 가능한 BPIV3 real-time RT-PCR 시험법을 확립하였다. BPIV3에 특이적인 primer를 선별하였으며, 형광염료 SYBR Green I을 사용하여 BPIV3 RNA 정량 검출 시험법을 최적화하였다. 세포배양법에 의한 감염역가와 비교한 결과 real-time RT-PCR 민감도는 2.8 $TCID_{50}/mL$이었다. 확립된 시험법의 신뢰성 (reliability)을 보증하기 위해 시험법 검증을 실시한 결과 특이성 (specificity)과 재현성 (reproducibility)이 우수함을 확인하였다. 확립된 real-time RT-PCR을 생물의 약품 제조공정 검증에 적용할 수 있는지 확인하기 위하여 인위적으로 BPIV3를 오염시킨 CHO 세포주와 소유래 콜라겐에서 BPIV3 검출 시험을 실시하였다. BPIV3를 감염시킨 CHO 세포와 세포배양 상청액에서 BPIV3를 정량적으로 검출할 수 있었다. 소유래 콜라겐에서도 7.8 $TCID_{50}/mL$ 까지 정량적으로 검출할 수 있었다. 위와 같은 결과에서 확립된 BPIV3 real-time RT-PCR 시험법은 생물의약품 안전성 보증을 위한 세포주 검증, 생물의약품 생산 공정 검증, 바이러스 제거 공정 검증 등에서 감염역가 시험법과 같은 생물학적 시험법을 대신할 수 있는 신속하고, 특이성과 민감성이 우수한 시험법임을 확인하였다.

• 대한피부과학회지
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• 제56권9호
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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.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-2
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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)

• 한국가금학회지
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• 제43권2호
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• pp.111-118
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• 2016

본 연구에서는 곰팡이 독소에 대한 노출을 확인하기 위한 목적으로 닭의 간, 신장 조직에서 곰팡이 독소 분석법을 확립하였다. 곰팡이 독소의 경우 닭에서 독성이 강하며, 본 실험에서는 가축의 사료에서 주로 확인되는 곰팡이 독소 6종(아플라톡신 $B_1{\cdot}M_1$, 오크라톡신 A, 푸모니신 $B_1$, 데옥시니발레놀, 제랄레논)을 선별하여 추출, 정제조건을 확립하고 LC-MS/MS를 이용하여 분석하였다. 확립된 분석조건에서 검량선은 $R^2$값이 0.99 이상으로 우수한 직선성을 나타내었다. QUECHERS법을 응용하여 닭 간, 신장 시료에서 곰팡이 독소를 추출, 정제하여 분석하였을 때 곰팡이 독소 4종(아플라톡신 $B_1$, 오크라톡신 A, 데옥시니발레놀, 제랄레논)의 평균 회수율은 80.94~98.10%이고, 상대표준편차도 14% 미만으로 조사되어 높은 정확도와 정밀도를 확인할 수 있었다. 검량선에 근거하였을 때 곰팡이 독소 6종에 대하여 닭 간 시료의 경우 검출한계는 $7.6{\sim}145.79{\mu}g/kg$, 정량한계는 $23.04{\sim}441.78{\mu}g/kg$이었다. 닭 신장의 경우 검출한계는 $6.07{\sim}197.20{\mu}g/kg$, 정량한계는 $18.40{\sim}597.59{\mu}g/kg$으로 나타났다. 본 연구의 결과 LC-MS/MS를 이용하여 닭의 간, 신장에서 곰팡이 독소 6종 동시 분석법을 확립하였으며, 이는 생체시료에서 효율적인 곰팡이 독소 동시 분석법으로 활용이 가능할 것으로 기대된다.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• 제24권4호
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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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• 제21권5호
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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.

• 통상정보연구
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• 제18권4호
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• pp.165-193
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• 2016

본 논문은 한미FTA와 TPP협정을 비교분석하여 의약품 분야 국제통상규범이 어떻게 진화해가고 있는지 살펴본다. TRIPS협정 이후 양자 또는 지역 자유무역협정을 통해 자료독점 보장과 같은 의약품 분야의 지재권 보호 강화는 물론이고 의약품 판매 허가 및 약가 결정 방식 등 보건의료 제도 측면에서도 신약 개발자의 이익을 강화하는 방향으로 규제조화가 이루어져 왔으며, 그 전형적인 예가 한미 FTA와 TPP협정이다. 특히, 가장 처음으로 바이오의약품 자료보호 규정을 도입한 TPP협정은 향후 모든 협정의 기준으로 자리매김할 것이다. 그럼에도 불구하고 TPP협정은 한미FTA와 비교하여 의약품 분야 지재권 보호 정도가 전반적으로 더 강화되었다고 보기 어렵고, 부분적으로는 오히려 더 높은 정책적 유연성을 내포하고 있는 것으로 평가된다. 향후 한국이 TPP협정 가입 협상을 하게 되거나 한미FTA를 재협상해야 한다면, 두 협정 간 이러한 차이를 잘 활용한 적극적이고 선제적인 협상 전략을 도입할 필요가 있다.