Spontaneous reporting of adverse drug events by Korean regional pharmacovigilance centers

Shin, Yoo Seob,Lee, Yong-Won,Choi, Young Hwa,Park, Byungjoo,Jee, Young Koo,Choi, Sung-Kyu,Kim, Eung-Gyu,Park, Jung-Won,Hong, Chein-Soo John Wiley Sons, Ltd. 2009 PHARMACOEPIDEMIOLOGY AND DRUG SAFETY Vol.18 No.10

<B>Purpose</B><P>Patterns of prescriptions are markedly influenced by regional disease entities, medical education, culture, economic status, and available pharmaceutical companies. Features of adverse drug reactions (ADRs) may vary in different countries. In this study, we analyzed the causative drugs and clinical manifestations of spontaneously reported ADRs in Korea.</P><B>Methods</B><P>Six Korean Regional Pharmacovigilance Centers collected 1418 cases of spontaneously reported adverse drug events (ADEs) by doctors, pharmacists, and nurses, and the clinical features and causative drugs were evaluated. The data were collected from general hospitals (76.5%), primary clinics, and pharmacies (23.5%).</P><B>Results</B><P>Based upon the World Health Organization (WHO)-Uppsala Monitoring Center criteria (certain—13.7%, probable—46.1%, possible—32.1%), 91.9% of the collected events were suspected to be ADRs and 15.8% of patients experienced serious ADRs. The most prevalent causative drugs were antibiotics (31.6%), followed by contrast dyes (14.0%), non-steroidal anti-inflammatory drugs (NSAIDs) (11.1%), anti-psychotics (5.4%), anti-convulsants (5.2%), cardiovascular agents (4.8%), anti-neoplastics (4.6%), and opiates and non-opiate pain killers (3.5%). Among the antibiotics, cephalosporins (8.1%) were the most common, followed by anti-tuberculosis agents (5.7%), quinolones (4.0%), vancomycin (3.1%), and penicillin (2.8%). The most common side effect was skin manifestations, which were seen in 42% of the patients, followed by neurologic manifestations (14%), gastrointestinal involvements (12.9%), generalized reactions (9.4%), and respiratory involvements (4.5%).</P><B>Conclusion</B><P>Antibiotics, contrast dyes, and NSAIDs were the most common causative drugs for ADRs, which reflects the prescription pattern and the prevalence of diseases in Korea. These data may be useful in establishing a Korean pharmacovigilance system. Copyright © 2009 John Wiley & Sons, Ltd.</P>

Transplantation of Autologous Chondrocytes Seeded on a Fibrin/Hyaluronic Acid Composite Gel into Vocal Fold in Rabbits: Preliminary Results

( Yoo Seob Shin ),( Jin Seok Lee ),( Jae Won Choi ),( Byoung Hyun Min ),( Jae Won Chang ),( Jae Yol Lim ),( Chul Ho Kim ) 한국조직공학·재생의학회 2012 조직공학과 재생의학 Vol.9 No.4

Injection laryngoplasty is an option for treatment of glottic insufficiency following vocal fold paralysis, vocal fold atrophy or scarring. We intended to evaluate the plausibility of autologous chondrocytes cultured with fibrin/hyaluronic acid (HA) for permanent vocal fold augmentation. Chondrocytes from rabbit auricular cartilage were expanded and cultured with fibrin/HA composite gel. 0.1 mL dosages of fibrin/HA gel with autologous chondrocytes were injected into the left vocal folds of six rabbits. Four months postoperatively, the site was evaluated endoscopically, histologically, and radiologically. None of the six rabbits showed signs of respiratory distress. Computed tomography images and endoscopic evaluation revealed sufficient augmentation volume of the injected vocal fold. Histologic data showed that the injected material did not migrate from their original insertion site. Even though the number of chondrocyte that settled down and survived in the injected site was varying in rabbits, chondrocytes successfully formed neo-cartilage at four months postoperatively in all cases. Histologically, the grafts showed no signs of inflammatory reaction and were covered with ciliated epithelium. The chondrocytes cultured with fibrin/HA could be a plausible injection material for vocal fold augmentation.

Successful Treatment of Chronic Eosinophilic Pneumonia with Anti-IgE Therapy

Shin, Yoo Seob,Jin, Hyun Jung,Yoo, Hye-Soo,Hwang, Eui-kyung,Nam, Young Hee,Ye, Young-Min,Park, Hae-Sim The Korean Academy of Medical Sciences 2012 JOURNAL OF KOREAN MEDICAL SCIENCE Vol.27 No.10

<P>Anti-IgE therapy, using recombinant humanized anti-IgE antibodies, is clinically effective in patients with eosinophil-related disorders such as allergic asthma, allergic rhinitis, and chronic urticaria. Chronic eosinophilic pneumonia tends to respond promptly to systemic corticosteroid therapy, however; relapses are common following corticosteroid tapering. We treated two patients (17- and 19-yr-old males) of chronic eosinophilic pneumonia whose symptoms were cough and dyspnea on exertion. The symptoms were recurrent while tapering off corticosteroid. They were treated with anti-IgE antibody without recurrence for 2 yr and 15 months. Here, we first describe clinical experience of the 2 cases of chronic eosinophilic pneumonia.</P>

Cells and mediators in diisocyanate-induced occupational asthma

Shin, Yoo Seob,Kim, Mi Ae,Pham, Le-Duy,Park, Hae-Sim Lippincott Williams Wilkins, Inc. 2013 Current opinion in allergy and clinical immunology Vol.13 No.2

PURPOSE OF REVIEW: Diisocyanates are the most common cause of occupational asthma in many industrialized countries, and various pathogenic mechanisms have been suggested to be involved. Occupational asthma causes airway remodeling unless diagnosed and treated within a proper time frame. However, treatment modalities are limited because of an insufficient understanding regarding underlying pathogenic mechanisms. RECENT FINDINGS: Several immunological and nonimmunological mechanisms have been suggested, indicating that the pathogenesis of occupational asthma may be more complex than other types of asthma. Airway epithelial cells are the first to encounter diisocyanates and orchestrate various responses, such as cytokine release, oxidative stress generation, and autoantibody formation. Some evidence supports the involvement of adaptive immune responses. Additional evidence suggests that other mechanisms are involved in diisocyanate-induced occupational asthma. One such candidate mechanism is oxidative stress. Oxidative stress has been shown to trigger and aid in the development of diisocyanate-induced occupational asthma in human samples and genetic studies, and some therapeutic trials were performed based on this finding. SUMMARY: Diisocyanate-induced occupational asthma may be caused by a complex interaction of innate and adaptive immune responses. The knowledge presented in this review may help lead to the development of new treatment modalities through an increased understanding of occupational asthma pathogenesis.

Endotoxin Is Not Essential for the Development of Cockroach Induced Allergic Airway Inflammation

Shin, Yoo Seob,Sohn, Jung-Ho,Kim, Joo-Young,Lee, Jae Hyun,Cho, Sang-Heon,Hong, Soo-Jong,Lee, Joo-Shil,Hong, Chein-Soo,Park, Jung-Won Yonsei University College of Medicine 2012 Yonsei medical journal Vol.53 No.3

<P><B>Purpose</B></P><P>Cockroach (CR) is an important inhalant allergen and can induce allergic asthma. However, the mechanism by which CR induces airway allergic inflammation and the role of endotoxin in CR extract are not clearly understood in regards to the development of airway inflammation. In this study, we evaluated whether endotoxin is essential to the development of CR induced airway allergic inflammation in mice.</P><P><B>Materials and Methods</B></P><P>Airway allergic inflammation was induced by intranasal administration of either CR extract, CR with additional endotoxin, or endotoxin depleted CR extract, respectively, in BALB/c wild type mice. CR induced inflammation was also evaluated with toll like receptor-4 (TLR-4) mutant (C3H/HeJ) and wild type (C3H/HeN) mice.</P><P><B>Results</B></P><P>Intranasal administration of CR extracts significantly induced airway hyperresponsiveness (AHR), eosinophilic and neutrophilic airway inflammation, as well as goblet cell hyperplasia in a dose-dependent manner. The addition of endotoxin along with CR allergen attenuated eosinophilic inflammation, interleukin (IL)-13 level, and goblet cell hyperplasia of respiratory epithelium; however, it did not affect the development of AHR. Endotoxin depletion in CR extract did not attenuate eosinophilic inflammation and lymphocytosis in BAL fluid, AHR and IL-13 expression in the lungs compared to CR alone. The attenuation of AHR, eosinophilic inflammation, and goblet cell hyperplasia induced by CR extract alone was not different between TLR-4 mutant and the wild type mice. In addition, heat inactivated CR extract administration induced attenuated AHR and eosinophilic inflammation.</P><P><B>Conclusion</B></P><P>Endotoxin in CR extracts may not be essential to the development of airway inflammation.</P>

구강암편평세포암에서 c-Met 발현여부에 따른 (-)-Epigallocatechin-3-Gallate의 세포사멸 및 종양침습억제효과의 변화분석

신유섭(Yoo Seob Shin),고윤우(Yoon Woo Koh),최은창(, Eun Chang Choi),강성운(Sung Un Kang),황혜숙(Hye Sook Hwang),추옥성(Oak-Sung Choo),이한빈(Han Bin Lee),김철호(Chul-Ho Kim) 대한두경부종양학회 2011 대한두경부 종양학회지 Vol.27 No.1

Hepatocyte growth factor(HGF) and c-Met play an important role in the control of tumor growth and inva-sion, and they are known to be good prognostic indicators of patient outcome. Epigallocatechin-3-gallate (EGCG) has been shown to have chemopreventive and therapeutic properties by modulating multiple signal pathways regarding the control of proliferation and invasion of cells. In this study, we evaluated the role of c-Met in EGCG-induced inhibition of invasion and apoptosis in an oral cancer cell line. In KB cells where c-Met was knocked down with siRNA, we performed invasion assay and FACS with Annexin V-FITC/PT staining. In addition, we checked the change of mitochondrial membrane potential(MMP) and the generation of reactive ox-ygen species(ROS). EGCG-induced inhibition of invasiveness was significantly decreased after the knock-down of c-Met. EGCG-induced apoptosis, MMP change and ROS generation was also reduced in c-Met knock-ed-down KB cells. These results suggest that c-Met is involved in EGCG-induced apoptosis and inhibition of invasiveness of oral cancer cell line.

블랙초크베리(Aronia melanocarpa)의 유용 성분 함량 및 항산화 활성 능력

신유섭(Yoo-Seob Shin),김원우(Won-Woo Kim),김성무(Cheng-Wu Jin ),조동하(Dong-Ha Cho) 한국약용작물학회 2012 한국약용작물학회 학술대회논문집 Vol.2012 No.1

설문조사 분석을 활용한 제조업 작업자의 위험행동 요인 분석

신지섭(Ji-Seob Shin),이훈기(Hunggi Lee),유상우(Sangwoo Yoo),신동일(Dongil Shin) 한국가스학회 2021 한국가스학회지 Vol.25 No.2

제조업 작업자들에 대한 위험행동 요인의 분석은 효과적인 휴먼에러 예방과 효율적인 안전관리제도의 시스템화를 가능하게 한다. 본 연구는 작업자들의 작업심리, 작업환경, 작업일탈 요인이 위험행동의도에 미치는 영향과 이러한 위험행동의도가 위험행동에 미치는 영향의 관계를, 중소 제조업 중 제조가공업 작업자 80명을 대상으로, 설문조사를 중심으로 분석하였다. 결과를 살펴보면, 작업심리와 작업일탈은 위험행동의도에 영향을 미치는 것으로 나타났으나, 직무만족과 작업부하에 해당하는 작업환경요인은 위험행동의도에 영향을 미치지 않는 것으로 나타났다. 동료들과의 관계, 업무의 만족 내지는 불만족 정도, 작업자가 느끼는 직무의 중요성 정도와 많은 작업량을 소화하기 위한 시간의 촉박함 등이 의도적인 위험 작업 유발에는 영향을 미치지 않지만, 위험행동에는 영향을 미치는 것으로 나타나, 의도성이 결여된 상태에서 작업환경요인은 위험행동을 수반하는 것으로 나타났다. Analysis of risky behavior factors for workers in the manufacturing industry enables effective human error prevention and systemization of an efficient safety management system. This study examines the relationship between the effects of workers work psychology, work environment, and work deviation factors on risky behavior intentions and the effects of such risky behavior intentions on risky behaviors. Among the small and medium-sized manufacturing industries, the analysis was focused on a survey of 80 workers in the manufacturing and processing industry. Looking at the results, it was found that work psychology and work deviation had an effect on the intention of risky behavior, but the work environment factors corresponding to job satisfaction and workload did not affect the intention of risky behavior. The relationship with colleagues, the degree of satisfaction or dissatisfaction with the job, the degree of importance of the job that the worker feels, and the tightness of time to digest a large amount of work do not affect intentionally inducing dangerous work, but they do affect risky behavior. In the absence of intention, the work environment factor was found to accompany dangerous behavior.

A Case of Codeine Induced Anaphylaxis via Oral Route

Yoo, Hye-Soo,Yang, Eun-Mi,Kim, Mi-Ae,Hwang, Sun-Hyuk,Shin, Yoo-Seob,Ye, Young-Min,Nahm, Dong-Ho,Park, Hae-Sim The Korean Academy of Asthma, Allergy and Clinical 2014 Allergy, Asthma & Immunology Research Vol.6 No.1

<P>Codeine is widely prescribed in clinical settings for the relief of pain and non-productive coughs. Common adverse drug reactions to codeine include constipation, euphoria, nausea, and drowsiness. However, there have been few reports of serious adverse reactions after codeine ingestion in adults. Here, we present a case of severe anaphylaxis after oral ingestion of a therapeutic dose of codeine. A 30-year-old Korean woman complained of the sudden onset of dyspnea, urticaria, chest tightness, and dizziness 10 minutes after taking a 10-mg dose of codeine to treat a chronic cough following a viral infection. She had previously experienced episodes of asthma exacerbation following upper respiratory infections, and had non-atopic rhinitis and a food allergy to seafood. A skin prick test showed a positive response to 1-10 mg/mL of codeine extract, with a mean wheal size of 3.5 mm, while negative results were obtained in 3 healthy adult controls. A basophil histamine release test showed a notable dose-dependent increase in histamine following serial incubations with codeine phosphate, while there were minimal changes in the healthy controls. Following a CYP2D6 genotype analysis, the patient was found to have the CYP2D6*1/*10 allele, indicating she was an intermediate metabolizer. An open label oral challenge test was positive. To the best of our knowledge, this is the first report of a patient presenting with severe anaphylaxis after the ingestion of a therapeutic dose of codeine, which may be mediated by the direct release of histamine by basophils following exposure to codeine.</P>

최근 3년간 중증 외상 환자의 치료성적 비교

신준섭,정구영,유진현 대한외상학회 1998 大韓外傷學會誌 Vol.11 No.1

We examined the quality assurance of trauma care for 266 severely injured patients, with a Revised Trauma Score of less than 11 who were brought to ED from March 1994 to February 1997 and analyzed the elements which impacted on the outcome of trauma care. We used the TRISS method, . And W statistics for evaluation of the quality of trauma care. The z scores were -4.76, -6.12, -4.28 and W score were -13.40, -18.75, -15.07 in 1994, 1995, 1996 respectively. There was no improvement in the quality of trauma care. In 1995, the prehospital time was 99 rninutes which was greater than in 1994 and 1996, and the ED mortality was 30.2% (25.8% in 1994, 28.8% in 1996). The operation rate was significantly increased from 26.4% in 1994 to 43.1% in 1996(p<0.05). After admission, non-CNS trauma deaths were increased from 23.8% in 1994 to 47.1% in 1996. The effort to improve the care for severely injured patients was gradually increased without actual improvement of the mortality. For the improvement of trauma care, it is important to reduce prehospital time and delay in time to surgery. The surgeon should play a rnam role in critical or postoperative care.