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식품의약품안전청의 의약품안전사용정보방 웹사이트 구축을 위한 컨텐츠 개발
지은희(Eunhee Ji),박효영(Hyo Yung Park),노혜진(Hyejin Noh),이동은(Dong Eun Lee),한나영(Nayoung Han),정소현(Sohyun Jeong),김인화(In-Wha Kim),신완균(Wan Gyoon Shin),오정미(Jung Mi Oh) 대한약학회 2012 약학회지 Vol.56 No.3
The purpose of this study was to construct database for a drug safety information website to serve as an access point of up-to-date resources for a wide variety of drug-safety information helping patients and healthcare professionals make well-informed decisions about medication use. All the contents developed were confirmed by the council of advisors who were the experts in drug safety. The detailed contents of database on frequently prescribed drug including 9 NSAIDs, 19 antibiotics, 24 cardiovascular, 21 metabolic, 14 respiratory, 20 digestive, 22 hormonal, 10 genitourinary, 10 anti-allergic, 27 antifungal/antiviral, and 71 neuropsychiatric agents were developed based on the approved drug labeling of the Korean FDA. A separately searchable database of drug-specific safety information for patients and health professionals was constructed for users in need of different depth of knowledge on using medications safely. The safety information on highly prevalent chronic diseases and drug classes was also developed. Finally the most recent global drug safety news was provided. The consumer directed information was developed in layman’s terms as means of proving user-friendly information. The creation of this type of website is part of the Korean FDA’s ongoing initiative to address and promote the safe use of medications for the public.
항히스타민제의 대리결과변수로서 히스타민에 의한 피내주사반응 유용성에 대한 고찰
한나영, 송병정, 백현문, 정에벤, 유영훈, 전지현, 구성우, 윤휘열, 권광일 충남대학교 약학대학 의약품개발연구소 2017 藥學論文集 Vol.32 No.-
In this study, it is reviewed that histamine-induced wheal and flare responses are potential sur-rogate endpoints for predicting the clinical effects of antihistamines in patients with allergic skin diseases. Histamine plays an important role in allergic response by inducing degranulation of mast cells due to allergen exposure and mediating the inflammatory reaction. Thus, suppression of histamine-induced wheal and flare has been noted as surrogate markers for efficacy of Hl receptor antagonists. In addition, allergy skin prick test and intradermal test using histamine have been used to diagnose the histamin-induced allergic reaction. However, it has been well known that allergic diseases are not only mediated by histamine. but also by var-ious immunological inflammatory responses. Previous studies reported that there is a lack of evidence about the correlation between antihistamines to predict clinical efficacy and antihistamine efficacy, although hista-mine-induced wheal and flare responses may be useful indicators of the dose-response relationship. In con-clusion, the evaluation for the suppression of wheal and flare after histamine injection is reasonable for de-termining the treatment of allergic simple skin diseases, but there is a limit to evaluate the efficacy in com-plex inflammatory diseases mediated IgE or T cells, or other immune complex. Therefore, further studies are needed to identify additional surrogate endpoints to predict the therapeutic effect of antihistamines in other inflammatory diseases such as allergic rhinitis, atopic conjunctivitis, allergic asthma, and so on.
당뇨병 치료를 위한 SGLT2 억제제의 심혈관계 안전성 관련 최근 임상시험 결과고찰
김혜럼, 한나영, 유미선, 권광일, 윤휘열 충남대학교 약학대학 의약품개발연구소 2017 藥學論文集 Vol.32 No.-
Patients with type 2 diabetes have a two-to three-times greater risk of developing car-diovascular disease than people without diabetes, and the mortality rate from cardiovascular disease is also reported to increase. The reason why cardiovascular disease is more common in type 2 diabetic patients is not only that cardiovascular risk factors are more common than non-diabetic patients, but also that diabetes itself is an independent risk factor for cardiovascular disease. Since rosiglitazone. which was introduced as a treatment for type 2 diabetes in 2000, has been argued to increase cardiovascular disease sluch as myocardial infarction. there were clinical trials of cardiovascular safety of it such as DREAM. ADOPT and RECORD. As a result. rosiglitazone has been banned due to the risk of cardiovascular disease. The US FDA and other regulatory agencies have required clinical trials for type 2 diabetes treatments afterward. 1n this study. it is reviewed that recently developed SGL T2 inhibitors has cardiovascular benefits as a novel mechanism of type 2 diabetes treatment. SGL T2 inhibitors inhibit the renal sodium glucose co-transporter(SGLT2), thereby reducing glucose reabsorption and increasing excretion of it. and consequently lowering blood glucose levels. Recent papers on ongoing cardiovascular-related clinical trials of SGL T2 in-hibitors such as CANVAS. CANVAS-R. CREDENCE of canagliflozin, DECLARE-TIMI 58 of dapagliflozin. and EMPA -REG outcomes of empagliflozin were examined thoroughly as well.