피부질환 치료에서 경구 사이클로스포린의 안정성 및 부작용 양상: 한국인 환자들을 대상으로 한 단일기관 후향적 연구

Abstract

Background: In dermatologic field, cyclosporine (CS) has been used successfully as primary or secondary therapy for various skin diseases including psoriasis, atopic dermatitis, and chronic idiopathic urticaria. However, many dermatologists have been concerned with using this important drug in their clinical practices because of its adverse effects. Objective: The aim of this study was to investigate adverse effects of CS in the field of dermatology. Methods: We performed a retrospective study of 1,890 patients with CS treatment in Department of Dermatology, Hanyang University Hospital between January 1, 2008 and December 31, 2015. Results: Of 1,890 patients, 359 patients (19.0%) and 427 cases showed adverse effects and obvious laboratory changes. Gastrointestinal (GI) symptoms including heartburn, nausea and vomiting, abdominal discomfort, etc. were the most common adverse effect, they occurred in 202 patients (10.7%). Other side effects were as follows; hypertrichosis (2.2%), hypercholesterolemia (1.6%), headache (1.4%), hypertriglyceridemia (1.3%), hypertension (1.3%), dizziness (0.7%), paraesthesia (0.7%), renal dysfunction (0.6%), infection (0.5%), elevated liver enzymes (0.4%), tremor (0.3%), in order of frequency. Hypertriglyceridemia occurred more often in men but, GI symptoms, hypertrichosis, and paresthesia in women. GI symptoms, hypercholesterolemia, hypertension, and paresthesia were more common in adults but hypertrichosis in pediatric patients. Hypertension and hypercholesterolemia have been remarkable in psoriasis patients, and hypertrichosis in patients with atopic dermatitis. GI symptoms and headache occurred more often within 12 weeks of CS treatment, however, hypercholesterolemia, hypertriglyceridemia, hypertension, renal dysfunction and infections 12 weeks after. With reference to CS dose, GI symptoms were more often in group with higher initial dose and lower cumulative dose. Hypertriglyceridemia, hypertension, renal dysfunction, and infections occurred more often in higher CS cumulative dose group. Conclusions: We identified various adverse effects of CS and were able to apprehend the types and frequency of each adverse effects. However, as compared with previous studies, the frequency of adverse effects including GI symptoms after CS treatment was proven to be low and serious adverse effects were not reported in this study. Almost all of the adverse effects were well controlled and resolved after discontinuation of medication. Therefore, in dermatologic field, we suggest that CS is a relatively safe drug under careful monitoring.