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Institutional review board (IRB) and ethical issues in clinical research
김원옥 대한마취통증의학회 2012 Korean Journal of Anesthesiology Vol.62 No.1
Clinical research has expanded tremendously in the past few decades and consequently there has been growing interest in the ethical guidelines that are being followed for the protection of human subjects. This review summarizes historical scandals and social responses chronologically from World War II to the Death of Ellen Roche (2001) to emphasize the lessons we must learn from history. International ethical guidelines for studies with human subjects are also briefly described in order to understand the circumstances of clinical research. The tasks and responsibilities of the institutions and investigators in human subject research to preserve the safety and welfare of research subjects are summarized. Next, several debated ethical issues and insights are arranged as controversial topics. This brief review and summary seeks to highlight important arguments and make suggestions to institutional review boards (IRBs) to contribute to the future evolution of ethics in clinical research as we advance forward.
Treatment of Compensatory Gustatory Hyperhidrosis with Topical Glycopyrrolate
김원옥,길혜금,윤덕미,조민정 연세대학교의과대학 2003 Yonsei medical journal Vol.44 No.4
Gustatory hyperhidrosis is facial sweating usually associated with the eating of hot spicy food or even smelling this food. Current options of treatment include oral anticholinergic drugs, the topical application of anticholinergics or aluminum chloride, and the injection of botulinum toxin. Thirteen patients have been treated to date with 1.5% or 2% topical glycopyrrolate. All patients had gustatory hyperhidrosis, which interfered with their social activities, after transthroacic endoscopic sympathectomy, and which was associated with compensatory focal hyperhidrosis. After applying topical glycopyrrolate, the subjective effect was excellent (no sweating after eating hot spicy food) in 10 patients (77%), and fair (clearly reduced sweating) in 3 patients (23%). All had reported incidents of being very embrasssed whilst eating hot spicy foods. Adverse effects included a mildly dry mouth and a sore throat in 2 patients (2% glycopyrrolate), a light headache in 1 patient (1.5% glycopyrrolate). The topical application of a glycopyrrolate pad appeared to be safe, efficacious, well tolerated, and a convenient method of treatment for moderate to severe symptoms of gustatory hyperhidrosis in post transthoracic endoscopic sympathectomy or sympathicotomy patients, with few side effects.
김원옥,박광원,길혜금,성낙순 대한마취과학회 1989 Korean Journal of Anesthesiology Vol.22 No.6
A 39 years old, ASA PS I. healthy female patient was scheduled for surgical resection of a paraganglioma surrounding right carotid artery bifurcation area. Anesthesia was induced with thiopental and sucinylcholine and maintained with 0.75-1.25 Vo1% halothane in 50% nitrous oxide in oxygen. Reconstructive carotid artery surgery with intraluminal shunt was performed due to laceration of carotid artery bifurcation area during wide dissection of tumor mass. Duration of the carotid artery clamp and release was 35 minutes and any significant changes in vital signs and EEG were not found. Soon after the patient was recovered from anesthesia. She was delivered to recovery room and then she was transferred to intensive care unit. She was discharged from hospital without any neurologic sequelae on the 13th postoperative day.
김원옥,정재흥,강태욱,송재만,정현철 대한비뇨의학회 2014 Investigative and Clinical Urology Vol.55 No.1
Purpose: To assess changes in lower urinary tract symptoms (LUTS), prostate volume,and serum prostate-specific antigen (PSA) after discontinuation of 5-alpha reductaseinhibitor (5ARI) combination therapy in patients with benign prostatic hyperplasia(BPH). Materials and Methods: From December 2003 to December 2012, data were collectedretrospectively from 81 men more than 40 years of age with moderate to severe BPHsymptoms (International Prostate Symptom Score [IPSS]≥8). The men were classifiedinto group 1 (n=42) and group 2 (n=39) according to the use of 5ARI therapy. A combinationof dutasteride 0.5 mg with tamsulosin 0.2 mg was given daily to all patients for1 year. For the next 1 year, group 1 (n=42) received the combination therapy and group2 (n=39) received tamsulosin 0.2 mg monotherapy only. The IPSS, prostate volume,and PSA level were measured at baseline and at 12 and 24 months according to theuse of dutasteride. Results: Discontinuation of dutasteride led to significant deterioration of LUTS, increasedprostate volume, and increased PSA level. The repeated-measures analysis ofvariance showed that the changes in IPSS, prostate volume, and PSA level over timealso differed significantly between groups 1 and 2 (p<0.001). Conclusions: Withdrawal of 5ARI during combination therapy resulted in prostate regrowthand deterioration of LUTS. The PSA level is also affected by the use of 5ARI. Therefore, regular check-up of the IPSS and PSA level may be helpful for all patientswho either continue or discontinue the use of 5ARI.