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인체세포ㆍ조직이용 의료제품 등의 규제에 관한 국내외 규정 비교 및 안전관리 개선방안 연구
이지훈(Jihoon Lee),최수경(Soo Kyung Choi),김주희(Juhui Gim),박미영(Miyoung Park),박수현(Soo Hyun Park),최진희(Jinhee Choi),임화경(Hwakyung Lim),노혜민(Hyemin Noh),이윤희(Yun hee Lee),윤재석(Jaesuk Yun) 대한약학회 2018 약학회지 Vol.62 No.3
Over the past several decades, human-derived cells, tissues, and cell- and tissue-based therapies have contributed to essential body function regeneration in the absence of effective alternative medicine substitute. This study reviewed strength and weakness of the regulation related to human-derived cells, tissues based pharmaceutical products compared to the US regulation, and suggested points for improvement classified into three categories. First, it is necessary to supplement regulations and guidelines on donor eligibility for pharmaceutical products. Second, there is a need to integrate regulations related to classify pharmaceutical product into biologics, device, and combination products. Finally, there is a need to develop and supplement the traceability of biological traces and the regulations for biological monitoring systems of pharmaceutical products. Collectively, it would be necessary to revise the regulations and the guidelines for the approval, manufacture, management and tracking of human cell/tissue derived pharmaceutical products by collecting opinions from researchers, industry, and clinical health care workers with a systematic long-term goal.
산과적 출혈 처치에 있어서 응급 자궁적출술 및 경피적 혈관색전술 적용의 임상적 양상과 효과 비교
윤지영 ( Ji Yeong Yoon ),류의남 ( Ui Nam Ryoo ),노수경 ( Soo Kyung Noh ),송승은 ( Seung Eun Song ),서은성 ( Eun Sung Seo ),이수호 ( Su Ho Lee ),최석주 ( Suk Joo Choi ),오수영 ( Soo Young Oh ),노정래 ( Cheong Rae Roh ),김종화 ( Jon 대한산부인과학회 2009 Obstetrics & Gynecology Science Vol.52 No.2
Objective: To compare the clinical characteristics and outcome of hysterectomy and angiographic embolization in the management of obstetrical hemorrhage unresponsive to conservative management. Methods: We retrospectively analyzed 88 patients who underwent hysterectomy and 53 patients who underwent angiographic embolization for the management of obstetrical hemorrhage from January 1999 to July 2007. We analyzed the maternal characteristics and outcomes by the review of medical records and telephone interview. Nonparametric test was performed for comparison of both groups. Results: Angiographic embolization for the management of obstetrical hemorrhage is on the increase year by year, consisting of about three quarters of total cases in the last year. The most common indication of hysterectomy was abnormal placentation (68.2%) followed by uterine atony (25.0%). For the embolization, the most common indication was uterine atony (54.7%) followed by abnormal placentation (17%). The median pre-operative hemoglobin was significantly lower in embolization group than hysterectomy group [8.3 (3.8~12.7 g/dL) vs. 10.8 (2.4~13.7 g/dL), P<0.001]. There was no difference in the total transfusion amount of packed RBC between the two groups. The median hospital stay was shorter in embolization group [8 (5~57 days) vs. 6 (3~14 days), P<0.001]. Overall success rate of embolization was 89% and procedure-related acute complications were not occurred. Of the total population, there was one maternal death in the hysterectomy group. We found that most women who underwent the embolization resume normal menstruation. Conclusion: Angiographic embolization for the management of obstetrical hemorrhage is more commonly performed in recent years. Angiographic embolization was associated with shorter hospital stay, reasonable success rate, and minimal complication rate.