한국인 말단 비대증에서 long acting lanreotide의 치료
Therapeutic effects of a long-acting formulation of lanreotide in Korean patients with acromegaly
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목적 : 본 연구의 목적은 한국의 말단 비대증 환자에서 수술 후 long-acting formulation of lanreotide을 사용하였을 때의 치료 효과와 내당능 장애 및 부작용에 관하여 살펴 보고자 함에 있다. 방법 : 본 연구는 말단 비대증으로 진단받고 수술한 이후 고대 구로병원에서 long-acting formulation of lanreotide을 사용한 환자들을 대상으로 연령, 성별, 체질량 지수(BMI) 및 serum IGF-1, 75 gm OGTT 후 GH level, HbA1c 및 원발 종양의 크기를 long-acting formulation of lanreotide 사용 전과 후 6개월, 12개월 추적검사를 시행하였다. 결과 : 총 11명의 환자 중 10명에서 투약 전후 성장 호르몬 수치를 측정하였는데, 3예에서는 목표치인 1 ng/mL에 가까운 정도로 감소하였고, 그 외의 환자들도 기저치에 비하여 감소하는 경향을 보였다. IGF-1은 투약 전 862±314.06 ng/mL이었으나 6개월째에는 549±371.62 ng/mL (p=0.003, vs baseline, n=11), 12개월째에는 439±342.53 ng/mL (p=0.005, vs baseline, n=10)으로 통계학적으로 유의한 감소를 보였다(표 3). 투약에 따른 부작용으로 우려되었던 내당능 장애 혹은 당뇨에 대하여 평가하기 위하여 투약을 시작할 때 위험군으로 사료되었던 8명의 환자를 대상으로 당화 혈색소 값을 측정하였으며, 5.8±0.5%에서 5.9±0.3%으로 별다른 변화를 보이지 않았다. 대상 환자들 중 당뇨가 있던 3명의 환자들 역시 기저치의 당화 혈색소와 큰 차이는 없었다. 연구 기간 동안 환자들에게 특별한 부작용은 나타나지 않았다. 결론 : 본 연구에서 국내의 long-acting formulation of lanreotide의 치료효과는 외국에서 시행되었던 연구와 유사하게 기존 약제에 비하여 특별한 부작용 없이 사용방법의 간편화 및 순응도의 개선을 보였다. 그러나 이후 약제의 장기적인 치료 효과 및 부작용, 치료 반응에 대한 예측인자에 대한 연구는 많은 환자를 대상으로 더 진행되어야 할 것이다. Aknowlegement 과거, 치료에많은 어려움을 겪던 말단 비대증 환자들에게 말단비대증 재단을 설립하여 양질의 진료를 가능케 하여주신 김선우 이사장님과 여러 관계자 분들, 그리고 어려운 시작을 해주셨던 한국 입센에게 깊은 감사를 드립니다.
Abstract
Background : The present study was conducted to examine the effects of a long-acting formulation of lanreotide (Somatulin-AutogelⓇ) in Korean acromegalic patients who had undergone surgery. Methods : The subjects in the study were 11 acromegalic patients (5 men and 6 women) who had undergone transsphenoidal tumor resection at Korea University Guro Hospital. The anthropometric parameters, blood pressure, fasting blood glucose (FBG), IGF-1, HbA1C, mass size and GH level following a 75 gm oral glucose tolerance test (OGTT) were measured in each subject before and after treatment with a long-acting formulation of lanreotide. Results : The median age of the subjects was 41 yrs (range: 28-52 yrs) (Table 1). The mean pre-operative levels of serum IGF-1 in the 11 patients was 1185±323.58 ng/mL, and post-operatively it was 862±314.06 ng/mL. The mean serum IGF-1 concentration decreased from 862±314.06 ng/mL to 549±371.62 ng/mL after 6 months treatment with the long-acting formulation of lanreotide (p=0.003, vs baseline, n=11), and it decreased further to 439±342.53 ng/mL after 12 months treatment (p=0.005 vs baseline, n=10) (Table 3). Two patients achieved the target level of IGF-1. The HbA1C measured before and after lanreotide treatment was 5.8±0.5% and 5.9±0.3%, respectively. Conclusions : This study showed that a long-acting formulation of lanreotide decreased the IGF-1 and GH levels without significant side effects. In spite of the small number of subjects in this study, these findings suggest that this formulation of lanreotide is effective for the post-operative management of acromegaly.(Korean J Med 73:50-57, 2007)
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