폐경기 골감소증 여성에서 호르몬 요법과 랄록시펜이 골밀도와 지질 대사에 미치는 영향
A Comparison of the Effects of Raloxifene and Hormon Therapy on Lipid Profile and Bone Mineral Density in Postmenopausal Osteopenia Women
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목적: 한국 폐경 여성을 대상으로 한 에스트로겐과 랄록시펜에 대한 비교 연구가 희소하여 이에 저자는 한국 폐경 여성을 대상으로 랄록시펜과 에스트로겐을 24개월 동안 투여하였을 때 지질 대사와 골밀도 변화에 미치는 영향을 비교하여 알아보기 위하여 본 연구를 시행하게 되었다. 방법: 약물의 투여는 랄록시펜 투여군(N=42)에서는 매일 Evista® 60mg을 투여하였고, 에스트로겐 요법군(N=84)에서는 매일 Progyniva® 2mg을 투여하였다. 약물 투여 전 골밀도 및 공복 시 혈중 총 콜레스테롤, 중성 지방, 고밀도 지단백 콜레스테롤, 저밀도 지단백 콜레스테롤을 측정하였으며 이후 매 1년마다 총 2년간 위 검사를 시행하였다. 결과: 총 콜레스테롤은 랄록시펜 투여군에서는 4.8% 감소하였으며 에스트로겐 요법군에서는 1.1% 감소하였고 고밀도 지단백 콜레스테롤은 랄록시펜 투여군에서는 7.1% 증가하였으며 에스트로겐 요법군에서는 5.3% 증가하였고 저밀도 단백질 콜레스테롤은 랄록시펜 투여군에서는 1.7% 증가하였으며 에스트로겐 요법군에서는 6.1% 증가하였고 중성 지방은 랄록시펜 투여군에서는 5.4% 감소하였고 에스트로켄 요법군에서는 2.5% 증가하였고 대퇴골 골밀도는 랄록시펜 투여군에서는 109% 증가하였으며 에스트로겐 요법군에서는 0.7% 증가하였고 척추 골밀도는 랄록시펜 투여군에서는 1.0% 증가하였으며 에스트로겐 요법군에서는 2.7% 감소하였다. 결론: 본 연구에서 랄록시펜 투여군과 에스트로겐 요법군에서 각각 기저치에 비해 지질 대사와 골밀도에 있어 유의한 변화를 보이지 않았으며 또한 두 군 간의 유의한 차이를 보이지 않았다. 이는 대조군이 없다는 점과 한국 폐경 여성을 대상으로 하였다는 점, 그리고 대상수가 적고 환자의 투약 순응도에 대한 평가가 없었다는 점 등을 그 원인으로 유추할 수 있으며 향후 한국 폐경 여성을 대상으로 두 약제의 지질 대사와 골밀도 변화에 미치는 영향을 확인할 수 있는 다기관 전향적 연구가 시행되어야 할 것으로 생각된다.
Abstract
Objectives: To compare the raloxifene lipid profile and bone mineral density to estrogen therapy in postmenopausal women with osteopenia. Methods: In this prospective clinical trial, a total of 132 natural or surgical menopausal women at the Department of Obstetrics and Gynecology of Kosin University Hospital between June 2007 and December 2008 were studied. The effects of raloxifene(Evista® 60mg/day, N=42) and estrogen therapy(Premarin® 0.625mg/day, N=84) were compared in terms of the lipid profile(total cholesterol, low-density lipoprotein cholesterol(LDL-C), high-density lipoprotein cholesterol(HDL-C), and triglyceride) changes in bone mineral density over 24 months. The lipid profile and bone mineral density measurements were performed at baseline, and at 12 and 24months. Results: Women treated with raloxifene for 24 months had a decrease in the total cholesterol and triglyceride levels by 4.8% and 5.5%, and increase in the LDL-C and HDL-C levels by 1.7% and 7.1%, respectively these differences were not statistically significant. Women treated with estrogen for 24 months had a decrease in the total cholesterol level by 1.1%, an increase in the triglyceride level, LDL-C and HDL-C levels by 2.5%, 6.1%, and 5.3%, respectively these differences were not statistically significant. Women treated with estrogen for 24 months had a decrease in the bone mineral density of the lumbar spine by 2.7% and increase in the bone mineral density of the femur neck by 0.7%, respectively these differences were not statistically significant. There was no statistically significant difference in total cholesterol, LDL-C and HDL-C, triglyceride, and bone mineral density between the raloxifene and estrogen therapy groups. Conclusion: There was no statistically significant difference in the effects of raloxifene and estrogen on the lipid profile and bone mineral density in postmenopausal women after 24 months. Further studies are necessary to establish a definitive comparison of the effects of raloxifene and estrogen therapy on the lipid profile and bone mineral density of postmenopausal women.
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