Thử nghiệm ngẫu nhiên so sánh liệu pháp hormon thay thế liều thấp và HRT cộng với 1α-OH-vitamin D3 (alfacalcidol) trong điều trị tình trạng mất xương sau mãn kinh

Springer Science and Business Media LLC - Tập 24 - Trang 11-15 - 2006
Hideki Mizunuma1, Masataka Shiraki2, Masafumi Shintani3, Itsuo Gorai4, Kazuya Makita5, Shunichi Itoga6, Yoshiko Mochizuki7, Hiromichi Mogi8, Yasuhisa Iwaoki9, Shouichirou Kosha10, Toshiyuki Yasui11, Osamu Ishihara12, Takumi Kurabayashi13, Yoshio Kasuga14, Kunihiko Hayashi15
1Department of Obstetrics and Gynecology, Hirosaki University School of Medicine, Hirosaki, Japan
2Research Institute and Practice for Involutional Diseases, Nagano, Japan
3Department of Obstetrics and Gynecology, Narakenritsu Mimuro Hospital, Nara, Japan
4Department of Obstetrics and Gynecology, International University of Health and Welfare, Atami Hospital, Atami, Japan
5Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo, Japan
6Department of Obstetrics and Gynecology, Tone Central Hospital, Numata, Japan
7Department of Obstetrics and Gynecology, Dokkyo University School of Medicine, Tochigi, Japan
8Department of Obstetrics and Gynecology, Maebashi Kyouritu Hospital, Maebashi, Japan
9Department of Obstetrics and Gynecology, Kouseiren Yoshida General Hospital, Hiroshima, Japan
10Department of Obstetrics and Gynecology, Kagoshima University School of Medicine, Kagoshima, Japan
11Department of Obstetrics and Gynecology, Tokushima University School of Medicine, Tokushima, Japan
12Department of Obstetrics and Gynecology, Saitama Medical School, Saitama, Japan
13Department of Obstetrics and Gynecology, Niigata University School of Medicine, Niigata, Japan
14Department of Obstetrics and Gynecology, Ashikaga Red Cross Hospital, Tochigi, Japan
15Department of Basic Allied Medicine, School of Health Sciences, Faculty of Medicine, Gunma University, Maebashi, Japan

Tóm tắt

Chúng tôi đã thực hiện một thử nghiệm ngẫu nhiên, đa trung tâm, mờ nhãn kéo dài 2 năm với 76 phụ nữ sau mãn kinh từ 60 tuổi trở lên có mật độ khoáng xương lưng thấp (T-score dưới -1). Nhóm được điều trị bằng liệu pháp hormon thay thế (HRT) nhận liều estrogen phân đoạn thấp (CEE) là 0,31 mg/ngày ± axetat medroxyprogesterone (MPA) 2,5 mg/ngày. Nhóm HRT/D nhận cùng một liều HRT kết hợp với alfacalcidol với liều hàng ngày là 1,0 µg/ngày. Các thay đổi về mật độ khoáng xương lưng được đo bằng phương pháp hấp thụ tia X năng lượng kép (DXA) được theo dõi 6 tháng một lần trong 2 năm. Mật độ khoáng xương lưng của nhóm HRT đã tăng 3,37% [khoảng tin cậy 95% (CI) 1,6%–5,2%], 4,00% (95% CI 1,6%–6,4%), và 2,32% (95% CI −0,7% đến 5,3%) ở các thời điểm 12, 18 và 24 tháng, trong đó giá trị cơ bản được coi là 0%. Mật độ khoáng xương lưng của nhóm HRT/D cho thấy sự gia tăng đáng kể sau 6 tháng. Tỷ lệ gia tăng của nhóm này ở các thời điểm 6, 12, 18 và 24 tháng lần lượt là 6,18% (95% CI 1,3%–6,6%), 6,18% (95% CI 3,9%–8,5%), 7,17% (95% CI 4,3%–10,0%), và 8,75% (95% CI 6,0%–11,5%). Thêm vào đó, có sự khác biệt đáng kể về các thay đổi mật độ khoáng xương lưng giữa hai nhóm ở 24 tháng, cho thấy rằng sự kết hợp giữa HRT và alfacalcidol có hiệu quả hơn so với HRT đơn thuần về tác động mật độ khoáng xương. Nghiên cứu này là thử nghiệm tiềm năng đầu tiên cho thấy tác dụng bổ sung của alfacalcidol lên mật độ khoáng xương lưng ở phụ nữ sau mãn kinh nhận HRT liều thấp. Nghiên cứu gợi ý rằng liệu pháp kết hợp có thể được xem xét như một phương pháp điều trị tiềm năng cho tình trạng mất xương sau mãn kinh.

Từ khóa

#HRT #alfacalcidol #mật độ khoáng xương #mãn kinh #điều trị mất xương

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