部份中文艾地骨化醇处方资料（仅供参考）
商品名：EDIROL
英文名：Eldecalcitol
中文名：艾地骨化醇软胶囊
生产商：中外制药
药品简介
日本厚生省于2011年1月21日批准骨质疏松症治疗药物—艾地骨化醇软胶囊上市，其有效物质艾地骨化醇是继阿法骨化醇后又一新的用于治疗骨质疏松症的活性维生素D3衍生物。一项由1054例骨质疏松症患者参加的历时3年的Ⅲ期临床数据显示，艾尔骨化醇疗效优于阿法骨化醇，且安全性与阿法骨化醇相似，具有较好的应用前景。
エディロールカプセル0.5μg/エディロールカプセル0.75μg
藥用類別名稱
骨質疏鬆症治療劑 (活性維生素D3製劑)
批准日期：2011年4月
商標名
EDIROL
一般名
エルデカルシトール（Eldecalcitol）（JAN）
化学名
（1R,2R,3R,5Z,7E）-2-（3-Hydroxypropyloxy）-9,10-secocholesta-5,7,10（19）-triene-1,3,25-triol
構造式
分子式
C30H50O5
分子量
490.72
性　状
它是一種白色淡黃色粉末。
n, 易溶于正二甲基甲醯胺和乙醇(99.5), 微溶于氯仿, 微溶于乙腈, 不易溶于水。
熔點
約132°c
藥用藥理學
1. 行動機制
鈣調尿素醇是活性維生素d3(鈣調尿素三醇) 的衍生物, 具有以下藥理作用。
(1) 抑制影響人破骨細胞祖細胞的破骨細胞的形成 (體外)。
(2) 大鼠小腸 (體外) 鈣吸收促進作用增強, 血清鈣濃度明顯。
(3) 在kulu病模型大鼠中, 骨軟骨內寬度指數下降。
(4) 卵巢切除大鼠骨代謝旋轉參數值下降。
由此, el de calcineurin醇主要抑制骨代謝旋轉, 相信可以提高骨密度和骨強度。
2. 藥理作用
(1) 對骨密度和骨強度的影響
1) 在試驗中反復給卵巢切除大鼠口服 12個月, 給藥的鈣調尿素為0.03μgg, 骨密度降低, 腰椎和股骨骨骨強度因噴刺而降低, 顯著抑制。
2) 在測試中, 卵巢切除猴子反復口服鈣調尿素16個月, 腰和股骨密度為el de calcineurin至0.07μgg day給藥組不低於噴空對照組。 此外, 還觀察到了降低骨骼強度等不利影響。
3個
觀察到噴水大鼠和猴子的骨密度與骨強度呈正相關。
(2) 對骨組織圖像的影響
1) 在試驗中反復口服12個月, 觀察到卵巢切除大鼠骨組織圖像異常。
2) 在卵巢切除的猴子el de calcineurin ol 0.0175, 0.0175, 0.0175μgg 一天的試驗中重複口服 16個月, 在骨組織圖像中觀察到異常。
(3) 對骨折癒合的影響
在骨折模型大鼠中, el de鈣調尿素至0.015, 骨折手術前0.05μgggg天, 骨折手術後16周反復口服不影響骨折部位的形狀和機械強度。
适应症
骨質疏鬆症
用法与用量
成人口服0.75微克, 每天一次作為el de鈣調尿素醇。然而, 要減輕體重到0.5微克, 每天一次適當的症狀。
臨床結果
原發性骨質疏鬆症患者1,054例(el de calcineurin tol組528例, 男性9例, 阿爾鈣素娃娃組528例男性15例)在隨機雙盲組比較試驗中, 三年非創傷性新椎體骨折發生頻率是一個主要的評價專案, el de calcineurin tor組(0.75微克/天一次)13.4%, 阿爾法鈣素娃娃集團(每天1.0微克)17.5%(相對降低風險率26%), el de calcineurin tor對Alpha calcineurin dor的優越性通過[分層對數排名測試: p=0.0460 (一側)]得到了驗證。此外, 3年非創傷性前骨折發生率在el de calcineurin tol group為1.1%, 在阿爾法鈣調素娃娃集團為3.6%(相對風險降低率 71%), 觀察到顯著差異[分層測階測試: p=0.0048(單面)]。三年後, el de calcineurin 組的腰椎密度平均變化率為3.4%(每天0.75 微克), 阿爾法鈣調素娃娃的平均變化率為0.1%(每天1.0微克)。學生t測試: p<0.001(兩側) 顯示骨密度顯著增加效果相比, 阿爾法鈣素娃娃組。另外, 在股骨骨密度平均變化率3年後, 在el de calcineurin tol組中,-2.3% 在阿爾卡替努林娃娃組, 顯示出顯著的骨密度增加效應[學生t測試: p<0.001(雙方)]。
包装
0.5微克: 100 粒膠囊 (ptp10膠囊x10)140粒膠囊(ptp14膠囊x10)
0.75微克: 100粒膠囊(ptp10膠囊x10)140粒膠囊(ptp14膠囊x10)500膠囊(ptp10膠囊x50瓶装)700膠囊 (ptp14 膠囊 x50)
生产厂家
中外制药
注：以上中文不够完整，使用者以原处方资料为准。
完整说明附件：http://www.info.pmda.go.jp/go/pack/3112006M1022_1_08/ 
 

商標名
EDIROL

EDIROL Capsule 0.5mcg（エディロールカプセル0.5μg）
Brand name : EDIROL Capsule 0.5mcg
　Active ingredient: Eldecalcitol
　Dosage form: opaque brownish white capsule (φ: 6.6mm)
　Print on wrapping: エディロール0.5μg
Effects of this medicine
This activated vitamin D3 derivative enhances digestive absorption of calcium and improves bone metabolic turnover. As the result, it increases bone mineral density, makes bones strong and prevents fractures caused by osteoporosis. It is usually used to treat osteoporosis.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reaction (itch, rash etc.) to any medicines.
If you are a patient with hypercalcemia, renal function disorder, malignancy, hyperparathyroidism, or hepatic function disorder.
If you have or ever had urinary calculus.
•If you are pregnant, possibly pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is<<to be written by a healthcare professional>>
•The dosage of this medicine is adjusted under a fully controlled condition of serum calcium level.
In general, for adults, take 0.75mcg of the active ingredient once a day. It should be decreased according to your symptoms. 1 capsule contains 0.5mcg of the active ingredient. Strictly follow the instructions.
•If you missed a dose, skip the missed dose and continue your regular dosing schedule. However, you should never take two doses at one time.
•If you accidentally took more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•Fetal malformation and lacteal transfer has been reported in animal experiments. If you have a possibility of getting pregnant, avoid pregnancy while you are taking the medicine.
•If you take a large amount of calcium or vitamin D contained in OTC medicine or food while taking this medicine, you may have a higher risk of side effects. Check with your doctor about it beforehand.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include hypercalcemia. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•lassitude, loss of appetite, feeling irritated, absent-mindedness, unable to concentrate, nausea, vomiting, dry mouth, excess intake of water, increased urinary volume [hypercalcemia]
•decreased urinary volume, swollen body/legs/eyes, lassitude, easy fatigability, decreased consciousness, headache, breathlessness [acute renal failure]
•severe low-back/back pain, abdominal pain, bloody urine [urinary calculus]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store in a covered container, at room temperature (1-30℃), away from light and moisture.
•Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.
Chugai Pharmaceutical Co., Ltd.Internal
Revised: 7/2013
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.