Strontium Ranelate藥物治療可穩定骨質疏鬆症病患的骨質


  Sept. 26, 2005(那什維爾)- 根據美國骨骼與礦物質研究(ASBMR)第27屆年會中發表的研究結果指出,Strontium Ranelate是第一種可以降低骨質再吸收,並增加骨質形成的一種雙重作用藥物。
  
  在一場記者會中,法國里昂克勞第伯納大學風濕病醫學教授Pierre D. Delmas 醫學博士指出,Strontium Ranelate可降低骨質再吸收,並增加骨質形成,這種藥物可以降低破損細胞並增加格根保爾氏細胞。
  
  這項藥物由Servier製造,最近在歐盟已獲得上市核准,但尚無法在美國銷售。
  
  先前研究已顯示,Strontium Ranelate可以明顯的降低危險群婦女的脊椎及臀部挫傷;而目前研究則顯示,這項藥物的雙重作用可獲致骨質的穩定。
  
  在最近研究中,服用每日2克Strontium Ranelate的試驗組,或安慰劑的136名罹患骨質疏鬆症的婦女,皆進行基線腸骨骨質切片檢查;從治療開始後第1、2、3、4、5年,每年進行後續切片檢查;所有病患皆需補充鈣片及維他命D。
  
  研究人員發現,接受治療之婦女,造骨細胞表面高出38%,較大的礦物質並列比率(MAR),網狀骨質增加8%,外皮骨質增加11%。
  
  研究人員在報告中指出,組織層的催化活動並無明顯重大的改變。
  
  Delmas醫學博士指出,再吸收作用的影響,包含低層骨內衣侵蝕表面、骨髓細胞與網狀骨質破損細胞表面,以及破骨細胞的數量等。
  
  Delmas醫學博士表示,就安全性而言,接受治療婦女網狀骨質的類骨質厚度是明顯降低的,其MAR亦明顯高出,但在類骨質的量及礦物化的延滯方面並無改變;此外,主要的礦化程度並未被減弱,而這個效果來自於藥物刺激。
  
  Delmas醫學博士進一步表示,結果顯示,Strontium Ranelate有增加造骨細胞數的效果,以及適度的降緩骨質再吸收的作用;這項結果確認確認出,Strontium Ranelate在增加骨質形成及降低骨質再吸收上,有著雙重的作用。
  
  早期的研究顯示,Strontium Ranelate可降低危險群婦女的脊椎挫傷比率達40%,可降低74歲以上婦女臀部受傷比率達36%。
  
  Delmas博士在這次年會上的簡報上表示,最近期的研究專注在評估這種藥物在細胞或骨質組織層作用的機制,並評估使用在骨質上的安全性。
  
  她表示,當這藥物被知道可增加骨髓密度時,研究學者想知道,骨髓與骨質強度是否有相關性。
  
  試驗組較之對照組,MAR高出10%,且類骨質厚度低了16%;相較於其他治療骨質疏鬆症的方式,這項藥物在於骨質形成及再吸收的影響效果是不同的。
  
  研究顯示,Strontium Ranelate是安全的,因新形成骨質在前5年都不會產生沉積作用,這是穩定的骨質。
  
  ASBMR協會主席當選人Elizabeth Shane醫學博士,在一份新聞稿中指出,這項研究結果是相當重要的,數據資料提供了第一個直接活組織的檢查證據,這項藥物緊密相連著骨質形成與再吸收的過程,這種效果可以降低挫傷的風險;他表示,在治療骨質疏鬆症的藥物中,Strontium被證明是特別有效的。

Strontium Ranelate Produces St

By Linda Little
Medscape Medical News

Sept. 26, 2005 (Nashville) — Strontium ranelate is one of the first drugs to have a dual action that both decreases bone resorption and increases bone formation, according to a study presented here at the American Society for Bone and Mineral Research (ASBMR) 27th annual meeting.

"Strontium ranelate decreased bone resportion and increased formation," said Pierre D. Delmas, MD, PhD, a professor of medicine and rheumatology at the Université Claude Bernard in Lyon, France, during a press conference. "There was a decrease in osteoclasts and an increase in osteoblasts."

The drug, manufactured by Servier, recently received market approval in the Europe Union, but it is not yet available in the U.S.

Previous studies have shown that strontium ranelate dramatically reduces spine and hip fractures in at-risk women; the present study shows that the drug's dual action produces stable bone.

In the current study, baseline transiliac bone biopsies were performed in 136 osteoporotic women who were assigned to take either strontium ranelate (2 g/day) or placebo. Follow-up biopsies were performed at one, two, three, four, or five years from the start of treatment. All patients received calcium and vitamin D supplementation.

The researchers found that treated women had 38% higher osteoblastic surfaces and a greater mineral apposition rate (MAR) with an 8% increase in cancellous bone and 11% increase in cortical bone.

There was no significant change in activation frequency at the tissue level, the researchers reported.

The effects on resorption consisted of a trend toward lower endosteal eroded surfaces, endosteal and cancellous osteoclast surfaces, and osteoclast numbers, Dr. Delmas said.

In terms of safety, cancellous osteoid thickness was significantly lower in the treated women, the MAR significantly was higher in treated women, and there with no change in osteoid volume and mineralization lag time, said Dr. Delmas. In addition, the primary mineralization rate was not impaired and actually was stimulated by the drug.

"The results reveal the stimulating effects of strontium ranelate on the bone's osteoblastic population and a moderate decrease in bone resportion," Dr. Delmas said. "The results confirm the dual action of strontium ranelate with an increase in bone formation and a decrease in bone resorption."

Earlier studies showed that strontium ranelate reduces the vertebral fracture rate by about 40% in at-risk women and reduced hip fractures by 36% in women aged 74 years or older.

The latest study was undertaken to assess the mechanism of action of the drug at the cellular or bone tissue level and to evaluate safety of its use in the bone, Dr. Delmas said during his presentation at the meeting.

While it was known that the drug increases bone marrow density, the researchers wanted to see if there was a correlation of the marrow and strength of the bone, he said.

Treated patients had a MAR that was 10% higher than the control group and osteoid thickness was 16% lower. "Clearly the action of the drug is different than other treatments for osteoporosis with both formation and resorption affects," Dr. Delmas said.

Moreover, the study showed that strontium ranelate is safe for the bone with no mineral deposition of the newly formed bone for up to five years, he said. "It is stable bone."

Elizabeth Shane, MD, the ASBMR president-elect, described the results as "highly significant" in a press release. The data provide the first direct biopsy evidence that tightly linked the drug to the process of bone formation and resorption, which lowers the risk of fracture. "Strontium should prove to be a useful addition to the group of drugs used to treat osteoporosis," she said.

ASBMR 27th Annual Meeting: Abstract 1084. Presented Sept. 25, 2005.

Reviewed by Gary D. Vogin, MD

    
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