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[【学科前沿】] 药源性骨质疏松:Forteo可能比福善美有效

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发表于 2008-4-27 07:20:48 | 显示全部楼层 |阅读模式
Forteo Helps Drug-Induced Osteoporosis

Daily Shots of the Osteoporosis Drug May Trump Fosamax Pills in Some People With Steroid-Related Osteoporosis

Nov. 14, 2007 -- A new study shows that in people at high risk for bone fracture due to steroid-related osteoporosis, the drug Forteo may trump Fosamax.

The study included 428 people with osteoporosis tied to long-term use of steroids such as prednisone to treat other conditions. Over time, some steroids can cause bone loss.

All of the patients took a pill and got a shot every day for 18 months.

Half of the patients got Fosamax and a shot containing no medicine. The other half of the group got an empty pill and a shot of Forteo.

The patients didn't know whether they were taking Forteo or Fosamax. All of them also took calcium and vitamin D.

Participants got bone density scans of their hip and lumbar spine periodically throughout the study.

After 18 months of treatment, patients in the Forteo group had a 7% increase in their lumbar spine bone mineral density and a 3.8% increase in their total hip bone mineral density.

People taking Fosamax showed smaller gains, with a 3.4% increase in lumbar spine bone mineral density and a 2.4% increase in their total hip bone mineral density.

Of the 11 people who suffered a spine fracture during the study, 10 were taking Fosamax and one was taking Forteo.

The researchers -- who included Kenneth Saag, MD, of the University of Alabama at Birmingham -- report similar safety profiles for each drug.

But a journal editorial notes that the study is due to continue for another 18 months, and those results aren't in yet.

Editorialist Philip Sambrook, MD, of Australia's University of Sydney also notes that the study only included \"the group most severely affected by [steroid]-induced bone loss and the most difficult to treat.\"

The study, published in tomorrow's edition of The New England Journal of Medicine, was funded by Eli Lilly, which makes Forteo.

In the journal, Saag reports financial ties to Eli Lilly and to Merck, which makes Fosamax. Sambrook notes no potential conflicts of interest.

Merck spokeswoman Kim Hamilton tells WebMD that Merck doesn't have an immediate comment but looks forward to reviewing the study.
Forteo治疗药源性骨质疏松
----在一些类固醇相关性骨质疏松患者中每日注射抗骨质疏松药可能胜过服用福善美

2007年11月14日----一项新的研究表明,一项新的研究表明,在类固醇相关性骨质疏松并有骨折高危性的患者中药物Forteo疗效可能胜过福善美。
这项研究纳入了428例骨质疏松患者,他们因为治疗其它疾病的需要而长期服用类固醇激素,如泼尼松。随着时间推移,一些类固醇可导致骨丢失。
所有的患者在18月的研究中均每天服用一片药并注射一针。
半数患者口服福善美并注射安慰剂,另一半患者口服安慰剂并注射Forteo。
患者不知道自己用的是Forteo还是福善美。所有患者也口服钙剂和维生素D。
在整个研究过程中患者定期接受髋部和腰椎的骨密度检查。
经过18个月治疗后,Forteo组患者腰椎骨矿密度增加了7%,髋骨骨矿密度增加了3.8%。
而福善美组患者获得的收益偏少,腰椎骨矿密度增加了3.4%,髋骨骨矿密度增加了2.4%。
研究中有11例患者发生脊柱骨折,10例为福善美组,1例为Forteo组。
包括伯明翰阿拉巴马大学Kenneth Saag博士的研究者们报告两种药物的安全性相似。
但是一份杂志的社论中评价该试验预计持续再进行18个月,因此这些结果仍然不确定。
社论的主笔澳大利亚悉尼大学的Philip Sambrook博士也指出这个研究仅仅纳入了“由于(类固醇)所致骨丢失最严重和最难治疗的患者”。
这个研究将发表在明天出版的《新英格兰杂志》(NEJM),该研究受生产Forteo的礼来公司(Eli Lilly)赞助。
在杂志中,Saag最后声明接受过礼来公司和生产福善美的默克公司(Merck)的赞助。Sambrook强调没有潜在的利益冲突。
默克的发言人Kim Hamilton告诉WebMD默克没有直接评论但是期待回顾该研究。
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