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【drug-news】FDA研究发现他丁类药物并不增加ALS的风险

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September 30, 2008, 8:55 am
FDA Study Shows Statins Don’t Increase Risk of ALS
Posted by Jacob Goldstein

FDAGive millions of people a drug, and some of them are going to come down with rare diseases. Of course, if you follow millions of people who aren’t taking any drugs, some of them are going to come down with rare diseases, too. So it can be tough to tell whether a drug slightly increases the risk of trouble.

That’s been an issue for statins, the wildly popular class of cholesterol drugs that includes Pfizer’s Lipitor, Merck’s Zocor and AstraZeneca’s Crestor. Sporadic reports had come in of patients developing ALS, also known as Lou Gehrig’s disease, while taking statins. As we noted last year, at least one prominent researcher thought there might be a connection there.

Indeed, the reports were substantive enough to compel the FDA to look into the issue.

The agency collected data from 41 clinical trials in which patients were randomly assigned to receive either a statin or a placebo. Overall, they found that patients who took statins were not more likely than those who took placebos to develop ALS. The full findings were published yesterday in the journal Pharmacoepidemiology and Drug Safety.

Still, the study may not be the final word. In a statement yesterday, the FDA noted that data from a Stanford study on statins and ALS should be available in six to nine months.

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2008-10-01 15:37 浏览 : 610 回复 : 2

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• #医生的昵称有多好笑#这是你们热爱工作的表现吗？哈哈哈哈

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September 30, 2008, 8:55 am
FDA Study Shows Statins Don’t Increase Risk of ALS
Posted by Jacob Goldstein
2008,9.30
FDA研究显示他汀类药物不会增加患者的ALS风险

FDAGive millions of people a drug, and some of them are going to come down with rare diseases. Of course, if you follow millions of people who aren’t taking any drugs, some of them are going to come down with rare diseases, too. So it can be tough to tell whether a drug slightly increases the risk of trouble.
在数百万服用某药的患者中，有一些人出现罕见的疾病。当然，如果追踪调查不服任何药物的百万人群，也会发现有些人出现比较罕见的疾病。所以因此而确定某个药物是否轻微增加某些疾病的风险显得比较草率。

That’s been an issue for statins, the wildly popular class of cholesterol drugs that includes Pfizer’s Lipitor, Merck’s Zocor and AstraZeneca’s Crestor. Sporadic reports had come in of patients developing ALS, also known as Lou Gehrig’s disease, while taking statins. As we noted last year, at least one prominent researcher thought there might be a connection there.
这便是他汀类药物遇到的问题，他汀类药物是应用广泛的一类降胆固醇药物，其中包括辉瑞的立普妥、默克的舒降之及阿斯利康的冠脂妥。在服用他汀类药物期间，某些患者出现ALS(重症肌无力)，也称为葛雷克氏症。去年当我们发现这种情况时，至少有一位主要研究人员认为在这两者间存在某种联系。

Indeed, the reports were substantive enough to compel the FDA to look into the issue.
这些报告的确足以引起FDA对该问题的关注。

The agency collected data from 41 clinical trials in which patients were randomly assigned to receive either a statin or a placebo. Overall, they found that patients who took statins were not more likely than those who took placebos to develop ALS. The full findings were published yesterday in the journal Pharmacoepidemiology and Drug Safety.
FDA搜集了41项随机安慰剂对照试验的临床数据。总体上讲，（他们发现）服用他汀类药物的患者出现ALS的几率并不比安慰剂组高。完整的研究结果发表在昨天的《药物流行病学和药物安全》杂志上。

Still, the study may not be the final word. In a statement yesterday, the FDA noted that data from a Stanford study on statins and ALS should be available in six to nine months.
该研究仍然并非最终结论。在昨天的一项声明中，FDA提到斯坦福一项关于他汀类药物和ALS的研究将在6-9个月后得出结果。

2008-10-15 21:03

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ginnyran 编辑于 2008-10-15 21:17

• # 妇儿联动 # 启动期，作为妇产科/儿科医生，你有哪些问题，想请教对方？

ginnyran

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编译：

FDA研究显示他汀类药物不会增加患者的ALS风险

2008年9月30日新闻报道，在数百万服用某药的患者中，有一些人出现罕见的疾病。如果追踪调查不服任何药物的百万人群，也会发现有些人出现比较罕见的疾病。所以由此而确定某个药物是否轻微增加某些疾病的风险显得比较草率。

而这正是他汀类药物遇到的问题。他汀类药物是应用广泛的一类降胆固醇药物，其中包括辉瑞的立普妥、默克的舒降之及阿斯利康的冠脂妥。在服用他汀类药物期间，某些患者出现ALS(重症肌无力)。研究人员称，当2007年发现这种情况时，不止一位主要研究人员认为两者间存在某种联系。

这些报告确实引起了FDA对该问题的关注。 FDA搜集了41项随机安慰剂对照试验的临床数据。总体上讲，服用他汀类药物的患者出现ALS的几率并不比安慰剂组高。完整的研究结果发表在前一天的《药物流行病学和药物安全》杂志上。

该研究仍然并非最终结论。在前一天的一项声明中，FDA称斯坦福一项关于他汀类药物和ALS的研究将在6-9个月后得出结果。（丁香）

2008-10-15 21:16

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ginnyran 编辑于 2008-10-15 21:21

• 死亡患者危重讨论怎么写？

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