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以西立伐他汀(Lipobay)为例的关于药物不良反应和治疗适应症的信息(“药品说明书”)

[Information regarding adverse drug effects and treatment indications ("package inserts") exemplified by cervistatin (Lipobay)].

作者信息

Braun Robert N, Halhuber Max J, Hitzenberger Gerhart

机构信息

Arbeitsgemeinschaft zur Erforschung-der Allgemeinmedizin, Lüt-zowgasse 6/3/21, A-1140 Wien.

出版信息

Wien Med Wochenschr. 2003;153(3-4):80-2. doi: 10.1046/j.1563-258x.2003.02029.x.

DOI:10.1046/j.1563-258x.2003.02029.x
PMID:12658968
Abstract

A worldwide frequently applied HMG-CoA-reductase-inhibitor ("statin") recently has been withdrawn from the market. This obviously has been caused by serious adverse events. The question is whether the package inserts sufficiently inform about the risks. But, although they list up numerous side effects, they lack informations concerning the frequency of them, so the patients when reading the package inserts become confused. Thus they have to rely on their doctors choice regarding the danger outlined in the inserts. In that respect packing inserts could be improved.

摘要

一种在全球广泛应用的HMG-CoA还原酶抑制剂(“他汀类药物”)最近已被撤出市场。这显然是由严重的不良事件导致的。问题在于药品说明书是否充分告知了相关风险。但是,尽管它们列出了众多副作用,却缺乏关于这些副作用发生频率的信息,所以患者在阅读药品说明书时会感到困惑。因此,他们不得不依赖医生对说明书中所述风险的判断。在这方面,药品说明书是可以改进的。

相似文献

1
[Information regarding adverse drug effects and treatment indications ("package inserts") exemplified by cervistatin (Lipobay)].以西立伐他汀(Lipobay)为例的关于药物不良反应和治疗适应症的信息(“药品说明书”)
Wien Med Wochenschr. 2003;153(3-4):80-2. doi: 10.1046/j.1563-258x.2003.02029.x.
2
Baycol withdrawn from market.拜可洛(Baycol)退出市场。
Circulation. 2001 Aug 21;104(8):E9015-6.
3
Safety and statin therapy: reconsidering the risks and benefits.安全性与他汀类药物治疗:重新审视风险与获益
Arch Intern Med. 2003 Mar 24;163(6):657-9. doi: 10.1001/archinte.163.6.657.
4
[Rhabdomyolysis following cerivastatin monotherapy--implications for therapy with HMG-CoA reductase inhibitors].[西立伐他汀单药治疗后横纹肌溶解症——对HMG-CoA还原酶抑制剂治疗的启示]
Nervenarzt. 2003 Feb;74(2):167-71. doi: 10.1007/s00115-002-1441-x.
5
Muscular adverse effects of statins.
Prescrire Int. 2003 Feb;12(63):21.
6
Bayer's response to "potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis".拜耳对“药物不良反应评估中潜在的利益冲突:西立伐他汀的使用与横纹肌溶解风险”的回应。
JAMA. 2004 Dec 1;292(21):2655-7; discussion 2658-9. doi: 10.1001/jama.292.21.2655. Epub 2004 Nov 22.
7
[Safety profile of statins].[他汀类药物的安全性概况]
Rev Med Chil. 2001 Nov;129(11):1237-40.
8
Rhabdomyolysis and renal failure associated with cerivastatin-gemfibrozil combination therapy.与西立伐他汀-吉非贝齐联合治疗相关的横纹肌溶解症和肾衰竭。
Am J Cardiol. 1999 Apr 1;83(7):1146. doi: 10.1016/s0002-9149(99)00034-x.
9
Extending therapy options in treating lipid disorders: a clinical review of cerivastatin, a novel HMG-CoA reductase inhibitor.扩展脂质紊乱治疗的选择:新型HMG-CoA还原酶抑制剂西立伐他汀的临床综述
Drugs. 1998;56 Suppl 1:25-31; discussion 33. doi: 10.2165/00003495-199856001-00004.
10
Failure to continue lipid-lowering drug use following the withdrawal of cerivastatin.在西立伐他汀撤市后未能继续使用降脂药物。
Drug Saf. 2004;27(1):63-70. doi: 10.2165/00002018-200427010-00004.

本文引用的文献

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2
Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events.测定C反应蛋白以指导他汀类药物治疗在急性冠脉事件一级预防中的应用。
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Case of the month: February 1999--54 year old man with severe muscle weakness.本月病例:1999年2月——一名54岁的严重肌无力男性。
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Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels.普伐他汀对冠心病及初始胆固醇水平范围广泛的患者心血管事件和死亡的预防作用。
N Engl J Med. 1998 Nov 5;339(19):1349-57. doi: 10.1056/NEJM199811053391902.
8
Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study.洛伐他汀对胆固醇水平正常的男性和女性急性冠脉事件的一级预防:空军/德州冠状动脉粥样硬化预防研究(AFCAPS/TexCAPS)的结果
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Upregulation of endothelial nitric oxide synthase by HMG CoA reductase inhibitors.HMG CoA还原酶抑制剂对内皮型一氧化氮合酶的上调作用。
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The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators.普伐他汀对胆固醇水平正常的心肌梗死患者冠状动脉事件的影响。胆固醇与再发事件试验研究人员。
N Engl J Med. 1996 Oct 3;335(14):1001-9. doi: 10.1056/NEJM199610033351401.