van der Harst Pim, Voors Adriaan A, van Gilst Wiek H, Böhm Michael, van Veldhuisen Dirk J
Department of Cardiology, Thoraxcenter, University Medical Center Groningen, University of Groningen, Netherlands.
PLoS Med. 2006 Aug;3(8):e333. doi: 10.1371/journal.pmed.0030333.
The efficacy of statin therapy in patients with established chronic heart failure (CHF) is a subject of much debate.
We conducted three systematic literature searches to assess the evidence supporting the prescription of statins in CHF. First, we investigated the participation of CHF patients in randomized placebo-controlled clinical trials designed to evaluate the efficacy of statins in reducing major cardiovascular events and mortality. Second, we assessed the association between serum cholesterol and outcome in CHF. Finally, we evaluated the ability of statin treatment to modify surrogate endpoint parameters in CHF. Using validated search strategies, we systematically searched PubMed for our three queries. In addition, we searched the reference lists from eligible studies, used the "see related articles" feature for key publications in PubMed, consulted the Cochrane Library, and searched the ISI Web of Knowledge for papers citing key publications. Search 1 resulted in the retrieval of 47 placebo-controlled clinical statin trials involving more than 100,000 patients. CHF patients had, however, been systematically excluded from these trials. Search 2 resulted in the retrieval of eight studies assessing the relationship between cholesterol levels and outcome in CHF patients. Lower serum cholesterol was consistently associated with increased mortality. Search 3 resulted in the retrieval of 18 studies on the efficacy of statin treatment in CHF. On the whole, these studies reported favorable outcomes for almost all surrogate endpoints.
Since CHF patients have been systematically excluded from randomized, controlled clinical cholesterol-lowering trials, the effect of statin therapy in these patients remains to be established. Currently, two large, randomized, placebo-controlled statin trials are under way to evaluate the efficacy of statin treatment in terms of reducing clinical endpoints in CHF patients in particular.
他汀类药物治疗已确诊慢性心力衰竭（CHF）患者的疗效存在诸多争议。
我们进行了三项系统文献检索，以评估支持在CHF中使用他汀类药物的证据。首先，我们调查了CHF患者参与旨在评估他汀类药物降低主要心血管事件和死亡率疗效的随机安慰剂对照临床试验的情况。其次，我们评估了CHF患者血清胆固醇与预后之间的关联。最后，我们评估了他汀类药物治疗改变CHF替代终点参数的能力。我们使用经过验证的检索策略，针对这三个问题在PubMed上进行系统检索。此外，我们还检索了符合条件研究的参考文献列表，利用PubMed中关键出版物的“查看相关文章”功能，查阅了Cochrane图书馆，并在ISI知识网络中检索引用关键出版物的论文。检索1检索到47项他汀类药物安慰剂对照临床试验，涉及超过10万名患者。然而，CHF患者被系统地排除在这些试验之外。检索2检索到八项评估CHF患者胆固醇水平与预后关系的研究。较低的血清胆固醇水平一直与死亡率增加相关。检索3检索到18项关于他汀类药物治疗CHF疗效的研究。总体而言，这些研究报告了几乎所有替代终点的良好结果。
由于CHF患者被系统地排除在随机对照临床降脂试验之外，他汀类药物治疗对这些患者的效果仍有待确定。目前，两项大型、随机、安慰剂对照的他汀类药物试验正在进行中，以特别评估他汀类药物治疗在降低CHF患者临床终点方面的疗效。
