Lenzen Mattie J, Boersma Eric, Reimer Wilma J M Scholte Op, Balk Aggie H M M, Komajda Michel, Swedberg Karl, Follath Ferenc, Jimenez-Navarro Manuel, Simoons Maarten L, Cleland John G F
Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.
Eur Heart J. 2005 Dec;26(24):2706-13. doi: 10.1093/eurheartj/ehi499. Epub 2005 Sep 23.
Surveys on heart failure management suggest under-utilization of life-saving evidence-based treatment. Evidence-based medicine and clinical guidelines are based on the results of randomized controlled trials. Therefore, we investigated how patients who fulfilled the enrolment criteria of randomized trials were treated in real life.
We selected three large placebo-controlled trials of patients with chronic heart failure, in which ACE-inhibitors (ACE-Is), beta-blockers, and spironolactone proved to be safe and effective. The major enrolment criteria of trials were identified and applied to patients enrolled in the Euro Heart Survey on Heart Failure to identify the proportion of patients eligible for treatment and also treated appropriately. Of the 10 701 patients who were enrolled in the Euro Heart Survey on Heart Failure, only a small percentage (13%) would have qualified for participation in at least one of the selected trials. Patients who fulfilled enrolment criteria of the identified trials were more likely to be treated with ACE-Is (83% of SOLVD-eligible patients), beta-blockers (54% of MERIT-HF-eligible patients), and aldosterone antagonists (43% of RALES-eligible patients) than trial-ineligible patients. Almost half of SOLVD-eligible patients who were treated with ACE-Is received the target dose as recommended in the guidelines, but only <10% of MERIT-HF eligible patients who were treated with beta-blockers received the target dose.
ACE-Is are widely utilized but given in lower doses than proven effective in clinical trials. beta-Blockers are underused and given in lower doses to patients who fulfil the enrolment criteria of relevant landmark trials.
关于心力衰竭管理的调查表明,挽救生命的循证治疗未得到充分利用。循证医学和临床指南是基于随机对照试验的结果制定的。因此,我们研究了符合随机试验入组标准的患者在现实生活中的治疗情况。
我们选取了三项针对慢性心力衰竭患者的大型安慰剂对照试验,其中血管紧张素转换酶抑制剂(ACE-Is)、β受体阻滞剂和螺内酯已被证明是安全有效的。确定了试验的主要入组标准,并将其应用于参加欧洲心力衰竭调查的患者,以确定符合治疗条件且得到适当治疗的患者比例。在参加欧洲心力衰竭调查的10701名患者中,只有一小部分(13%)符合至少一项所选试验的参与标准。与不符合试验标准的患者相比,符合已确定试验入组标准的患者更有可能接受ACE-Is治疗(符合SOLVD标准的患者中有83%)、β受体阻滞剂治疗(符合MERIT-HF标准的患者中有54%)和醛固酮拮抗剂治疗(符合RALES标准的患者中有43%)。接受ACE-Is治疗的符合SOLVD标准的患者中,近一半接受了指南推荐的目标剂量,但接受β受体阻滞剂治疗的符合MERIT-HF标准的患者中,只有不到10%接受了目标剂量。
ACE-Is被广泛使用,但给药剂量低于临床试验中证明有效的剂量。β受体阻滞剂未得到充分利用,且给予符合相关标志性试验入组标准的患者的剂量较低。