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[ESC2008]TIME-CHF研究:老年充血性心力衰竭(HF)的强化治疗(BNP指导) vs. 标准治疗(症状指导)
Trial of Intensified (BNP-guided) versus standard (symptom-guided) Medical therapy in Elderly patients with Congestive Heart Failure TIME-CHF
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 关键字:充血性心力衰竭 HF TIME-CHF研究  

    目的:评估强化的N末端脑钠肽(NT-BNP)指导下的HF治疗与症状指导下的标准治疗相比,能否改善预后,对于年龄≥75岁的患者和<75岁的患者是否有所差异。

    方法:499例收缩性HF患者(射血分数≤45%)随机接受NT-BNP指导或症状指导的治疗方案,并且根据患者的年龄分层:年龄≥75岁和60~74岁。入选患者为纽约心脏协会心功能分级(NYHA)≥II级、1年内因HF住院以及NT-BNP>400 pg/ml(60~74岁)或 800 pg/ml(≥75岁)。治疗方法依照指南,目标为缓解症状至NYHA≤II级或进一步使NT-BNP低于上述标准。主要终点为18个月内无任何原因引起的住院以及生存质量。次要终点为存活以及无HF住院。

    结果:与标准治疗相比,强化治疗未改善主要终点(危险比[HR] 0.92,P=0.46),但是改善了更多疾病特异的无HF住院的生存终点(HR 0.66,P=0.008)。强化治疗减少了总的死亡率(HR 0.38,P=0.01),并且在较年轻的患者中改善了无HF住院的生存(HR 0.41,P=0.002),但是≥75岁的患者未获改善。此外,尽管症状和BNP的降低相似,但在年龄较大的患者中强化治疗组生存质量的改善程度低于标准治疗组。

    结论:与标准治疗相比,强化HF治疗未改善总的临床结果。然而,强化治疗改善了无HF住院的生存并且降低了<75岁患者的死亡率,但在年龄较大的患者中没有相似的益处。

    编译:陈学颖 上海中山医院

文献摘要:
Study Question:
Is intensified heart failure (HF) therapy guided by N-terminal brain natriuretic peptide (BNP) superior to symptom-guided therapy?

Methods: This study was a randomized controlled multicenter trial of 499 patients ages ≥60 years with systolic HF (left ventricular ejection fraction [LVEF] <45%), New York Heart Association (NYHA) class ≥II, prior hospitalization for HF within 1 year, and N-terminal BNP level of ≥2 ULN. The study had an 18-month follow-up period. HF patients underwent uptitration of guideline-based treatments to reduce symptoms to NYHA class of ≥II (symptom-guided therapy) and BNP level of ≤2 times ULN and symptoms to NYHA class of ≤II (BNP-guided therapy). The primary outcomes were 18-month survival free of all-cause hospitalizations and quality of life as assessed by structured validated questionnaires.

Results: The investigators found that HF therapy guided by N-terminal BNP and symptom-guided therapy resulted in similar rates of survival free of all-cause hospitalizations (41% vs. 40%, respectively; hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.72-1.14; p = 0.39). Over the 18-month follow-up period, the quality-of-life (QOL) metrics improved and were similar in both the N-terminal BNP�guided and symptom-guided strategies. When compared with the symptom-guided group, survival free of hospitalization for HF, a secondary endpoint, was higher among those in the N-terminal BNP�guided group (72% vs. 62%, respectively; HR, 0.68; 95% CI, 0.50-0.92; p = 0.01). HF treatment guided by N-terminal BNP improved outcomes in patients ages 60-75 years, but not in those ages ≥75 years (p < 0.02 for interaction).

Conclusions: The investigators concluded that in elderly patients, HF treatment guided by N-terminal BNP did not improve overall clinical outcomes or QOL when compared with symptom-guided treatment.

Perspective: The main advantages of evaluating BNP in HF are for risk stratification, predicting mortality, confirming the diagnosis, and monitoring therapy (STARS-BNP). Unlike the STARS-BNP trial (J Am Coll Cardiol 2007;49:1733-9) and the STARBRITE study (Am Heart J 2005;150:893-8), the findings of this study suggest the superiority of symptoms to BNP in monitoring response to therapy. Larger multicenter trials are needed to resolve these disparate results. 
 

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