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Aldo-DHF published: Spironolactone aids LV function but not symptoms 螺内酯可改善左室功能,但无助于症状改善  

2013-03-25 12:18:40|  分类: 药物学 |  标签: |举报 |字号 订阅

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《美国医学会杂志》2月27日发表的一项为期1年的研究显示,螺内酯可显著改善射血分数保留的心衰门诊患者左室舒张功能和重构,但上述受益并没有转化为心衰症状或生活质量的改善(JAMA 2013;309:781-91)。

奥地利格拉茨医科大学的Burkert M. Pieske博士报告称,在这项醛固酮受体拮抗剂治疗舒张性心衰多中心、双盲研究(Aldo-DHF)中,年龄≥50的男女患者被随机分组,分别每日口服螺内酯(213例)和安慰剂(209例),为期1年。结果显示,螺内酯组患者左室射血分数显著增加,左室收缩末期直径和左室重量指数均显著减少,收缩压也明显下降。


Burkert M. Pieske博士
 
但与安慰剂相比,螺内酯未能改善患者心衰症状、运动能力、抑郁症状或生活质量。研究者认为,或许由于受试者过于年轻或健康,治疗时间或许也太短,不足以观察到舒张功能改善转化为临床受益。

上述研究结果曾在去年夏季慕尼黑欧洲心脏病学会(ESC)年会上报告,专家对该结果表达了类似的担忧。

德国柏林查瑞特医科大学内科教授Stefan D. Anker博士评论指出,研究结果还显示,患者钾水平提高。更令人担忧的是,患者肾小球滤过率下降,平均下降约5 ml/min。在6分钟步行距离测试中,螺内酯组患者步行距离也明显减少,虽然仅减少15 m,但仍具有统计学意义。此外,患者还出现贫血程度恶化。

 
John G.F. Cleland博士
 
英国赫尔大学心脏病学教授John G.F. Cleland博士认为,虽然Aldo-DHF研究提供了新的重要信息,但并不是一项完全意义上的有关舒张性心衰的研究。患者中几乎没人使用利尿药物,入组时脑钠肽前体N 末端(NT-proBNP)水平非常正常,超声心动图检查轻度异常,心肺运动试验显示功能轻度受损。

Aldo-DHF研究由德国-奥地利心衰研究组和德国心衰协作网资助。研究者报告存在利益关系。

原文:

By: MARY ANN MOON

Spironolactone significantly improved left ventricular diastolic function and remodeling in a 1-year study of ambulatory patients who had heart failure with preserved ejection fraction, but that benefit did not translate into improvements in HF symptoms or quality of life, according to a report in the Feb. 27 issue of JAMA.

In the multicenter, double-blind Aldosterone Receptor Blockade in Diastolic HF (Aldo-DHF) clinical trial, 213 men and women aged 50 and older were randomly assigned to receive daily oral spironolactone and 209 to receive a matching placebo for 1 year. Patients on spironolactone had significantly increased LV ejection fraction, decreased LV end-diastolic diameter and LV mass index, and reduced systolic blood pressure, reported Dr. Burkert M. Pieske, professor and head of the department of cardiology at Medical University of Graz, Austria, and his associates.
 
The drug failed to improve HF symptoms, exercise capacity, depressive symptoms, or quality of life, compared with placebo. "Our study population may have been too young or too healthy, or the treatment period may have been too short, for observing a translation of improved diastolic function into a clinical benefit," the investigators said (JAMA 2013;309:781-91).

These results were presented at the annual meeting of the European Society of Cardiology in Munich last summer, and reported by this newspaper.

Experts reacting to the news at the meeting expressed similar misgivings.

"It was not all good news. Patients had an increase in their potassium level, and even more concerning, they had a reduction in their glomerular filtration rate, an average reduction of about 5 mL/min," commented Dr. Stefan D. Anker, professor of medicine at Charité Medical University in Berlin. In addition, the distance walked on the 6-minute walk test was "slightly decreased with spironolactone. Even though it was a small change of 15 m, it was statistically significant," he noted. On top of all this, "worsening of anemia was seen in patients," he added.

Study discussant Dr. John G.F. Cleland said that although the Aldo-DHF study adds important new information on the progression of diastolic heart failure as seen in the control group, it wasn’t really was a study of diastolic heart failure. Few of the patients were on diuretic drugs, at entry they had fairly normal levels of NT-proBNP, they had mild abnormalities detected by echocardiography, and they exhibited mild deficits in cardiopulmonary exercise testing, said Dr. Cleland, professor of cardiology at the University of Hull, Kingston-upon-Hull, England.

Aldo-DHF was supported by the German-Austrian Heart Failure Study Group and the German Competence Network of Heart Failure. Dr. Edelmann and his associates reported numerous ties to industry sources.

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