A PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL OF PREDNISONE FOR DILATED CARDIOMYOPATHY
A PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL OF PREDNISONE FOR DILATED CARDIOMYOPATHY
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DOI：
10.1056/nejm198910193211601
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发表时间：
1989-10-19
影响因子：
158.5
通讯作者：
FAUCI, AS
中科院分区：
文献类型：
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作者：
PARRILLO, JE;CUNNION, RE;FAUCI, AS
虽然泼尼松已被用于治疗特发性扩张型心肌病患者，但其疗效尚未得到严格研究。因此，我们将102例患者随机分配到泼尼松（每天60 mg）治疗组或对照组。在3个月时，在53%的接受泼尼松的患者和27%的对照组中观察到改善，其前瞻性定义为射血分数增加≥ 5个百分点（P = 0.005）。平均值（.+-. SE）射血分数增加4.3 ±。1.5百分之十七点九。1.0至22.0 .+-。1.6%），而泼尼松组为2.1 . ±. 0.8百分之十七点一。1.1至19.3 .+-。1.4对照组中的百分比（P = 0.054）。所有患者前瞻性分为两个单独的随机亚组。“反应性”患者（n = 60）是指肌内膜活检时有成纤维细胞（n = 36）、淋巴细胞（n = 2）浸润或免疫球蛋白沉积（n = 16）、镓扫描阳性（n = 7）或红细胞沉降率升高（n = 18）的患者。“无反应”患者（n = 42）没有这些特征。在三个月时，67%的接受泼尼松治疗的反应性患者有改善，而反应性对照组为28%（P = 0.004）。非反应性患者在泼尼松治疗后无显著改善（P = 0.51）。三个月后，每天接受泼尼松治疗的反应性患者改为隔日治疗（60 mg，每隔一天一次），六个月后，早期观察到的改善不再存在。这些数据表明，特发性扩张型心肌病患者在每天给予高剂量泼尼松时可能会有一些改善。然而，我们在泼尼松治疗期间观察到的射血分数的增加很小，持续时间有限，副作用很重要。总的来说，泼尼松被认为只有边际临床获益，不应作为扩张型心肌病的标准治疗。
Although prednisone has been used to treat patients with idiopathic dilated cardiomyopathy, its efficacy has not been rigourously studied. We therefore randomly assigned 102 patients to either treatment with prednisone (60 mg per day) or a control group. At three months, improvement, defined prospectively as an increase in the ejection fraction of .gtoreq.5 percentage points, was observed in 53 percent of the patients receiving prednisone and 27 percent of the controls (P = 0.005). The mean (.+-.SE) ejection fraction increased 4.3 .+-. 1.5 percentage points (from 17.9 .+-. 1.0 to 22.0 .+-. 1.6 percent) in the prednisone group, as compared with 2.1 .+-. 0.8 percentage points (from 17.1 .+-. 1.1 to 19.3 .+-. 1.4 percent) in the control group (P = 0.054). All patients were catagorized prospectively in two separatley randomized subgroups. "Reactive" patients (n = 60) were those who had fibroblastic (n = 36) of lymphocytic (n = 2) infiltration or immunoglobulin deposition (n = 16) on endomyocardial biopsy, a positive gallium scan (n = 7), or an elevated erythrocyte sedimentation rate (n = 18). "Nonreactive" patients (n = 42) had none of these features. At three months, 67 percent of the reactive patients who received prednisone had improvement, as compared with 28 percent of the reactive controls (P = 0.004). Nonreactive patients did not improve significantly with prednisone (P = 0.51). After three months, reactive patients who received prednisone daily were switched to alternate-day therapy (60 mg every other day), aand after six months the improvements seen earlier was no longer present. These data suggest that patients with idiopathic dilated cardiomyopathy may have some improvement when given a high dose of prednisone daily. However, the increases in the ejection fraction that we observed during prednisone treatment were small, their duration was limited, and the side effects were important. Overall, prednisone was judged to have only marginal clinical benefit, and should not be administered as standard therapy for dilated cardiomyopathy.