Randomized study on the efficacy of immunosuppressive therapy in patients with virus-negative inflammatory cardiomyopathy: the TIMIC study
Randomized study on the efficacy of immunosuppressive therapy in patients with virus-negative inflammatory cardiomyopathy: the TIMIC study
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DOI：
10.1093/eurheartj/ehp249
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发表时间：
2009-08-01
影响因子：
39.3
通讯作者：
Chimenti, Cristina
中科院分区：
文献类型：
--
作者：
Frustaci, Andrea;Russo, Matteo A.;Chimenti, Cristina
为了评价免疫抑制剂对病毒阴性炎性心肌病的疗效，这项随机、双盲、安慰剂对照的研究纳入了85例心肌炎和慢性（> 6个月）心力衰竭患者，这些患者对常规治疗无反应，没有心肌病毒基因组的证据。患者接受泼尼松1 mg kg（-1）d（-1）治疗4周，随后接受0.33 mg kg（-1）d（-1）治疗5个月，硫唑嘌呤2 mg kg（-1）d（-1）治疗6个月（43例患者，组1）或安慰剂（42例患者，组2）。主要结局为6个月时左心室功能改善。与基线相比，第1组显示左心室射血分数显著改善，左心室尺寸和体积显著降低。第2组患者均未显示射血分数改善，与基线相比显著恶化。免疫抑制剂没有引起严重的不良反应，这些数据证实了免疫抑制剂对病毒阴性的炎性心肌病的疗效。在12%的病例中缺乏反应表明存在未筛选的病毒或对免疫抑制不敏感的损伤和炎症机制。
To evaluate the efficacy of immunosuppression in virus-negative inflammatory cardiomyopathy.This randomized, double-blind, placebo-controlled study included 85 patients with myocarditis and chronic (> 6 months) heart failure unresponsive to conventional therapy, with no evidence of myocardial viral genomes. Patients received either prednisone 1 mg kg(-1) day(-1) for 4 weeks followed by 0.33 mg kg(-1) day(-1) for 5 months and azathioprine 2 mg kg(-1) day(-1) for 6 months (43 patients, Group 1) or placebo (42 patients, Group 2) in addition to conventional therapy for heart failure. Primary outcome was the 6 month improvement in left-ventricular function. Group 1 showed a significant improvement of left-ventricular ejection fraction and a significant decrease in left-ventricular dimensions and volumes compared with baseline. None of Group 2 patients showed improvement of ejection fraction, that significantly worsened compared with baseline. No major adverse reaction was registered as a result of immunosuppression.These data confirm the efficacy of immunosuppression in virus-negative inflammatory cardiomyopathy. Lack of response in 12% of cases suggests the presence of not screened viruses or mechanisms of damage and inflammation not susceptible to immunosuppression.