DINAMIT研究结果发现植入式心律复律除颤器应用的局限性

一项涉及了12个国家73个单位的大规模研究发现：植入式心律复律除颤器治疗并不能够降低近期有过心脏病发作高危患者的总体死亡率，但是该研究也发现植入式心律复律除颤器显著降低心律不齐患者的死亡率。

该研究得到了St. Jude医疗公司(St. Paul, MN, USA)的资助，项目叫做DINAMIT(除颤器在急性心肌梗塞患者中的临床试验)。入选患者年龄在18岁～80岁之间，入选标准为6天～40天内有心脏病发作、左心室射血分数小于等于35％以及出现心肌自主调节损害症状。这些研究结果发表在2004年11月9日的《新英格兰医学期刊》。

尽管研究结果显示总死亡率没有下降，研究人员也证实了在这个患者群体中，植入式心律复律除颤器治疗能够显著降低那些近期心脏病发作的患者的猝死以及高危心率不齐患者的死亡风险。St. Jude医疗公司是植入式心律复律除颤器的研发者和市场推广者。

该研究项目首席研究员、J.W. Goethe大学(Frankfurt, Germany)医学教授Stefan H. Hohnloser医生说：“尽管DINAMIT研究项目中，植入式心律复律除颤器治疗与心率不齐导致的死亡率显著下降相关，但是却被非心率不齐导致死亡率的升高所抵消。”

Study Finds Limitation to ICD Benefit
 
A large study involving 73 sites in 12 countries has found that implantable cardioverter defibrillator therapy does not reduce overall mortality in high-risk patients who have recently had a heart attack, but the study also found that ICDs significantly reduced mortality in patients with arrhythmia.

The study, sponsored by St. Jude Medical, Inc. (St. Paul, MN, USA), was called DINAMIT (defibrillator in acute myocardial infarction trial). Patients in the study ranged in age from 18-80, with additional inclusion criteria being a heart attack within six to 40 days, a left-ventricular ejection fraction of less than or equal to 35%, and signs of impaired cardiac autonomic modulation. The results were reported in the December 9, 2004, issue of The New England Journal of Medicine.

While the results showed no reduction in total mortality, they also demonstrated that in this patient population, ICD therapy can significantly reduce the risk of sudden death in patients who have had a recent heart attack and are at high risk of arrhythmic death. St. Jude Medical is a developer and marketer of ICDs.

“Although ICD therapy in the DINAMIT study was associated with a large, statistically significant reduction in the rate of death due to arrhythmia, it was offset by an increase in the rate of death from nonarrhythmic causes,” commented Stefan H. Hohnloser, M.D., professor of medicine, J.W. Goethe University (Frankfurt, Germany), and one of the principal investigators.