Lamas Gervasio A, Williams Adam
Mount Sinai Medical Center-Miami Heart Institute and the University of Miami School of Medicine, Miami Beach, Florida 33140, USA.
J Cardiovasc Electrophysiol. 2003 Sep;14(9 Suppl):S15-9. doi: 10.1046/j.1540-8167.14.s9.14.x.
Randomized clinical trials are the gold standard for the evaluation of new therapies. However, in the early years of pacing, the observational benefits were so great and the lifesaving benefits to patients so readily obvious that randomized trials were not necessary to prove benefit. As the technology has matured, advances have become more evolutionary than revolutionary, and observational analyses are unable to provide convincing evidence of small-to-moderate benefits. Thus, randomized trials of sufficient sample size are necessary to reliably assess the small-to-moderate effects of advances such as dual-chamber pacing, rate modulation, and mode switching. It is only during the last decade, however, that the evidence base for pacing with regard to randomized trials has begun to emerge. It is unclear whether the emerging results of these clinical trials have affected the clinical practice of pacing.
随机临床试验是评估新疗法的金标准。然而，在起搏治疗的早期，观察到的益处非常显著，对患者的救命益处也显而易见，以至于无需通过随机试验来证明其益处。随着技术的成熟，进展更多是渐进式的而非革命性的，观察性分析已无法为小到中等程度的益处提供令人信服的证据。因此，需要有足够样本量的随机试验来可靠地评估双腔起搏、频率调制和模式转换等进展所带来的小到中等程度的效果。然而，直到最近十年，关于起搏治疗的随机试验证据基础才开始出现。目前尚不清楚这些临床试验的新结果是否影响了起搏治疗的临床实践。
