Department of Cardiology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan.
Resuscitation. 2010 Jan;81(1):47-52. doi: 10.1016/j.resuscitation.2009.09.027. Epub 2009 Nov 13.
To compare the efficacy and safety of nifekalant, a pure class III anti-arrhythmic drug, and lidocaine in patients with shock-resistant in-hospital ventricular fibrillation (VF) or ventricular tachycardia (VT).
Between August 2005 and March 2008, we conducted a prospective, two-arm, cluster observational study, in which participating hospitals were pre-registered either to the nifekalant arm or the lidocaine arm. Patients were enrolled if they had in-hospital VF or VT resistant to at least two defibrillation shocks. Congenital or drug-induced long QT syndrome was excluded. The primary end-point was termination of VF or VT with/without additional shock. The secondary end-points were return of spontaneous circulation (ROSC), 1-month survival and survival to hospital discharge. We also assessed the frequency of adverse events, including asystole, pulseless electrical activity and torsade de pointes.
In total, 55 patients were enrolled. After nifekalant, 22 of 27 patients showed termination of VF or VT, as compared with 15 of 28 patients treated with lidocaine with/without additional shock (odds ratio (OR): 3.8; 95% confidence interval (CI): 1.1-13.0; P=0.03). Twenty-three of 27 patients given nifekalant showed ROSC, as compared with 15 of 28 patients given lidocaine (OR: 5.0; 95% CI: 1.4-18.2; P=0.01). There was no difference in 1-month survival or survival to hospital discharge between the nifekalant and lidocaine arms. There was a higher incidence of asystole with lidocaine (7 of 28 patients) than with nifekalant (0 of 27 patients) (P=0.005). Torsade de pointes was not observed.
Nifekalant was more effective than lidocaine for termination of arrhythmia and for ROSC in patients with shock-resistant in-hospital VF or VT (umin-CTR No. UMIN 000001781).
比较纯 III 类抗心律失常药物决奈达隆和利多卡因在治疗对至少两次除颤电击仍无效的院内持续性室颤（VF）或室性心动过速（VT）患者中的疗效和安全性。
2005 年 8 月至 2008 年 3 月，我们进行了一项前瞻性、双臂、整群观察性研究，参与医院预先注册至决奈达隆组或利多卡因组。入选标准为院内发生的对至少两次除颤电击仍无效的 VF 或 VT 患者。排除先天性或药物引起的长 QT 综合征患者。主要终点为 VF 或 VT 终止，是否需加用电击。次要终点为自主循环恢复（ROSC）、1 个月生存率和出院生存率。我们还评估了不良反应的发生率，包括心搏骤停、无脉性电活动和尖端扭转型室性心动过速。
共纳入 55 例患者。决奈达隆治疗后，27 例患者中有 22 例 VF 或 VT 终止，而利多卡因组 28 例患者中有 15 例 VF 或 VT 终止（优势比（OR）：3.8；95%置信区间（CI）：1.1-13.0；P=0.03）。27 例接受决奈达隆治疗的患者中有 23 例出现 ROSC，而 28 例接受利多卡因治疗的患者中有 15 例出现 ROSC（OR：5.0；95%CI：1.4-18.2；P=0.01）。决奈达隆组和利多卡因组 1 个月生存率或出院生存率无差异。利多卡因组（7 例）心搏骤停的发生率高于决奈达隆组（0 例）（P=0.005）。未观察到尖端扭转型室性心动过速。
在治疗对电击无效的院内持续性 VF 或 VT 患者时，决奈达隆较利多卡因更能有效终止心律失常和恢复自主循环（UMIN-CTR 号 UMIN 000001781）。
