发布日期：2011 年 12 月
英文标题：Efficacy and safety of tolvaptan in heart failure patients with volume overload despite the standard treatment with conventional diuretics: a phase III, randomized, double-blind, placebo-controlled study (QUEST study).
作者：Matsuzaki M, Hori M, Izumi T, Fukunami M; Tolvaptan Investigators.
出处：Cardiovasc Drugs Ther. 2011 Dec;25 Suppl 1:S33-45.
内容介绍：QUEST 研究的主要目的是评估对在使用常规利尿剂后仍有体液潴留的稳定性心衰患者加用托伐普坦的有效性和安全性。剂量为每日 15 mg，连续 1 个星期。患者在服用研究药物前体重基本稳定，整个研究期利尿剂剂量固定。结果显示，患者的摄水量和排尿量均增加，最终为负平衡；体重自服药后第 1 天就下降，持续整个服药期；托伐普坦对颈静脉怒张和肝肿大的改善均有统计学差异。整个治疗过程中，血钾无变化，血钠略升高但仍在正常范围内。
摘要展示：
PURPOSE: Diuretics are recommended to treat volume overload with heart failure (HF), however, they may cause serum electrolyte imbalance, limiting their use. Moreover, patients with advanced HF could poorly respond to these diuretics. In this study, we evaluated the efficacy and safety of Tolvaptan, a competitive vasopressin V2-receptor antagonist developed as a new drug to treat volume overload in HF patients.
METHODS: A phase III, multicenter, randomized, double-blind, placebo-controlled parallel study was performed to assess the efficacy and safety of tolvaptan in treating HF patients with volume overload despite the use of conventional diuretics. One hundred and ten patients were randomly assigned to receive either placebo or 15 mg/day tolvaptan for 7 consecutive days.
RESULTS: Compared with placebo, tolvaptan administered for 7 days significantly reduced body weight and improved symptoms associated with volume overload. The safety profile of tolvaptan was considered acceptable for clinical use with minimal adverse effects.
CONCLUSION: Tolvaptan reduced volume overload and improved congestive symptoms associated with HF by a potent water diuresis (aquaresis).
