■托伐普坦已被批准用于治疗肝硬化相关并发症根据日本和中国的实践指南,但不是欧洲或美国的实践指南,鉴于FDA对其肝毒性的警告。本研究旨在系统评价其在肝硬化中的疗效和安全性。
■PubMed,EMBASE,和Cochrane文库数据库进行检索,以确定评价托伐普坦治疗肝硬化疗效和/或安全性的随机对照试验(RCT).计算风险比(RR)和体重平均差异(WMD)。合并常见不良事件(AE)的发生率。
■包括八个RCT。托伐普坦与腹水(RR=1.49,P<0.001)和低钠血症(RR=1.80,P=0.005)的改善率以及任何不良事件的发生率(RR=1.18,P=0.003)显着相关,但未出现严重不良事件(RR=0.86,P=0.410)。托伐普坦与体重减轻显着相关(WMD=-1.30kg,P<0.001)和腹围(WMD=-1.71cm,P<0.001),并增加每日尿量(WMD=1299.84mL,P<0.001)和血清钠浓度(WMD=2.57mmol/L,P<0.001)。口干的合并发生率,口渴,便秘,花粉病占16%,24%,6%,17%,分别。
■对于对常规利尿剂反应不足的肝硬化腹水患者和低钠血症患者,可考虑短期使用托伐普坦。
[图:见正文]。
UNASSIGNED: Tolvaptan has been approved for the management of cirrhosis-related complications according to the Japanese and Chinese practice guidelines, but not the European or American practice guidelines in view of FDA warning about its hepatotoxicity. This study aimed to systematically evaluate its efficacy and safety in cirrhosis.
UNASSIGNED: The PubMed, EMBASE, and Cochrane library databases were searched to identify randomized controlled trials (RCTs) evaluating the efficacy and/or safety of
tolvaptan in cirrhosis. Risk ratios (RRs) and weight mean differences (WMDs) were calculated. The incidence of common adverse events (AEs) was pooled.
UNASSIGNED: Eight RCTs were included.
Tolvaptan was significantly associated with higher rates of improvement of ascites (RR = 1.49, P < 0.001) and hyponatremia (RR = 1.80, P = 0.005) and incidence of any AEs (RR = 1.18, P = 0.003), but not serious AEs (RR = 0.86, P = 0.410).
Tolvaptan was significantly associated with reductions in body weight (WMD = -1.30 kg, P < 0.001) and abdominal circumference (WMD = -1.71 cm, P < 0.001), and increases in daily urine volume (WMD = 1299.84 mL, P < 0.001) and serum sodium concentration (WMD = 2.57 mmol/L, P < 0.001). The pooled incidences of dry mouth, thirst, constipation, and pollakiuria were 16%, 24%, 6%, and 17%, respectively.
UNASSIGNED: Short-term use of
tolvaptan may be considered in cirrhotic patients with ascites who have inadequate response to conventional diuretics and those with hyponatremia.
[Figure: see text].