目的系统评价托伐普坦单用或联合袢利尿剂能否较单纯袢利尿剂减少急性失代偿性心力衰竭患者肾功能恶化的发生率.方法 计算机检索Pub Med、EMbase、The Cochrane Library(2018年04期)、Wan Fang Data、CBM和CNKI数据库,查找急性失代偿性心力衰竭患者治疗中托伐普坦单用或联合袢利尿剂和单用袢利尿剂的随机对照试验(randomized controlled trial,RCT),检索时限均从建库至2018年4月.由2位评价员按纳入与排除标准独立筛选文献、提取肾功能恶化发生率、短期死亡率、体重下降、血钠升高数据并评价纳入研究的偏倚风险后,采用Rev Man 5.3软件进行Meta分析.结果 共纳入7个RCT,包括937例患者,其中托伐普坦组466例,对照组471例.Meta分析结果显示:托伐普坦单用或联合袢利尿剂较单用袢利尿剂组未减少肾功能恶化的发生率(RR=0.78,95%CI:0.48~1.26,P=0.31)和短期死亡率(RR=0.85,95%CI:0.47~1.56,P=0.61).托伐普坦联合袢利尿剂组可减少2 d内体重(SMD=-0.49,95%CI:-0.64~-0.34,P＜0.00001)并升高血钠.结论 托伐普坦单用或联合袢利尿剂较单用利尿剂不能减少肾功能恶化的发生率和住院死亡率,但能在急性失代偿心力衰竭患者减少体重和升高血钠.鉴于文献的数量质量存在局限性,结论需要进一步研究的证实.
To review systematically the effects of tolvaptan used only, tolvaptan combined with loop diuretics or loop diuretics used only on incidence of worsening renal function (WRF) in patients with acute decompensated heart failure (ADHF). Methods The databases of Pub Med, EMbase, The Cochrane Library (Vol. 4, 2018), Wan Fang Data, CBM and CNKI were retrieved with computer for searching the randomized controlled trials (RCTs) about tolvaptan used only (tolvaptan group), tolvaptan combined with loop diuretics (combination group) or loop diuretics used only (loop diuretics group) in treatment of ADHF, and the retrieving duration was from database establishing time to Apr. 2018. The literature was screened according to inclusion and exclusion criteria, and data of WRF incidence, short-term mortality, decreased body weight and elevated blood sodium level were extracted by 2 researchers independently. After reviewed the risk of bias, all data was given a Meta-analysis by using Rev Man 5.3 software. Results There were totally 7 RCTs included involved 937 patients, and 466 in tolvaptan group and 471 in control group. The results of Meta-analysis showed that WRF incidence (RR=0.78, 95%CI: 0.48~1.26, P=0.31) and short-term mortality (RR=0.85, 95%CI: 0.47~1.56, P=0.61) were not decreased in tolvaptan group and combination group compared with loop diuretics group. The body weight within 2 d (SMD=-0.49, 95%CI:-0.64~-0.34, P<0.00001) was decreased and blood sodium level was increased in combination group. Conclusion Tolvaptan used only or tolvaptan combined with loop diuretics cannot reduce WRF incidence and in-hospital mortality, but can decrease body weight and increase blood sodium level compared with loop diuretics used only in ADHF patients. The conclusion should be verified by further studies due to the limitations of literature quality and quantity in this study.