沙库巴曲缬沙坦与ACEI/ARB类药物用于射血分数中间值心力衰竭的有效性与安全性比较:一项系统评价

目的：系统评价沙库巴曲缬沙坦与肾素-血管紧张素转化酶抑制剂/血管紧张素Ⅱ受体拮抗剂（ACEI/ARB）类药物用于射血分数中间值心力衰竭患者的有效性和安全性。方法：系统检索各大中英文文献数据库中与沙库巴曲缬沙坦治疗射血分数中间值心力衰竭有关的随机对照试验RCT。2名研究者独立进行文献筛选，确定纳入的原始研究。进行文献质量评价和数据提取后，采用Review manager 5.3软件进行Meta分析。结果：共纳入12篇临床研究，涉及1 310例患者。Meta分析结果显示，主要结局指标方面，沙库巴曲缬沙坦组心力衰竭再住院率[RR＝0.50，95% CI （0.37，0.67），P<0.000 01]低于ACEI/ARB组，纽约心脏病协会心功能分级改善显效率[RR＝1.67，95% CI （1.34，2.07），P<0.01]和总有效率[RR＝1.16，95% CI （1.07，1.25），P<0.000 01]高于ACEI/ARB组，有效率[RR＝0.79，95% CI （0.64，0.98），P=0.04]低于对照组，组间差异均有统计学意义；2组心血管相关死亡率[OR＝0.51，95% CI （0.21，1.23），P=0.13]相比，组间差异无统计学意义。安全性方面，症状性低血压、高血钾和肾功能恶化的发生率，2组间比较差异均无统计学意义。结论：沙库巴曲缬沙坦对射血分数中间值心力衰竭患者有效，与ACEI/ARB类药物相比，该药可进一步降低该类患者的心力衰竭再住院率、改善心功能且安全性相似。

Efficacy and safety of sacubitril/valsartan versus ACEI/ARB in heart failure with mid-range ejection fraction:a systematic review

OBJECTIVE To systematically review the efficacy and safety of sacubitril/valsartan and renin angiotensin converting enzyme inhibitor/angiotensin Ⅱ receptor antagonist (ACEI/ARB) in patients with heart failure with mid-range ejection fraction.METHODS Retrieved from the major Chinese and English literature databases, randomized controlled trials (RCTs) about sacubitril/valsartan (trial group) versus ACEI/ARB (control group) in the treatment of heart failure with mid-range ejection fraction (HFmrEF) were collected. Two researchers independently screened the literature to determine the included original studies. After literature quality evaluation and data extraction, Rev Man 5.3 software was used, and sensitivity analysis was conducted.RESULTS A total of 12 clinical studies were included, with a total of 1 310 patients involved. Meta analysis results showed that in terms of main outcome indicators, the re-hospitalization rate of heart failure[RR=0.50, 95%CI(0.37, 0.67), P<0.000 01] in sacubitril/valsartan group was significantly lower than that in ACEI/ARB group. The significant efficiency[RR=1.67, 95%CI(1.34, 2.07), P<0.000 01] and the total effective rate[RR=1.16, 95%CI(1.07, 1.25), P<0.000 1] of NYHA classification improvement in sacubitril/valsartan group were significantly higher than those in ACEI/ARB group, while the effective rate[RR=0.79, 95%CI(0.64, 0.98), P=0.04] of NYHA classification improvement in sacubitril/valsartan group was significantly lower than that in ACEI/ARB group. There was no statistical significance in the cardiovascular mortality between the two groups[OR=0.51, 95%CI(0.21, 1.23), P=0.13]. In terms of safety, there was no statistical significance in the incidence of symptomatic hypotension, hyperkalemia and deterioration of renal function between the two groups.CONCLUSION Sacubitril/valsartan is effective for patients with HFmrEF, it can further reduce the re-hospitalization rate, improve the heart function and has no obvious adverse reactions compared with ACEI/ARB.