METHODS: We searched PubMed, Embase, and the Cochrane databases for controlled trials that compared the outcomes of patients with and without EWKF after RASi treatment. Our primary outcome was all-cause mortality, and secondary outcomes were kidney and cardiovascular events. We pooled data using a random effects model.
RESULTS: A total of ten studies were enrolled, of which eight were randomized trials (including 33 454 patients) and two were observational studies (including 148 144 patients). Of the eight randomized trials, 4996 patients with type 2 diabetes, 19 118 with heart failure (HF), and 9340 with atherosclerotic vascular disease and diabetes with end-organ damage. Both observational studies investigated all kinds of patients with initial RASi treatment. In patients with RASi, the EWKF group had a higher risk of all-cause mortality than the no-EWKF group in the randomized studies (n = 13 581; RR, 1.22; 95% CI, 1.04-1.42; P = .02) and in observational studies (n = 148 144; OR, 1.70; 95% CI, 1.43-2.01; P < .00001). In patients who experienced EWKF, no statistically significant difference was found between the efficacy of RASi and placebo in all-cause mortality (n = 1762; RR, 0.85; 95% CI, 0.68-1.06; P = .14).
CONCLUSIONS: RASi treatment led to an increased incidence of EWKF which was associated with poorer long-term outcomes. As the benefit of RAS blockade to patients with EWKF was limited, we suggest clinicians use RASi with caution when EWKF occurs.
方法:我们搜索了PubMed,Embase,和Cochrane数据库的对照试验,比较了RASi治疗后有和无EWKF患者的结局。我们的主要结果是全因死亡率,次要结局为肾脏事件和心血管事件.我们使用随机效应模型汇集数据。
结果:共纳入10项研究,其中8项为随机试验(包括33454例患者),2项为观察性研究(包括148144例患者).在8项随机试验中,4996例2型糖尿病患者,19118心力衰竭(HF),9340患有动脉粥样硬化性血管疾病和终末器官损害的糖尿病。两项观察性研究均调查了初始RASi治疗的所有类型患者。在RASi患者中,在随机研究中,EWKF组比无EWKF组有更高的全因死亡率风险(n=13581;RR,1.22;95%CI,1.04-1.42;P=.02)和观察性研究(n=148144;OR,1.70;95%CI,1.43-2.01;P<.00001)。在经历EWKF的患者中,RASi和安慰剂在全因死亡率中的疗效无统计学意义(n=1762;RR,0.85;95%CI,0.68-1.06;P=.14)。
结论:RASi治疗导致EWKF发生率增加,这与较差的长期预后相关。由于RAS阻断对EWKF患者的益处有限,我们建议临床医生在发生EWKF时谨慎使用RASi.