目的:许多临床研究已经探索了钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)在慢性心力衰竭(CHF)患者中的作用,有或没有2型糖尿病(T2DM),和SGLT2i被证明显着减少CHF住院,心血管死亡,心血管死亡率,伴或不伴T2DM患者的全因死亡率和心肌梗死。然而,只有少数人研究了SGLT-2i对HF疾病特异性健康状况和心功能的影响.本荟萃分析旨在评估SGLT2i对CHF患者疾病特异性健康状况和心功能的影响。
方法:通过在PubMed,EMBASE,中部,Scopus,和WebofScience,和两个中文数据库(CNKI和万方),临床试验(http://www.
结果:gov)也进行了搜索。
结果:共有18项随机对照试验(RCT),包括23,953名参与者,纳入荟萃分析。SGLT2抑制剂与对照组或安慰剂组在有或没有T2DM的CHF中的作用进行比较。SGLT2抑制剂组显示b型利钠肽原(NT-proBNP)水平显着降低136.03pg/ml(95%置信区间[CI]:-253.36,-18.70;P=0.02)。此外,SGLT2抑制剂组中更多的患者显示NT-proBNP下降≥20%(RR=1.45,95%CI[0.92,2.29],p=0.072)。然而,对B型利钠肽(BNP)的影响无统计学差异.SGLT-2抑制剂的使用导致LVEF显著改善2.79%(95%CI[0.18,5.39];P=0.036)。就健康状况而言,根据堪萨斯城心肌病问卷(KCCQ)和6分钟步行距离的评估,SGLT2抑制剂导致KCCQ临床总结(KCCQ-CS)评分显著改善(WMD=1.7,95%CI[1.67,1.73],P<0.00001),KCCQ总体总结(KCCQ-OS)得分(WMD=1.73,95%CI[0.94,2.52],P<0.00001),和KCCQ总症状(KCCQ-TS)评分(WMD=2.88,95%CI[1.7,4.06],P<0.00001)。此外,发生KCCQ-CS和KCCQ-OS评分增加≥5分的相对危险度(RR)为1.25(95%CI[1.11,1.42],P<0.00001)和1.15(95%CI[1.09,1.22],P<0.00001),分别。总的来说,与对照组/安慰剂相比,SGLT2抑制剂使6分钟步行距离从基线增加23.98m(95%CI[8.34,39.62];P=0.003)。
结论:SGLT2抑制剂治疗提供了改善NT-proBNP水平的有效策略,堪萨斯城心肌病问卷评分和6分钟步行距离CHF伴或不伴T2DM。这些研究结果表明,SGLT2i改善CHF伴或不伴T2DM患者的心功能和健康状况,并为临床医生制定CHF患者的治疗决策提供有价值的指导。
Numerous clinical studies have explored sodium-glucose cotransporter 2 inhibitor (SGLT2i) in patients with chronic heart failure (CHF), with or without type 2 diabetes mellitus (T2DM), and SGLT2i were proved to significantly reduce CHF hospitalization, cardiovascular death, cardiovascular mortality, all-cause mortality and myocardial infarction in patients with or without T2DM. However, only a limited few have investigated the effects of SGLT-2i on HF disease-specific health status and cardiac function. This meta-analysis aims to assess the effects of SGLT2i on disease-specific health status and cardiac function in CHF patients.
A comprehensive search was conducted of trials by searching in PubMed, EMBASE, CENTRAL, Scopus, and Web of Science, and two Chinese databases (CNKI and Wanfang), Clinical Trials ( http://www.
gov ) were also searched.
A total of 18 randomized controlled trials (RCTs) involving 23,953 participants were included in the meta-analysis. The effects of SGLT2 inhibitors were compared with control or placebo groups in CHF with or without T2DM. The SGLT2 inhibitors group exhibited a significant reduction in pro b-type natriuretic peptide (NT-proBNP) levels by 136.03 pg/ml (95% confidence interval [CI]: -253.36, - 18.70; P = 0.02). Additionally, a greater proportion of patients in the SGLT2 inhibitors group showed a ≥ 20% decrease in NT-proBNP (RR = 1.45, 95% CI [0.92, 2.29], p = 0.072). However, no statistically significant difference was observed for the effects on B-type natriuretic peptide (BNP). The use of SGLT-2 inhibitors led to a noteworthy improvement in LVEF by 2.79% (95% CI [0.18, 5.39];P = 0.036). In terms of health status, as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and 6-minute walk distance, SGLT2 inhibitors led to a significant improvement in KCCQ clinical summary (KCCQ-CS) score (WMD = 1.7, 95% CI [1.67, 1.73], P < 0.00001), KCCQ overall summary (KCCQ-OS) score (WMD = 1.73, 95% CI [0.94, 2.52], P < 0.00001), and KCCQ total symptom (KCCQ-TS) score (WMD = 2.88, 95% CI [1.7, 4.06], P < 0.00001). Furthermore, the occurrence of KCCQ-CS and KCCQ-OS score increases ≥ 5 points had relative risks (RR) of 1.25 (95% CI [1.11, 1.42], P < 0.00001) and 1.15 (95% CI [1.09, 1.22], P < 0.00001), respectively. Overall, SGLT2 inhibitors increased the 6-minute walk distance by 23.98 m (95% CI [8.34, 39.62]; P = 0.003) compared to control/placebo from baseline.
The SGLT2 inhibitors treatment offers an effective strategy for improving NT-proBNP levels, Kansas City Cardiomyopathy Questionnaire scores and 6-minute walk distance in CHF with or without T2DM. These findings indicate that SGLT2i improve cardiac function and health status in CHF with or without T2DM, and provide valuable guidance for clinicians making treatment decisions for patients with CHF.