钠-葡萄糖共转运蛋白2抑制剂对伴有严重肾功能不全的2型糖尿病患者心血管保护作用的Meta分析
Cardiovascular protective effects of sodium-glucose cotransporter 2 inhibitors in type 2 diabetes mellitus patients with severe renal insufficiency: A meta-analysis
Received date: 2021-09-07
Online published: 2022-01-20
目的 评价钠-葡萄糖共转运蛋白2(sodium-glucose cotransporter 2,SGLT2)抑制剂对伴严重肾功能不全的2型糖尿病患者(diabetes mellitus type 2,T2DM)心血管保护作用及其不良反应。方法 检索Medline、Embase和 Cochrane Library数据库,收集关于SGLT2抑制剂在糖尿病肾病患者中的随机对照研究,检索时限为建库以来至2021年8月。结果 共纳入6项RCT研究,包括3 679例伴有严重肾功能异常的糖尿病患者。Meta分析结果显示:与安慰剂组相比,SGLT2抑制剂明显降低了因心力衰竭住院(HR=0.74,95%CI=0.55~0.99,P=0.04)和中风风险(HR=0.75,95 %CI=0.60~0.93,P=0.008)。SGLT2 抑制剂组心血管死亡(HR=0.89,95% CI=0.60~1.30,P=0.54)及全因死亡发生率(HR=0.84,95% CI=0.56~1.28,P=0.43)与安慰剂相似。至于不良反应方面,包括总不良事件(RR=1.00,95% CI=0.94~1.07,P=0.96)、骨折(RR=2.34,95%CI=0.52~10.51,P=0.27)、泌尿道感染(RR=1.22,95% CI=0.64~2.35,P=0.54)、低血压(RR=1.32,95%CI=0.59~2.95,P=0.49)、生殖道感染(RR=0.67,95% CI=0.15~2.93,P=0.6)及急性肾损伤(RR=0.96,95% CI=0.41~2.26,P=0.93),两组差异均无统计学意义。结论 在伴有严重肾功能不全的T2DM患者中应用SGLT2抑制剂后,患者因心力衰竭住院和中风风险降低,且没有增加不良事件的发生风险。SGLT2抑制剂可能对伴有严重肾功能不全的T2DM患者的心血管结局事件具有保护作用且相对安全。未来需要更多的临床试验来支持 SGLT2 抑制剂对严重肾功能不全的T2DM患者心血管结局的影响。
关键词： 糖尿病,2型; 钠-葡萄糖共转运蛋白2抑制剂; 肾功能不全; 心血管保护
许藏丹 , 赵新 , 顾文元 . 钠-葡萄糖共转运蛋白2抑制剂对伴有严重肾功能不全的2型糖尿病患者心血管保护作用的Meta分析[J]. 临床荟萃, 2022 , 37(1) : 14 -19 . DOI: 10.3969/j.issn.1004-583X.2022.01.002
Objective To evaluate the cardiovascular protective effects and adverse reaction of sodium-glucose cotransporter 2 (SGLT2) inhibitors in type 2 diabetes mellitus (T2DM) patients with severe renal insufficiency. Methods We searched three public databases, including Medline, Embase and Cochrane Library, to collect randomized controlled trials on SGLT2 inhibitors in patients with diabetic nephropathy from the inception to August 2021. Results A total of six RCTs were included, including 3679 diabetic patients with severe renal insufficiency. The meta-analysis showed that SGLT2 inhibitor had significantly reduced the risk of hospitalization (HR=0.74, 95% CI=0.55-0.99, P=0.04) and stroke (HR=0.75, 95% CI=0.60-0.93, P=0.008) due to heart failure in comparison with placebo group. The incidence of cardiovascular death (HR=0.89, 95% CI=0.60-1.30, P=0.54) and all-cause death (HR=0.84, 95% CI=0.56-1.28, P=0.43) in the SGLT2 inhibitor group was similar to that in placebo group. As for side effects, there was no significant difference in total adverse events (RR=1.00, 95% CI=0.94-1.07, P=0.96), fracture (RR=2.34, 95% CI=0.52-10.51, P=0.27), urinary tract infection (RR=1.22, 95% CI=0.64-2.35, P=0.54), hypotension (RR=1.32, 95% CI=0.59-2.95, P=0.49), reproductive tract infection (RR=0.67, 95% CI=0.15-2.93, P=0.6) and acute kidney injury (RR=0.96, 95% CI=0.41-2.26, P=0.93) between groups. Conclusion For T2DM patients with severe renal insufficiency, the administration of SGLT2 inhibitors is capable of reducing the risks of hospitalization and stroke due to heart failure, without increasing the risk of adverse events. SGLT2 inhibitors may have a protective and relatively safe effect on their cardiovascular outcomes. Future clinical trials are needed to support the impact of SGLT2 inhibitors on cardiovascular benefits in T2DM patients.
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