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钠-葡萄糖共转运蛋白2抑制剂对2型糖尿病患者酮症酸中毒影响的Meta分析
孔德华
李敬文
周红
作者及单位信息
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DOI： 10.3760/cma.j.cn115791-20220409-00148
Effects of sodium-glucose cotransporter 2 inhibitors on ketoacidosis in patients with type 2 diabetes mellitus: a meta-analysis
Kong Dehua
Li Jingwen
Zhou Hong
Authors Info & Affiliations
Kong Dehua
Department of Endocrinology, Second Hospital of Hebei Medical University, Shijiazhuang 050000, China
Li Jingwen
Department of Endocrinology, Second Hospital of Hebei Medical University, Shijiazhuang 050000, China
Zhou Hong
Department of Endocrinology, Second Hospital of Hebei Medical University, Shijiazhuang 050000, China
·
DOI： 10.3760/cma.j.cn115791-20220409-00148
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摘要

目的系统评价钠-葡萄糖共转运蛋白2抑制剂（SGLT2i）对2型糖尿病（T2DM）患者发生酮症酸中毒（DKA）风险的影响。

方法计算机检索美国国立医学图书馆数据库（Pubmed）、医学文摘数据库（Embase）和Cochrane循证医学数据库（Cochrane Library）从建库至2021年11月30日收录的有关SGLT2i治疗T2DM患者的随机对照试验（RCT）。提取纳入文献的样本量、研究对象年龄、体重指数（BMI）、发生DKA情况、使用降糖药种类及时间。采用RevMan 5.4软件进行Meta分析，二分类变量用相对危险度（RR）值及95%CI作为效应量。

结果共纳入36个RCT涉及69 760例T2DM患者，共发生DKA事件139个，其中SGLT2i组106个，对照组33个。与对照组相比，SGLT2i组发生DKA的风险更高（RR=2.70，95%CI 1.83~3.98， P<0.001）。亚组分析显示，与各自的对照组相比，年龄>60岁（RR=2.72，95%CI 1.83~4.04， P<0.001）、BMI≥31 kg/m 2（RR=2.72，95%CI 1.82~4.06， P<0.001）、用药时间>52周（RR=2.72，95%CI 1.83~4.04， P<0.001）接受SGLT2i治疗的T2DM患者发生DKA的风险更高；在药物种类亚组中，卡格列净（RR=4.81，95%CI 1.69~13.63， P=0.003）、埃格列净（RR=4.09，95%CI 1.10~15.19， P=0.040）比对照组发生DKA的风险更高。

结论SGLT2i会增加T2DM患者发生DKA的风险。而且年龄越大、BMI越高、用药时间越长，发生DKA的风险越高，并且DKA的高风险与药物种类有关。

糖尿病，2型;钠-葡萄糖共转运蛋白2抑制剂;糖尿病酮症酸中毒;Meta分析
ABSTRACT

ObjectiveTo systematically evaluate whether sodium-glucose cotransporter receptor-2 inhibitors (SGLT2i) increase the risk of diabetic ketoacidosis (DKA) in adults with type 2 diabetes mellitus (T2DM).

MethodsRandomized controlled trials (RCT) of SGLT2i in patients with T2DM included in Pubmed, Embase and Cochrane Evidence Based Medicine databases were searched from the establishment of the databases to November 30, 2021. Data such as sample size, age of subjects, body mass index (BMI), occurrence of DKA, type and time of hypoglycemic drugs used were extracted. Revman 5.4 software was used for meta-analysis. The risk ratio (RR) value and 95%CI were used as effect variables for dichotomous variables.

ResultsA total of 36 RCT involving 69 760 T2DM patients were included, and 139 DKA events occurred, including 106 DKA events in the SGLT2i group and 33 DKA events in the control group. Compared with the control group, SGLT2i group had a higher risk of DKA (RR=2.70, 95%CI 1.83-3.98, P<0.001). Subgroup analysis showed that T2DM patients with age>60 years (RR=2.72, 95%CI 1.83-4.04, P<0.001), BMI≥31 kg/m 2 (RR=2.72, 95%CI 1.82-4.06, P<0.001) and medication duration >52 weeks (RR=2.72, 95%CI 1.83-4.04, P<0.001) who received SGLT2i had a higher risk of DKA compared with their respective control groups. In the subgroups of drug types, the risk of DKA was higher in canagliflozin (RR=4.81, 95%CI 1.69-13.63, P=0.003) and ertugliflozin (RR=4.09, 95%CI 1.10-15.19, P=0.04) than in the control group.

ConclusionsThis study suggests that SGLT2i increase the risk of DKA in patients with T2DM. Moreover, the older the age, the higher the BMI, and the longer the duration of receiving SGLT2i, the higher the risk of developing DKA, and the risk of DKA is also related to the type of medication.

Diabetes mellitus, type 2;Sodium-glucose cotransporter 2 inhibitors;Diabetic ketoacidosis;Meta-analysis
Zhou Hong, Email: mocdef.3ab613102sbuohz
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引用本文

孔德华,李敬文,周红. 钠-葡萄糖共转运蛋白2抑制剂对2型糖尿病患者酮症酸中毒影响的Meta分析[J]. 中华糖尿病杂志,2023,15(02)：144-151.

DOI:10.3760/cma.j.cn115791-20220409-00148

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近年来，随着人们生活方式和饮食习惯的改变，糖尿病的患病率也随之增加。为更好地控制糖尿病，不断有新的降糖药物研发上市。钠-葡萄糖共转运蛋白2抑制剂（sodium-glucose cotransporter 2 inhibitor，SGLT2i）通过抑制肾脏近曲小管对葡萄糖的重吸收，使葡萄糖从尿液中排出而起到降糖作用。恩格列净心血管结局研究（empagliflozin cardiovascular outcome event trial in type 2 diabetes mellitus patients，EMPA-REG OUTCOME）结果显示，恩格列净不仅能够降糖减重，而且能显著降低2型糖尿病（type 2 diabetes mellitus，T2DM）伴有心血管疾病人群的心血管死亡风险、心衰住院风险以及肾脏终点事件 ［ 1 ］ 。此后，卡格列净心血管评估研究（CANagliflozin cardiovascular assessment study，CANVAS） ［ 2 ］ 、达格列净心血管结局研究（multicenter trial to evaluate the effect of dapagliflozin on the incidence of cardiovascular events，DECLARE-TIMI 58）也证实了卡格列净和达格列净在T2DM患者中的心肾获益 ［ 3 ］ 。由于有多项大型研究显示，SGLT2i具有降糖、降压、减重、降低尿酸及心肾保护等作用，使这类药物受到临床医师的青睐和关注。但是这些临床研究也发现了SGLT2i的不良事件，如CANVAS研究显示卡格列净导致截肢风险增加，DECLARE-TIMI 58研究显示达格列净增加了泌尿系感染的风险等。这引起了糖尿病领域学者的关注并进行了大量研究。目前关于应用SGLT2i治疗T2DM是否会增加糖尿病酮症酸中毒（diabetic ketoacidosis，DKA）的风险尚没有统一的结论，我们通过Meta分析探讨SGLT2i对T2DM患者发生酮症酸中毒（DKA）风险的影响，以期使临床医师对SGLT2i的疗效和不良反应有更全面的认识。
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备注信息
A
周红，Email： mocdef.3ab613102sbuohz
B

孔德华：试验设计、实施研究、采集数据、数据整理、统计学分析、文章撰写；李敬文：采集数据、支持性贡献；周红：研究指导、文章修改、经费支持

C
孔德华, 李敬文, 周红. 钠-葡萄糖共转运蛋白2抑制剂对2型糖尿病患者酮症酸中毒影响的Meta分析[J]. 中华糖尿病杂志, 2023, 15(2): 144-151. DOI: 10.3760/cma.j.cn115791-20220409-00148.
D
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