Abstract:

Objective To strengthen nursing awareness and attention，and improve the quality of medication and nursing care，Meta-analysis was used to evaluate the occurrence of sodium-glucose transporter 2 inhibitor related ketoacidosis. Methods Relevant randomized controlled trials were searched in 6 databases，such as CNKI，PubMed，Embase，and the Clinical trial platform，and the literature was screened based on inclusion and exclusion criteria. The search time was from the establishment of databases to January 2023. Revman 5.4.1 was used for quality evaluation and Meta-analysis. Results 24 randomized controlled trials were included. The Meta-analysis results showed that sodium-glucose transporter 2 inhibitors increased the incidence of ketoacidosis（RR=2.52，95%CI [1.82，3.49]，P<0.001）. Subgroup analysis showed that the sodium-glucose transporter 2 inhibitors increased the incidence of ketoacidosis in patients with type 2 diabetes（RR=2.42，95%CI[1.70，3.43]，P<0.001），cardiovascular disease（RR=2.32，95%CI[1.59，3.39]，P<0.001），and chronic kidney disease（RR=2.82，95%CI[1.73，4.58]，P<0.001）. Cargliflozin（RR=3.21，95%CI[1.43，7.18]，P=0.005），Daggliflozin（RR=2.73，95%CI[1.51，4.93]，P<0.001），and Sogliflozin（RR=1.92，95%CI[1.06，3.50]，P=0.030） increased the incidence of ketoacidosis，while Engliflozin（RR=1.80，95%CI[0.79，4.11]，P=0.160） did not have a significant effect. When the eGFR of patients≤60（mL/min/1.73m²）（RR=2.74，95%CI[1.63，4.60]，P<0.001），the duration of medication≤12 month（RR=3.31，95%CI[1.79，6.12]，P<0.001），or the duration of medication>12 month（RR=2.19，95%CI[1.23，3.91]，P=0.008），the sodium-glucose transporter 2 inhibitors increased the occurrence of ketoacidosis. Conclusion For patients receiving sodium-glucose transporter 2 inhibitors treatment regardless of whether they are complicated with diabetes，especially those with heart and kidney diseases，in the early and middle stages of medication，with eGFR≤60 ml/（min·1.73m²），and those with other susceptibility factors，we should strengthen the observation of patients’ medication，optimize medication care，and early identify and intervene in the occurrence of ketoacidosis.

Key words: Sodium-Glucose Transporter 2 Inhibitor, Ketoacidosis, Randomized Controlled Trials, Meta-Analysis, Type 2 Diabetes Mellitus, Cardiovascular Disease, Chronic Kidney Disease, Evidence-Based Nursing

摘要：

目的 通过Meta分析评价钠-葡萄糖共转运蛋白2抑制剂（sodium-glucose transporter 2 inhibitor，SGLT2i）相关性酮症酸中毒的发生，加强护理应对措施，提高用药护理质量。方法 系统检索自建库至2023年1月28日的中国知网、PubMed、Embase等6个中英文数据库和ClinicalTrials平台中SGLT2i相关的随机对照试验，按照纳入和排除标准筛选文献。采用Revman 5.4.1软件进行文献质量评价和Meta分析。结果 最终纳入24项随机对照试验。Meta分析结果显示，SGLT2i增加了酮症酸中毒发生（RR=2.52，95%CI[1.82，3.49]，P<0.001）。亚组分析显示，在2型糖尿病（RR=2.42，95%CI[1.70，3.43]，P<0.001）、心血管疾病（RR=2.32，95%CI[1.59，3.39]，P<0.001）、慢性肾脏疾病（RR=2.82， 95%CI[1.73，4.58]，P<0.001）患者中，SGLT2i增加了酮症酸中毒发生。常用药物卡格列净（RR=3.21，95%CI[1.43， 7.18]，P=0.005）、达格列净（RR=2.73，95%CI[1.51，4.93]，P<0.001）和索格列净（RR=1.92，95%CI[1.06，3.50]，P=0.030）增加了酮症酸中毒的发生，恩格列净（RR=1.80，95%CI[0.79，4.11]，P=0.160）没有明显影响。当患者估算肾小球滤过率（estimated glomerular filtration rate，eGFR）≤60 ml/（min·1.73 m²）（RR=2.74，95%CI[1.63，4.60]，P<0.001）、用药时间≤12个月（RR=3.31，95%CI[1.79，6.12]，P<0.001）或用药时间>12个月（RR=2.19，95%CI[1.23，3.91]，P=0.008）时，SGLT2i增加了酮症酸中毒发生。结论 对无论是否合并糖尿病的接受SGLT2i治疗的患者，尤其是患有多种心肾疾病、用药初中期、eGFR≤60 ml/ （min·1.73 m²）的患者，应该针对性地加强对患者的用药观察，优化用药护理，及早识别并干预酮症酸中毒的发生。

关键词: 钠-葡萄糖共转运蛋白2抑制剂, 酮症酸中毒, 随机对照试验, Meta分析, 2型糖尿病, 心血管疾病, 慢性肾脏病, 循证护理学