Clinical Observation of SGLT-2 Inhibitors in Delaying the Progression of Diabetic Nephropathy
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摘要:
目的 基于“真实世界”临床数据，探讨SGLT-2抑制剂延缓糖尿病肾病进展的临床疗效观察。 方法 回顾性分析2019年1月至2022年12月昆明医科大学第二附属医院MMC数据库中使用SGLT-2抑制剂的糖尿病患者98例，以患者开始使用SGLT-2抑制剂治疗日期为基线，收集使用SGLT-2抑制剂基线与治疗6个月的数据，对比基线与治疗6个月的数据：（1）一般资料：年龄、性别、身高、体质指数、收缩压、舒张压；（2）糖代谢指标：血糖、糖化血红蛋白（HbA1c）；（3）肝功能指标：谷草转氨酶（AST）、谷丙转氨酶（ALT）、碱性磷酸酯酶（ALP）、谷氨酰转移酶（Y-GT）、白蛋白（ALB） ；（4）血脂指标：总胆固醇（TC）、甘油三酯（TG）、高密度脂蛋白（HDL-c）、低密度脂蛋白（LDL-c）；（5）肾功能指标：尿肌酐、尿微量白蛋白、尿微量白蛋白/肌酐（UACR）、尿素氮（BUN）、尿酸（UA）、肌酐（Cr）。遵从“6个月时间间隔”的方法进行分组，将昆明医科大学第二附属医院2019年1月至2022年12月收治的数据相对完整的98例糖尿病肾病患者分为基线组（98例，初次使用SGLT-2抑制剂）和6个月组（98例，SGLT-2抑制剂达治疗6个月）。 结果 所纳入患者基线年龄为（52.85±8.98）岁，基线身高为（167.62±8.04）cm，其中男性72例，占比73.47%；女性26例，占比26.53%。患者治疗6个月后的数据：（1）一般资料BMI、收缩压、舒张压较基线降低，舒张压比较差异有统计学意义（P < 0.05）；（2）糖代谢指标血糖、糖化血红蛋白（HbA1c）较基线降低，2个指标的比较差异均有统计学意义（P < 0.05）；（3）肝功能指标AST、ALT、ALP、Y-GT、ALB较基线降低，ALT比较差异有统计学意义（P < 0.05）；（4）血脂指标TC、TG、LDL-c较基线降低，HDL-c 较基线升高，TG、HDL-c指标的比较差异有统计学意义（P < 0.05）；（5）肾功能指标尿微量白蛋白、尿微量白蛋白/肌酐（UACR）、尿素氮（BUN）较基线降低，尿肌酐、尿酸（UA），肌酐（Cr）较基线升高，尿微量白蛋白/肌酐（UACR）指标的比较差异均有统计学意义（P < 0.05）。不良反应：2组均未观察到低血糖、严重胃肠道反应、尿路感染、下肢创口损伤及截肢情况。 结论 SGLT-2抑制剂对糖尿病肾病患者有降低血压、降低体重指数、控制血糖水平、调节脂代谢，改善肾功能、减少尿蛋白的作用，可以延缓糖尿病肾病的进展且临床安全性较高。 Abstract:Objective To investigate the clinical efficacy of SGLT2 inhibitors in delaying the progression of diabetic nephropathy based on "real world" clinical data. Methods A retrospective analysis was performed on 98 patients with diabetes who were treated with SGLT2 inhibitors from the MMC database of the Second Affiliated Hospital of Kunming Medical University from January 2019 to December 2022. The baseline data of treatment with SGLT2 inhibitors were taken as the baseline and the data of 6 months of treatment were collected. （1） General data [age, sex, height, BMI, systolic blood pressure, diastolic blood pressure] were compared between baseline and 6 months of the treatment; （2） Indexes of glucose metabolism [blood glucose, glycosylated hemoglobin （HbA1c）]; （3） Liver function indexes [AST, ALT, alkaline phosphatase, YGT, ALB]; （4） Lipid indexes [total cholesterol （TC）, triglyceride （TG）, high density lipoprotein （HDLc）, low density lipoprotein （LDLc）]; （5） Renal function indicators [urinary creatinine, urinary microalbumin, urinary microalbumin/creatinine （UACR）, urea nitrogen （BUN）, uric acid （UA）, creatinine （Cr）]. Following the "6 month interval" method, 98 patients with relatively complete data admitted to the hospital from January 2019 to December 2022 were divided into baseline group （98 cases, initial use of SGLT2 inhibitor） and 6 month group （98 cases, SGLT2 inhibitor treatment for 6 months）. Results The baseline age of the patients included in this study was 52.85±8.98 years old, and the baseline height was 167.62±8.04cm, including 72 males, accounting for 73.47%, and 26 females, accounting for 26.53%.After the 6 months of treatment: （1） The BMI, systolic blood pressure and diastolic blood pressure of the patients were lower than the baseline. There were significant differences in diastolic blood pressure （P < 0.05）. （2） The indexes of glucose metabolism, blood glucose and HbA1c were lower than the baseline, and the differences between the two indexes were statistically significant （P < 0.05）. （3） The liver function indexes AST, ALT, ALP, YGT and ALB were lower than the baseline, and the difference in ALT was statistically significant （P < 0.05）. （4） Lipid indexes TC, TG and LDLc were lower than the baseline, while HDLc was higher than the baseline, and the difference between TG and HDLc indexes was statistically significant （P < 0.05）. （5） The renal function indexes as urinary microalbumin, urinary microalbumin/creatinine （UACR） and urea nitrogen （BUN） were lower than the baseline, urinary creatinine, uric acid （UA） and creatinine （Cr） were higher than the baseline, and the differences in urinary microalbumin/creatinine （UACR） indexes were statistically significant （P<0.05）. Adverse reactions: In this study, no hypoglycemia, severe gastrointestinal reaction, urinary tract infection, lower limb wound injury or amputation were observed between the two groups. Conclusion SGLT2 inhibitors have the effects of lowering blood pressure, reducing body massindex controlling blood sugar level, regulating lipid metabolism, improving the renal function and reducing urinary protein in diabetic nephropathy patients. It can delay the progression of diabetic nephropathy and has high clinical safety. -
Key words:
- Diabetic nephropathy /
- SGLT2 inhibitors /
- Clinical efficacy /
- Safety
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表 1 研究对象的基线和治疗第6个月的一般资料比较（
$\bar x \pm s $ ）Table 1. Comparison of general data between baseline and the sixth month of treatment in research subjects （
$\bar x \pm s $ ）项目 基线 治疗6个月 t P 年龄（岁） 52.85 ± 8.98 − 58.241 − 男性[n（%）] 72（73.47） 72（73.47） − − 身高（cm） 167.62 ± 8.04 − 206.497 − BMI（kg/m2） 25.09 ± 3.13 24.77 ± 3.20 0.704 0.797 收缩压（mmHg） 127.06 ± 14.14 125.48 ± 11.58 0.857 0.137 舒张压（mmHg） 78.41 ± 8.84 76.55 ± 6.56 1.670 0.016* *P < 0.05。 
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表 2 研究对象的基线和治疗第6个月的血糖及糖化血红蛋白比较（
$\bar x \pm s $ ）Table 2. Comparison of fasting plasma glucose and glycosylated hemoglobin between baseline and 6 months after treatment in research subjects （
$\bar x \pm s $ ）项目 基线 治疗6月 t P 空腹血糖（mmol/L） 8.54 ± 3.59 7.40 ± 2.24 2.662 0.001** 糖化血红蛋白（%） 8.16 ± 1.89 7.16 ± 1.22 4.409 0.000** **P < 0.01。
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表 3 研究对象的基线和治疗第6个月的肝功能比较（
$\bar x \pm s $ ）Table 3. Comparison of liver function between baseline and 6 months after treatment in research subjects （
$\bar x \pm s $ ）项目 基线 治疗6个月 t P AST（U/L） 24.75 ± 11.22 24.10 ± 1048 0.420 0.271 ALT（U/L） 31.65 ± 24.99 27.24 ± 12.29 1.567 0.003** ALP（U/L） 83.20 ± 23.84 81.20 ± 22.37 0.479 0.586 Y-GT（U/L） 45.52 ± 5.08 43.53 ± 5.75 0.260 0.938 ALB（g/L） 42.96 ± 5.61 41.86 ± 3.77 1.278 0.659 **P < 0.01。
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表 4 研究对象的基线和治疗第6个月的血脂比较（
$\bar x \pm s $ ）Table 4. Comparison of blood lipids between baseline and 6 months after treatment in research subjects （
$\bar x \pm s $ ）项目 基线 治疗6月 t P TC（mmol/L） 5.00 ± 1.28 4.75 ± 0.89 1.590 0.058 TG（mmol/L） 3.47 ± 0.62 2.48 ± 0.24 1.479 0.027* HDL-c（mmol/L） 1.21 ± 0.37 1.47 ± 0.62 −3.535 0.001** LDL-c（mmol/L） 3.01 ± 0.90 2.76 ± 0.81 2.086 0.458 *P < 0.05；**P < 0.01。
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表 5 研究对象的基线和治疗第6个月的肾功能比较（
$\bar x \pm s $ ）Table 5. Comparison of renal function between baseline and 6 months after treatment in research subjects （
$\bar x \pm s $ ）项目 基线 治疗6个月 t P 尿液肌酐（μmol/L） 9332.15 ± 4741.63 9381.40 ± 7345.26 −0.055 0.653 尿微量白蛋白（mg/dL） 6.18 ± 2.35 5.14 ± 1.35 0.386 0.356 UACR（mg/g cr） 93.02 ± 46.56 28.79 ± 6.35 1.360 0.015* BUN（mmol/L） 5.97 ± 1.72 5.91 ± 1.66 0.212 0.889 UA（μmol/L） 339.83 ± 83.50 347.19 ± 83.86 −0.609 0.727 Cr（μmol/L） 69.37 ± 19.62 73.27 ± 18.66 −1.428 0.827 *P < 0.05。
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