三种新型降糖药物在重度糖尿病肾病患者中的疗效和安全性比较：一项随机对照试验的系统评价和网络荟萃分析。
Comparison of efficacy and safety of three novel hypoglycemic agents in patients with severe diabetic kidney disease: A systematic review and network meta-analysis of randomized controlled trials.
机构信息
Department of Endocrinology, The First Medical Center of Chinese PLA General Hospital, Beijing, China.
The First Health Care Department, the Second Medical Center & National Clinical Research Center for Geriatric Diseases, Chinese PLA General Hospital, Beijing, China.
出版信息
Front Endocrinol (Lausanne). 2022 Oct 24;13:1003263. doi: 10.3389/fendo.2022.1003263. eCollection 2022.
OBJECTIVE
To analyze the efficacy and safety of three novel hypoglycemic agents, glucagon-like peptidyl-1 receptor agonists, dipeptidyl peptidase-4 inhibitors (DPP-4i), and sodium-glucose cotransporter two inhibitors (SGLT2i) in type 2 diabetes mellitus (T2DM) patients with severe chronic kidney disease (CKD) (defined in this study as CKD stage 3 B or above, eGFR< 45 mL/min/1.73 m²) based on important RCTs to date.
METHODS
We retrieved studies published before April 15, 2022, from EMBASE, PubMed/MEDLINE, Cochrane Library and included randomized controlled trials in which the participants were patients with T2DM and severe CKD. Frequentist methods were used in the network meta-analysis.
RESULTS
Nineteen studies of 17 trials involving 6,607 participants met our inclusion criteria. Compared with placebo and DPP-4i, SGLT2i demonstrated a significantly lower incidence of serious renal-related adverse events or renal death, and the odds ratios (OR) were 0.69 (0.58, 0.81) and 0.63 (0.40, 1.00), respectively. Compared with placebo, SGLT2i significantly reduced the incidence of all-cause death and severe AE; the ORs were 0.72 (0.55, 0.94) and 0.65 (0.47, 0.91), respectively. Compared with placebo, DPP-4i significantly reduced the level of HbA1c, and the difference between mean changes from baseline was -0.36 (-0.63, -0.09).
CONCLUSIONS
Patients with T2DM complicated by severe CKD may benefit from SGLT2i. SGLT2i can reduce the incidence of serious renal-related AEs or renal death, as well as severe side effects, and has a positive effect on the patient's renal function and survival, even for only CKD patients can also be considered. GLP-1 RAs can be used as a supplement if blood sugar control is poor. For dialysis patients, DPP-4i can assist blood glucose control, reduce insulin dosage, and reduce the risk of hypoglycemia.
SYSTEMATIC REVIEW REGISTRATION
INPLASY https://inplasy.com/inplasy-2021-12-0106/, identifier INPLASY2021120106.
目的
基于目前为止的重要 RCT，分析三种新型降糖药（胰高血糖素样肽-1 受体激动剂、二肽基肽酶-4 抑制剂[DPP-4i]和钠-葡萄糖协同转运蛋白 2 抑制剂[SGLT2i]）在伴有严重慢性肾脏病（CKD）的 2 型糖尿病（T2DM）患者中的疗效和安全性，其中严重 CKD 在本研究中定义为 CKD 3B 期及以上，肾小球滤过率（eGFR）<45 mL/min/1.73 m²。
方法
我们检索了截至 2022 年 4 月 15 日之前在 EMBASE、PubMed/MEDLINE、Cochrane 图书馆发表的研究，纳入了 T2DM 伴严重 CKD 患者的随机对照试验。使用网络荟萃分析的频率方法。
结果
纳入的 17 项试验中有 19 项研究，涉及 6607 名参与者。与安慰剂和 DPP-4i 相比，SGLT2i 发生严重肾脏相关不良事件或肾脏死亡的发生率显著降低，比值比（OR）分别为 0.69（0.58，0.81）和 0.63（0.40，1.00）。与安慰剂相比，SGLT2i 显著降低全因死亡和严重不良事件的发生率，OR 分别为 0.72（0.55，0.94）和 0.65（0.47，0.91）。与安慰剂相比，DPP-4i 显著降低 HbA1c 水平，从基线的平均变化差值为-0.36（-0.63，-0.09）。
结论
伴有严重 CKD 的 T2DM 患者可能受益于 SGLT2i。SGLT2i 可降低严重肾脏相关不良事件或肾脏死亡的发生率和严重不良反应的发生率，对患者的肾功能和生存有积极影响，即使仅为 CKD 患者也可考虑使用。如果血糖控制不佳，GLP-1 RAs 可作为补充。对于透析患者，DPP-4i 可辅助血糖控制，减少胰岛素用量，降低低血糖风险。
系统评价注册
INPLASY https://inplasy.com/inplasy-2021-12-0106/，注册号 INPLASY2021120106。
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