SGLT2抑制剂治疗2型糖尿病伴肾损害患者的安全性和有效性的Meta分析

发布时间：2018-03-12 18:48

本文选题：钠-葡萄糖转运蛋白　切入点：糖尿病　出处：《中国新药与临床杂志》2017年09期 　论文类型：期刊论文

【摘要】：目的评价钠-葡萄糖共转运蛋白2(SGLT2)抑制剂治疗伴肾损害的2型糖尿病(T2DM)的有效性和安全性。方法计算机检索Cochrane、Pub Med、Embase、中国生物医学文献数据库、相关期刊论文、万方数据库和维普数据库,收集SGLT2抑制剂治疗伴肾损害的T2DM的随机对照试验(RCT)。由2位研究者按照纳入与排除标准独立筛选文献,提取资料及文献质量评价后,采用Rev Man5.3软件进行Meta分析。结果最终共纳入6项RCT,受试者8 855例。Meta分析结果显示:SGLT2抑制剂组比安慰剂组能更有效地改善糖化血红蛋白(Hb A1c)水平[WMD=-0.33,95%CI(-0.45,-0.21),P0.01]、空腹血糖(FPG)水平[SMD=-1.06,95%CI(-1.79,-0.34),P=0.004],减轻体重[WMD=-1.37,95%CI(-1.43,-1.31),P0.000 01],降低收缩压(SBP)[WMD=-5.20,95%CI(-6.79,-3.60),P0.000 01]、舒张压(DBP)[WMD=-1.96,95%CI(-2.83,-1.09),P0.000 01]。亚组分析结果显示,在重度肾损害中,SGLT2抑制剂与安慰剂在改善Hb A1c、FPG和体重方面均无显著差异;在中度肾损害中,SGLT2抑制剂降低肾小球滤过率的风险显著高于安慰剂[WMD=-2.53,95%CI(-2.92,-2.14),P0.000 01]。SGLT2抑制剂还增加发生生殖道感染的风险[RR=2.87,95%CI(2.18,3.78),P0.000 01],但在发生低血糖风险、泌尿系统感染的风险及总不良反应的风险方面与安慰剂比较差异无显著意义(均P0.05)。结论在轻度肾损害中,SGLT2抑制剂有良好的疗效及安全性;在中重度肾损害中,SGLT2抑制剂可能达不到满意的降糖效果,尚需开展更大样本更高质量的多中心的RCT予以证实。
[Abstract]:Objective to evaluate the efficacy and safety of sodium glucose co-transporter 2SGLT2 (SGLT2) inhibitor in the treatment of type 2 diabetes mellitus (T2DM) with renal damage. Methods Cochranepub MedEmbase, Chinese Biomedical Literature Database and Chinese Journal Full-text Database were searched by computer. A randomized controlled trial of SGLT2 inhibitor therapy for T2DM with renal damage was conducted. The two researchers independently screened the literature according to the inclusion and exclusion criteria, extracted the data and evaluated the quality of the literature. Rev Man5.3 software was used to carry out the Meta analysis. The results of a meta-analysis of 8 855 patients showed that the level of HbA1c in the w SGLT2 inhibitor group was more effective than that in the placebo group [WMD-0.33 ~ 95CI-0.45- 0.21P0.01], and the fasting blood glucose level was higher than that of the placebo group. [SMD-1.06C95 CI-1.79-0.34P0.004], weight loss [WMD-1.375-95CI-1.43C -1.31K P0.00001] [WMD-5.2095CI-6.79- 3.60CI-3.60CI-3.60 P0.00001] [WMD-1.995CI-2.83CI-1.09P0.00001]. There was no significant difference between SGLT2 inhibitor and placebo in improving HbA1cFPG and body weight in patients with severe renal damage. The risk of reducing glomerular filtration rate by SGLT2 inhibitor in moderate renal damage was significantly higher than that of placebo [WMD-2.53N95] .SGLT2 inhibitor also increased the risk of reproductive tract infection [RRRN 2.87-95 CI 2.183.78 P0.00001], but at the risk of hypoglycemia, SGLT2 inhibitor also increased the risk of reproductive tract infection. There was no significant difference in the risk of urinary tract infection and total adverse reactions compared with placebo (P 0.05). Conclusion SGLT2 inhibitor has good efficacy and safety in mild renal injury. SGLT2 inhibitors may not be able to achieve satisfactory hypoglycemic effects in moderate and severe renal lesions, and need to be confirmed by a larger sample of higher quality multicenter RCT.
【作者单位】：川北医学院药学院;川北医学院附属医院药剂科;
【基金】：四川省医学会科研课题(SHD11-22)
【分类号】：R587.1;R692

【相似文献】