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目的评价Dapagliflozin治疗T2DM的疗效和安全性。方法检索PubMed、Embase、Medline、Cochrane图书馆、CNKI、万方、维普、CBM 8个数据库,按Cochrane系统评价的方法评价纳入研究质量,并使用RevMan 5.2软件进行Meta分析。结果共纳入12项研究,4914例患者。与安慰剂相比,Dapagliflozin降低HbA1c(WMD=-0.58,95%CI:-0.63~-0.53,P<0.00001)、FPG(WMD=-1.23,95%CI:-1.45,-1.00,P<0.00001)和体重(WMD=-1.77,95%CI:-1.95~-1.58,P<0.00001)疗效差异均有统计学意义。安全性方面二者发生总不良反应事件(RR=1.03,95%CI:0.99~1.07,P=0.09)和低血糖事件的风险差异均无统计学意义(RR=0.96,95%CI:0.74~1.25,P=0.77)。Dapagliflozin与安慰剂比较发生生殖道真菌感染(RR=3.39,95%CI:2.56~4.50,P=0.0007)及尿路感染(RR=1.45,95%CI:1.17~1.80,P<0.00001)的风险升高。结论 Dapagliflozin与安慰剂比较能更为显著的改善T2DM患者血糖控制,减轻体重;总不良反应事件和低血糖事件发生率与安慰剂相当,可增加患者泌尿系统感染及生殖系统感染的风险。
Objective To evaluate the efficacy and safety of Dapagliflozin in the treatment of T2DM. Methods The databases of PubMed, Embase, Medline, Cochrane Library, CNKI, Wanfang, Vip and CBM databases were searched. The quality of the included studies was evaluated according to the Cochrane systematic review. Meta-analysis was performed using RevMan 5.2 software. Results A total of 12 studies were included, with 4914 patients. Dapagliflozin reduced HbA1c (WMD = -0.58, 95% CI: -0.63 -0.53, P <0.00001), FPG (WMD = -1.23, 95% CI -1.45, -1.00, P <0.00001 compared to placebo ) And body weight (WMD = -1.77, 95% CI: -1.95 ~ -1.58, P <0.00001) were statistically significant. There was no significant difference in the risk of adverse events (RR = 0.93, 95% CI: 0.99 ~ 1.07, P = 0.09) and hypoglycemic events in the two groups (RR = 1.25, P = 0.77). Dapagliflozin was associated with a higher incidence of genital tract fungal infections (RR = 3.39, 95% CI: 2.56-4.50, P = 0.0007) and urinary tract infections (RR = 1.45,95% CI: 1.17-1.80, P <0.00001) Rise. Conclusion Compared with placebo, Dapagliflozin can significantly improve blood glucose control and reduce body weight in T2DM patients. The incidence of adverse events and hypoglycemic events is comparable with that of placebo, which may increase the risk of urinary tract infection and genital infection.