【摘要】：目的系統(tǒng)評(píng)價(jià)SGLT-2抑制劑對(duì)2型糖尿病患者大血管病變危險(xiǎn)因素的影響,為制定降糖方案提供一定理論依據(jù)。方法計(jì)算機(jī)檢索PubMed、EMBASE、Cochrane Library、中國(guó)知網(wǎng)(CNKI)、萬(wàn)方、重慶維普(VIP)、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)(CBM)等數(shù)據(jù)庫(kù)建庫(kù)截至2015年3月的有關(guān)文獻(xiàn)。納入以SGLT-2抑制劑與安慰劑比較對(duì)2型糖尿病(T2DM)患者大血管病變危險(xiǎn)因素影響的隨機(jī)對(duì)照試驗(yàn)(RCT),根據(jù)Cochrane系統(tǒng)評(píng)價(jià)手冊(cè)5.1質(zhì)量評(píng)價(jià)標(biāo)準(zhǔn)評(píng)價(jià),采用RevMan5.2軟件進(jìn)行meta分析。二分類(lèi)變量(計(jì)數(shù)資料)采用相對(duì)危險(xiǎn)度RR、連續(xù)性變量(計(jì)量資料)采用標(biāo)準(zhǔn)均數(shù)差(SMD)作為效應(yīng)量,各效應(yīng)量都選用95%可信區(qū)間(CI)及P值表示。采用卡方檢驗(yàn)分析各研究或各亞組研究之間的統(tǒng)計(jì)學(xué)異質(zhì)性,當(dāng)各研究或各亞組研究之間無(wú)統(tǒng)計(jì)學(xué)異質(zhì)性(P≥0.1,I2≤50%),采用固定效應(yīng)模型實(shí)施Meta分析；當(dāng)各研究或各亞組研究間存在統(tǒng)計(jì)學(xué)異質(zhì)性(P0.1,I250%),分析異質(zhì)性的原因,采用亞組分析進(jìn)行分析。對(duì)異質(zhì)性過(guò)大或無(wú)法獲得原始數(shù)據(jù)來(lái)源時(shí),采用描述性分析。P0.05,表明有統(tǒng)計(jì)學(xué)意義。采用漏斗圖(Funnel plot)評(píng)價(jià)發(fā)表偏倚。結(jié)果共納入15個(gè)前瞻性隨機(jī)對(duì)照試驗(yàn)進(jìn)行分析,發(fā)表語(yǔ)種均為英文,包括5220例2型糖尿病患者,其中SGLT-2抑制劑組3393例,對(duì)照組1827例,試驗(yàn)時(shí)間最長(zhǎng)52周,最短12周。Meta分析結(jié)果顯示,①與安慰劑組相比,SGLT-2抑制劑能更有效降低糖化血紅蛋白,合并效應(yīng)量為[SMD=-0.94,95%CI (-1.14,-0.74), P＜0.00001],異質(zhì)性檢驗(yàn)提示各研究間存在統(tǒng)計(jì)學(xué)異質(zhì)性(P0.00001,I2=90%),進(jìn)行亞組分析提示無(wú)論病程長(zhǎng)短、療程長(zhǎng)短、合并用藥與否,SGLT-2抑制劑能更有效降低糖化血紅蛋白。②有效減輕體重,合并效應(yīng)量為[SMD=-0.72,95%CI(-0.88,-0.55),P0.00001]。③有一定降低收縮壓、舒張壓的效果,合并效應(yīng)量分別為[SMD=-0.32,95%CI(-0.38,-0.26),P0.00001]、[SMD=-0.28,95%CI(-0.34,-0.21),P0.00001]。④有效減少甘油三酯水平[SMD=-0.17,95%CI(-0.23,-0.11),P0.00001]；增加高密度脂蛋白膽固醇[SMD=0.30,95%CI(0.21,0.38),P0.00001]；有一定增加低密度脂蛋白膽固醇水平的風(fēng)險(xiǎn)[SMD=0.17,95%CI(0.11.,0.23),P0.0.0001]。結(jié)論SGLT-2抑制劑可有效降低2型糖尿病患者的糖化血紅蛋白、體重、血壓、甘油三酯,增加高密度脂蛋白膽固醇,有一定增加低密度脂蛋白膽固醇水平的風(fēng)險(xiǎn)。
[Abstract]:Objective to evaluate the effect of SGLT-2 inhibitor on the risk factors of macroangiopathy in patients with type 2 diabetes mellitus and to provide a theoretical basis for developing a hypoglycemic regimen. Methods the relevant documents were searched by computer in PubMed,EMBASE,Cochrane Library, (CNKI), Wanfang, Weipu (VIP), Chongqing, China Biomedical Literature Database (CBM), and so on, until March 2015. A randomized controlled trial (RCT), in which SGLT-2 inhibitors were compared with placebo on the risk factors of macrovascular disease in type 2 diabetes mellitus (T2DM) patients, was evaluated according to the Cochrane system evaluation manual 5.1 quality evaluation criteria. Meta analysis was performed with RevMan5.2 software. The second classification variable (counting data) uses the relative risk RR, continuity variable (the measurement data) to adopt the standard mean difference (SMD) as the effect quantity, each effect quantity all uses 95% confidence interval (CI) and the P value to express. The statistical heterogeneity was analyzed by chi-square test. When there was no statistical heterogeneity among the studies or subgroups (P 鈮，

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