口服索马鲁肽治疗2型糖尿病疗效和安全性的系统评价
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篇名: 口服索马鲁肽治疗2型糖尿病疗效和安全性的系统评价
TITLE: Efficacy and Safety of Oral Semaglutide in the Treatment of Type 2 Diabetes Mellitus :A Systematic Review
摘要: 目的:系统评价口服胰高血糖素样肽1受体激动药索马鲁肽治疗2型糖尿病(T2DM)的疗效与安全性,为临床治疗T2DM提供循证参考。方法:计算机检索PubMed、Embase、Cochrane图书馆、ClinicalTrials.gov、中国生物医学文献数据库、中国期刊全文数据库、中文科技期刊数据库,收集各数据库建库起至2020年5月间发表的口服3、7、14mg索马鲁肽(试验组)对比安慰剂或其他降糖药(对照组)治疗T2DM的疗效与安全性的随机对照试验(RCT)。对符合纳入标准的临床研究进行资料提取,并采用Co-chrane系统评价手册5.1.0进行质量评价后,采用RevMan5.3统计软件进行Meta分析。结果:共纳入6项RCT,合计5334例患者。Meta分析结果显示,与对照组比较,试验组方案可显著降低HbA1c水平{治疗26周[MD=-0.62,95%CI(-0.88,-0.36),P<0.001]、52周[MD=-0.51,95%CI(-0.72,-0.29),P<0.001]}、FPG水平{治疗26周[MD=-0.89,95%CI(-1.31,-0.48),P<0.001]、52周[MD=-0.68,95%CI(-1.05,-0.31),P<0.001]},显著提高HbA1c<7.0%达标率{治疗26周[RR=2.22,95%CI(1.68,2.93),P<0.001]、52周[RR=2.02,95%CI(1.51,2.70),P<0.001]},同时可显著降低治疗26、52周的自测血糖水平、体质量和收缩压(DBP),治疗26周的自测餐后血糖水平和治疗52周的舒张压(SBP)(P<0.05)。索马鲁肽不同剂量的亚组分析中,与对照组比较,3mg亚组方案可显著降低治疗26、52周的体质量以及治疗52周的DBP;7mg亚组方案可显著降低治疗26、52周的HbA1c水平以及体质量,治疗26周的FPG水平、自测血糖水平以及治疗52周的SBP,提高治疗26周的HbA1c<7.0%达标率;14mg亚组方案可显著降低治疗26、52周的HbA1c、FPG、自测血糖水平、体质量和SBP以及治疗26周的自测餐后血糖水平,提高治疗26、52周的HbA1c<7.0%达标率(P<0.05)。试验组患者低血糖事件发生率[RR=0.84,95%CI(0.72,0.97),P=0.02]显著低于对照组,但不良事件发生率[RR=1.23,95%CI(1.09,1.40),P=0.001]和胃肠道不良事件发生率[RR=1.99,95%CI(1.55,2.57),P<0.001]显著高于对照组。两组患者严重不良事件发生率和感染发生率比较,差异均无统计学意义(P>0.05)。结论:口服索马鲁肽可有效降低T2DM患者血糖水平、提高HbA1c<7.0%达标率、减轻体质量、降低血压水平,其中以14mg亚组疗效最优。但在使用索马鲁肽时应注意不良事件尤其是胃肠道不良事件的发生。
ABSTRACT: OBJECTIVE:To systematically evaluate th e efficacy and safety of glucagon-like peptide 1 receptor agonists semaglutide in the treatment of type 2 diabetes mellitus (T2DM),and to provide evidence-based reference for clinical treatment of T2DM. METHODS :Retrieved from PubMed ,Embase,the Cochrane library ,ClinicalTrials.gov,CBM,CNKI and VIP , randomized controlled trials (RCT) about oral semaglutide 3 mg,7 mg and 14 mg (trial group ) versus placebo or other glucose-lowering drugs (control group )in the treatment of T 2DM were selected during the inception to May 2020. After extracting data from clinical studies that met the inclusion criteria ,quality evaluation was carried out with Cochrane systematic evaluation manual 5.1.0,Meta-analysis was performed by using Rev Man 5.3 statistical software. RESULTS :A total of 6 RCTs involving 5 334 patients were included. Results of Meta-analysis showed that compared with control group ,trial group could significantly decreased HbA 1c level { 26 weeks [MD=-0.62,95%CI(-0.88,-0.36),P<0.001],52 weeks [MD=-0.51,95%CI(-0.72, -0.29),P<0.001]},FPG level { 26 weeks [MD=-0.89,95% CI(-1.31,-0.48),P<0.001],52 weeks [MD=-0.68,95%CI (-1.05,-0.31),P<0.001]};significantly increased the compliance rate of HbA 1c<7% {26 weeks [RR=2.22,95%CI(1.68, 2.93),P<0.001],52 weeks [RR=2.02,95%CI(1.51,2.70),P<0.001]};significantly decreased the self-measured plasma glucose , body weight and diastolic blood pressure (DBP)after 26 and 52 weeks of treatment,self-measured postprandial glucose cstc2015zdcy-ztzx120005) after 26 weeks of treatment and systolic blood pressure (SBP) E-mail: after 52 weeks of treatment(P<0.05). Subgroup analysis of different doses showed that compared with control group ,3 mg subgroup could significantly decreased the body weight after 26 and 52 weeks of treatment and DBP a fter 52 weeks of treatment ;7 mg subgroup could significantly decreased the HbA 1c levels and body weight after 26 and 52 weeks of treatment ,the FPG levels and the self-measured plasma glucose after 26 weeks of treatment and the SBP after 52 weeks of treatment ,increased the compliance rate of HbA 1c<7% after 26 weeks of treatment. The 14 mg subgroup could significantly decreased the HbA 1c levels ,the FPG levels ,the self-measured plasma glucose levels ,the body weight and the SBP after 26 and 52 weeks of treatment ,and self-measured postprandial glucose after 26 weeks of treatment ,while increased the complication rate of HbA 1c<7% after 26 and 52 weeks of treatment (P<0.05). The incidence of hypoglycemia events in trial group [RR =0.84,95%CI(0.72,0.97),P=0.02] was significantly lower than control group ,but the incidence of adverse events [RR =1.23,95%CI(1.09,1.40),P=0.001] and gastrointestinal reaction [RR =1.99,95%CI(1.55,2.57),P<0.001] were significantly higher than control group. There was no significant difference in the incidence of serious adverse events or infection between 2 groups(P>0.05). CONCLUSIONS :Oral semaglutide can effectively decrease blood glucose level ,increase the compliance rate of HbA 1c<7.0%,reduce the body weight and blood pressure level of T 2DM patients ,and the 14 mg subgroup has the best effect. When using somaluptide , we should pay attention to the occurrence of adverse events , especially gastrointestinal adverse events.
期刊: 2020年第31卷第19期
作者: 覃渝,左丹妮,高倩,夏培元
AUTHORS: QIN Yu,ZUO Danni,GAO Qian,XIA Peiyuan
关键字: 索马鲁肽;2型糖尿病;疗效;安全性;系统评价
KEYWORDS: Semaglutide;Type 2 diabetes mellitus ;Efficacy;Safety;Systematic review
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