| ObjectiveTo evaluate the efficacy and safety of saxagliptin combined with insulin and insulin independently on patients with type 2 diabetes at home and abroad systematically.To provide more reliable evidence of evidence-based medicine for the treatment of type 2 diabetes.MethodsCNKI、 Wanfang、 VIP、 Pubmed、Cochrane Library、 CBM databases were searched systematically.The time was from 2009 to 2017(January 1,2009 to June 30,2017).We retrieved randomized controlled trials of saxagliptin combined with insulin and insulin independently on patients with type 2 diabetes which had been published in domestic and foreign journals.The literature were screened strictly according to the inclusion and exclusion criteria.Jaded scale was used to evaluate the quality.The Rev Man5.3 statistical software was used for meta-analysis.The Stata12.0 was used to carry out Egger’s test and sensitivity analysis.Results(1)A total of 502 articles were detected initially and 21 articles were included in this meta-analysis,including 21 RCTs,whose language were Chinese.There was 1 high quality research and 20 low quality researches among them.(2)Heterogeneity test showed that there were no significant heterogeneities on the levels of Hb A1c、FBG and PBG before experiments between the experiment and control group among the articles(I2=0%),so the fixed effect model was chose to conduct meta-analysis.The results of meta-analysis showed that there were no statistical differences between the indexes before the experiment in Hb A1 c [MD=0.02,95%CI(-0.14,0.18),P=0.84],FBG [MD=0.10,95%CI(-0.13,0.33),P=0.40],PBG [MD=0.09,95%CI(-0.21,0.38),P=0.57].Comparative analysis of efficacy: The treatment group was superior to the control group in the reduction of Hb A1 c levels on patients with type 2 diabetes mellitus(MD=-0.83,95%CI(-1.01,-0.64),P<0.00001),suggesting that the treatment group of saxagliptin combined with insulin was better than the control group with insulin alone in reducing the level of Hb A1 c in patients with type 2 diabetes mellitus;in reducing FBG and PBG levels on patients with type 2 diabetes mellitus,the treatment group was superior to the control group(MD=-0.89,95%CI(-1.17,-0.61),P<0.00001)、(MD=-1.26,95%CI(-1.61,-0.91),P<0.00001),suggesting that the treatment group of saxagliptin combined with insulin was better than the control group with insulin alone in reducing the level of FBG and PBG in patients with type 2 diabetes mellitus;in controlling fasting serum C peptide levels on patients with type 2 diabetes,the treatment and control group has the same effect with no statistical differences(MD=0.05,95%CI(-0.06,0.16),P=0.35),suggesting that the effect in controlling fasting serum C peptide levels between the treatment group of saxagliptin combined with insulin and the control group with insulin alone was equivalent;in terms of controlling postprandial 2 hours C peptide on patients with type 2 diabetes mellitus,the treatment group was superior to the control group(MD=0.51,95%CI(0.25,0.77),P=0.0001),suggesting that the treatment group of saxagliptin combined with insulin was better than the control group with insulin alone in improving the effect of postprandial 2 hours C peptide in patients with type 2 diabetes mellitus;in reducing the level of daily insulin dosage of type 2 diabetes patients,the treatment group was superior to the control group(MD=-16.64,95%CI(-20.02,-13.25),P<0.00001),suggesting that the treatment group of saxagliptin combined with insulin was better than the control group with insulin alone in reducing the level of daily insulin dosage of type 2 diabetes patients.Publication bias analysis results showed that in addition to the funnel-plot of Hb A1c(P= 0.017),the funnel-plot of other indicators displayed a symmetrical figure,indicating there was no publication bias;sensitivity analysis performed by Stata 12.0 software showed that there was no difference of all the indicators,suggesting that the results are stable.Analysis of safety indicators: the incidence of adverse reaction of the treatment group was superior to the control group(MD=0.38,95%CI(0.28,0.53),P<0.00001),suggesting that the incidence of adverse reaction was lower than the control group;the incidence of hypoglycemia of the treatment group was superior to the control group(MD=0.31,95%CI(0.22,0.45),P<0.00001),suggesting that the incidence of hypoglycemia was lower than the control group;the treatment group was superior to the control group in controlling patients’ body mass index(MD=-3.17,95%CI(-5.31,-1.03),P=0.004),suggesting that the treatment group of saxagliptin combined with insulin was better than the control group with insulin alone in improving the level of body mass index of type 2 diabetes patients.Publication bias analysis results showed that in addition to the funnel-plot of the incidence of adverse reaction(P= 0.003),the funnel-plot of other indicators displayed a symmetrical figure,indicating there was no publication bias;sensitivity analysis performed by Stata 12.0 software showed that there was no difference of all the indicators,suggesting that the results are stable.ConclusionsThis meta-analysis showed that compared with insulin alone,saxagliptin combined with insulin therapy had certain advantages to reduce the type 2 diabetes patients with Hb A1 c,FPG and PBG levels effectively,reduce the daily amount of insulin,improve the patients’ potprandial 2-hour C peptide levels,and had high safety.Saxagliptin combined with insulin therapy didn’t increase the risk of hypoglycemia and other adverse reactions could lose weight.Therefore,saxagliptin combined with insulin therapy in clinical applications is a safe,effective,alternative treatment options.However,most of the 21 studies included in this study were Chinese,and the quality of most of them were low.Some of the results had publication bias analysis and could influence the results.And the current time of Saxagliptin coming into the market is not very long,so the number of literatures included in the study is limited.The efficacy and safety of long-term prescription also need more evidence to support,large samples and high-quality clinical randomized controlled trials to carry out. |
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