| Objective: To establish the rational clinical application evaluation system for the treatment of type 2 diabetes mellitus by using the method of systematic review,and to provide a evidence for the specification of drug use.Methods: The randomized controlled trials(RCT)of albiglutide in treatment of T2 DM were searched from EBSCO,PubMed(Medline),OVID(including Embase),Cochrane library,CNKI,Wangfang detabase,and VIP database by computer.Data were collected from January 2000 to October 2016 and also retrieved manually.Two researchers according to the inclusion and exclusion criteria for screening literature,data extraction and cross check,and assess them by literature quality evaluation standard.The effect index of each intervention group was analyzed by Meta-analysis and evaluated them bias with RevMan 5.0 software.Results: A total of 10 randomizd controlled trail(RCT)were included,and there was no significant abnormality in bias evaluation,8 of them belong to high quality research,involving patients with type 2 diabetes mellitus 2360,including 1199 patients of albiglutide group,613 patients in the placebo group and 548 patients in the active drug group.Meta-analysis results show that,end of treatment period,(1)compared with those in the placebo group,the patients of albiglutide group of glycosylated hemoglobin A1c(Hb A1c)levels(MD =-0.89,95%CI:-1.11 ~-0.66,P<0.001),fastingplasma glucose(FPG)levels(MD =-1.58,95%CI:-1.90 ~-1.26,P<0.001),reaching standard rate of HbA1c(<7.0%)(RR= 3.01,95%CI:2.34 ~ 3.87,P<0.001),hypoglycemia incidence rate(RR= 1.55,95%CI:1.10 ~ 2.19,P<0.05),and incidence rate of injection site reaction(ISR)(RR= 2.36,95%CI:1.61 ~ 3.47,P<0.001)had significant difference,HbA1 c,FPG level is low and the range of fluctuation is not high,reaching standard rate of HbA1c(<7.0%)is high,but the incidence of hypoglycemia and ISR is high,withdrawal rate for adverse events(AE),incidence rate of severe adverse events(SAE)(fatal or non fatal),and other incidence rate of adverse reactions(diarrhea,nausea,vomiting,constipation,dyspepsia,headache,dizziness,back pain,abdominal pain,high blood pressure,nasopharyngitis,upper respiratory tract infection,urinary tract infection and exfoliative rash)had no significant difference(P>0.05).(2)Compared with patients in the active drug(sitaglipin)group,the patients of albiglutide group of HbA1 c levels(MD =-0.36,95%CI:-0.47 ~-0.25,P<0.001),FPG levels(MD =-1.06,95%CI:-1.35 ~-0.77,P<0.001),reaching standard rate of HbA1c(<7.0%)(RR= 1.40,95%CI:1.10 ~ 1.78,P<0.05),hypoglycemia incidence rate(RR=1.55,95%CI:1.10 ~ 2.19,P<0.05),and incidence rate of ISR(RR= 2.56,95%CI:1.69 ~ 3.89,P<0.001)had significant difference,HbA1 c,FPG level is low and the range of fluctuation is not high,reaching standard rate of HbA1c(<7.0%)is high too,but the incidence of hypoglycemia and ISR is high too,withdrawal rate for AE,incidence rate of SAE(fatal or non fatal),and other incidence rate of adverse reactions(diarrhea,nausea,high blood pressure,nasopharyngitis,upperrespiratory tract infection)had no significant difference(P > 0.05).Conclusion:(1)As far as the current evidence is concerned,albiglutide has good control effect on HbA1 c and FPG in treatment of T2 DM,HbA1c(<7.0%)reaching standard rate is more ideal,common gastrointestinal reactions,such as Nausea,vomiting,diarrhea,constipation and abdominal pain and other symptoms of patients can be tolerated,and did not affect the continued treatment,with low incidence of high blood pressure,nasopharyngitis,upper respiratory tract infection,urinary tract infection and exfoliative rash and rare,but the incidence of hypoglycemia,ISR than that of the control group was higher,which may affect the long-term treatment of the drug.(2)Due to limitation of randomized controlled trial(RCT)design,such as sample size,treatment period and follow-up period,individual differences in subjects and uncertainty of other objective environment factors can affect test results,and may also affect the results of the two analysis,therefore,still needed a large sample,high quality and strict design randomized controlled trials of the efficacy and safety of long term research on albiglutide to validate. |
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