| Objectives:After compared with other treatments for type 2 diabetes,such as Chinese medicine therapy,exercise therapy,diet therapy,etc.,this study analyzed and evaluated the efficacy and safety of acarbose in the treatment of type 2 diabetes in detail.The purpose of this research is to provide evidence-based medical evidence for promoting the rational clinical use of acarbose and medical and health related departments' scientifically making relevant health decisions,and to better treat type 2 diabetes and improve the quality of life of type 2 diabetes patients.Methods:1.In order to have a preliminary understanding of meta-analysis,type 2 diabetes and its treatment methods,we should review the published literature at home and abroad on type 2 diabetes mellitus and its therapeutic drugs,acarbose,meta-analysis,and so on.Afterwards,"Acarbose","Type 2 diabetes","Meta-analysis" and "Acarbose","glucosidase inhibitor","T2DM","Meta-analysis" were used as Chinese and English search terms,and "title" and"keywords"were used as search fields.In this way,we retrieved documents from the National Medical Library of the United States(PubMed),Springer Link Journal Full Text Database(Biomedical Album),China Journal Full Text Database(CNKI),Wan Fang Data and Vip Chinese Science and Technology Journal Full Text Database(VIP),and supplementd relevant documents by manual retrieval.The retrieval period was from January 2010 to December 2018,and this study collected the papers published in public during this period and the full-text resources were available only.2.According to the accepted rejection criteria that have been formulated,the patients who met the criteria of WHO or American Diabetes Association(ADA)were selected as the subj ects for definite diagnosis of type 2 diabetes mellitus.Randomized controlled trials(RCTs)were designed as the type of study.Acarbose or acarbose combined with other type 2 diabetes mellitus were selected as the observation group/experimental group.While the control group was treated with diet therapy,exercise therapy,other hypoglycemic drugs(including traditional Chinese and Western medicine)and other treatment methods for type 2 diabetes mellitus.The outcome indicators included total effective rate,fasting blood glucose(FBG),postprandial blood glucose(2hPG),glycosylated hemoglobin(HbAlc),total cholesterol(TC),body mass index(BMI)and secondary outcomes such as gastrointestinal adverse reactions,liver injury and allergic reactions.3.Data were extracted from eligible included literature,which including general information(title of literature,name of author,date of publication and name of journal),basic information of the trial(baseline information of two groups of patients participating in the trial,illness,number of sample cases,intervention measures of treatment group/observation group/study group,intervention measures of control group,etc.),and outcome therapy effective indicators of the study(total effective rate,fasting blood sugar,2h postprandial blood sugar,glycosylated hemoglobin,total cholesterol,body mass index and other major outcomes as well as gastrointestinal adverse reactions,liver inj ury,allergic reactions and other secondary outcomes).4.After the extraction of literature data,the improved Jadad 7 subscale was used to evaluate the quality of the included literature.Moreover,the score was 0-7,of which 1-3 was low-quality research and 4-7 was high-quality research.According to the extracted data,the research uses RevMan 5.3 software for quantitative statistical analysis,and the relevant results are explained and discussed.Contents:In this study,a randomized controlled clinical trial of acarbose in the treatment of type 2 diabetes mellitus was retrieved from PubMed,Springer Link,CNKI,Wanfang and Weipu databases.Through searching and reading relevant literatures,scientifically formulating and according to relevant search strategies and inclusion exclusion criteria,reasonably incorporating the required research and carrying out meta-analysis,which mainly including heterogeneity testing,effect value calculation and so on.Sensitivity analysis and publication bias analysis should also be conducted when it is necessary to evaluate the efficacy and safety of acarbose compared with other therapies in the treatment of type 2 diabetes mellitus.Results:1.According to the strategies and methods of document retrieval which have been formulated,2325 full-text papers were retrieved in PubMed,Springer Link,CNKI,Wanfang,Weipu and other databases.Through reading the title,abstract and full-text of the papers,and combining with inclusion and exclusion criteria,49 randomized controlled studies were finally included,totaling 7235 cases.There were 3565 patients in the experimental group/research group/observation group and 3670 patients in the control group.All the experimental group/study group/observation group were treated with acarbose or acarbose combined with other treatment methods.2.After completing the work of document data extraction,the improved Jadad scale(assessment scale with 7 scores)was used to evaluate the quality of the included literatures.Only one of the included literatures scored 4 points,which belonged to the scope of high-quality research.The rest belonged to the scope of low-quality research,and most of them scored only 1 point.Studies on the efficacy and safety of acarbose have not paid attention to the implementation of specific randomized grouping methods,the application of randomized concealment,blind method and other bias control.The quality of research is generally low,and the quality of clinical research needs to be improved.3.According to the total effective rate of clinical treatment,2-hour postprandial blood glucose level and glycosylated hemoglobin level,the corresponding data were recorded and analyzed with RevMan 5.3 software.The results were as follows:?The total effective rate of clinical treatment[RR= 1.18,95%CI(1.15,1.21),P<0.000001],the difference was statistically significant;after eliminating the possible factors,the results did not change significantly,the stability was good;funnel diagram was asymmetric,and there was a certain publication bias;?2-hour postprandial blood glucose level[SMD=0.60,95%CI(-0.97,-0.23),P=0.0001<0.01],the difference was statistically significant;after eliminating the possible influencing factors,the results did not change significantly,the stability was better;funnel diagram was asymmetric,and there was a certain publication bias;?glycosylated hemoglobin level[SMD= 2.27,95%CI(-3.81,-0.74),P<0.00001],the difference was statistically significant;After eliminating the possible influencing factors,the results changed obviously and had certain sensitivity;only 4 literatures with glycosylated hemoglobin level as the outcome index were delineated,and the number was less than 10,which was not not appropriate to make funnel plots for publication bias analysis because of the insufficient test efficiency probably.4.Meta-analysis showed that there were significant differences in the analysis results of various indicators,indicating that the efficacy of acarbose or acarbose combined with other therapies in the treatment of type 2 diabetes mellitus was different from that of the control group,and the therapeutic effect was better than that of the control group.However,acarbose and its combination therapy in the application process will also produce some adverse reactions,which need our attention.There are many adverse reactions reported in the literature in this study,such as hypoglycemia,abdominal distension,diarrhea,abdominal pain,increased exhaust,headache,nausea,vomiting,cough,etc.According to the results of this study,hypoglycemia,gastrointestinal adverse reactions and digestive system disorders have occurred more,and the use of drugs in the experimental group/research group/observation group can only reduce the number of cases,which cannot be prevented.Therefore,more attention should be paid to prevention.Conclusions:1.Acarbose and its combination therapy in the treatment of type2 diabetes mellitus has significant effect,and has certain advantages compared with other therapies.2.Acarbose and its combination therapy can also produce some adverse reactions in the course of treatment,but compared with other therapies,the adverse reactions did not increase significantly and the number of cases generally decreased. |
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