Comparative Study On Clinical Effect And Cost-effectiveness Of Bariatric Surgery For Patients With Type 2 Diabetes Mellitus

Background As society develops and lifestyles change.after cardiovascular disease and the tumor,diabetes mellitus has become the third largest chronic diseases,threatening to reduce life expectancy for humans around the global.Diabetes mellitus is the common public health problem faced by the whole world due to its high cost,high disability,and high lethality.The situation of diabetes appears more severe in China.The prevalence of type 2 diabetes in China has exploded in the past two decades.In 1980,the prevalence of Chinese males was less than 5%;in 2010.the prevalence of diabetes in China was about 11.6%.In 2015.China has about 110 million people with diabetes,accounting for about one-tenth of the total number of Chinese adults.More seriously,nearly half of China's adults are in the early stages of diabetes,about 500 million people.This not oinly brings the risk of developing type 2 diabetes,but also the risk of cardiovascular disease and other diseases.Although the field of diabetes treatments has made great progress in the past few years,making the weight loss and blood glucose reduced partly of patients.Unfortunately,the current traditional treatment failed to cure diabetes completely,and can not delay the occurrence of diabetic complications.In recent years,bariatric surgery has made a breakthrough in obese type 2 diabetes treatment.Bariatric surgery was originally used to treat morbid obesity.In the 1990s,bariatric surgery is not only significant to weight loss,but also good to control of blood glucose.A prospective controlled study found that,the patients can maintain the normal blood glucose without drugs by went the surgery,and diabetes-related complications and mortality significantly reduced significantly than non-surgical group.Given the situation that medical treatments were difficult to maintain long-term stable effect of morbid obesity and type 2 diabetes,bariatric surgery become an eff-ective method to treat the patients with type 2 diabetes.Bariatric surgery becomes a new consensus in the treatment of diabetes.However,there are still several research gaps at the present stage of bariatric surgery in the treatment of type 2 diabetes.First,meta-analysis of clinical effect on diabetes treatment between bariatric surgery strategy and non-surgical strategy in the Asian population was still lacking.At present.the meta-analysis of clinical effect on diabetes treatment between bariatric surgery strategy and non-surgical strategy,and meta-analysis of clinical effect on diabetes treatment between dif-ferent bariatric surgeries have been studied slightly.but for the Asian population.Imeta-analysis is still lacking.For type 2 diabetes is associated with insulin resistance,and the insulin resistance index varies f-rom different races.Therefore,it is necessary to conduct a meta-analysis of clinical effect on diabetes treatment between bariatric surgery strategy and non-surgical strategy for the Asian population.Secondly.randomized controlled trials(RCT)of clinical effect on diabetes treatment between laparoscopic Roux-en-Y gastric bypass(LRYGB)and laparoscopic sleeve gastrectomy(LSG)are inadequate.LRYGB and LSG are the most widely used and most recognized bariatric surgeries,and the evaluation and comparative analysis of clinical effect between these two surgeries have been confirmed in several observational studies.However.RCT of clinical effect on diabetes treatment between LRYGB and LSG are still inadequate in our country.Thirdly,the study of clinical effect on diabetes treatment between LRYGB and LSG is still lack based on Propensity Score Matching(PSM)in the "real" world.Although RCT have some advantages,such as good compatibility between groups,prevention of selective bias,and exact diagnosis of subjects,but due to their strict inclusion and exclusion criteria,some limitations of unrepresentativeness and weak external authenticity would exist in the their findings.Therefore,it is necessary to research the clinical effect on diabetes treatment between LRYGB and LSG in the"real" world based on the PSM.Finally,the cost-effectiveness evaluation on diabetes treatment between bariatric surgery strategy and non-surgical strategy is lacking.The short-term clinical evaluation on diabetes treatment between LRYGB and LSG has been confirmed by a number of large studies,but the effectiveness of unit quality adjustment life years(QALY)on diabetes treatment between bariatric surgery strategy and non-surgical strategy from the perspective of health economics is still lacking.ObjectivesBased on the method of Meta-analysis,PSM,Markov model,the data from Diabetes Surgery Center of Beijing Shi Ji Tan Hospital Affiliated to Capital University of Medical Sciences,and the funding of "The Design and Empirical Study on the Reimbursement for the Use of Essential Medicine at Primary Health Providers among Elderly Patients with Chronic Diseases under the Background of Building Hierarchical Medical System" of National Natural Science Foundation of China(No.71673169).we did the "Comparative Study on Clinical Effect and Cost-Effectiveness of Bariatric Surgery for patients with Type 2 Diabetes Mellitus".The current study by means of ? Meta-analysis of clinical effect on diabetes treatment between bariatric surgery strategy and non-surgical strategy in the Asian population;? Clinical effect evaluation on diabetes treatment between LRYGB and LSG-a randomized controlled trial;? Clinical effect evaluation on diabetes treatment between LRYGB and LSG-a retrospective cohort study based on PSM;? Evaluation of cost-effectiveness on diabetes treatment between LRYGB and LSG-an economic evaluation based on Markov Model,aiming at ? realizing the competitive advantage treatment strategy of clinical effect on diabetes between bariatric surgery strategy and non-surgical strategy for the Asian population,?confirming the clinical effect and statistical differences of diabetes treatment between LRYGB and LSG.and finally ? finding out the highest cost-effect strategy between bariatric surgery and non-surgical program,which can provid useful clues and clinical data for the developmet of type 2 diabetes treatment.Material and methodThe current study researched the clinical effect and cost-effectiveness of LRYGB and LSG for type 2 diabetes mellitus.adding the existing evidence and providing the reference information for the developmet of type 2 diabetes treatment.Given this,the research methods can be summarized as follows:? Meta-analysis of clinical effect on diabetes treatment between bariatric surgery strategy and non-surgical strategy in the Asian population;? Clinical effect evaluation on diabetes treatment between LRYGB and LSG-a randomized controlled trial;? Clinical effect evaluation on diabetes treatment between LRYGB and LSG-a retrospective cohort study based on PSM;? Evaluation of cost-effectiveness on diabetes treatment between LRYGB and LSG-an economic evaluation based on Markov Model.Main ResultsBased on the above analysis and discussion,the main conclusions of this study as followings:? The results of Meta-analysis showed that the bariatric surgery can effectively improve the situation of blood glucose,body mass index,weight,low density lipoprotein cholesterin,high density lipoprotein cholesterol,triglyceride and diabetes remission rate,and it was significantly better than non-surgical treatment.? The results of RCT showed that LRYGB and LSG are the effective treatment methods for patients with type 2 diabetes,and there has no statistical difference of clinical effect evaluation on diabetes treatment between LRYGB and LSG.as same as the other researches.? The results of cohort study based on PSM showed that LRYGB and LSG are the effective treatment methods for patients with type 2 diabetes,and there has no statistical diff-erence of clinical effect evaluation on diabetes treatment between LRYGB and LSG,as same as the other researches.In addition,LRYGB is more suitable for the patients whose weight is smaller,and LSG is more suitable for the patients who have obesity-based symptoms.Moreover,LRYGB and LSG are reliable for patients' safety.? The results of cost-effectiveness based on Markov model showed that the cost-effectiveness ratios of LRYGB and LSG are higher than the non-surgical treatment strategy.Policy Suggestion? Further developing the pathways standardized of surgical treatment type 2 diabetes;? Strengthening the degree of science popularization of the surgical treatments for type 2 diabetes;? Promoting the combination and teamwork of public health department and clinical system:? While encouraging surgical treatment,the development of internal medicine should be further studied.Innovations and Shortcomings(1)Innovations:? We compare the retrospective data by 1:1 based on the PSM and then bring the results into the "real world" to prove the reliability of the study,providing the data support for evidence-based medicine.?Evaluation of cost-effectiveness on diabetes treatment between LRYGB and LSG-an economic evaluation based on Markov Model,finding out the highest cost-effect strategy between bariatric surgery and non-surgical program,which can provid useful clues and clinical data for the developmet of type 2 diabetes treatment.(2)Shortcomings:? The first stems mainly from its relatively small sample size.Limited data on the long-term eff-ects of bariatric surgery are available,which means the follow-up in current study was only two years,so that a consistent remission as defined by the ADA was not evident;? Limited data on the questionnaire survey of "quality of life".If we can collect this part of data,we can conduct the further research and better enhance the comprehensiveness of this study,providing more evidence to evidence-based medicine.