Systematic Review Of Evidence-based Clinical Practice Guidelines And Economic Study For Drug Treatment Of Postmenopausal Osteoporosis

Objectives1.Evaluate the methodological quality of evidence-based clinical practice guidelines for PMOP published in China and abroad,aiming to provide reference for the choice of drugs for PMOP treatment,clarify the reference scheme for pharmacoeconomic evaluation,and promote the improvement of the quality of clinical practice guidelines in China.2.By evaluating the methodological quality of PMOP pharmacoeconomic evaluation in China systematically,to identify the economic characteristics of different anti-osteoporosis drugs and the research status of PMOP pharmacoeconomic evaluation,and to determine the direction of further research.3.Based on the recommendations of the guidelines for the treatment of PMOP,the pharmacoeconomic evaluation of PMOP in China was carried out by using Markov model from the perspective of Chinese health care system,so as to provide safe,effective and economical treatment strategies for clinical treatment,improve the overall efficiency of the use of medical resources,and reduce medical burden.Methods1.Clinical practice guidelines for PMOP published in China and abroad were electronically retrieved.Two researchers were in strict accordance with the inclusion and exclusion criteria for literature screening,and evidence-based clinical practice guidelines were included.The methodological quality of the inclusion guidelines was evaluated by using AGREE II,and the recommendations of drug treatment were compared and summarized.2.The pharmacoeconomic evaluation literatures on the treatment of PMOP in China were systematically searched and screened independently by two researchers in strict accordance with the inclusion and exclusion criteria.The methodological quality of the literature was evaluated by using QHES,and it was finally included in the high-quality literature.The relevant data of the literature were extracted and analyzed,and the economic research results of different treatment schemes of PMOP were systematically evaluated.3.A Markov model of postmenopausal osteoporosis was developed using Tree Age Pro 2015 software,combined with the epidemiological data,medical cost data and utility index of osteoporotic fracture in China,as well as the treatment adherence of patients in clinical practice,to evaluate the economy of alendronate,risedronate,zoledronate,raloxifene and teriparatide.The model took 1 year as a cycle and simulated the disease progression of PMOP for 40 cycles.Taking QALY and ICUR as economic evaluation indicators,the cost-utility analysis was carried out,and the stability of the research results was tested by one-way sensitivity analyses and probabilistic sensitivity analyses.Results1.A total of 9 PMOP evidence-based clinical practice guidelines were included,all of which were recommended at grade B.The average standardized scores of the guidelines in the six domains of AGREE II were respectively 85% in scope and purpose,55% in stakeholder involvement,49% in rigor of development,86% in clarity of presentations,31% in applicability and 65% in independence.The recommendations for therapeutic drugs in each guideline were slightly different.Based on the comprehensive analysis and integration of the recommendations,the recommendations for the treatment of PMOP were formed.2.A total of 8 medium and high quality economic evaluation studies were finally included,in which the model study method was used to evaluate the economy of anti-osteoporosis drugs from different perspectives.Anti-osteoporosis therapy in patients with PMOP was cost effective,but the relative cost effectiveness of different drugs varied according to the controlled measures,research objects,methods and perspectives.3.The results of Markov model showed that using risedronate,alendronate,zoledronate,raloxifene and teriparatide obtained 9.23 QALYs、9.24 QALYs、9.29QALYs、9.24 QALYs 和 9.31 QALYs,and the cumulative costs were (?)20140.38,(?)23700.38,(?)25689.47,(?)30114.60 and (?)99244.35,respectively.The ICER for zoledronate versus risedronate and alendronate was (?)99360.06/QALY and(?)43932.31/QALY,both of which were lower than the WTP set in this study.The one-way sensitivity analyses demonstrated that the two most impactful parameters were the relative risk of vertebral fracture with zoledronate and the zoledronate therapy persistence in the second year.In probabilistic sensitivity analyses,the probability of zoledronate being cost-effective was 77.4%.Conclusions1.The overall methodological quality of PMOP clinical practice guidelines was medium level,so we should strictly follow the standards of evidence-based guidelines and the requirements of AGREE II to formulate high-quality PMOP evidence-based clinical practice guidelines in China.At present,the available therapeutic drugs for PMOP in China are bisphosphonates,raloxifene,estrogens,teriparatide and so on.Individualized treatment plan should be made according to the specific conditions and needs of patients,combined with the costs and benefits of treatment.2.Due to the limitations of the number of included studies and heterogeneity among studies,it is not yet possible to make clear recommendations on the economy of PMOP therapeutic drugs in China.It is advocated to carry out more standardized and comprehensive pharmacoeconomic evaluation study according to China Guidelines for Pharmacoeconomic Evaluations,so as to provide high-quality health economic research evidence for medical decision-making.3.From the perspective of Chinese health care system,zoledronate was more cost effective than risedronate,alendronate,raloxifene and teriparatide at a WTP of(?)212676/ QALY.Risedronate is shown to be dominant in the case of full adherence.