基于B-SMART的类风湿关节炎分级诊疗的药物治疗管理模式构建与评价

Effective management of medication treatment can improve the joint function and structural of RA and avoid related disability/labor loss. The applicant initially opened the first pharmacist clinic in Shanghai and joined the community expert workshops. The applicant found major medication problems of RA patients were: the lack of adverse reaction monitoring, taking drug with inappropriate methods, self adjustment dose, missing dose, and even withdrawal. The health utility of RA patients in our hospital is the lowest among the surveyed rheumatic diseases; the annual direct medical cost per capita is close to that of Europe and America. In a graded diagnosis and treatment environment, the patient's referral to a community hospital is more likely to lack of standardized follow-up management. Thus, The scientific/standardized management model of drug treatment needs to be established urgently. In this project, we plan to: 1) further investigate the drug epidemiology of the community patients under the Medical Union, establish the compliance prediction model, and determine the key guardianship objects by risk stratification. 2) According to the prediction model built in the early stage, we adopted the B-SMART mode to take appropriate intervention measures for all kinds of drug problems and extend the outpatient clinical pharmacy services to the community hospital. 3) Use randomized controlled experiments to verify the effectiveness and continuous improvement of the new model with clinical outcomes and cost-effectiveness as the evaluation indicator. This project applies the B-SMART model to the RA, and constructs a pharmacist led community-tertiary hospital associated multi/individual/Internet management model. This study promotes the standardized treatment and follow-up management of RA and other chronic diseases to reduce the disease burden of patients and the state.

有效的药物治疗管理可改善类风湿关节炎(RA)的关节功能及结构破坏相关的残疾/劳动力丧失。申请人通过开设上海首家药师门诊与社区专家工作室，开展药物流行病调研发现：RA患者自主调整剂量/漏服、药品服用方法不当及缺乏副作用监护等重要药物治疗管理问题；在所调查疾病中健康效用值最低，人均年直接医疗成本接近欧美。分级诊疗环境下患者转诊到基层后更缺乏规范的后续管理，科学性/标准化的药物治疗管理模式亟待建立。.本项目拟基于B-SMART管理新模式，开展医联体下RA患者药物流行病调查并建立电子用药档案；以套索回归分析构建依从性数学预测模型，通过危险分层确定重点监护对象，向基层延伸三甲医院药学服务；以临床结局/成本-效益为评价指标，通过随机对照实验评价新模式并持续改进，最终构建“药师参与的社区-三级医院联动的多元/个体/互联网化”的药物治疗管理新模式，推动RA等慢病分级诊疗的科学管理，减轻患者及国家经济负担。

类风湿性关节炎（RA）是我国关节病所致肢体残疾的首位原因，造成患者丧失劳动力甚至自理能力，有效的药物治疗管理可延缓关节功能及结构破坏。项目负责人前期开展药物流行病调研发现：RA患者自主调整剂量、漏服、药品服用方法不当及缺乏副作用监护等重要药物治疗管理问题；并且在所调查疾病中其健康效用值最低，人均年直接医疗成本接近欧美。分级诊疗环境下，患者转诊到基层医院后更缺乏规范的后续管理，科学性、标准化的药物治疗管理模式亟待建立。.本项目基于B-SMART管理新模式，开展医联体下RA患者药物流行病调查并建立电子用药档案；以LASSO回归分析构建患者治疗依从性预测模型，通过危险分层确定重点监护对象，向基层延伸三甲医院同质化的药学服务；以临床结局、成本-效用为评价指标，通过随机对照实验评价新模式并持续改进。研究期间构建了难治性RA研究队列，目前共入组334名患者，其中127名进入随机对照试验并完成2年随访，64名患者加入了药师主导的药物治疗管理模式，63名为常规诊疗模式随访。在24月随访终点，药师干预MDT组患者的多项临床结局都显示出优越性：在疾病缓解率方面，药师干预组优于对照组（75% vs 9.5%, p＜0.001）；生活质量方面，药师干预组的效用值为0.8，对照组为0.7（p＜0.001）；vas-pain方面，药师干预组较对照组改善显著（1.5 vs 3.4，p＜0.001）。本研究构建的“药师参与的社区-三级医院联动的多元/个体/互联网化”的药物治疗管理新模式，推动了RA等慢病分级诊疗的科学管理，并减轻了患者及国家疾病负担。.本项目共发表论文5篇，申请专利1项，协助培养研究生1名。项目负责人多次参加国内学术会议并受邀作大会报告，并获2020年上海市“医苑新星”青年医学人才培养资助计划（SHWSRS(2021)_099）。本项目构建的RA药物治疗管理新模式通过真实世界有效性验证，并在实践中不断持续改进，可为其他慢性非传染性疾病在分级诊疗环境下的药物治疗管理提供科学性、标准化的参考模式，所得研究成果可为公共卫生政策的制定提供科学参考与建议。