中医干预慢性病疾病负担评估适宜模型的建立与评价

Chronic diseases are a major public health problem with serious damaging and huge economic burden throughout China. The remarkable longevity of traditional Chinese medicine (TCM) for chronic diseases implies its potential advantages, however,the methods for evaluating the reduction burdens of chronic diseases need to be established desperately. For TCM treatment is more difficult to assess due to the chronic disease is long course and complicated dynamic change of disease condition. Markov decision model can simulate development process of chronic disease and estimate the prognostic outcome and burden of chronic disease. We point out the hypothesis that Markov decision model is proper for evaluating the burdens of chronic diseases treated by TCM therapies. We will carry out the following study. Take TCM clinical trial for example, within 360 COPD patients, establish the status of Markov decision model and its outcomes prognosis approach through the natural disease course; calculate the cycle and transition probability based on the previous research data; calculate the value of quality adjusted life years (QALY) utility by questionnaire; measure the costing by designing the scale; estimate the costing and utility in each stage,and finally establish the Markov decision model,make cost-utility analysis of TCM therapies.Finally,evaluate the applicability of the established model by sensitivity analysis and expert consultation, and initially establish the model for COPD disease burden. The established model will provide the inspirations and methods model for explore the establishment of chronic disease burden TCM intervention model to assess the suitability.

慢性病危害大，疾病负担重，已成为我国重大公共卫生问题。中医防治慢性病具有较好效益，但疾病负担评估方法亟待建立。慢性病病程长，病情复杂呈动态变化，针对中医辨证治疗，评估更为困难。Markov决策模型能模拟慢性病动态发展过程，估计疾病发展结局及疾病负担。基于"Markov决策模型适宜中医干预慢性病疾病负担评估"的假说，本项目拟开展如下研究：以COPD为示范，根据自然病程和中医辨证治疗设立Markov状态及转归途径；基于既往数据，计算循环周期及转移概率；以360例中医干预临床试验为载体，采用量表法计算效用值（质量调整生命年）、设计问卷进行成本测量，估算各阶段费用和效用等步骤建立Markov决策模型，分析中医干预的疾病负担。通过灵敏度分析和专家咨询，评价模型适用性，探索建立中医干预慢性病疾病负担评估的适宜模型。

卫生经济学评价是慢性病评价的重要组成部分，评价模型的选择与建立尤为重要。本研究建立了中医干预慢性病疾病负担评价模型，并以慢性阻塞性肺疾病（COPD）为示范，评价COPD三种治疗方案的卫生经济学效益，同时评估所建立模型的适用性。数据来源依托李建生教授“中原学者”河南省科技攻关项目课题中四个分中心所纳入的患者236例，随机将患者分为西医组、中医组及联合组。首先根据COPD稳定期自然史建立Markov模型，包含GOLD1-2、GOLD3-4、死亡三种Markov状态，以1年为一个Markov周期，建立决策树-Markov模型，之后运用Treeage Pro 2011软件计算三种治疗方案下，患者在40个周期中的成本-效用比（CUR）和增量成本-效用比（ICUR），结果显示各组患者基线资料无统计学差异，Markov队列模拟计算结果显示西医组、中医组及联合组中每10万人40年后的累积QALYs分别为1702773年、1616797年、1709668年；CUR分别为87235元/QALY、74602元/QALY、87223元/QALY，联合组患者比西医组和中医组患者每增加一个QALY需要增加的成本分别为8707元和41705元。通过Treeage pro 2011软件对影响模型运行的参数进行单因素敏感性分析，结果显示除个别参数对本研究影响较大外，本研究结果的可靠性好，且模型运行较稳定。并以特发性肺纤维化为例，进行了基于生物标志物的病证结合探索性研究，结果显示SP-A在肺肾气虚证、SP-D在阴虚内热证患者中的变化趋势与其它两组不同。综合上述结果，本研究为中医干预慢性病卫生经济学评价奠定了一定基础，同时为中医及中西医结合治疗COPD有效性、经济性提供了新的有力证据，探索性研究可能成为以生物标志物为结合点的病证结合研究的突破点，为进一步精准辨证及开展基于证候的中医干预慢性病疾病负担评估奠定基础。项目资助已发表论文4篇，其中SCi 1篇，中文核心1篇，中国科技核心1篇，国家级期刊1篇，已接收待发表7篇，其中SCi 1篇，另有SCI 1篇审稿中，培养硕士研究生3名，中原领军人才1名，中原青年拔尖人才1名，申请软件著作权1项。