中文摘要
艾滋病是一种经血液和性传播为主的传染病,病死率高,疾病负担较重。中医药用于治疗艾滋病在临床实践中广泛运用并被证明有一定疗效,但尚缺乏明确的疗效优势和长期疗效证据。国家中医药治疗艾滋病项目首期启动省份包括广西和云南,其注册登记系统积累了大样本长期随访的数据,如何从观察性研究数据中分析疗效优势和最佳治疗方案,需要方法学的探索。本研究以贝叶斯方法对广西艾滋病数据库进行分析,优选中医药/中西医结合治疗方案;采用倾向性评分方法,将该数据库患者与单纯接受抗病毒治疗的患者队列进行匹配评价中医药治疗优势人群及作用环节;辅以巢式病例对照研究探索影响疾病预后的相关因素。最终,通过三部分研究结果,探索所建立的方法学的可行性和适用性,用于评价中医药治疗艾滋病不同分期不同证型患者的优势点,以形成HIV/AIDS中医综合治疗方案,基于真实世界数据构建的这一方法学探索,可能成为今后的中医药治疗慢性疾病疗效评价研究的方法。
英文摘要
Acquired Immune Deficiency Syndrome (AIDS) is an infectious disease, and it is transmitted mainly by sexually behavior and blood. The case fatality rate is high, and the disease burden is heavier. Traditional Chinese medicine (TCM) has been widely used in clinical practice for the treatment of AIDS and proved to have therapeutic effect. However, there is no definite evidence for the superior and long-term effect. Guangxi and Yunnan province are pilots of National Free TCM AIDS Treatment Program and data have been accumulated for a longer follow-up in the registered system. We intend to undertake a methodology study to analyze the data from the registered observational studies. We will use Bayesian method to analyze the data on registered database in Guangxi in order to understand what benefits are from the TCM treatment for which type of HIV/AIDS patients, and explore the best treatment protocols of TCM. The propensity score method will be used to compare the combined effect of TCM and Highly Active Anti-Retroviral Therapy (HAART). In addition, we will use a nested case-control study to explore the related factors influencing the prognosis of disease. In the end, by integrating the results from the three parts, we try to understand the feasibility and suitability of this methodological study in the evaluation of therapeutic effect of TCM in HIV/AIDS patients with different stages and syndromes, and develop a comprehensive treatment protocol of TCM for patients with HIV/AIDS. Besides, based on real world data, we would construct a method model for future studies in TCM.
