基于MCDA模型建立老年单纯收缩期高血压中西药联用效益风险评价方法

Isolated systolic hypertension (ISH) is a common type of hypertension in the elderly. It is an independent risk factor for cardiovascular and cerebrovascular events. At present, there is no ideal drug that can completely meet the lowering blood pressure requirement of elderly ISH. Is the combination of Chinese medicine and Western medicine in the treatment of elderly ISH better than Western medicine using alone or the combination of similar pharmacodynamic mechanism western medicine? Based on the MultiCriteria Decision Analysis, this study intends to establish benefit-risk assessment method of the combination of Chinese medicine and Western medicine in the treatment of elderly ISH. By literature sorting and Delphi method, with three ways intervention in elderly ISH, that is long acting CCB, long acting CCB and Yangxueqingnao granule, long acting CCB and ACEI/ARB, from the safety, efficacy and economy, we will build the benefit-risk evaluation index value tree for the combination of Chinese medicine and Western medicine in the treatment of elderly ISH. Applying the optimized MCDA model, we will make a comprehensive evaluation to the combination of Chinese medicine and Western medicine in the treatment of elderly ISH and explore the relationship between time and efficacy on the result of benefit-risk evaluation through subgroup analysis about treatment course. Finally, we will improve the assessment method by validation of clinical research. This study will scientifically annotate the overall effect of multiple targets of Chinese herbal compound and the time effect of advantage, provide references for the rational use of medicines, and provide a basis to construct the benefit- risk assessment system of the combination of Chinese medicine and Western medicine.

单纯收缩期高血压( ISH) 是老年高血压的常见类型，是心脑血管事件的独立危险因素，目前尚无完全符合老年ISH降压要求的理想药物。中西药联用治疗老年ISH是否优于西药单用或药效机理相似的西药联用？本研究拟基于多准则决策分析建立中西药联用干预老年ISH的效益风险评价方法，以长效CCB、长效CCB+养血清脑颗粒和长效CCB+ACEI/ARB三种方式干预老年ISH，应用文献整理、德尔菲法，从用药的安全性、有效性及经济性，形成中西药联用干预老年ISH的效益风险评价指标价值树；应用优化MCDA模型综合评价中西药联用干预老年ISH的效益风险，并以疗程为亚组分析，探索效益风险评价结果的时效关系；通过临床研究验证，完善评价方法。本研究将科学诠释中药复方多靶点的整体作用特点和作用优势的时间效应，为临床合理用药提供参考，为中西药联用效益风险评估体系的构建提供依据。

单纯收缩期高血压( ISH) 是老年高血压的常见类型，是心脑血管事件的独立危险因素，目前尚无完全符合老年ISH降压要求的理想药物。中西药联用治疗老年ISH是否优于西药单用或药效机理相似的西药联用？本研究基于多准则决策分析建立中西药联用干预老年ISH的效益风险评价方法，应用文献整理、德尔菲法，从用药的有效性和安全性，形成中西药联用干预老年ISH的效益风险评价指标价值树；应用优化MCDA模型对中西药联用干预老年ISH临床研究进行效益风险评价，并以疗程为亚组分析，探索效益风险评价结果的时效关系；以长效CCB、长效CCB+养血清脑颗粒和长效CCB+ACEI/ARB三种方式干预老年ISH，经过临床研究验证，完善了评价方法。优化MCDA模型综合评价得出：疗程为4周时中西药联用干预老年ISH效益-风险最优；临床研究得出：长效CCB+养血清脑颗粒在改善头痛、头晕症状，提高生活质量方面优于长效CCB单用和长效CCB+ACEI/ARB，长效CCB+养血清脑颗粒和长效CCB+ACEI/ARB在改善24h脉压差、降低血压变异性指标方面优于长效CCB单用， 且综合临床效果疗程4周优于疗程2周，研究科学诠释中药复方多靶点的整体作用特点和作用优势的时间效应，为临床合理用药提供参考，为中西药联用效益风险评估体系的构建提供依据。