脑脉泰胶囊治疗血管性痴呆的随机对照试验及成本效果分析

【作者】 王昕；

【导师】 胡立胜；

【作者基本信息】 北京中医药大学 ， 中西医结合基础， 2006， 博士

【摘要】 目的1.通过系统评价,分析中医药治疗血管性痴呆的临床疗效和不良反应。2.通过随机对照临床试验,对脑脉泰胶囊治疗血管性痴呆的临床疗效和安全性进行评价。3.比较脑脉泰胶囊与喜得镇片治疗血管性痴呆的成本-效果比,以发现其潜在的经济学价值。方法1.纳入以血管性痴呆患者为研究对象,比较中医药与西药治疗效果的随机对照试验。评价纳入研究的质量,并用Revman4.2软件对其进行Meta分析。2.采用随机、对照、双盲双模拟、非劣性试验设计。通过简易智力状态量表(MMSE)、Blessed-Roth行为量表(BBS)评分及中医证候积分评价脑脉泰胶囊治疗血管性痴呆的智能疗效、行为能力疗效和中医证候疗效。并对不良事件进行描述和分析。3.通过随机对照试验收集成本和健康结果数据,并进行成本效果和增量成本效果分析。结果1.系统评价:共纳入8个研究,包括823例患者和8种中药复方制剂。中药治疗血管性痴呆患者的疗效优于西药,其汇总OR 1.86 (95%CI 1.16~2.97);在提高HDS评分方面,中药的效果较西药好,汇总WMD 1.80 (95%CI 1.30~ 2.30)。未发现明显的不良反应。2.随机对照试验:共完成合格病例456例,脑脉泰组343例,喜得镇组113例。治疗前两组性别、年龄、病情、文化程度、重要既往史、药物治疗、合并疾病或症状、MMSE和BBS量表评分、中医证候积分等指标均具有良好的可比性,组间比较差异均无统计意义(P>0.05)。疗效分析:(1)智能疗效:两组疗效构成、显效率、有效率等,组间差异无统计意义(P>0.05);(2)行为能力疗效:两组疗效构成、基本控制率、显效率等,组间差异无统计意义(P>0.05);(3)中医证候疗效:两组疗效构成、临床痊愈率、显效率等,组间差异无统计意义(P>0.05);(4)中医证候总积分:治疗前后变化值及治疗后组间比较,差异均无统计意义(P>0.05)。试验期间发生10例不良事件,其中脑脉泰组9例,喜得镇组1例,但尚不能证实不良事件和服用药物的关系。3.成本效果分析:共有233例患者完成研究,脑脉泰组175例,喜得镇组58例。成本效果分析显示:脑脉泰组智能、中医证候显效率及智能、行为能力、中医证候有效率的成本效果比均低于喜得镇组,但脑脉泰组行为能力显效率、基本控制率及中医证候临床痊愈率的成本效果比高于喜得镇组。更多还原

【Abstract】 Objective1. Assess the benefits and adverse reaction of traditional Chinese medicine in the treatment of vascular dementia.2. Assess the clinical effects and safety of Naomaitai capsule on vascular dementia through randomized controlled trial.3. Compare the cost-effectiveness rates of Naomaitai capsule and hydergine tablet on vascular dementia, so as to find the economics value.Methods1. Randomized controlled trials on vascular dementia were collected, which aimed to compare the effects between traditional Chinese medicine and western medicine. The quality of included trials was evaluated and meta-analysis was conducted by RevMan 4.2.8.2. The trial was designed as a double-blinded double-dummy randomized controlled non-inferior trial. We evaluated the mental state, behavior capability and TCM syndrome effectiveness through the score of Mini-Mental State Examination, Blessed-Roth Behavior Scale and TCM syndrome, and had a description and analysis on adverse events.3. We collected cost and health outcome data through randomized controlled trial, and conducted cost-effectiveness and increment cost-effectiveness analysis.Results1. Systematic Review: We identified 8 studies including 823 patient and 8 traditional Chinese medicines. Compared with western medicine, traditional Chinese medicines are more effective in dementia effect and HDS, with total OR 1.86 (95% confidence interval 1.16 to2.97) and total WMD 1.80 (95% confidence interval 1.30 to 2.30). We didn’t find obvious adverse reaction.2. Randomized controlled trial: 456 eligible subjects have been collected, 343 in Naomaitai capsule group and 113 in hydergine tablet group.The baseline of two groups, such as gender, age, culture degree, important previous history, drug treatment, complicated disease, the grade of MMSE, BBS and TCM syndrome, were comparable. There weren’t statistics significance between two groups. Effectiveness analysis: (1) Intelligence effectiveness: The difference between two groups in effectiveness composition, excellence rate and effective power weren’t statistics significance. (2) Behavior capability effectiveness: The difference of effectiveness composition, essential control rate and excellence rate between two groups weren’t statistics significance. (3) TCM syndrome effectiveness: The difference of effectiveness composition, clinical recovery rate and excellence rate between two groups weren’t statistics significance. (4) Total scores of TCM syndrome: There weren’t statistics significance both in before-after change value and post-treatment group comparison.In this trial, we found 10 adverse events, 9 in Naomaitai capsule group and 1 in hydergine tablet group. But we can’t confirm the relation between adverse events and medicines. 3. Cost-effectiveness analysis: 233 subjects were completed, 175 in Naomaitai capsule更多还原