中医治疗帕金森病优化方案的信息处理研究

【作者】 赵世初；

【导师】 孟庆刚；

【作者基本信息】 北京中医药大学 ， 中医基础理论， 2006， 硕士

【摘要】 目的:以SAS8.0为依托建立信息处理平台,严格按照RCT要求和统计学需求设计试验方案,结合以Visual FoxPro6.0建立的数据库,对所收集的数据进行分析处理,就临床疗效评价的方案设计、数据库应用、数据分析处理等问题进行探讨,为中医药临床研究设计和数据信息处理提供方法学验证。方法:本课题以国家“十五”攻关课题“帕金森病综合治疗优化方案研究”收集的数据为研究对象,以SAS8.0为依托建立信息处理平台,进行临床试验设计及对所收集数据的分析处理,以Visual FoxPro6.0建立中医治疗帕金森病优化方案的信息数据库,进行数据的收集、管理和维护。以UPDRS评分为评价指标,采用多中心、随机、设盲、对比方法,根据270位受试者服用美多芭和未服美多芭的具体情况,对纳入病例分层、分组、对照中医、中西医结合治疗,针对所收集的数据进行西医疗效和中医证候疗效评价分析。结果:共纳入10个试验中心,270名受试者,完成242例,脱落22例,剔除6例。UPDRS总体疗效治疗组明显优于对照组(P<0.05),UPDRS总评分、UPDRS II评分、UPDRS III评分治疗后评分均明显低于治疗前(P均<0.01),治疗组下降幅度优于对照组(P<0.05);两组未服美多芭患者(A、B组)、服用美多芭患者(改良Hoehn & Yahr分级1.5～3级,C、D组)、服用美多芭患者(改良Hoehn & Yahr分级4级,E、F组)UPDRS评分比较治疗后明显低于治疗前,且A、B组治疗前后UPDRS评分差值比较无显著性差异,C、D组治疗组UPDRS总评分、UPDRS II评分下降幅度优于对照组,E、F组前后差值比较无显著性差异;左旋多巴用量比较A、B组和C、D组治疗组治疗后明显低于治疗前,对照组治疗前后药量比较无显著性差异,E、F组两组治疗前后用量比较,均无显著性差异;改良Hoehn & Yahr分级治疗前后比较均无显著性差异(P均>0.05);中医不同证型UPDRS评分治疗后评分均明显低于治疗前(P均<0.01)。结论:中医药临床疗效评价可以按RCT要求进行试验设计,同时体现其“辨证论治”,兼顾治疗的个性化;中医药临床疗效评价的试验设计、数据管理与分析,可通过以SAS为依托的信息处理平台及其与数据库的结合来实现。以SAS8.0为依托建立的具有针对性的信息处理平台,能够进行符合现代医学临床研究要求的临床试验设计,能对经验数据进行有效、合理的分析处理;数据库便于中医临床资料的数据查询、维护与利用,使用灵活简便。另外,以生存质量量表作为疗效评价指标,所收集的数据以定性资料为主,便于临床数据资料与数据库的结合。总之,SAS信息处理平台、数据库、生存质量量表三者结合得出的临床疗效评价结果与中医药的临床实际治疗效果基本相符,此方法不仅适应于本项课题,更可以作为一种评价模式广泛应用于类似的临床研究,有可能成为今后中医药临床研究方法学上的一种借鉴。更多还原

【Abstract】 Objective: We strictly follow the requirements of RCT and the statistics to clinical trials, to study clinical trails, database application and statistical analysis which investigate the processing methods in data storage and statistical analysis of TCM clinical research designs with FoxPro6.0 Database and SAS8.0.Methods:The research contains the clinical data of the national tenth five-year key project:Study of TCM optimized treating Parkinson’s disease. We established the information processing system by SAS8.0 to design the clinical trials and analysis the clinical data, and build the database of study of TCM optimized treating Parkinson’s disease by Visual FoxPro6.0 to gather and manage the data. We made UPDRS grades as evaluation index, and the clinical trials conformed to the principles of multicenter and randomized control tial. 270 patients with Parkinson’s disease were divided into two layers according to whether have taken the Madopar (Levodopa and Benserazide Tablet) or not.Results: Ten trial centers were identified, including a total of 242 patients with Parkinson’s disease. Compared with the placebo, therapy group was better than placebo on the total UPDRS curative effect (P<0.05), two groups had the same effect in reducing the scores of total UPDRS,UPDRS II and UPDRS III (P均<0.01). Therapy groups(A,C) in reducing the L-dopa’s dosage was remarkable, and the placebo(B,D) is not. On side of reforming Hoehn & Yahr’s grading, there was insignificant difference in both of therapy and placebo groups. All of TCM syndrome groups had the same effect in reducing the UPDRS scores.Conclusion: TCM clinical research should be designed by RCT principle. At the same time, the treatment based on categorical identification of TCM can be realized in the process of design to inform individuating treatment. The database and SAS 8.0 statistical software can be used in TCM clinical trials perfectly, Compared with traditional methods of TCM clinical research, the study methods would be scientific and the efficiency of the clinical data processing would be improved by database and statistical software. So it is necessary to bring together computer technology and TCM.更多还原