中医药治疗功能性胃肠病临床结局评价方法初探  

Discussion on Clinical Outcome Assessment Method of Traditonal Chinese Medicine for Treatment of Functional Gastrointestinal Disease

作　　者：李培武[1] 侯政昆[1] 刘凤斌[1] 

机构地区：[1]广州中医药大学第一附属医院,广州510405

出　　处：《中药新药与临床药理》2012年第5期591-594,598,共5页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：国家中医药管理局脾胃病学重点学科;脾胃病学重点专科建设项目资助(国中医药医政发[2012]2号);国家自然科学基金面上项目(81073163);广东省科学技术厅--广东省中医药科学院联合科研专项项目(2011B032200015)

摘　　要：目的探索完善中医药治疗功能性胃肠病的临床结局评价方法。方法采用前瞻性描述研究设计,纳入广州中医药大学第一附属医院等5个研究中心的功能性消化不良和腹泻型肠易激综合征患者,以中医药治疗4周,观察患者治疗前后的中医脾胃系疾病患者报告结局指标(SSD-PRO)量表评分和疗效指数。结果共有73例功能性消化不良患者和48例腹泻型肠易激综合征患者纳入分析。SSD-PRO量表整体信度为0.919;结构效度分析中,除医疗、大便情况外,其他6个方面和整体均与SF-36量表的8个维度存在中等强度的相关性;治疗后患者SSD-PRO量表的8个方面评分及总分都较治疗前明显提高(P<0.05),其中疼痛与不适、大便情况、消化功能、心理、精力与形色方面改善最明显;且其生理领域、总分评分变化与疗效指数有一定相关性。结论 SSD-PRO量表在中医药治疗功能性胃肠病患者中具有良好的信度、效度,可作为功能性胃肠病的临床结局评价方法之一。Objective To develop a method for clinical outcome assessment of traditional Chinese medicine（TCM） for treatment of functional gastrointestinal disease. Methods A prospective study was performed. During the period of April 2009 to April 2010, patients with functional dyspepsia（FD） and patients with diarrhea-predominant irritable bowel syndrome （IBS） from the First Affiliated Hospital of Guangzhou University of Chinese Medicine and other four research centers were collected. After treatment for 4 weeks with TCM, the scores of the Spleen and stomach disease-patient reported outcomes（SSD-PRO） scale and efficacy index before and after the treatment were compared. Results In total, 73 patients with FD and 48 patients with diarrhea-predominant IBS were collected. The reliability of the SSD-PRO scale was 0.919. As for construction validity of SSD-PRO scale, the whole scale and 6 other items except for the medical treatment and the situation of defecation, were moderately correlated with SF-36 scale. Scores of 8 items and the total score of SSD-PRO scale were improved distinctly in patients after the treatment, in which the items of the pain and discomfort, defecation situation, digestive function, mental state, energy and physical status were most distinctly improved. The improvement of total score and physical domains of the scale were correlated with the efficacy index. Conclusion The SSD-PRO scale shows good reliability, validity and responsiveness when using in patients with functional gastrointestinal disease. It provides a method for clinical outcomes assessment in functional gastrointestinal disease.

关 键 词：功能性消化不良 肠易激综合征 中医脾胃系疾病患者报告结局量表 

分 类 号：R285.6[医药卫生—中药学]