乙肝后肝硬化患者报告结局评价量表条目的建立及筛选  

Establishment and screening on entries of rating acale for patient reported outcomes of posthepatitic B cirrhosis

作　　者：胡鑫才[1] 张华[1] 周扬[1] 刘平[2] 

机构地区：[1]上海中医药大学附属曙光医院·上海市中医药研究院肝病研究所·上海中医药大学肝肾疾病病证教育部重点实验室·上海市中医临床重点实验室·国家中医药管理局重点研究室(慢性肝病虚损),上海201203 [2]上海中医药大学,上海高校中医内科学E研究院,上海201203

出　　处：《中华中医药杂志》2012年第6期1526-1530,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家重点基础研究发展(973计划)(No.2006CB504801);上海市重点学科建设项目资助(No.Y0302);上海市教育委员会E研究院建设计划项目(No.E03008);上海高校创新团队建设项目(第一期);上海市医学领军人才项目(No.2007A卫01)~~

摘　　要：目的:在中医理论指导下,对先期所构建的乙型病毒性肝炎(以下简称"乙肝")后肝硬化患者报告结局评价量表(PHBC-PRO)预试表进行条目筛选及考核,为乙肝后肝硬化的中医临床疗效评价提供科学、客观、可量化的工具。方法:基于病证结合研究思路及前期临床流行病学调查结果,建立由64条条目组成的PHBC-PRO量表条目池及预调查表。通过对临床预调查的147例患者量表资料采用条目分布考察法、t检验法、离散趋势法、分辨力系数法、相关分析法、克朗巴赫系数法等方法的分析,对条目进行筛选与优化。结果:设定条目被所选方法中至少4种同时删除为筛选标准,最终形成由57个条目组成、涵盖3个领域(生理、心理及社会)的PHBC-PRO量表,经克朗巴赫系数法检验,提示信度较好(α=0.955)。结论:遵循国际PRO量表研制的原则和方法构建的中医PHBC-PRO量表,符合中医理论及量表规范、具较强的可操作性及适用性,可用于中医对乙肝后肝硬化患者临床证候及疗效的客观评价。Objective： To develop rating scale for patient reported outcomes of posthepatitic B cirrhosis （PHBC- PRO） under the guidance of TCM theory, and offer scientific, objective and quantifiable tool for clinical efficacy evaluation of posthepatitic B cirrhosis in TCM. Methods： The Pre-Scale which included 64 entries was extracted out and the entry pool was established basing on research ideas of disease combined syndrome and result of clinical pre-investigation. Investigation method of entries distribution, t-test, discrete trend method, resolution coefficient method, correlation coefficient, cronbach＇s coefficient were used for screening and optimizing the entries of PHBC-PRO on the basis of 147 patients＇ informations. Results： Deleted simultaneously by at least 4 methods was the screening criteria. 57 entries what constituted PHBC-PRO with TCM characteristics had covered 3 domains. PHBC-PRO tested by cronbach＇s coefficient had good reliability（a =0.955）. Conclusion： PHBC- PRO, which based on international research principle and method, and accorded with TCM theroy and specifications, has good operability and applicability and evaluate objectively clinical syndrome and treatment of posthepatitic B cirrhosis.

关 键 词：乙肝后肝硬化 中医临床疗效评价 患者报告结局 量表 条目筛选 

分 类 号：R259[医药卫生—中西医结合]