慢性肝病中医生命质量量表的研制

容丽辉1，张涛1，2*，熊焰1，2,孙克伟1，2，陈斌1，2，谭元生1，雍苏南1

（1.湖南中医药大学第一附属医院，湖南长沙410007；2.国家肝病中医医疗中心，湖南长沙410007）

〔摘要〕目的研制慢性肝病中医生命质量量表,以科学、客观、全面地评价中医药对慢性肝病的临床疗效。方法参照国际通用量表研制的程序化方法，基于对中医基本理论藏象学中肝脏生理机能及特性的研究，结合患者报告结局指标（patient-reported outcomes, PRO），建立中医肝病临床疗效评价量表的理论模型。设立研究小组，通过建立条目池、研制初选量表、语言调试等形成临床初步调查表。开展临床预调查，共发放90份调查表，回收有效量表90份，应用离散趋势法（变异系数法）、克朗巴赫系数法统计方法，对调查结果进行系统分析以进一步筛选条目。结果研制出包含生理领域（29个条目）、心理领域（5个条目）和社会关系领域（27个条目），共61个条目的慢性肝病中医生命质量量表。结论慢性肝病中医生命质量量表，具有可操作性及可重复性，值得进一步考核并临床推广应用。

〔关键词〕慢性肝病；临床疗效；生命质量；量表；脾胃失调；气机郁滞；情志不畅；血虚

Development of Quality of Life for Chronic Liver Diseasein traditional Chinese Medicine

RONG Lihui1, ZHANG Tao1，2*, XIONG Yan1，2, SUN Kewei1，2, CHEN Bin1，2, TAN Yuansheng1, YONG Sunan1

（The First Affiliated Hospital of Hunan University of Chinese Medicine, Changsha 410007, China；2.National Center for Liver of Traditional Chinese Medicine, Changsha 410007, China）

〔Abstract〕Objective Objective To scientifically, objectively and roundly evaluate the clinical effect of traditional Chinese Medicine (TCM) by developing the TCM quality of life (QOL) scale for chronic liver disease. Methods According to the programmed method of international scale, based on liver physiological function and characteristic study of zang manifestation theory, combined with the patient reported outcomes (PRO), theoretical models of clinical efficacy scale for liver disease were built. A primary clinical scale was established after item pool screening, field test,culture adaptation and clinical pre-survey by the research staff. Finally, 90questionnaires were distributed and 90questionnaires were reclaimed. Statistical analysis was conducted to choose the items by discrete tendency and Crowns Bach coefficient methods. Results The chronic liver TCM QOL scale with total of 61items was developed including the final form of the physical domain contains (29items), the psychological field(5items) and social relations (27items). Conclusion The TCM QOL scale for chronic liver disease is practical and repeatable. It will be worthy of further examination and extended to clinical application.

〔Keywords〕chronic liver disease; clinical efficacy; quality of life; scale; dysfunction of spleen-stomach; blockage of Qi; poor emotions; blood deficiency

临床疗效是中医药生存和发展的基础，而目前中医治疗肝病疗效主要采用症状和实验室指标来进行评价，该类方法不能很好体现患者的精神痛苦和心理状态，以及对生活质量的影响，因此，不能满足现在临床和科研的需要。建立一套能体现中医药疗效优势和特色，且同时被国际认可的临床疗效评价体系，是中医药现代化、国际化进程中必不可少的重要环节，对于科学、客观地开展中医肝病临床疗效的评价具有重要意义[1]。……