慢性肝病中医生命质量量表的研制

摘要

〔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, 90 questionnaires were distributed and 90 questionnaires 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 61 items was developed including the final form of the physical domain contains (29 items), the psychological field (5 items) and social relations (27 items). 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.%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（pa-tient-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。