摘要目的:检验中文版慢性荨麻疹生活质量问卷（CU-Q2oL）的信效度。方法:翻译英文原版CU-Q2oL以及回译和文化调试，确定中文版CU-Q2oL的条目。2019年1-12月对北京大学第一医院皮肤性病科就诊的195例慢性自发性荨麻疹伴或不伴慢性诱导性荨麻疹患者每2周进行1次随访，随访时填写CU-Q2oL、皮肤病生活质量指数问卷（DLQI）以及1周疾病活动度问卷评分（UAS7），共随访2次。每次随访后，医生依据患者病情为每例患者调整治疗方案。通过探索性因子分析，提取问卷因子数目，并通过分析CU-Q2oL与DLQI、UAS7的相关性判断聚合效度，通过计算Cronbach α系数检测CU-Q2oL的内在一致性信度；通过分析UAS7的变化量与CU-Q2oL评分变化量的相关系数判断CU-Q2oL的敏感度。结果:自中文版CU-Q2oL问卷中提取出4个因子，分别为"症状"、"日常功能活动"、"睡眠问题"及"限制"因子，共23个条目，累计方差贡献率为74.011%。CU-Q2oL所有条目的Cronbach α系数为0.961，4个因子Cronbach α系数为0.804 ~ 0.933，提示极好的内部一致性。CU-Q2oL问卷总分和DLQI评分、UAS7分别呈中度相关，相关系数分别为0.437、0.560（均 P<0.01）。71例患者参与第2次随访，CU-Q2oL问卷总分变化量与UAS7评分变化量呈中度相关，相关系数为0.392（ P<0.01）。 结论:中文版CU-Q2oL具有极好的内部一致性信度和良好的信效度，可用于评估我国慢性自发性荨麻疹患者的生活质量。

abstractsObjective:To assess the reliability and validity of the Chinese version of chronic urticaria quality of life questionnaire (CU-Q2oL) .Methods:The original English version of CU-Q2oL was translated into Chinese after forward-backward translation and cultural adaption, and items of the Chinese version of CU-Q2oL were determined. From January to December 2019, 195 chronic spontaneous urticaria patients with or without chronic inducible urticaria were enrolled from Department of Dermatology and Venereology, Peking University First Hospital, and followed up every 2 weeks. A total of 2 follow-ups were carried out, and a questionnaire survey was conducted by using the Chinese version of CU-Q2oL, dermatology life quality index (DLQI) and urticaria activity score over 7 days (UAS7) during each follow-up. After each follow-up, the treatment protocol for each patient was adjusted by clinicians based on the patient′s condition. The number of questionnaire factors was extracted by exploratory factor analysis, convergent validity was estimated by analyzing correlations of CU-Q2oL with DLQI and UAS, and the internal consistency reliability of CU-Q2oL was evaluated by calculating Cronbach′s α coefficient; the sensitivity of CU-Q2oL was assessed by analyzing correlations of changes in UAS7 scores with changes in CU-Q2oL scores.Results:Four factors were extracted from the Chinese version of CU-Q2oL, namely "symptoms", "daily functional activities", "sleep problems" and "restrictions" factors. There were 23 items in total, and the cumulative variance contribution rate was 74.011%. The Cronbach′s α coefficient of all items in CU-Q2oL was 0.961, and the Cronbach′s α coefficient of the 4 factors ranged from 0.804 to 0.933, suggesting excellent internal consistency. The total score of CU-Q2oL was moderately correlated with DLQI and UAS7 scores, with correlation coefficients of 0.437 and 0.560, respectively (both P < 0.01) . A total of 71 patients completed the second follow-up. The change in the total score of CU-Q2oL was moderately correlated with that in the UAS7 score, with a correlation coefficient of 0.392 ( P < 0.01) . Conclusion:The Chinese version of CU-Q2oL has excellent internal consistency, good reliability and validity, and can be used to evaluate the quality of life of patients with chronic spontaneous urticaria in China.