关键词: 荨麻疹, 疾病影响状态调查, 荨麻疹控制评分, 疾病活动度, 慢性自发性荨麻疹, 慢性诱导性荨麻疹, 信度, 效度

Abstract: 【Abstract】 Objective To translate the Urticaria Control Test （UCT） into Chinese, and to assess reliability, validity, sensitivity and screening accuracy of the new-version scale. Methods After forward-backward translation and cultural adaption, items of the Chinese version of UCT were determined. The scale was used in 51 patients with chronic spontaneous urticaria （CSU）, 41 with chronic inducible urticaria （CIndU）, and 11 with CSU complicated by CIndU. Within 8 weeks after enrollment, 81 patients were treated with antihistamines, 8 with omalizumab, and 14 with antihistamines combined with omalizumab. At the time of enrollment and 4 and 8 weeks after enrollment, dermatology life quality index （DLQI） and urticaria activity score （UAS） were used to assess the quality of life impairment and disease activity. The internal consistency reliability of the questionnaire was estimated using Cronbach′s α coefficient. By comparing with DLQI and UAS28 scores, the Chinese version of UCT was tested for convergent validity, known-group validity, sensitivity and screening accuracy. Results The Chinese version of UCT contained 4 items, and could be used to retrospectively evaluate clinical symptoms and signs of the disease, impact on quality of life, treatment effects and overall disease control in the past 4 weeks. The Cronbach′s α coefficient of each item in the UCT scale was 0.886 - 0.945 in the CSU group, and 0.834 - 0.958 in the CIndU group. At the time of enrollment, the UCT score was significantly negatively correlated with the DLQI score in both the CSU group and CIndU group （rs = -0.672, -0.578, respectively, both P < 0.01）. At 4 and 8 weeks, the UCT score was significantly negatively correlated with UAS28 and DLQI scores in the CSU group （4 weeks: rs = -0.654, -0.829, respectively, both P < 0.01; 8 weeks: rs = -0.717, -0.765, respectively,both P < 0.01）, and it was also significantly negatively correlated with the DLQI score in the CIndU group （rs = -0.834, -0.778, respectively, both P < 0.01）. In the CSU group, the change in the UCT score between weeks 4 and 8 was significantly negatively correlated with the change in UAS score （rs = -0.569, P < 0.01）; compared with the baseline, the change in the UCT scores was also significantly negatively correlated with the change in the DLQI scores at weeks 4 and 8 （rs = -0.693, -0.447, respectively, both P < 0.01）. In the CIndU group, compared with the baseline, the change in the UCT scores at weeks 4 and 8 also showed a significant correlation with the change in DLQI scores （rs = -0.615, -0.408, respectively, both P < 0.01）. The UCT score significantly differed among different UAS and DLQI score groups （all P < 0.05）. Conclusions The Chinese version of the UCT is a valid and reliable tool for the clinical management of patients with CSU/CIndU. It can be used to evaluate disease control, and reflect disease activity and disease-related quality of life to a certain extent.

Key words: Urticaria, Sickness impact profile, Urticaria control test, Disease activity, Chronic spontaneous urticaria, Chronic inducible urticaria, Reliability, Validity