论著
ENGLISH ABSTRACT
中文版荨麻疹控制评分量表及信效度验证
于淼
陈玉迪
刘擘
宋晓婷
赵作涛
作者及单位信息
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DOI: 10.35541/cjd.20191190
The Chinese version of the Urticaria Control Test and validation of its reliability and validity
Yu Miao
Chen Yudi
Liu Bo
Song Xiaoting
Zhao Zuotao
Authors Info & Affiliations
Yu Miao
Peking University School of Nursing, Beijing 100191, China; Department of Dermatology and Venereology, Peking University First Hospital, National Clinical Research Center for Skin and Immune Diseases, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, Beijing 100034, China
Chen Yudi
Department of Dermatology and Venereology, Peking University First Hospital, National Clinical Research Center for Skin and Immune Diseases, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, Beijing 100034, China
Liu Bo
Department of Dermatology and Venereology, Peking University First Hospital, National Clinical Research Center for Skin and Immune Diseases, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, Beijing 100034, China
Song Xiaoting
Department of Dermatology and Venereology, Peking University First Hospital, National Clinical Research Center for Skin and Immune Diseases, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, Beijing 100034, China
Zhao Zuotao
Department of Dermatology and Venereology, Peking University First Hospital, National Clinical Research Center for Skin and Immune Diseases, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, Beijing 100034, China
·
DOI: 10.35541/cjd.20191190
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摘要

目的翻译荨麻疹控制评分(UCT),并检验该量表的信效度、敏感性以及筛选准确性。

方法经过翻译、回译和文化调试,确定荨麻疹控制评分量表的条目。应用该量表调查51例慢性自发性荨麻疹(CSU)、41例慢性诱导性荨麻疹(CIndU)患者和11例CSU合并CIndU患者。入组后8周内,81例使用抗组胺药治疗,8例使用奥马珠单抗治疗,14例抗组胺药联合奥马珠单抗治疗。入组时和入组后第4、8周时,用皮肤病学生活质量指数(DLQI)、荨麻疹活动评分(UAS)评估生活质量损害和疾病活动情况。采用Cronbach′s α系数评估问卷内部一致性信度。通过与DLQI、UAS28评分比较,检验中文版UCT的聚合效度、已知族群效度、敏感性及筛选准确性。

结果中文版UCT包含4个条目,回顾性评价过去4周内疾病的临床症状和体征、对生活质量的影响、治疗效果和总体疾病控制情况。CSU组UCT量表各条目得分的Cronbach′s α系数为0.886~0.945,CIndU组为0.834~0.958。入组时,CSU组与CIndU组UCT与DLQI评分显著负相关( r s值分别为-0.672,-0.578,均 P<0.01)。第4周和8周时,CSU组UCT与UAS28、DLQI评分均呈显著负相关(4周: r s值分别为-0.654、-0.829,均 P<0.01;8周: r s值分别为-0.717、-0.765,均 P<0.01),CIndU组UCT与DLQI评分亦显著负相关( r s值分别为-0.834、-0.778,均 P<0.01)。CSU组第4周与第8周之间UCT变化量与UAS变化量显著相关( r s=-0.569, P<0.01);与入组时比较,第4、8周时UCT变化量与相应DLQI评分变化量显著相关( r s值分别为-0.693、-0.447,均 P<0.01)。对于CIndU组,与入组时比较,第4周与第8周时UCT变化量与DLQI变化量亦显著相关( r s值分别为-0.615、-0.408,均 P<0.01)。不同UAS、DLQI评分组间UCT评分差异均有统计学意义(均 P<0.05)。

结论中文版UCT是有效、可靠的CSU和CIndU患者的临床管理工具,可用于评估疾病控制情况,在一定程度上反映疾病活动度及疾病相关生活质量。

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

ObjectiveTo translate the Urticaria Control Test (UCT) into Chinese, and to assess reliability, validity, sensitivity and screening accuracy of the new-version scale.

MethodsAfter 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.

ResultsThe 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 ( r s = -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: r s = -0.654, -0.829, respectively, both P < 0.01; 8 weeks: r s = -0.717, -0.765, respectively,both P < 0.01) , and it was also significantly negatively correlated with the DLQI score in the CIndU group ( r s = -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 ( r s = -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 ( r s = -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 ( r s = -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) .

ConclusionsThe 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.

Urticaria;Sickness impact profile;Urticaria control test;Disease activity;Chronic spontaneous urticaria;Chronic inducible urticaria;Reliability;Validity
Zhao Zuotao, Email: mocdef.3ab61oatoatouzoahz
引用本文

于淼,陈玉迪,刘擘,等. 中文版荨麻疹控制评分量表及信效度验证[J]. 中华皮肤科杂志,2020,53(07):533-538.

DOI:10.35541/cjd.20191190

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*以上评分为匿名评价
慢性荨麻疹(chronic urticaria,CU)主要表现为皮肤风团和/或血管性水肿,病程超过6周,皮疹反复发作且常伴剧烈瘙痒,严重影响患者的生活质量 [ 1 ]。目前,尚无特异性生物标志物用于反映CU患者的疾病控制情况 [ 2 ]。临床研究多采用患者报告结局评分评估疗效,其中,荨麻疹控制评分(Urticaria Control Test,UCT)使用最为广泛,在多项国外研究中显示出良好的信效度 [ 3 , 4 , 5 , 6 ],而我国目前尚无使用UCT评估的相关研究。因此,我们引进UCT量表,将其汉化并进行信效度检验,以便在我国进一步应用和推广,从而建立与国际接轨的CU评价体系,促进临床患者管理规范化。
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备注信息
A
赵作涛,Email: mocdef.3ab61oatoatouzoahz
B
中国临床试验注册中心,ChiCTR1900028653
C
Chinese Clinical Trial Registry, ChiCTR1900028653
D
所有作者均声明不存在利益冲突
E
国家自然科学基金中德合作项目 (GZ901)
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