中华皮肤科杂志 ›› 2018, Vol. 51 ›› Issue (10): 745-748.doi: 10.3760/cma.j.issn.0412-4030.2018.10.009

• 研究报道 • 上一篇    下一篇

基于银屑病体表受累面积标准化操作规范评估病情严重程度的多中心临床一致性研究

伍慧媚,姚丹霓,郭洁,卢传坚   

  1. 510000 广州，广东省中医院皮肤科
  • 收稿日期:2018-03-19 修回日期:2018-07-01 出版日期:2018-10-15 发布日期:2018-10-03
  • 通讯作者: 卢传坚 E-mail:luchuanjian888@vip.sina.com
  • 基金资助:
    国家“十二五”科技支撑计划课题（2013BAI02B00）；广东省中医药局科研课题（20161111、20183005）

Measurement of psoriasis-involved body surface area based on a standard operating procedure for evaluating psoriasis severity: a multicenter clinical study on consistency

Wu Huimei, Yao Danni, Guo Jie, Lu Chuanjian   

  1. Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510000, China
  • Received:2018-03-19 Revised:2018-07-01 Online:2018-10-15 Published:2018-10-03
  • Contact: Lu Chuanjian E-mail:luchuanjian888@vip.sina.com
  • Supported by:
    National Science and Technology Infrastructure Program of China during the 12th Five-Year Plan Period （2013BAI02B00）; Traditional Chinese Medicine Bureau Foundation of Guangdong Province （20161111, 20183005）

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摘要： 目的 测评基于银屑病体表受累面积（BSA）标准化操作步骤（SOP）评估银屑病严重程度的多中心临床一致性，为临床医生提供一个准确性高且操作性强的银屑病评估方法。方法 ①来自广东省中医院的2名评分员在经过系统的BSA-SOP评分培训后，采用前后交换的方式，对40例银屑病患者独立进行评分；②广东省中医院1名评分员与全国各地11个分中心的11名评分员采取同样方式，对209例银屑病患者进行BSA一致性测评。结局指标采用组内相关系数（ICC）进行统计分析。结果 ①广东省中医院2位评分员在BSA评分上具有非常良好的一致性（ICC = 0.989，95%可信区间：0.979 ~ 0.994）；②广东省中医院的1名评分员与11个分中心11名评分员之间总BSA评分结果也保持良好的一致性（ICC波动于0.849 ~ 0.998）。结论 来自不同中心的评分员经过BSA-SOP培训后，BSA评分可保持相当高的一致性，可为开展多中心合作的临床研究提供可靠的参考。

关键词: 银屑病, 疾病严重程度指数, 体表受累面积, 一致性

Abstract: Objective To evaluate the consistency of psoriasis-involved body surface area （BSA） measurement among raters from different clinical centers after training in a new standard operating procedure （SOP） for involved BSA measurement, so as to provide a method for the evaluation of psoriasis with high accuracy and operability. Methods Firstly, two raters from Guangdong Provincial Hospital of Chinese Medicine（GPHCM） independently and alternately assessed the disease severity in 40 patients with psoriasis after systematic training in the BSA-SOP. Then, one of the raters from GPHCM and 11 raters from 11 subcenters separately assessed the disease severity in 209 patients with psoriasis by using the BSA-SOP, and the consistency was evaluated by using intraclass correlation coefficient （ICC）. Results There was a very high degree of consistency in involved BSA values between the 2 raters from GPHCM （ICC = 0.989, 95% confidence interval: 0.979 - 0.994）. The consistency of involved BSA values for the assessment of psoriasis severity was also high among the rater from GPHCM and the raters from 11 subcenters （ICC ranging from 0.849 to 0.998）. Conclusion The raters from different centers showed high consistency of involved BSA measurement for the assessment of psoriasis severity after training in the new BSA-SOP, so the BSA-SOP can serve as a reliable reference for multicenter clinical studies.

Key words: Psoriasis, Severity of illness index, Body surface area, Consistency