Gerding M N, Prummel M F, Kalmann R, Koornneef L, Wiersinga W M
Department of Endocrinology, Academic Medical Center, Amsterdam, The Netherlands.
J Endocrinol Invest. 1998 Jul-Aug;21(7):459-62. doi: 10.1007/BF03347327.
There is a need for more reliable and validated methods to assess the eye changes in Graves' disease. Such measurements are now available for the assessment of proptosis, eye muscle dysfunction, and optic nerve involvement. However, no validated objective measurement exists for NO SPECS class II signs. The present study compares the use of colour slides with clinical grading for assessing soft-tissue involvement. Forty-three patients were treated with retrobulbar irradiation. Pre-treatment, and 6 months post-treatment the severity of class II signs was graded from 0 to grade c in two ways; 1) Clinically, by two independent, experienced observers, who recorded their scores on the same day; 2) From colour slides, taken at the same visits, which were graded afterwards in one session independently by the same observers. Inter-observer agreement about clinical grading was low (Kappa 0.32), and was not improved by using the slides (Kappa 0.35). However, by using the clinical scores, the observers disagreed on treatment outcome in 21/43 patients (49%), whereas using the slides disagreement occurred in only 6/43 (14%, p < 0.01). It is concluded that the grading of soft-tissue involvement is highly subjective. However, the use of colour slides does provide a more reliable way to assess a treatment effect and should be used in clinical trials.
需要更可靠且经过验证的方法来评估格雷夫斯病的眼部变化。目前已有此类测量方法可用于评估眼球突出、眼肌功能障碍和视神经受累情况。然而,对于NO SPECS II级体征,尚无经过验证的客观测量方法。本研究比较了使用彩色幻灯片与临床分级来评估软组织受累情况。43例患者接受了球后照射治疗。在治疗前及治疗后6个月,通过两种方式对II级体征的严重程度从0到c级进行分级:1)临床评估,由两名独立的、经验丰富的观察者在同一天记录评分;2)根据在相同就诊时拍摄的彩色幻灯片,随后由相同的观察者在一次会议上独立进行分级。观察者间关于临床分级的一致性较低(kappa值为0.32),使用幻灯片后也未得到改善(kappa值为0.35)。然而,根据临床评分,观察者对43例患者中的21例(49%)的治疗结果存在分歧,而使用幻灯片时,仅有6/43例(14%,p<0.01)出现分歧。结论是,软组织受累的分级具有高度主观性。然而,使用彩色幻灯片确实提供了一种更可靠的评估治疗效果的方法,应在临床试验中使用。