Giustina Andrea, Bronstein Marcello D, Chanson Philippe, Petersenn Stephan, Casanueva Felipe F, Sert Caroline, Houchard Aude, Melmed Shlomo
Institute of Endocrine and Metabolic Sciences, Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital, 20132, Milan, Italy.
Hospital das Clínicas da Universidade de São Paulo, São Paulo-SP, 05403-000, Brazil.
J Clin Endocrinol Metab. 2021 Nov 19;106(12):3555-3568. doi: 10.1210/clinem/dgab536.
The SAGIT® instrument (SAGIT) has been developed to enable accurate characterization of acromegaly disease activity.
We evaluated the ability of SAGIT to discriminate acromegaly disease control status.
This multicenter, noninterventional, prospective and retrospective, longitudinal study, conducted at academic and private clinical practice sites, included patients aged ≥ 18 years with a diagnosis of controlled (n = 109) or non-controlled (n = 105) acromegaly, assessed by clinical global evaluation of disease control (CGE-DC) questionnaire, investigator therapeutic decision, and international guidelines. Control status was not determined at baseline for 13 patients. Since 9 patients were enrolled retrospectively, all presented analyses are based on the prospective population (N = 227). Patients were assessed over a 2-year follow-up period. Classification and regression tree (CART) analyses were performed to investigate how SAGIT components at baseline (signs/symptoms [S], associated comorbidities [A], growth hormone levels [G], insulin-like growth factor 1 levels [I], tumor features [T]) discriminate between controlled and non-controlled acromegaly.
Baseline mean subscores S, G, I, and T were significantly lower in patients with CGE-DC controlled vs CGE-DC non-controlled acromegaly. SAGIT components I and G for CGE-DC and S, A, G, I, and T for the clinician's therapeutic decision were retained by CART analyses. For international guidelines, only SAGIT component I was retained. The risk for undergoing ≥ 1 treatment change during the study was 3.44 times greater for CGE-DC non-controlled acromegaly relative to CGE-DC controlled acromegaly.
The SAGIT instrument is a valid and sensitive tool to comprehensively and accurately assess acromegaly severity.
研发SAGIT®仪器（SAGIT）是为了能够准确描述肢端肥大症的疾病活动情况。
我们评估了SAGIT区分肢端肥大症疾病控制状态的能力。
这项多中心、非干预性、前瞻性和回顾性的纵向研究在学术和私人临床实践场所进行，纳入了年龄≥18岁、经疾病控制临床综合评估（CGE-DC）问卷、研究者治疗决策和国际指南评估为疾病得到控制（n = 109）或未得到控制（n = 105）的肢端肥大症患者。13例患者在基线时未确定控制状态。由于9例患者是回顾性纳入的，所有呈现的分析均基于前瞻性人群（N = 227）。在2年的随访期内对患者进行评估。进行分类和回归树（CART）分析，以研究基线时SAGIT的组成部分（体征/症状[S]、相关合并症[A]、生长激素水平[G]、胰岛素样生长因子1水平[I]、肿瘤特征[T]）如何区分疾病得到控制和未得到控制的肢端肥大症。
CGE-DC评估为疾病得到控制的肢端肥大症患者，其基线时S、G、I和T的平均子评分显著低于CGE-DC评估为疾病未得到控制的患者。CART分析保留了用于CGE-DC的SAGIT组成部分I和G，以及用于临床医生治疗决策的S、A、G、I和T。对于国际指南，仅保留了SAGIT组成部分I。在研究期间，CGE-DC评估为疾病未得到控制的肢端肥大症患者接受≥1次治疗改变的风险是CGE-DC评估为疾病得到控制的肢端肥大症患者的3.44倍。
SAGIT仪器是一种有效且敏感的工具，可全面、准确地评估肢端肥大症的严重程度。
