aUniversity of Michigan, Ann Arbor, Michigan bCedars Sinai Medical Center, Los Angeles, California cUniversity of Utah, Salt Lake City, Utah, USA.
Curr Opin Rheumatol. 2013 Nov;25(6):700-6. doi: 10.1097/01.bor.0000434668.32150.e5.
Gastrointestinal tract (GIT) involvement in systemic sclerosis (scleroderma, SSc) is the most common internal complication. This review discusses the outcome measures to capture GIT involvement in clinical care and trials.
Patient-reported outcome measures have been validated (UCLA Scleroderma Clinical Trial Consortium GIT 2.0 and NIH PROMIS scales) in SSc-GIT. Multiple objective measures are available to assess mucosal involvement and motility in GIT. However, these need to be validated in SSc for trials.
GIT is a common cause of morbidity and has negative impact on quality of life in SSc. Recommendations are given for trial design and evaluation of GIT involvement in SSc.
胃肠道(GI)受累是系统性硬化症(硬皮病,SSc)最常见的内脏并发症。本文讨论了用于临床护理和临床试验中评估 GI 受累的结局指标。
患者报告的结局指标已在 SSc-GI 中得到验证(加州大学洛杉矶分校硬皮病临床试验联盟 GIT 2.0 和 NIH PROMIS 量表)。有多种客观指标可用于评估 GI 黏膜受累和运动功能。然而,这些指标需要在 SSc 中进行验证,才能用于临床试验。
GI 是导致发病率的常见原因,对 SSc 的生活质量有负面影响。本文为 SSc 中 GI 受累的临床试验设计和评估提供了建议。