器官功能障碍的解决作为预测坏死性软组织感染长期生存的指标：坏死性软组织感染 AB103 临床综合终点研究和回顾性理赔数据库链接图表研究的分析。

Resolution of organ dysfunction as a predictor of long-term survival in necrotizing soft tissue infections: Analysis of the AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections trial and a retrospective claims database-linked chart study.

机构信息

From the Department of Surgery (S.C.B.), University of Florida College of Medicine, Gainesville, Florida; Atox Bio, Ltd (D.A.W., W.M.D.), Durham, North Carolina; Biomedical Statistical Consulting (G.M.), Wynnewood, Pennsylvania; Health Economics and Outcomes Research, Optum (K.E.A., V.W.), Eden Prairie, Minnesota; Division of Acute Care Surgery (A.K.M.), Atrium Health, Charlotte, North Carolina; Department of Surgery (E.M.B.) University of Washington, Harborview Medical Center, Seattle, Washington.

出版信息

J Trauma Acute Care Surg. 2021 Aug 1;91(2):384-392. doi: 10.1097/TA.0000000000003183.

DOI:10.1097/TA.0000000000003183

PMID:33797490

Abstract

BACKGROUND

Necrotizing soft tissue infections (NSTIs) are an acute surgical condition with high morbidity and mortality. Timely identification, resuscitation, and aggressive surgical management have significantly decreased inpatient mortality. However, reduced inpatient mortality has shifted the burden of disease to long-term mortality associated with persistent organ dysfunction.

METHODS

We performed a combined analysis of NSTI patients from the AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections randomized-controlled interventional trial (ATB-202) and comprehensive administrative database (ATB-204) to determine the association of persistent organ dysfunction on inpatient and long-term outcomes. Persistent organ dysfunction was defined as a modified Sequential Organ Failure Assessment (mSOFA) score of 2 or greater at Day 14 (D14) after NSTI diagnosis, and resolution of organ dysfunction defined as mSOFA score of 1 or less.

RESULTS

The analysis included 506 hospitalized NSTI patients requiring surgical debridement, including 247 from ATB-202, and 259 from ATB-204. In both study cohorts, age and comorbidity burden were higher in the D14 mSOFA ≥2 group. Patients with D14 mSOFA score of 1 or less had significantly lower 90-day mortality than those with mSOFA score of 2 or higher in both ATB-202 (2.4% vs. 21.5%; p < 0.001) and ATB-204 (6% vs. 16%: p = 0.008) studies. In addition, in an adjusted covariate analysis of the combined study data sets D14 mSOFA score of 1 or lesss was an independent predictor of lower 90-day mortality (odds ratio, 0.26; 95% confidence interval, 0.13-0.53; p = 0.001). In both studies, D14 mSOFA score of 1 or less was associated with more favorable discharge status and decreased resource utilization.

CONCLUSION

For patients with NSTI undergoing surgical management, persistent organ dysfunction at 14 days, strongly predicts higher resource utilization, poor discharge disposition, and higher long-term mortality. Promoting the resolution of acute organ dysfunction after NSTI should be considered as a target for investigational therapies to improve long-term outcomes after NSTI.

LEVEL OF EVIDENCE

Prognostic/epidemiology study, level III.

摘要

背景

坏死性软组织感染（NSTI）是一种具有高发病率和死亡率的急性外科病症。及时识别、复苏和积极的外科治疗显著降低了住院死亡率。然而，住院死亡率的降低将疾病负担转移到与持续性器官功能障碍相关的长期死亡率上。

方法

我们对来自坏死性软组织感染 AB103 临床复合终点研究的 NSTI 患者进行了联合分析，该研究是一项坏死性软组织感染的随机对照干预试验（ATB-202）和综合行政数据库（ATB-204），以确定持续性器官功能障碍与住院和长期结局的关系。持续性器官功能障碍定义为 NSTI 诊断后 14 天（D14）时改良序贯器官衰竭评估（mSOFA）评分≥2，器官功能障碍的缓解定义为 mSOFA 评分≤1。

结果

该分析包括 506 例需要手术清创的住院 NSTI 患者，其中 247 例来自 ATB-202，259 例来自 ATB-204。在这两个研究队列中，D14 mSOFA≥2 组的年龄和合并症负担更高。在 ATB-202（2.4% vs. 21.5%；p<0.001）和 ATB-204（6% vs. 16%：p=0.008）研究中，D14 mSOFA 评分 1 或更低的患者 90 天死亡率显著低于 mSOFA 评分 2 或更高的患者。此外，在联合研究数据集的调整协变量分析中，D14 mSOFA 评分 1 或更低是 90 天死亡率较低的独立预测因素（比值比，0.26；95%置信区间，0.13-0.53；p=0.001）。在这两项研究中，D14 mSOFA 评分 1 或更低与更好的出院状态和减少资源利用相关。