Department of Vascular and Endovascular Surgery, Wake Forest University School of Medicine, Winston Salem, NC.
Department of Vascular Surgery, University of Michigan School of Medicine, Ann Arbor, MI.
Ann Vasc Surg. 2021 May;73:254-263. doi: 10.1016/j.avsg.2020.10.022. Epub 2020 Nov 26.
Diabetes mellitus is a major risk factor for progression to lower extremity amputation (LEA) due to progressive neuropathy and glycemia-induced vasculopathy. In this study, we evaluated risk factors for incident LEA type 2 diabetics during a randomized controlled trial and extended post-trial follow-up.
The Action to Control Cardiovascular Risk in Diabetes trial randomized 10,251 type 2 diabetics to intensive glycemic control (Hemoglobin A1c (HbA1c) target <6.0%) versus standard glycemic control (HbA1c target 7.0-7.9%). Using backward elimination logistic regression models, we examined relationships between neuropathy using the Michigan Neuropathy Screening Instrument (MNSI) and glycemic control and incident LEA during the clinical trial and subsequent follow-up.
9,746 patients were followed for a mean of 7.9 +/-3.1 (median 8.9) years after randomization. Ninety-eight (1%) participants underwent an incident LEA during the trial or post-trial follow-up period. Baseline demographics and traditional risk factors were examined by incident amputation status. Multivariable models revealed that abnormal 10 gm filament test (HR 4.50, 95% CI 2.92-6.95, P < 0.0001), presence of ulceration (HR 4.22, 95% CI 1.65-10.8, P = 0.0004), abnormal appearance on foot examination (HR 4.75, 95% CI 2.30-9.83, P < 0.0001), and mean postrandomization HbA1c (HR 1.65, 95% CI 1.35-2.00, P < 0.0001) were strongly predictive of LEA when accounting for other common risk factors for amputation.
In this post hoc analysis of a large randomized controlled population of diabetic patients, we found that components of the MNSI score including presence of ulceration, abnormal appearance of the foot, and 10 gm filament monofilament scoring were strongly predictive of LEA. This adds a valuable clinical tool in the risk stratification of diabetic patients for LEA.
由于糖尿病患者的神经病变和血糖诱导的血管病变逐渐进展，糖尿病是导致下肢截肢（LEA）的主要危险因素。在这项研究中，我们评估了在一项随机对照试验和延长的试验后随访期间，2 型糖尿病患者发生事件性 LEA 的危险因素。
心血管风险行动（Action to Control Cardiovascular Risk in Diabetes）试验将 10251 例 2 型糖尿病患者随机分为强化血糖控制（糖化血红蛋白（HbA1c）目标<6.0%）与标准血糖控制（HbA1c 目标 7.0-7.9%）组。使用向后消除逻辑回归模型，我们检查了密歇根州周围神经病变筛查工具（Michigan Neuropathy Screening Instrument，MNSI）的神经病变与临床试验期间和随后随访期间的血糖控制和事件性 LEA 之间的关系。
9746 例患者在随机分组后平均随访 7.9±3.1（中位数 8.9）年。98 例（1%）患者在试验期间或试验后随访期间发生事件性 LEA。通过截肢事件状态检查基线人口统计学和传统危险因素。多变量模型显示，10 克丝纤维试验异常（HR 4.50，95%CI 2.92-6.95，P<0.0001）、溃疡（HR 4.22，95%CI 1.65-10.8，P=0.0004）、足部检查异常（HR 4.75，95%CI 2.30-9.83，P<0.0001）和平均随机后 HbA1c（HR 1.65，95%CI 1.35-2.00，P<0.0001）是在考虑其他常见截肢危险因素后预测 LEA 的重要因素。
在这项大型随机对照人群的事后分析中，我们发现 MNSI 评分的组成部分，包括溃疡、足部异常外观和 10 克丝纤维单丝评分，强烈预测 LEA。这为糖尿病患者的 LEA 风险分层增加了一种有价值的临床工具。
