Hasan Rim, Firwana Belal, Elraiyah Tarig, Domecq Juan Pablo, Prutsky Gabriela, Nabhan Mohammed, Prokop Larry J, Henke Peter, Tsapas Apostolos, Montori Victor M, Murad Mohammad Hassan
Evidence-based Practice Center, Mayo Clinic, Rochester, Minn; Department of Internal Medicine, University of Missouri, Columbia, Mo.
Evidence-based Practice Center, Mayo Clinic, Rochester, Minn.
J Vasc Surg. 2016 Feb;63(2 Suppl):22S-28S.e1-2. doi: 10.1016/j.jvs.2015.10.005.
The objective of this review was to synthesize the available randomized controlled trials (RCTs) estimating the relative efficacy and safety of intensive vs less intensive glycemic control in preventing diabetic foot syndrome.
We used the umbrella design (systematic review of systematic reviews) to identify eligible RCTs. Two reviewers determined RCT eligibility and extracted descriptive, methodologic, and diabetic foot outcome data. Random-effects meta-analysis was used to pool outcome data across studies, and the I(2) statistic was used to quantify heterogeneity.
Nine RCTs enrolling 10,897 patients with type 2 diabetes were included and deemed to be at moderate risk of bias. Compared with less intensive glycemic control, intensive control (hemoglobin A1c, 6%-7.5%) was associated with a significant decrease in risk of amputation (relative risk [RR], 0.65; 95% confidence interval [CI], 0.45-0.94; I(2) = 0%). Intensive control was significantly associated with slower decline in sensory vibration threshold (mean difference, -8.27; 95% CI, -9.75 to -6.79). There was no effect on other neuropathic changes (RR, 0.89; 95% CI, 0.75-1.05; I(2) = 32%) or ischemic changes (RR, 0.92; 95% CI, 0.67-1.26; I(2) = 0%). The quality of evidence is likely moderate.
Compared with less intensive glycemic control therapy, intensive control may decrease the risk of amputation in patients with diabetic foot syndrome. The reported risk reduction is likely overestimated because the trials were open and the decision to proceed with amputation could be influenced by glycemic control.
本综述的目的是综合现有随机对照试验（RCT），评估强化血糖控制与较低强度血糖控制在预防糖尿病足综合征方面的相对疗效和安全性。
我们采用伞形设计（系统评价的系统评价）来识别符合条件的RCT。两名研究者确定RCT的合格性，并提取描述性、方法学和糖尿病足结局数据。采用随机效应荟萃分析对各研究的结局数据进行汇总，并用I²统计量对异质性进行量化。
纳入了9项RCT，共10897例2型糖尿病患者，这些研究被认为存在中度偏倚风险。与较低强度血糖控制相比，强化控制（糖化血红蛋白6%-7.5%）与截肢风险显著降低相关（相对风险[RR]，0.65；95%置信区间[CI]，0.45-0.94；I² = 0%）。强化控制与感觉振动阈值下降较慢显著相关（平均差值，-8.27；95%CI，-9.75至-6.79）。对其他神经病变改变（RR，0.89；95%CI，0.75-1.05；I² = 32%）或缺血性改变（RR，0.92；95%CI，0.67-1.26；I² = 0%）无影响。证据质量可能为中等。
与较低强度血糖控制治疗相比，强化控制可能降低糖尿病足综合征患者的截肢风险。所报道的风险降低可能被高估，因为这些试验是开放性的，且截肢决策可能受血糖控制影响。
