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预防糖尿病患者足部溃疡复发:意大利糖尿病足综合征治疗指南制定的随机对照试验的系统评价和荟萃分析。

Prevention of foot ulcers recurrence in patients with diabetes: a systematic review and meta-analysis of randomized controlled trials for the development of the italian guidelines for the treatment of diabetic foot syndrome.

机构信息

Azienda Sanitaria Universitaria Giuliana Isontina, Monfalcone, Italy.

ASUGI Monfalcone-Gorizia, Trieste, Italy.

出版信息

Acta Diabetol. 2024 Nov;61(11):1363-1373. doi: 10.1007/s00592-024-02353-7. Epub 2024 Sep 5.

Abstract

AIM

To compare the effectiveness of preventive interventions in reducing reccurrent diabetic foot ulcers. Meta-analysis (MA) was conducted to address clinical questions on this topic of the Italian guidelines on diabetic foot.

METHODS

This MA includes randomized controlled trials evaluating the effectiveness of various preventive interventions, namely: treatment of pre-ulcerative foot lesions, structured educational programs, psychological interventions and the use of therapeutic footwear to relieve plantar pressure in people with diabetes mellitus and a history of previous ulcers.

RESULTS

A total of 731 studies were identified and 14 were considered eligible for the analysis. We found that treatments of pre-ulcerative foot lesions did not provide any statistically significant effects (MH-OR: 0.84 [0.31, 2.33], p = 0.74, I = 38%). Conversely, structured educational programs were associated with a trend toward reduction of ulcer recurrence risk (MH-OR: 0.13 [0.01, 1.64], p = 0.10, I = 88%). No randomized controlled studies assessing the efficacy of psychological interventions have been retrieved. The use of therapeutic footwears can effectively reduce the risk of reulceration in diabetic patients with an history of previous DFU, in particular prefabricated rigid-soled therapeutic footwears showed a significant reduction of the risk of ulcer recurrence in comparison with semirigid soles (MH-OR: 0.17 [0.05, 0.57], p = 0.004).

CONCLUSIONS

The study provides low-certainty evidence that, among preventive strategies in patients with previous DFU, rigid-sole therapeutic footwear and structured education programs are capable of reducing the risk of foot re-ulceration.

摘要

目的

比较预防干预措施在减少复发性糖尿病足溃疡方面的效果。本研究对意大利糖尿病足指南中关于该主题的临床问题进行了荟萃分析(MA)。

方法

本 MA 纳入了评估各种预防干预措施有效性的随机对照试验,这些预防干预措施包括:治疗溃疡前期足部病变、结构化教育计划、心理干预以及使用治疗性鞋具来减轻有既往溃疡史的糖尿病患者的足底压力。

结果

共确定了 731 项研究,其中 14 项被认为符合分析条件。我们发现,治疗溃疡前期足部病变并不能提供任何具有统计学意义的效果(MH-OR:0.84 [0.31, 2.33],p=0.74,I=38%)。相反,结构化教育计划与降低溃疡复发风险呈趋势相关(MH-OR:0.13 [0.01, 1.64],p=0.10,I=88%)。没有检索到评估心理干预疗效的随机对照研究。治疗性鞋具的使用可以有效地降低有既往 DFU 史的糖尿病患者再溃疡的风险,特别是预制刚性鞋底治疗性鞋具与半刚性鞋底相比,显著降低了溃疡复发的风险(MH-OR:0.17 [0.05, 0.57],p=0.004)。

结论

本研究提供了低确定性证据,表明在既往有 DFU 的患者中,刚性鞋底治疗性鞋具和结构化教育计划是能够降低足部再溃疡风险的预防策略。

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