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口服鱼油对糖尿病足溃疡患者伤口愈合影响的随机双盲安慰剂对照研究

Effect of oral fish oil on wound healing in patients with diabetic foot ulcers:a randomized,double-blind,placebo-controlled study
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摘要 目的探讨口服鱼油对糖尿病足溃疡(DFU)患者的伤口愈合及相关指标的影响。方法采用随机、双盲、安慰剂对照设计,共招募该院68例年龄18~80岁的DFU患者,收集患者的基线临床资料。通过Excel生成随机数将患者随机分为试验组(32例,鱼油软胶囊,3 g/d)和对照组(33例,玉米油软胶囊,3 g/d),干预12周。主要指标包括伤口完全愈合和愈合面积≥50%的比例,次要指标包括伤口面积、愈合时间、炎症指标、糖代谢指标和营养相关指标,以及伤口再感染情况。分析伤口愈合的影响因素。结果干预后,试验组伤口完全愈合和愈合面积≥50%的比例明显高于对照组(P=0.007、0.039);在伤口完全愈合患者中,试验组愈合时间短于对照组,但差异无统计学意义(P=0.132);试验组伤口缩小面积明显大于对照组(P=0.045),白细胞介素(IL)-6和IL-8的降低值明显高于对照组(P<0.05)。两组C反应蛋白(CRP)、肿瘤坏死因子-α(TNF-α)、中性粒细胞与淋巴细胞比值(NLR)、糖化血红蛋白(HbA1c)和血小板与淋巴细胞比值(PLR)的降低值无明显差异(P>0.05)。试验组前清蛋白(PA)改善幅度大于对照组,但差异无统计学意义(P>0.05)。多因素logistic回归分析显示,干预措施(OR=6.771,95%CI:1.787~25.652)、HbA1c(OR=4.149,95%CI:1.026~16.770)、溃疡类型(OR=4.319,95%CI:1.026~18.173)是伤口愈合的影响因素(P<0.05)。结论口服鱼油能促进DFU患者伤口愈合,可能与改善机体慢性炎症水平相关。 Objective To investigate the effect of oral fish oil on wound healing and related indexes in patients with diabetic foot ulcer(DFU).Methods A randomized,double-blind,placebo-controlled design was used to recruit 68 patients with DFU aged 18-80 years old in the hospital,and the baseline clinical data of the patients were collected.The patients were randomly divided into experimental group(32 cases,fish oil soft capsule,3 g/d)and control group(33 cases,corn oil soft capsule,3 g/d)by random number generated by Excel,and the intervention lasted for 12 weeks.The primary endpoints included the proportion of complete wound healing and healing area≥50%.The secondary endpoints included wound area,healing time,inflammation index,glucose metabolism index,nutrition related index and wound reinfection.Additionally,the influencing factors of wound healing were analyzed.Results After intervention,the proportion of complete wound healing and healing area≥50%in the experimental group was significantly higher than that in the control group(P=0.007,0.039).In the subjects with complete wound healing,the mean healing time in the experimental group was shorter than that in the control group,but the difference was not statistically significant(P=0.132).The reduction area of wound area in the experimental group was significantly larger than that in the control group(P=0.045).The decrease of interleukin(IL)-6 and IL-8 in the experimental group was significantly higher than that in the control group(P<0.05).There was no significant difference in the reduction of C-reactive protein(CRP),tumor necrosis factor-α(TNF-α),neutrophil-to-lymphocyte ratio(NLR),glycated hemoglobin A1c(HbA1c)and platelet-to-lymphocyte ratio(PLR)between the two groups(P>0.05).The improvement of prealbumin(PA)in the experimental group was higher than that in the control group,but the difference was not statistically significant(P>0.05).Multivariate logistic regression analysis showed that oral fish oil intervention(OR=6.771,95%CI:1.787-25.652),HbA1c(OR=4.149,95%CI:1.026-16.770)and ulcer type(OR=4.319,95%CI:1.026-18.173)were the influencing factors of wound healing(P<0.05).Conclusion Oral fish oil promotes wound healing in patients with DFU,which may be related to improving the level of chronic inflammation in the body.
作者 张灏 徐静 童强 时梦苒 王敏 杜蓥漩 王渊 张春林 刘佳为 郭小芹 梁馨予 王建 ZHANG Chunlin;LIU Jiawei;GUO Xiaoqin;LIANG Xinyu;WANG Jian(Department of Nutrition,the Second Affiliated Hospital of Army Medical University,Chongqing 400037,China;Department of Endocrinology,the Second Affiliated Hospital of Army Medical University,Chongqing 400037,China)
出处 《重庆医学》 CAS 2024年第5期669-676,共8页 Chongqing medicine
基金 重庆英才·创新领军人才(医学领域)计划项目(CQYC20220303514)。
关键词 鱼油 糖尿病足溃疡 伤口愈合 慢性炎症 fish oil diabetic foot ulcer wound healing chronic inflammation
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