评价生物酶纱布创面敷料用于糖尿病足创面换药的临床疗效和安全性。

选取2015年10月至2016年10月石家庄市中医院、石家庄市第一医院、石家庄市第二医院、石家庄长城医院、河北省沧州中西医结合医院及邯郸市中医院60例糖尿病足溃疡患者，按随机数字表法分为2组，分别应用生物酶纱布创面敷料（试验组30例）和0.9%氯化钠溶液敷料（对照组30例）换药，每天更换，持续42 d。患者年龄、体质量、空腹血糖、餐后血糖、创面面积、创面愈合时间以及治疗费用经统计学分析符合正态分布，以±s表示，采用成组t检验比较上述指标之间的差异。患者性别构成比、细菌清除率、创面渗出和创缘反应采用卡方检验或Fisher精确检验。

2组患者年龄、体质量、空腹血糖以及餐后血糖等指标经统计学检验差异均无统计学意义（P值均>0.05），具有可比性。试验组7、14 d的细菌清除率分别为84%和96%，分别高于对照组的36%和44%，差异具有统计学意义（χ²=5.30，P=0.020；χ²=9.00，P=0.003）。治疗14、21、28 d后，试验组的创面渗出评分均优于对照组，差异具有统计学意义（P<0.05）。治疗7、14、21 d后，试验组的创缘反应评分均优于对照组，差异具有统计学意义（P<0.05）。治疗1、7、14、21、28 d后，试验组的创面面积变化情况均优于对照组，差异具有统计学意义（P<0.05）。治疗28 d后，试验组和对照组的创面愈合率分别为75.42%和16.67%。创面愈合时间试验组为（28.56±13.21）d，对照组为（38.38±15.40）d，差异具有统计学意义（t=-2.65，P=0.036）。试验组患者平均治疗费用（18 202.15±9189.92）元，对照组为（26 249.86±11 458.13）元，差异具有统计学意义（t=-3.00，P=0.020）。2组患者均未发生局部和全身不良反应。

生物酶纱布创面敷料具有良好的杀菌效果，能减少渗出和减轻创缘反应，促进创面早日愈合，减少治疗费用。

To evaluate the clinical effects and safety of a wound dressing containing bio-enzymes in the treatment of diabetic foot ulcer.

A total of 60 patients with diabetic foot ulcer were randomly assigned to either a trial group or a control group, in which a wound dressing containing bio-enzymes and a wound dressing containing normal saline were applied every day for 42 d, respectively. Patient′s age, body mass, fasting blood glucose, postprandial blood glucose, wound area, wound healing time, and treatment cost were compared between the two groups by Student′s t-test. Chi-square test and Fisher exact test were performed to compare the sex composition ratio, bacterial clearance rate, wound-surface exudation, and wound-edge response.

The age, body mass, fasting blood glucose, and postprandial blood glucose were statistically comparable in the two groups. The bacterial clearance rates at 7 d and 14 d in the trial group were 84% and 96%, respectively, which were significantly higher than those in the control group (36% and 44%, respectively; P<0.05). At 14, 21, and 28 d, the scores of wound-surface exudation in the trial group were significantly better than those in the control group (P<0.05). At 7, 14, and 21 d, the scores of wound-edge response in the trial group were significantly better than those in the control group (P<0.05). At 1, 7, 14, 21, and 28 d, the wound areas of the trial group were significantly better than those of the control group (P<0.05). At 28 d, the wound healing rates of the trial group and the control group were 75.42% and 16.67%, respectively. The time to wound-surface healing was significantly shorter in the trial group than in the control group [(28.56±13.21) d vs (38.38±15.40) d, P<0.05)]. The average total cost of the trial group was significantly lower in the trial group (18 202.15±9189.92 yuan) than in the control group (26 249.86±11 458.13 yuan; P<0.05). No local or systemic adverse reactions occurred in either group.

The wound dressing containing bio-enzymes has good germicidal action, can reduce wound-edge response and wound-surface, and thus promotes wound-surface healing early, with high safety but low cost.