羧甲基壳聚糖生物胶液负压滴灌治疗糖尿病足溃疡的疗效

目的探讨羧甲基壳聚糖生物胶液负压滴灌治疗糖尿病足溃疡的临床疗效。方法为前瞻性研究。收集2019年2月至2020年3月北京中医药大学东直门医院的60例糖尿病足患者,采用随机数字表法将患者分为试验组和对照组,各30例。对照组在基础治疗的同时采用生理盐水滴灌负压治疗,试验组采用羧甲基壳聚糖生物胶液进行滴灌负压治疗。治疗14 d,记录两组患者的的创面容积减少值以及糖尿病足溃疡疗效指标评分,并采用t检验和秩和检验进行比较。观察记录不良事件和不良反应。结果对照组中有1例患者在负压治疗中出现渗漏,最终共59例患者完成并纳入统计数据。治疗后试验组患者的创面容积减少值为9.00(7.75,12.00)ml,对照组为5.00(3.00,6.00)ml,试验组优于对照组,差异有统计学意义(Z=-4.444,P<0.01)。试验组治疗后糖尿病足溃疡疗效指标评分为(16.96±1.74)分,对照组为(20.40±7.06)分,差异有统计学意义(t=-2.544,P=0.014)。两组患者安全性指标监测均无异常变化,无严重不良事件及反应。结论羧甲基壳聚糖生物胶液作为滴灌液进行负压滴灌治疗可以促进糖尿病足溃疡,效果优于生理盐水。

Clinical efficacy of negative-pressure wound therapy with instillation of carboxymethyl chitosan bio-glue in diabetic foot ulcer

Objective To research the clinical efficacy of negative-pressure wound therapy with instillation of Carboxymethyl Chitosan Biological Glue in diabetic foot ulcer.Methods The study was prospective.A total of 60 patients with diabetic foot ulcers in Dongzhimen Hospital,Beijing University of Chinese Medicine were collected from February 2019 to March 2020.The patients were randomly divided into experimental group(n=30)and control group(n=30)according to the random number method.The control group was based on at the same time of treatment,normal saline drip irrigation was used for negative pressure therapy,and the experimental group was used for drip irrigation negative pressure therapy with carboxymethyl chitosan biological glue.The wound volume reduction value and the quantification and scoring criteria of the diabetic foot ulcer curative effect index were recorded in the two groups,and the t test and the rank sum test were used for statistical analysis.Results In the control group,there was 1 case of leakage in the negative pressure treatment,and finally a total of 59 patients completed and were included in the statistical data.After 14 days of treatment,the wound volume of patients in the experimental group was significantly better than that of the control group9.00(7.75,12.00)ml vs.5.00(3.00,6.00)ml,P<0.01];the quantification of diabetic foot ulcer curative effect index and scoring in the experimentalgroup was smaller than that in the control group(16.96±1.74 vs.20.40±7.06,P<0.05).There was no serious adverse events and reactions in the two groups.Conclusion Carboxymethyl chitosan bio-glue as a drip irrigation solution for negative pressure drip irrigation can promote diabetic foot ulcers,and the effect is better than normal saline.