紫朱软膏联合清筋术治疗非缺血型糖尿病足溃疡的临床疗效及对血清NLRP3、IL-1β、IL-18水平的影响

Effects of Zizhu Ointment Combined with Tendon Clearance on Serum Levels of NLRP3， IL-1β， and IL-18， in Treatment of Non-ischemic Diabetic Foot Ulcers

摘要:

目的 观察清筋术联合紫朱软膏治疗非缺血型糖尿病足溃疡的临床疗效及其对血清核苷酸结合寡聚化结构域样受体蛋白3（NLRP3）炎症小体、白细胞介素（IL）-1β、IL-18表达水平的影响。方法 选取2023年3月至2024年3月年在上海中医药大学附属曙光医院周围血管病科门诊及病房就诊的非缺血型糖尿病足溃疡患者106例。采用简单随机数字表法将符合纳入标准的非缺血型糖尿病足溃疡患者分为观察组和对照组，每组各53例。两组患者均接受基础治疗，观察组局部溃疡采用清筋术联合紫朱软膏填充，对照组采用清创术联合牛碱性成纤维细胞生长因子外用溶液，观察两组患者治疗前后溃疡愈合率、血清NLRP3、IL-1β、IL-18水平、溃疡面积、中医证候积分、视觉模拟评分（VAS评分）、糖尿病足溃疡愈合量表（DMIST）评分，记录两组患者的不良事件发生情况。结果 溃疡愈合率比较，观察组愈合率显著高于对照组（P<0.01）。与本组治疗前比较，两组患者的血清NLRP3、IL-1β、IL-18水平、溃疡面积、中医证候积分、VAS评分、DMIST评分均显著下降（P<0.01）。与对照组治疗后比较，观察组血清NLRP3、IL-1β、IL-18水平、溃疡面积、中医证候积分、VAS评分、DMIST评分明显降低（P<0.05，P<0.01）。两组患者治疗前后肝肾功能比较均无统计学差异，两组患者在治疗过程中均未发生明显不良反应。结论 清筋术联合紫朱软膏治疗非缺血型糖尿病足溃疡具有较好的临床疗效，并具有良好的安全性，其作用机制可能与降低局部创面的炎症有关。

Abstract:

Objective To observe the effect of tendon clearing combined with Zizhu ointment on the serum levels of nucleotide-binding oligomerization domain-like receptor protein 3 （NLRP3） inflammasomes， interleukin （IL）-1β， and IL-18 in the treatment of non-ischemic diabetic foot ulcers.Method A total of 106 patients with non-defective diabetic foot ulcers who attended the outpatient clinic and wards of the Vascular Surgery Department of Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine from March 2023 to March 2024 were selected. The patients with non-ischemic diabetic foot ulcers who met the inclusion criteria were assigned with the random number table method into an observation group and a control group， with 53 patients in each group. Patients in both groups received basic treatment. The local ulcers in the observation group received tendon clearing combined with Zizhu ointment， while those in the control group received conventional debridement combined with topical solution of bovine basic fibroblast growth factor. The serum NLRP3， IL-1β， and IL-18 levels， ulcer area， traditional Chinese medicine （TCM） symptom scores， visual analogue scale （VAS） score， and DMIST score were measured and recorded in the two groups before and after treatment. The ulcer healing rate and incidence of adverse reactions were compared between the two groups.Result The observation group had higher ulcer healing rate than the control group （P<0.01）. After treatment， both groups showed lowered serum NLRP3， IL-1β， and IL-18 levels， reduced ulcer area， and declined TCM symptom score， VAS score， and DMIST score （P<0.01）. Moreover， these indicators were lower in the observation group than in the control group （P<0.05， P<0.01）. Neither group showed significant changes in the liver and kidney function indicators after treatment. Significant adverse reactions occurred in neither group during the treatment course.Conclusion Tendon clearance combined with Zizhu ointment was effective and safe in treating non-ischemic diabetic foot ulcers. It may exert the therapeutic effect by reducing the inflammation of the local ulcers.