目的: 评估糖宁通络片及糖宁通络乳膏对2型糖尿病足溃疡患者的临床疗效及安全性。方法: 纳入100例糖尿病足患者,随机分为5组,对照组（常规治疗）、口服组（常规治疗+糖宁通络片）、外敷组（常规治疗+糖宁通络膏）及联合组（常规+糖宁通络片+糖宁通络膏）、大剂量口服组（常规治疗+糖宁通络片大剂量口服）,最终剔除5例,实际分析病例为95例,收集并比较各组患者基线特征,比较观察患者治疗1个月和3个月的结局、血清学指标变化以及Wagner分级<4级或Wagner分级=4级的溃疡结局并记录整个治疗期间的不良反应。结果: 患者各组间基线资料比较无显著性差异。治疗后1个月,总体人群和Wagner分级<4级患者的愈合率差异不显著;治疗后3个月时,总体人群和Wagner分级<4级患者的愈合率存在显著差异,口服组、外敷组、联合组和大剂量口服组的愈合率均显著高于对照组。治疗后3个月,大剂量口服组白细胞水平显著降低;除对照组外,其余各组中性粒细胞计数均明显下降,各组谷丙转氨酶、谷草转氨酶、白蛋白及肌酐水平治疗前后无显著变化。在整个治疗过程中患者均未出现任何不良反应。结论: 联合使用糖宁通络片与糖宁通络乳膏,可以有效减轻创面感染并促进创面愈合,其长期临床疗效显著高于常规治疗,且安全性良好,改善了患者的临床预后,具有较高的临床应用价值。
Abstract
Objective To evaluate the clinical efficacy and safety of Tangning Tongluo tablets and Tangning Tongluo cream in patients with type 2 diabetic foot ulcer. Methods 100 patients with diabetic foot were randomly divided into 5 groups: control group (routine treatment), oral group (routine treatment+Tangning Tongluo tablet), external application group (routine treatment+Tangning Tongluo ointment), combined group (routine treatment+Tangning Tongluo tablet+Tangning Tongluo ointment) and high-dose oral group (routine treatment+Tangning Tongluo tablet). Finally, 5 cases were excluded. The outcomes of patients treated for 1 month and 3 months, the changes of serological indexes, and the ulcer outcomes with Wagner grade<4 or Wagner grade=4 were compared and observed, and the adverse reactions during the whole treatment period were recorded. Results There was no significant difference in baseline data between the groups. One month after treatment, there was no significant difference in the healing rate between the general population and patients with Wagner grade<4. Three months after treatment, there were significant differences in the healing rate between the general population and patients with Wagner grade<4, and the healing rates of oral group, external application group, combined group and high-dose oral group were significantly higher than those of the control group. Serological indicators, 3 months after treatment, the level of white blood cells in the high-dose oral group decreased significantly; Except for the control group, the neutrophil count in other groups decreased significantly, and the levels of alanine aminotransferase, aspartate aminotransferase, albumin and creatinine in each group did not change significantly before and after treatment. Safety evaluation showed that the patients did not have any adverse reactions during the whole treatment. Conclusion The combined use of Tangning Tongluo Tablet and Tangning Tongluo Cream can effectively reduce wound infection and promote wound healing. Its long-term clinical efficacy is significantly higher than that of conventional treatment, and its safety is good, which improves the clinical prognosis of patients and has high clinical application value.
关键词
糖宁通络 /
糖尿病足溃疡 /
2型糖尿病
Key words
Tangning Tongluo /
diabetic foot ulcer /
type 2 diabetes
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基金
南通市科技计划项目“糖尿病足多学科规范化诊疗”（MSZ2023155）;南通市科技计划项目“氧化应激诱导脂肪干细胞外泌体综合改善创面微环境促糖尿病足溃疡愈合机制研究”（JCZ2023004）;南通大学附属医院研究型医院建设经费“揭榜挂帅”——研究型学科（联合）发展基金（YJXYY202204-XKB09）
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