复方黄柏液辅助治疗糖尿病足溃疡的临床疗效分析

目的:探讨复方黄柏液治疗糖尿病足溃疡的临床疗效。方法:选择2014年3月—2015年4月间天津医科大学代谢病医院足科确诊的糖尿病足溃疡住院患者252例,随机分为试验组和对照组,各126例,两组患者均采用标准化创面处理,试验组在此基础上局部应用复方黄柏液冲洗及浸润,对照组用生理盐水冲洗。治疗8周后,对两组患者溃疡面积,炎症相关指标,临床总有效率,不良事件发生情况进行统计学分析。结果:240例患者完成了该试验(每组各120例),治疗8周后试验组患者在缩小溃疡面积,降低炎症相关指标(白细胞,中性粒细胞百分比,血沉,C反应蛋白)及临床总有效率方面均优于对照组(P0.05),两组患者治疗期间不良事件发生率无统计学差异,试验组内缺血与非缺血患者相比,在缩小溃疡面积,降低炎症指标方面均无统计学差异。结论:复方黄柏液对溃疡创面愈合有明显疗效,对缺血或非缺血性溃疡患者均适用,是辅助治疗糖尿病足溃疡有效、安全的药物。

Analysis on Clinical Efficacy of Compound Huangbai Fluid as Adjunctive Treatment for Diabetic Foot Ulcer

Objective: To explore the clinical efficacy of compound Huangbai fluid for the treatment of diabetic foot ulcer (DFU). Method: The 252 patients with DFU were recruited from the Metabolic Diseases Hospital of Tianjin Medical University between March 2014 and April 2015. They were randomly divided into the experimental group (EG, n = 126) and control group (CG, n=126). The standardized wound treatment was used in both groups, however, the ulcer wounds in the EG were also rinsed and infiltrated with compound Huangbai fluid, while in the CG, normal saline was used for rinsing. After treatment for 8 weeks, the ulcer size, inflammation related indicators, total clinical efficiency and incidence of adverse events were compared with statistical analysis between two groups. Result: The 240 subjects completed this study (n=120 in each group). After treatment for 8 weeks, the EG was superior to CG in term of the reduction of ulcer size,reduction of inflammation related indicators(white blood cell, neutrophil, C-reactive protein, erythrocyte sedimentation rate), and total clinical efficacy (P< 0.05). No significant differences in adverse events were found between two groups. There were no statistical differences in the reduction of ulcer size and inflammation related indicators were observed between ischemic and non-ischemic patients in EG. Conclusion: Compound Huangbai fluid has obvious clinical efficacy on ulcer wound healing and it is applicable to both ischemic and non-ischemic ulcer patients, so it is an effective and safe drug as an adjunctive treatment of DFU.