Department of Endocrinology, Southwest Hospital, Third Military Medical University, Chongqing, China.
J Ethnopharmacol. 2011 Jan 27;133(2):543-50. doi: 10.1016/j.jep.2010.10.040. Epub 2010 Dec 1.
The purpose of this study was to evaluate the efficacy and safety of a topical Chinese herbal medicine (CHM) compound Tangzu Yuyang Ointment (TYO) for treatment of chronic diabetic foot ulcers.
This multi-center, prospective, randomized, controlled and add-on clinical trial was conducted at seven centers in the China mainland. Fifty-seven patients with chronic diabetic foot ulcers of Wagner's ulcer grade 1-3 were enrolled in this study. Patients who were randomly assigned to the control group (n=28) received standard wound therapy (SWT), whereas those randomized to the treatment group (n=28) received SWT plus topical TYO. Only 48 patients who finished 24 weeks of observations were entered for data analysis.
The TYO and SWT groups were comparable for baseline characteristics. Ulcer improvement was 79.2% in the TYO group and 41.7% in the SWT group (P=0.017) at 12 weeks, and 91.7% vs. 62.5% (P=0.036) at 24 weeks. The number of ulcers that were completely healed at 4, 12 and 24 weeks was similar in both groups, as were the numbers of adverse events. Healing time was 96±56 days (n=19) in the TYO group and 75±53 days (n=14) in the SWT group (P=0.271).
TYO plus SWT is more effective than SWT in the management of chronic diabetic foot ulcers and has few side-effects.
本研究旨在评估一种中药复方软膏（TYO）——糖足愈疡软膏治疗慢性糖尿病足溃疡的疗效和安全性。
这是一项多中心、前瞻性、随机、对照、附加临床试验，在中国内地的 7 家中心进行。共纳入 57 例 Wagner 溃疡分级 1-3 级的慢性糖尿病足溃疡患者。将患者随机分为对照组（n=28）和治疗组（n=28），对照组接受标准伤口治疗（SWT），治疗组在 SWT 基础上加用 TYO 治疗。仅对完成 24 周观察的 48 例患者进行数据分析。
两组患者的基线特征具有可比性。治疗 12 周时，TYO 组和 SWT 组溃疡改善率分别为 79.2%和 41.7%（P=0.017），治疗 24 周时分别为 91.7%和 62.5%（P=0.036）。两组在第 4、12 和 24 周完全愈合的溃疡数量、不良事件数量均相似。TYO 组愈合时间为 96±56 天（n=19），SWT 组为 75±53 天（n=14）（P=0.271）。
与 SWT 相比，TYO 联合 SWT 治疗慢性糖尿病足溃疡更有效，且副作用较少。
