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.
Key words
Tangning Tongluo /
diabetic foot ulcer /
type 2 diabetes
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References
[1] ZHANG P, LU J, JING Y, et al. Global epidemiology of diabetic foot ulceration: a systematic review and meta-analysis[J]. Ann Med, 2017 Mar, 49(2): 106-116.
[2] NDOSI M, WRIGHT-HUGHES A, BROWN S, et al. Prognosis of the infected diabetic foot ulcer: a 12-month prospective observational study[J]. Diabet Med, 2018 Jan, 35(1): 78-88.
[3] SCHAPER NC, VAN NETTEN JJ, APELQVIST J, et al.Practical guidelines on the prevention and management of diabetes-related foot disease (IWGDF 2023 update)[J]. Diabetes Metab Res Rev, 2024, 40(3): e3657.
[4] 朱信霖, 扈东营, 陈显振, 等. 糖尿病足溃疡发病机制及治疗相关研究进展[J/OL]. 中国皮肤性病学杂志, 1-12[2025-09-22]. https://link.cnki.net/urlid/61.1197.R.20221202.1306.003.
[5] DURANDO P, FERREIRA A, CELIS ME.Acute administration of alpha-melanotropin exerts a stimulatory control on puberty[J]. Acta Endocrinol (Copenh), 1989, 120(5): 661-666.
[6] 金德, 连凤梅, 仝小林. 糖宁通络胶囊“六郁”解[J]. 北京中医药, 2017, 36(06): 543-546.
[7] 卢珊, 王婷婷, 李永吉. 糖宁通络胶囊对db/db小鼠高血糖症以及视网膜肾脏病变的疗效研究[J]. 中国现代中药, 2015, 17(06): 551-555.
[8] 张富文, 段俊国, 夏文, 等. 糖宁通络片治疗非增殖期糖尿病视网膜病变的临床疗效[J]. 中国实验方剂学杂志, 2025, 31(03): 132-139.
[9] 王林华, 卢敏, 段航, 等. 胫骨横向骨搬移微创导板技术联合桃红四物汤治疗糖尿病足溃疡的疗效分析[J]. 湖南中医药大学学报, 2024, 44(09): 1646-1652.
[10] 张雪芹, 曲玮, 梁敬钰. 车前草化学成分和药理作用研究进展[J]. 海峡药学, 2013, 25(11): 1-8.
[11] 金情政, 李钦, 赵吟. 瓜蒌子油对糖尿病小鼠降血糖作用的研究[J]. 药学实践杂志, 2015, 33(04): 324-327.
[12] 庄雅舒, 王丽, 霍晶晶. 基于网络药理学探讨鸡血藤对糖尿病周围神经病变的作用机制[J]. 中医临床研究, 2021, 13(35): 10-14.
[13] 周玲玉. 金银花改善糖尿病视网膜病变药效活性及其机理[D]. 乌鲁木齐: 新疆医科大学, 2016.
[14] 陈文鹏, 卢健棋, 庞延, 等. 仙鹤草化学成分、药理作用及临床应用研究进展[J]. 辽宁中医药大学学报, 2022, 24(06): 118-122.
[15] ARMSTRONG DG, TAN TW, BOULTON AJM, et al.Diabetic Foot Ulcers: A Review[J]. JAMA, 2023, 330(1): 62-75.
[16] CHANG M, NGUYEN TT.Strategy for Treatment of Infected Diabetic Foot Ulcers[J]. Acc Chem Res, 2021, 54(5): 1080-1093.
[17] QIU Y, AI PF, SONG JJ, et al.Total Flavonoid Extract from Abelmoschus manihot (L. ) Medic Flowers Attenuates d-Galactose-Induced Oxidative Stress in Mouse Liver Through the Nrf2 Pathway[J]. J Med Food, 2017, 20(6): 557-567.
[18] 蔡曾晓瑞. 糖宁通络片对糖尿病小鼠的治疗作用及相关机制研究[D]. 锦州: 锦州医科大学, 2023.
[19] WANG N, ZHANG C, XU Y, et al.OMICs approaches-assisted identification of macrophages-derived MIP-1γ as the therapeutic target of botanical products TNTL in diabetic retinopathy[J]. Cell Commun Signal, 2019, 17(1): 81.
[20] REN Y, HU X, QI M, et al.Tangningtongluo Tablet ameliorates pancreatic damage in diabetic mice by inducing autophagy and inhibiting the PI3K/Akt/mTOR signaling pathway[J]. Int Immunopharmacol, 2024, 142(Pt A): 113032.
[21] 陈均, 杨恵. 糖宁通络胶囊治疗糖尿病足的临床经验[J]. 中国医药导报, 2016, 13(34): 89-92, 104.
[22] CHENG L, SONG J, LI G, et al.[Corrigendum] Effects of the Tangningtongluo formula as an alternative strategy for diabetics via upregulation of insulin receptor substrate-1[J]. Mol Med Rep, 2019, 20(5): 4391-4392.
[23] CHENG L, MENG XB, LU S, et al.Evaluation of hypoglycemic efficacy of tangningtongluo formula, a traditional Chinese Miao medicine, in two rodent animal models[J]. J Diabetes Res, 2014, 2014: 745419.