You Wei-hua, Wang Ping, Li Mao-qing, Zhang Yu, Peng Yu-lan, Zhang Feng-ling
Department of Internal Medicine, Maoming Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Maoming 525000, Guangdong Province, China.
Zhong Xi Yi Jie He Xue Bao. 2009 Jul;7(7):622-8. doi: 10.3736/jcim20090705.
Many studies have demonstrated association between advanced glycation end products (AGEs) and diabetic angiopathy. There are certain advantages of traditional Chinese medicine (TCM) therapy in treatment of these diseases.
To evaluate the therapeutic effects and safety of modified Danggui Sini Decoction, a compound traditional Chinese herbal medicine for nourishing blood to warm meridians, on plasma level of AGEs in patients with Wagner grade 0 diabetic foot ulcers of blood stasis or/and kidney yang deficiency syndrome.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: A random and positive control method was adopted. Seventy-two cases of Wagner classification of grade 0 diabetic foot ulcers with blood stasis or/and kidney yang deficiency syndrome were randomly divided into treatment group and control group. There were thirty-six cases in each group. All the patients were collected from Maoming Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine. Patients received oral and written information about the clinical procedures before giving their written informed consent. The study was approved by the Ethics Committee of Maoming Hospital of Traditional Chinese Medicine. The patients in the treatment group were treated with modified Danggui Sini Decoction, and the patients in the control group were treated with cilostazol. A course of treatment was 14 days, and the patients in the two groups were treated for 3 courses.
The changes of clinical symptoms, ankle-brachial index (ABI), electromyography, lower extremity arteries measured by ultrasonic Doppler, fasting blood glucose, hemoglobin A1c, fibrinogen, and plasma level of AGEs were detected in the two groups before and after treatment. The safety of modified Danggui Sini Decoction was assessed by laboratory data and adverse events.
There were statistical differences in clinical efficacy, ABI, lower extremity arteries hemodynamics, and nerve conduction velocity between the two groups (P<0.05, P<0.01). The plasma level of AGEs after treatment was significantly decreased in the two groups, and the level of AGEs in the treatment group was lower than that in the control group (P<0.05).
Modified Danggui Sini Decoction can improve clinical symptoms in patients with diabetic foot ulcers of Wagner grade 0 and it shows therapeutic effects on diabetes complicated with vascular diseases.
许多研究已证实晚期糖基化终末产物（AGEs）与糖尿病血管病变之间存在关联。中医治疗这些疾病具有一定优势。
评价养血温经复方中药加味当归四逆汤对瓦格纳分级0级糖尿病足溃疡血瘀或/和肾阳虚证患者血浆AGEs水平的治疗效果及安全性。
设计、地点、参与者和干预措施：采用随机阳性对照方法。将72例瓦格纳分级0级糖尿病足溃疡血瘀或/和肾阳虚证患者随机分为治疗组和对照组。每组36例。所有患者均来自广州中医药大学附属茂名医院。在患者签署书面知情同意书之前，向其提供有关临床程序的口头和书面信息。本研究经茂名市中医院伦理委员会批准。治疗组患者服用加味当归四逆汤，对照组患者服用西洛他唑。一个疗程为14天，两组患者均接受3个疗程的治疗。
检测两组治疗前后的临床症状、踝肱指数（ABI）、肌电图、下肢动脉超声多普勒测量、空腹血糖、糖化血红蛋白、纤维蛋白原及血浆AGEs水平的变化。通过实验室数据和不良事件评估加味当归四逆汤的安全性。
两组临床疗效、ABI、下肢动脉血流动力学及神经传导速度比较，差异有统计学意义（P<0.05，P<0.01）。两组治疗后血浆AGEs水平均显著降低，且治疗组AGEs水平低于对照组（P<0.05）。
加味当归四逆汤可改善瓦格纳分级0级糖尿病足溃疡患者的临床症状，对糖尿病合并血管病变具有治疗作用。
