摘要
背景:许多研究证实晚期糖基化终产物(advanced glycation end product,AGE)与糖尿病血管病变密切相关,中医药在该类疾病治疗中存在一定优势。目的:评价加味当归四逆汤治疗Wagner0级糖尿病足患者的临床疗效、安全性及其对血清AGE水平的影响。设计、场所、受试者和干预措施:采用随机、阳性药物对照研究方案。将72例血瘀证、肾阳虚证Wagner0级糖尿病足患者随机分为治疗组和对照组,每组36例,均为广州中医药大学茂名市中医院门诊和住院患者。患者签署知情同意书之前已经被口头或者书面告知研究过程。该研究由广州中医药大学茂名中医院医学伦理委员会批准。治疗组口服加味当归四逆汤,对照组予西药西洛他唑治疗。两组均以14d为1个疗程,连续治疗3个疗程。主要结局指标:观察两组治疗前后临床症状、踝肱指数(ankle-brachial index,ABI)、肌电图、下肢动脉超声多普勒血流动力学指标、空腹血糖、糖基化血红蛋白、纤维蛋白原和AGE水平变化。记录实验室检查结果和不良事件作为安全性评估的依据。结果:治疗组治疗后临床症状、ABI、下肢动脉超声多普勒血流动力学和神经传导速度等指标均较对照组改善,差异有统计学意义(P<0.05,P<0.01)。治疗后两组血清AGE均明显下降,且治疗组与对照组比较,差异亦有统计学意义(P<0.01)。结论:加味当归四逆汤能改善Wagner0级糖尿病足患者的临床症状,并对糖尿病血管病变有一定的治疗作用。
Background： 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.
Objective： 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 thirtysix 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. Main outcome measures： The changes of clinical symptoms, ankle-brachial index （ABI）, electromyography, lower extremity arteries measured by ultrasonic Doppler, fasting blood glucose, hemoglobin Alc, 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. Results： 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）. Conclusion： 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.
出处
《中西医结合学报》
CAS
2009年第7期622-628,共7页
Journal of Chinese Integrative Medicine
