加味当归四逆汤治疗0级糖尿病足的疗效及对血清晚期糖基化终产物水平的影响：随机对照试验

doi:10.3736/jcim20090705

Abstract

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 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.Main outcome measures: 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.
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.

Key words: Diabetic foot, Wagner grade 0, Danggui Sini Decoction, Glycosylation end products, Randomized controlled trial

Wei-hua You, Ping Wang, Mao-qing Li, Yu Zhang , Yu-lan Peng, Feng-ling Zhang. Therapeutic effects of modified Danggui Sini Decoction on plasma level of advanced glycation end products in patients with Wagner grade 0 diabetic foot: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2009, 7(7): 622-628.

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URL: http://www.jcimjournal.com/EN/10.3736/jcim20090705

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Item	n	Treatment group	Control group
Male/Female (Cases)	36	17/19	20/16
Age ($\bar{x}$±s, years)	36	63.35±7.04	64.09±7.30
Diabetic duration ($\bar{x}$±s, years)	36	5.14±2.88	4.77±1.52
Diabetic foot duration ($\bar{x}$±s, months)	36	24.0±18.2	21.6±17.2

Group	n	Diameter (cm)	Blood flow (mL/min)	Peak flow (cm/s)
Control
Before treatment	36	0.18±0.03	22.04±5.35	32.86±4.43
After treatment	36	0.20±0.04*	24.54±5.19*	36.26±3.93**
Treatment
Before treatment	36	0.18±0.04	21.70±5.12	34.05±5.36
After treatment	36	0.26±0.05**^△△	34.46±8.11**^△	41.14±5.50**^△△

Group	n	Diameter (cm)	Blood flow (mL/min)	Peak flow (cm/s)
Control
Before treatment	36	0.42±0.05	197.41±17.46	50.55±5.22
After treatment	36	0.45±0.05*	209.85±22.67*	53.45±5.36*
Treatment
Before treatment	36	0.40±0.06	196.73±26.85	52.25±9.42
After treatment	36	0.52±0.07**^△△	269.18±22.14**^△△	60.53±8.79**^△△

Group	n	MNCV (m/s)	SNCV (m/s)	ABI
Control
Before treatment	36	38.57±4.35	32.25±3.57	1.09±0.31
After treatment	36	39.75±4.58	33.96±3.66	1.18±0.29
Treatment
Before treatment	36	37.75±5.21	32.46±3.92	1.08±0.32
After treatment	36	43.46±4.32**^△	38.25±4.06**^△	1.24±0.30^△

Group	n	FBG (mmol/L)	HbA1c (%)	FIB (g/L)	AGEs (mg/L)
Control
Before treatment	36	10.7±0.9	8.9±1.7	7.89±0.82	38.4±11.8
After treatment	36	7.2±0.6**	6.8±1.9**	5.21±0.74*	31.3±10.8*
Treatment
Before treatment	36	10.1±1.4	8.7±2.1	7.87±1.05	37.2±9.8
After treatment	36	6.9±0.8**	6.7±0.7*	4.02±0.81*^△△	26.6±8.6**^△

Therapeutic effects of modified Danggui Sini Decoction on plasma level of advanced glycation end products in patients with Wagner grade 0 diabetic foot: A randomized controlled trial

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