A Randomized Controlled Study of Jiedu Tongluo Kaibi Formula(解毒通络开痹方)in Diabetic Lower Extremity Arteriosclerosis Obstruction Patients with Qi Deficiency and Blood Stasis
Objective To verify the hypoglycemic,lipid-lowering,anti-inflammatory and vascular protective effects of Jiedu Tongluo Kaibi Formula(解毒通络开痹方)on diabetic lower extremity arteriosclerosis obstruction(DLASO)patients with Qi de-ficiency,blood stasis and toxin.Method Ninety subjects who passed the inclusion criteria and signed informed consent forms were randomly divided into an experimental group and a control group using a random number table,and the groups were hidden.The control group was given basic treatment,including diabetes education,exercise,diet and conventional western medicine for lower-ing blood sugar and lipid.The experimental group received the intervention of Jiedu Tongluo Kaibi Formula on the basis of the control group.The course of treatment of both groups was 15 weeks.Blood glucose,blood lipids,body mass index(BMI),lower limb artery diameter,ankle brachial index and related inflammatory factors were measured,and traditional Chinese medicine syn-drome scores were evaluated after 15 weeks.Safety assessments were conducted at enrollment,6 and 15 weeks of intervention,and statistical analysis was performed using SPSS software.Results After treatment,the levels of fasting blood glucose(FBG),glycosylated hemoglobin(HbA1c),total cholesterol(TC),low density lipoprotein cholesterol(LDL-C),BMI,internal diameter of bilateral femoral arteries,popliteal arteries,dorsalis pedis arteries,homocysteine(HCY),C-reactive protein(CRP),cystatin C(CysC),and total score of traditional Chinese medicine syndrome in the experimental group decreased compared to before inter-vention(P＜0.05),while high density lipoprotein cholesterol(HDL-C)and ankle brachial index(ABI)increased compared to before intervention(P＜0.05).There was no statistically significant difference in triglyceride(TG)and internal diameter of bi-lateral anterior tibial arteries(P＞0.05).In the control group,the levels of HbA1c,the internal diameter of bilateral common femoral arteries,and total scores of traditional Chinese medicine syndromes decreased compared to those before intervention(P＜0.05),while ABI increased compared to that before intervention(P＜0.05),and there was no significant difference in FBG,TC,TG,LDL-C,HDL-C,BMI,internal diameter of bilateral popliteal arteries,anterior tibial arteries,dorsalis pedis arteries,HCY,CRP or CysC compared to those before intervention(P＞0.05).There was a statistically significant difference in ABI,bilateral common femoral artery diameter,and total scores of traditional Chinese medicine syndromes after treatment(P＜0.05),but no statistically significant difference in HbA1c between the two groups after treatment(P＞0.05).The total clinical effective rate of the experimental group was 85.71％,while that of the control group was 61.90％.The overall safety was good.Conclusion Jiedu Tongluo Kaibi Formula can effectively improve the clinical symptoms of DLASO patients with Qi deficiency,blood stasis and tox-in,reduce blood sugar and weight,regulate blood lipids,reduce homocysteine,C-reactive protein and cystatin C,expand the in-ner diameter of lower limb arteries,and reduce plaques and vascular stenosis with good safety.
Jiedu Tongluo Kaibi Formula(解毒通络开痹方)type 2 diabetesarteriosclerosisclinical research
万方数据
维普
