Clinical trial of Qishen Tongluo granules in the treatment of diabetic nephropathy in stage Ⅲ
10.13699/j.cnki.1001-6821.2018.07.012
- VernacularTitle:芪参通络颗粒治疗Ⅲ期糖尿病肾病的临床研究
- Author:
Ying-Chun CHEN
1
;
Zhong-Xiang LIU
;
Ya-Mei WANG
;
Yan-Hong LI
;
Yan-Fei DONG
;
Cong-Kun XIANG
Author Information
1. 河北省中医院药剂科
- Keywords:
Qishen Tongluo granule;
losartan potassium tablet;
diabetic nephropathy;
safety
- From:
The Chinese Journal of Clinical Pharmacology
2018;34(7):777-779
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety of Qishen Tongluo granules in the treatment of diabetic nephropathy (DN) in stage Ⅲ.Methods One hundred and four patients with DN in stage Ⅲ were randomly divided into control and treatment groups with 52 cases per group.Control group was given potassium choride tablets 100 mg per time,qn,orally.Treatment group was given Qishen Tongluo granule 20 g per time,bid,orally.Two groups were treated for 12 weeks.The clinical efficacy,fasting plasma glucose (FPG),hemoglobin A1 c (HbA1c),homostasis model assessment of insulin resistance index (HOMA-IR),urinary albumin excretion rate (UAER),serum creatinine (SCr) and adverse drug reactions (ADR) were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 86.54％ (45 cases/52 cases) and 69.23％ (36 cases/52 cases) with significant difference (P ＜ 0.05).After treatment,the main indexes in treatment and control groups were compared:FPG were (6.54±0.68) and (7.16 ±0.74) mmol · L-1,HbA1c were (7.18 ±0.72)％ and (7.62-± 0.79)％,HOMA-IR were (4.71 ±1.06) and (5.65±1.10),UAERwere (58.34 ±16.52) and (82.15±19.05) mg· 24 h-1,SCr were (85.60 ± 15.69) and (94.25 ± 16.77) μmol · L-1,the differences were statistically significant (all P ＜0.01).The adverse drug reactions in two groups were nausea,abdominal discomfort,lack of appetite and dizziness.The total incidences of ADR were 9.62％ and 13.46％ without significant difference (P ＞ 0.05).Conclusion Qishen Tongluo granules have a definitive clinical efficacy and safety in the treatment of DN in stage Ⅲ,which can effectively improve the renal function and insulin resistanc,and reduce blood glucose.
