摘要
目的观察芪参通络颗粒治疗Ⅲ期糖尿病肾病(DN)的临床疗效及安全性。方法将104例Ⅲ期DN患者随机分为对照组52例和试验组52例。对照组予以氯沙坦钾片每次100 mg,睡前口服;试验组予以芪参通络颗粒每次10 g,bid,口服。2组患者均连续治疗12周。比较2组患者的临床疗效、空腹血糖(FPG)、糖化血红蛋白(Hb A1c)、胰岛素抵抗指数(HOMA-IR)、尿蛋白排泄率(UAER)、血清肌酸酐(SCr),以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为86.54%(45例/52例)和69.23%(36例/52例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的FPG分别为(6.54±0.68)和(7.16±0.74)mmol·L^(-1),Hb A1c分别为(7.18±0.72)%和(7.62±0.79)%,HOMA-IR分别为(4.71±1.06)和(5.65±1.10),UAER分别为(58.34±16.52)和(82.15±19.05)mg·24 h^(-1),SCr分别为(85.60±15.69)和(94.25±16.77)μmol·L^(-1),差异均有统计学意义(均P<0.01)。2组患者的药物不良反应以恶心、腹部不适、食欲缺乏和头晕为主,试验组和对照组的总药物不良反应率分别为9.62%和13.46%,差异无统计学意义(P>0.05)。结论芪参通络颗粒治疗Ⅲ期DN的临床疗效显著,其可显著改善患者的肾功能,降低血糖,改善胰岛素抵抗,且不增加药物不良反应的发生率。
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 ehoride 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 clini- cal efficacy, fasting plasma glucose （FPG） , hemoglobin A1 c （ HbA1 c ）, 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） μmol·L-1, HbAlc were （7.18±0.72）% and （7.62 ± 0.79）%, HOMA - IR were（4.71 ±1.06） and （5.65±1.10）, UAER were （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 inci- dences 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.
作者
陈迎春
刘中香
王亚梅
李艳红
董燕飞
相聪坤
CHEN Ying - chun, LIU Zhong - xiang2, WANG Ya - mei3, LI Yan - hongTM, DONG Yan- feiTM, XIANG Cong - kun1(1. ca Department of Pharmacy; b. Department of Rehabilitation, Hebei Provincial Hospital of Traditional Chinese Medicine, Shijiazhuang 050011, China; 2. Department of Phamuwy, Qingxian County Maternal and Child Healthcare Station, Qingxian 062650, Hebei Province, China ; 3. Department of Pharmacy, Chengde Center Hospital, Chengde 067000, Hebei Province, Chin)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2018年第7期777-779,共3页
The Chinese Journal of Clinical Pharmacology
基金
河北省中医药管理局科研计划基金资助项目(2017162)
关键词
芪参通络颗粒
氯沙坦钾片
糖尿病肾病
安全性
Qishen Tongluo granule
losartan potassium tablet
diabetic nephropathy
safety
