Institute of Integrative Medicine, Fudan University, Shanghai, China.
J Integr Med. 2013 May;11(3):175-83. doi: 10.3736/jintegrmed2013032.
Microalbuminuria (MAU) is a key component of metabolic syndrome (MetS) and is an early sign of diabetic nephropathy as well. Although routine Western medicine treatments are given to MetS patients to control high blood pressure, hyperglycemia and dyslipidemia, some patients still experience progressive renal lesions and it is necessary to modify and improve the treatment strategy for MetS patients.
To investigate the efficacy of Yiqi Huaju Qingli Herb Formula, a compound traditional Chinese herbal medicine, in MetS patients with MAU when it is combined with routine Western medicine treatment.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: Sixty patients with MetS were randomized into the Chinese herbal formula group (CHF, Yiqi Huaju Qingli formula treatment in combination with Western medicine) and control group (placebo in combination with Western medicine). All treatments were administered for 12 weeks.
Urinary microalbumin (MA), urinary albumin-to-creatinine ratio (UACR), 24-hour total urine protein (24-hTP), body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2-hPPG), glycosylated hemoglobin (HbA1c), homeostasis model assessment for insulin resistance (HOMA-IR), blood lipid profile and blood pressure were observed.
Compared with the control group, CHF treatment significantly decreased BMI (P<0.05), WC (P<0.01) and WHR (P<0.01). Both groups had significant decreases in FPG, 2-hPPG, HbA1c, HOMA-IR, MA, and UACR, with CHF treatment showing better effects on these parameters compared with the control treatment (P<0.05). Both treatments significantly reduced the levels of total cholesterol, low-density lipoprotein cholesterol and triacylglycerol (TAG), and a greater reduction in TAG was observed with CHF treatment (P<0.05). The level of high-density lipoprotein cholesterol did not change in the control group after treatment (P>0.05), whereas it significantly increased with CHF treatment (P<0.01). Compared with before the treatment, significant decreases in systolic blood pressure, diastolic blood pressure and mean arterial blood pressure were observed in both groups (P<0.01). However, there was no significant difference between the two groups (P>0.05).
Combined treatment of Yiqi Huaju Qingli Formula and Western medicine significantly alleviated MAU, which may correlate with the improvement of insulin sensitivity and glucose and lipid metabolism. TRIAL REGISTRATION IDENTIFIER: This trial was registered in the Chinese Clinical Trial Registry with the identifier ChiCTR-TRC-11001633.
微量白蛋白尿（MAU）是代谢综合征（MetS）的一个关键组成部分，也是糖尿病肾病的早期迹象。尽管常规的西药治疗用于控制 MetS 患者的高血压、高血糖和血脂异常，但一些患者仍会出现进行性肾脏损伤，因此需要修改和完善 MetS 患者的治疗策略。
探讨复方中药益气化瘀清热方联合西药常规治疗 MetS 合并 MAU 的疗效。
设计、地点、参与者和干预措施：将 60 例 MetS 患者随机分为中药组（CHF，益气化瘀清热方联合西药治疗）和对照组（安慰剂联合西药治疗）。所有治疗均持续 12 周。
尿微量白蛋白（MA）、尿白蛋白/肌酐比值（UACR）、24 小时总尿蛋白（24-hTP）、体重指数（BMI）、腰围（WC）、腰臀比（WHR）、空腹血糖（FPG）、餐后 2 小时血糖（2-hPPG）、糖化血红蛋白（HbA1c）、胰岛素抵抗指数（HOMA-IR）、血脂谱和血压。
与对照组相比，CHF 治疗显著降低 BMI（P<0.05）、WC（P<0.01）和 WHR（P<0.01）。两组 FPG、2-hPPG、HbA1c、HOMA-IR、MA 和 UACR 均显著降低，CHF 治疗效果优于对照组（P<0.05）。两组治疗均显著降低总胆固醇、低密度脂蛋白胆固醇和三酰甘油（TAG）水平，CHF 治疗降低 TAG 水平更为显著（P<0.05）。对照组治疗后高密度脂蛋白胆固醇水平无变化（P>0.05），CHF 治疗后显著升高（P<0.01）。与治疗前相比，两组收缩压、舒张压和平均动脉压均显著降低（P<0.01）。但两组间无显著性差异（P>0.05）。
益气化瘀清热方联合西药治疗可显著缓解 MAU，这可能与改善胰岛素敏感性及血糖和脂代谢有关。
本试验在中国临床试验注册中心注册，注册号 ChiCTR-TRC-11001633。
