固本泄浊颗粒治疗特发性膜性肾病气虚湿阻证临床观察

Clinical observation of Guben Xiezhuo Granule in Treatment of Idiopathic Membranous Nephropathy with Qi Deficiency and Dampness Obstruction Syndrome

目的:观察固本泄浊颗粒治疗特发性膜性肾病气虚湿阻证的临床疗效。方法:将40例特发性膜性肾病气虚湿阻证患者,采用平行对照研究方法,随机分为治疗组和对照组,每组20例。对照组给予低盐优质蛋白饮食及降血压、抗凝血、降血脂等对症治疗,并联合氯沙坦钾片治疗,每天1次,每次5~10 mg,使血压控制在140/90 mm Hg(1 mm Hg=0.133kPa)以下。治疗组在对照组治疗基础上加服固本泄浊颗粒治疗,方药组成:黄芪15 g,党参10 g,熟地黄10 g,怀山药10 g,茯苓10 g,泽泻10 g,川芎6 g,车前子9 g。偏于气虚者加黄精9 g,白术6 g;偏于阳虚者加肉桂6 g,仙灵脾9 g;偏于阴虚者加沙参6 g,知母5 g;偏于血瘀者加地龙6 g,红花6 g;偏于湿热者加黄连3 g,竹茹5 g;水肿明显者加冬瓜皮10 g,赤小豆9 g。以上药物均选用中药颗粒,加水冲服,每天2次。两组患者均治疗2个月。观察两组患者的临床疗效、中医证候积分、中医证候疗效和各项生化指标变化情况。结果:两组患者中医证候积分和中医证候疗效比较,治疗后治疗组均优于对照组,差异均有统计学意义(P<0.05);两组患者治疗后,24小时尿蛋白定量(24 hour urinary protein,24h UTP)、血清白蛋白(serum albumin,ALB)与治疗前比较,以及治疗后两组比较,差异均有统计学意义(P<0.01);治疗后两组患者肾小球滤过率(estimated glomerular filtration rate,e GFR)比较,差异无统计学意义(P>0.05)。治疗后两组患者临床疗效比较,差异有统计学意义(P<0.05)。两组患者安全性指标比较,谷氨酸氨基转移酶(alanine amino transferase,ALT)、天冬氨酸氨基转移酶(aspartate amino transferase,AST)和血钾(K+)指标,同组治疗前后比较以及治疗后两组患者组间比较,差异均无统计学意义(P>0.05)。结论:固本泄浊颗粒治疗特发性膜性肾病气虚湿阻证能改善患者的临床症状,减少蛋白尿,提高血清白蛋白水平,且无严重不良反应。

Objective： To observe the clinical curative effect of Guben Xiezhuo Granules in treatment of idiopathic membranous nephropathy Qi Deficiency and Dampness Obstruction Syndrome. Methods： Forty patients were randomly divided into treatment group and control group,with 20 patients in each group. The control group was given a low-salt high-quality protein diet and symptomatic treatment such as lowering blood pressure,anticoagulant,and hypolipidemic effect,and was treated with losartan potassium tablets once a day for 5 to 10 mg each time,so that the blood pressure was controlled at 140/90 mm Hg. The treatment group was treated with Guben Xiezhuo Granules in addition to that of the treatment of the control group. Formula composition： Astragalus 15 g,Codonopsis 10 g,Rehmannia glutinosa 10 g,Dioscorea opposita 10 g,Poria 10 g,Alisma 10 g,Chuanxiong 6 g,Plantago 9 g. Prejudice to deficiency of Qi adding Huang Jing 9 g,Atractylodes 6 g; biased to Yang deficiency plus cinnamon 6 g,Epimedium 9 g; biased to Yin deficiency Gazaginseng 6 g,Anemarrhenae 5 g; biased to bloody persons plus Dilong 6 g,safflower 6 g; Partially hot and humid were added Coptis 3 g,Zhuru 5 g; Obvious edema plus melon skin 10 g,red bean 9 g. The above medicines were all Chinese medicine granules and were taken with water,twice a day. Both groups were treated for 2 months. The clinical efficacy,TCM syndrome scores,TCM syndrome efficacy and changes in biochemical indicators of the two groups of patients were observed. Results：The clinical efficacy and TCM syndromes of the two groups were better than the control group after treatment,and the difference was statistically significant(P 〈 0. 05）. After treatment,the 24 hours urinary protein quantitation,serum albumin(ALB） levels were significantly different than those before and after treatment(P 〈 0. 01）. The glomerular filtration rate was significantly higher in the two groups after treatment(estimated glomerular,24 h UTP） and serum albumin(ALB）. There was no significant difference in filtration rate(e GFR） between the two groups(P 〉 0. 05）. The clinical efficacy of the two groups after treatment was statistically significant(P 〈 0. 05）. Comparison of the efficacy indicators between the two groups of patients,after treatment,UTP indicators decreased while Alb indicators were increased in both groups,and the difference between the two groups was statistically significant(P 〈 0. 05）; There were no significant difference between the two groups in e GFR indicators(P 〉 0. 05）. There were no differences in Alanine aminotransferase(ALT）,aspartate aminotransferase(AST） and serum potassium(K＋） between the two groups before and after treatment(P 〉 0. 05）. Conclusion： Guben Xiezhuo Granules can improve the clinical symptoms of patients with idiopathic membranous nephropathy with Qi Deficiency and Dampness Obstruction Syndrome,which can reduce albuminuria and increase serum albumin level without serious adverse reactions.