肾宁合剂治疗IgA肾病的临床观察

Clinical observation on Shenning mixture in treating IgA nephropathy

目的观察中药肾宁合剂治疗系膜增生性IgA肾病的疗效。方法观察2007年1月至2011年1月在武汉大学人民医院行肾穿刺活检确诊为系膜增生性IgA肾病患者40例，已除外继发性IgA肾病，随机分为研究组和对照组，其中研究组20例，给予中药肾宁合剂50ml，3次／d，并给予对症治疗（钙通道阻滞剂和利尿剂降压治疗）；对照组20例，给予贝那普利10-20mg／d，对症治疗与研究组相同，2个月为1疗程，1个疗程后评定疗效。观察2组治疗前、后的血尿、24h尿蛋白定量、血清胱抑素C（cystatin C，Cys-C）、血肌酐、血尿素氮及尿N-乙酰-β-D-氨基葡萄糖苷酶（N-acetyl-β-D-glucosaminidase，NAG）等指标。结果对照组有3例患者因头痛及无法忍受的咳嗽而改用其他药物，退出观察。研究组均完成疗程。2组治疗前各项指标比较，差异均无统计学意义。研究组治疗后24h尿蛋白定量为（0．8875±0．2767）g，较治疗前的（1．6615±0．1879）g明显改善（P〈0．05）。对照组治疗后24h尿蛋白定量为（0．9871±0．1385）g，较治疗前的（1．5160±0．2290）g下降（P〈0．05）。2组治疗后比较差异无统计学意义。2组治疗后血尿素氮及肌酐较治疗前无明显改变。对照组治疗后CysC为（0．870±0．168）mg／L，与治疗前的（1．231±0．088）mg／L比较，P〈0．05；研究组治疗后CysC为（0．829±0．161）mg／L，与治疗前的（1．211±0．108）mg／L比较，P〈O．05，2组治疗后均较治疗前下降。对照组治疗后尿红细胞较治疗前无改变，研究组治疗后尿红细胞为（50．47±28．07）个／μl，较治疗前的（189．39±67．48）个／μl减少（P〈0．05）。对照组治疗后尿NAG无明显改变，研究组治疗后尿NAG为（14．35±2．37）U／L，较治疗前的（25．1±10．8）U／L下降（P〈0．05）。2组总有效率分别为85．0％和76．5％，差异无统计学意义。结论肾宁合剂和贝那普利均能降低尿蛋白，改善早期肾功能受损。肾宁合剂同时还能改善血尿和肾小管功能，可用于治疗系膜增生性IgA肾病。

Objective To study the effect of Shenning mixture on mesangial proliferative IgA nephropathy. Methods Forty patients diagnosed as having mesangial proliferative IgA nephropathy by renal biopsy were randomly divided into two groups （observation group and control group）. The patients in the observation group （n=20） were given Shenning mixture, and those in the control group （n= 20） were given benazepril （10-20 mg/day）. Symptomatic treatments were given in the two groups. After two months, the curative effectiveness was evaluated. Clinical remission was defined as 24 h urine volume of proteins ≤0. 3 g with normal kidney function. The significant effect was defined as proteinuria reduction of 50% or greater from baseline and normal kidney function. The effect was defined asproteinuria reduction of 25%-50%, from baseline and normal kidney function. No effect was defined as none of above. The levels of hematuria, 24 h urine protein quantity, blood Cys C, blood creatinine, blood urea nitrogen and the urine NAG enzyme were determined in two groups before and after treatment. Results Three of the patients in the control group dropped out for headache and/ or unbearable cough. All of the patients in the observation group finished the treatment. There was no significant difference between two groups before treatment. The 24 h urine protein quantity in observation group after the treatment was significantly reduced as compared with that before treatment[（0. 8875 ±0. 2767） g vs. （1. 6615 ± 0. 1879） g, P〈0. 051. The 24 h urine protein quantitative in control group was reduced after treatment [（0.9871 ± 0. 1385） g vs. （1.5160± 0.2290） g, P〈 0. 05]. No significant difference in 24 h urine protein quantity was observed in the two groups after the treatment. No apparent change in the level of blood urea nitrogen and creatinine was observed after treatment in the two groups. Cys-C was reduced in the observation and control groups after therapy [control group： （0. 870 ±0. 168） mg/L and （1. 231 ± 0. 088） mg/L respectively, P〈0. 05; observation group： （0.829±0. 161） mg/L vs. （1.211 ±0. 108） mg/L, P〈0.05 for both] There was no change of hematuria in the control groupa after treatment. Hematuria was alleviated in the observation group after treatment [（50. 47± 28. 07） eell/μL vs. （189.39 ± 67. 48） cells/μL, P〈0. 052. No significant change of urinary NAG enzyme was seen in the control group after treatment. The level of NAG enzyme was decreased in the observation group after treatment [（25. 1± 10. 8） U/L vs. （14. 35 ± 2. 37） U/L; P〈0. 05]. The total effective rate was 85.0% in observation group and 76. 5% in control group. There was no significant difference in the effective rate between the two groups. Conclusions Shenning mixture and benazepril can reduce urinary protein volume, and alleviate early kidney damage. Shenning mixture can also improve hematuria and tubule function. Shenning mixture can be used to treat mesangial-proliferative IgA nephropathy.