肾华片治疗IgA肾病(气阴两虚证)多中心随机对照临床观察

Multicentered,Randomized,Controlled Clinical Trial on Patients with IgA Nephropathy of Qi-yin Deficiency Syndrome Type

目的以血管紧张素转化酶抑制剂福辛普利为阳性对照药,评价中药复方肾华片治疗IgA肾病气阴两虚证的疗效及安全性。方法采用前瞻性、多中心、双盲双模拟、随机对照试验设计方案,将131例IgA肾病气阴两虚证患者随机分为福辛普利组(66例)和肾华组(65例),治疗12周,观察尿蛋白定量、血肌酐、尿素氮、内生肌酐清除率、中医主症积分等疗效指标以及肝功能、不良事件等安全性指标。结果两组的基线人口学特征及肉眼血尿、高血压、肾功能不全发生率、总病程、尿蛋白、中医主症积分、肾脏病理Kata-fuchi积分、肾小球积分、肾小管间质积分、血管积分、Lee分级情况等临床特征无统计学差异。治疗12周后福辛普利组和肾华组的24h尿蛋白分别较治疗前下降(0.26±0.92)g/24h和(0.26±0.95)g/24h(P<0.01),两组差异无显著性(P>0.05)。福辛普利组和肾华组中医主症积分分别下降1.74±2.12和2.52±2.34(P<0.01),两组差异有显著性(P<0.05)。与基线比较,两组的血肌酐、尿素氮、内生肌酐清除率均无明显变化(P>0.05),治疗后两组中医兼症积分均明显下降(P<0.01),但组间差异无显著性(P>0.05)。观察过程中两药不良事件发生率差异无显著性,且均未发生严重不良事件。结论与阳性对照药福辛普利相似,肾华片可以降低IgA肾病气阴两虚证患者的尿蛋白,明显改善临床证候,无严重不良反应。

Objective To evaluate the effect and safety of Chinese medicine Compound Shenhua Tablet （SPIT） on IgA nephropathy patients of TCM Qi-yin deficiency syndrome type, by using angiotensin-converting enzyme inhibitors （ACEI） fosinopril as the positive control. Methods Adopting prospective, multieentered, double-blinded,double-dummy, randomized, controlled trial design, 131 patients with IgA nephropathy of Qiyin deficiency syndrome type were assigned to two groups, the 65 patients in the treated group （SHG） and the 66 in the control group treated with SHT and fosinopril respectively for 12 weeks. The indexes of efficacy, including TCM syndrome scores, urinary protein, serum creatinine, urea nitrogen and endogenous creatinine clearance rate, as well as the indexes of safety, including liver function and occurrence of adverse events were observed. Results There was no significant statistical difference between the two groups in aspects of baseline demographic characteristics and clinical figures, including gross hematuria, hypertension, incidence of renal insufficiency, total course of disease, urinary protein, TCM syndrome score, renal pathological Katafuchi score, glomerular score, tubular-interstitial score, vascular score and Lee grading. Afte 12 weeks of treatment, the content of 24- h urinary protein significantly decreased by 0.26 ± 0.95 g/24 h and 0.26 ± 0.92 g/24 h respectively in the two groups,showing significant difference in comparing with baseline, but insignificant difference between the two groups （ P 〉 0.05） ; the scores of TCM dominant syndromes in them decreased by 2.52 ± 2.34 scores and 1.74 ± 2.12 scores respectively with significant difference as compared with baseline （ P 〈 0.01 ）, and in comparison between groups （P 〈 0.05）. No significant change in levels of serum creatinine, urea nitrogen, endogenous creatinine clearance rate in both groups was found （P 〉 0.05）. Scores of TCM accompanied syndromes in the two groups was significantly decreased （P 〈 0.01 ）, but the difference between them was insignificant （P 〉0.05）. No severe adverse event occurred during treatment, and the occurrence in the two groups was similar. Conclusion SHT, just like the positive control medicine fosinopril, can effectively decrease the proteinuria and improve clinical syndrome of IgA nephropathy patients of Qi-yin deficiency syndrome type, and shows no serious adverse reaction.