[Multicentered, randomized, controlled clinical trial on patients with IgA nephropathy of Qi-yin deficiency syndrome type].

OBJECTIVE: To evaluate the effect and safety of Chinese medicine Compound Shenhua Tablet (SHT) 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, multicentered, double-blinded, double-dummy, randomized, controlled trial design, 131 patients with IgA nephropathy of Qi-yin 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.