Abstract:

Objective

To evaluate the effect of Yiqiheluo formula combined with valsartan in the treatment of IgA nephropathy with deficiency of both qi and yin plus blood stasis syndrome.

Methods

A randomized， controlled， double-blind research was conducted. The subjects were 60 patients with IgA nephropathy with deficiency of both qi and yin plus blood stasis syndrome in the department of nephrology of the Beijing Changping District Hospital of Integrated Traditional Chinese and Western Medicine from October 2020 to October 2022. They were randomly divided into a treatment group and a control group，with 30 cases in each. Both groups received the capsule of valsartan （80 mg， once a day）， while the treatment group were added with Yiqiheluo particles formula （1 dose， twice a day）， and the control group was added with Yiqiheluo simulation agent， the therapy course of which was 48 weeks. Relevant laboratory indicators were measured before the treatment as well as after 12 weeks，24 weeks，and 48 weeks of the treatment，including serum creatinine， blood urea nitrogen， albumin， IgA， complement C3， triglyceride， total cholesterol，together with urinary red blood cell count and 24 h urinary protein quantity， etc. The total effective rate and the changes of the relevant indexes were compared between the two groups.

Results

Compared with those before treatment，the treatment group showed lower levels of 24 h urinary protein quantity，urinary red blood cell count，serum IgA，blood urea nitrogen，and serum creatinine after 24 and 48 weeks of the treatment （all P ＜0.05），but higher levels of estimated glomerular filtration rate （eGFR） and serum complement C3 （both P ＜0.05）. After 48 weeks of the treatment，the control group displayed lower levels of 24 h urinary protein and red blood cell count（P ＜0.05），but no significant changes in levels of serum IgA，blood urea nitrogen， and serum creatinine （P ＞0.05）. Compared with the control group，the treatment group had significantly lower levels of 24 h urinary protein quantity，urinary red blood cell count，serum IgA，blood urea nitrogen，and serum creatinine（all P ＜0.05），but higher levels of eGFR and serum complement C3 （all P ＜0.05） after 48 weeks of the treatment. After 12 weeks，24 weeks，and 48 weeks of the treatment， the main symptom scores and total symptom scores of the treatment group were significantly lower than those of the control group（P ＜0.05）. The total effective rate of the syndromes was significantly higher in the treatment group than in the control group after 48 weeks of the treatment ［26 cases（86.7%） vs 19 cases （63.3%）， P ＜0.05］， and the total clinical effective rate was significantly higher in the treatment group than in the control group ［23 cases （76.7%） vs 13 cases （43.3%）， P ＜0.05］. No adverse events occurred in both of the two groups during the treatment.

Conclusion

In the treatment of IgA nephropathy with deficiency of both qi and yin plus blood stasis syndrome， the Yiqiheluo formula combined with valsartan treatment was superior to valsartan treatment alone in improving the remission rate of proteinuria， clinical symptoms，and quality of life of the patients.

Key words: IgA nephropathy, Deficiency of both qi and yin plus blood stasis syndrome, Yiqiheluo formula, Efficacy of treatment