P0394EFFICACY AND SAFETY OF A CHINESE PATENT MEDICINE-SHENYANKANGFU TABLETS FOR PRIMARY GLOMERULONEPHRITIS:A RANDOMISED CONTROLLED TRIAL
Authors: Wu Jie , Duan Shuwei , Yang Hongtao , Cai Guang-Yan , Chen Xiangmei , Deng Yueyi , He Yani , Ni Zhaohui , Zhan Yongli , Fang Jingai , Li Wei , Liu Xusheng 
Published: June 2020

Abstract

Background and Aims
Chronic kidney disease is a common disease. Most chronic kidney diseases evolve from primary glomerulonephritis. Proteinuria is an independent risk factor for the progression of chronic kidney disease. The general consensus is that therapy administered to decrease proteinuria should include steroids and/or immunosuppressants, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers. However, the side effects of, and adverse reactions to, these agents reduce the benefits to patients. Therefore, additional effective drugs to decrease proteinuria are urgently needed. Shenyankangfu tablets (SYKFT) have been a widely applied Chinese patent medicine for many years to decrease proteinuria. However, there is a lack of research-derived data regarding the clinical use. Therefore, we designed the present trial to compare the efficacy and safety of SYKFT versus losartan potassium for control of proteinuria in patients with primary glomerulonephritis.

Method
This was a multicenter, prospective, double-blind, double-dummy, randomized controlled clinical trial. Primary glomerulonephritis patients aged 18 to 70 years, blood pressure ≤140/90 mmHg, estimated glomerular filtration rate ≥45 mL/min/1.73 m2, 24-hour proteinuria level of 0.5 to 3.0 g, were recruited in 41 hospitals across 19 provinces in China and were randomly divided into the following groups at a 1:1:1:1:1 ratio: SYKFT group, losartan potassium 50 mg group, losartan potassium 100 mg group, SYKFT plus losartan potassium 50 mg group, and SYKFT plus losartan potassium 100 mg group. All groups were followed up for 48 weeks; follow-up visits were performed, at weeks 0, 4, 8, 12, 24, 36, and 48. The primary efficacy outcome was the post-treatment change in the 24-hour proteinuria level, and the secondary efficacy outcomes was the post-treatment changes in the serum creatinine level, estimated glomerular filtration rate (eGFR), traditional Chinese medicine (TCM) syndrome score, and serum albumin level. The protocol was approved by the Ethics Committee of each participating center. This trial was registered at the clinicaltrials.gov (NCT02063100).

Results
A total of 720 participants were enrolled and 673 patients were included in the analysis. The difference in the urine protein reduction among different groups was statistically significant (Z=20.084, P=0.001). The urine protein reduction in the SYKFT group [-150.000 (-692.500, 153.000) mg/d], more than that in the losartan potassium 50mg alone group [-80.000 (-420.000, 295.250) mg/d, Z=-2.015, P=0.044], was not less than that in the losartan potassium 100mg group [-260.000 (-623.900, 84.000) mg/d, Z=-0.339, P=0.734]. The urine protein reduction in the SYKFT plus losartan potassium 50mg group [-269.150 (-755.000, 159.085) mg/d] was more than that in the losartan potassium 50mg alone group [Z=-2.582, P=0.010]. The urine protein reduction in the SYKFT plus losartan potassium 100mg group [-388.000 (-743.500, -10.000) mg/d] was more than that in the losartan potassium 100mg alone group [Z=-1.999, P=0.046]. The changes in serum creatinine, eGFR, and serum albumin from the baseline were not statistically significant among different groups (P all &gt;0.05). The change in TCM syndrome scores between the patients who took SYKFT and who did not take SYKFT was statistically significant (P=0.003).

Conclusion
SYKFT can decrease the proteinuria of primary glomerulonephritis patients with minor- to moderate-range proteinuria. SYKFT plus losartan potassium therapy can decrease proteinuria to a relatively large extent compared with losartan potassium therapy alone. And SYKFT can also improve the TCM syndrome scores of the patients.