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The patient's response to drug treatment is usually systems-wide based on multi-spots through either direct or indirect targets. Thus, the evaluation of the treatment cannot rely on single targeted biomarker, especially for complex diseases such as chronic kidney disease. In the present study, we performed a systems-wide analysis using proteomic approach to quantify changes in the proteomic profiles of the plasma from IgA nephropathy (IgAN) patients before and after treatment. In particular, the patient-to-health distances based on global proteome quantification before and after treatment were calculated and considered as quantitative readouts to measure patient divergences from the healthy condition. We found that the patient-to-health distance nicely correlated with the patient's response to drug treatment and long-term prognosis, which created a self-tracking platform for personalized evaluation. In addition, the steroid treatment plays a role in immunosuppression, while the Chinese Traditional Medicine (TCM) can modulate whole-body systems. Our results indicated that STC therapy normalized the proteomic profile more significantly than SA therapy. This work provides an omics-based and systematic platform for personalized evaluation of disease treatment. This strategy could help us to evaluate treatment outcomes and predict prognosis in patients with IgAN and other complex diseases. [ABSTRACT FROM AUTHOR]

Background 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. In addition, the cost of these drugs is relatively high. Therefore, identification of inexpensive and effective drugs to decrease proteinuria is urgently needed. Shenyankangfu tablets 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 randomized controlled clinical trial to compare the efficacy and safety of Shenyankangfu tablets versus losartan potassium for control of proteinuria in patients with primary glomerulonephritis. Methods/design This study will be a multicenter, prospective, double-blind, double-dummy, randomized controlled clinical trial. We will enroll 720 patients diagnosed with primary glomerulonephritis. The eligible patients will be randomly divided into the following groups at a 1:1:1:1:1 ratio: Shenyankangfu tablets group, losartan potassium 50 mg group, losartan potassium 100 mg group, Shenyankangfu tablets + losartan potassium 50 mg group, and Shenyankangfu tablets + losartan potassium 100 mg group. All groups will be followed up for 48 weeks; follow-up visits will be performed, at weeks 0, 4, 8, 12, 24, 36, and 48. The primary efficacy outcome will be the post-treatment change in the 24-hour proteinuria level, and the secondary efficacy outcomes will be the post-treatment changes in the serum creatinine level, estimated glomerular filtration rate, traditional Chinese medicine syndrome score, and serum albumin level. Discussion The results of this trial will provide solid data for use in evidence-based medicine with respect to the efficacy and safety of Shenyankangfu tablets for control of proteinuria in patients with primary glomerulonephritis compared to those of losartan potassium. Moreover, we infer that therapy comprising Shenyankangfu tablets + losartan potassium can decrease proteinuria to a larger extent than Shenyankangfu tablets or losartan potassium can alone. [ABSTRACT FROM AUTHOR]