ABSTRACT
Pre-rheumatoid arthritis （Pre-RA） is the asymptomatic state of rheumatoid arthritis （RA）， and its progression showed complexity， dynamics and significant individual differences. The dynamic prediction model is valuable in identifying individual risks and taking timely preventive and control measures. It is believed that applying the dynamic prediction model to traditional Chinese medicine （TCM） clinical studies of Pre-RA is expected to predict the critical state of Pre-RA to RA， reveal the evolution of Pre-RA， reflect the external authenticity of the TCM clinical studies， and complement the clinical efficacy evaluation method. Accordingly， it is envisioned to construct a dynamic prediction model for Pre-RA progression based on TCM clinical trial data through the dynamic prediction model algorithm， and to apply long-term follow-up cohort data for external validation， thereby providing a basis for scientific warning and clinical decision-making on the evolution of Pre-RA.
ABSTRACT
Objective:To discuss the efficacy and safety of Shenwu Yishenpian on stage 4-5 chronic kidney disease-nondialysis （CKD） with deficiency of spleen and kidney Qi， and the effect on renal interstitial fibrosis （RIF） and microinflammation. Method:One hundred and twenty patients were randomly divided into observation group and control group. A total of 58 patients in control group completed the treatment （including 2 patients falling off or lost）. And 58 patients in observation group completed the treatment （including 1 patient was falling off or lost visit， and 1 eliminated）. Both groups got comprehensive treatment of western medicine. Patients in control group got simulated medicine of Shenwu Yishenpian， 4 pieces/time， 3 times/day. Patients in observation group got Shenwu Yishenpian， 4 pieces/time， 3 times/day. The treatment lasted for 6 months until the renal replacement therapy， and the 6-month follow-up was recorded. For every month， blood creatinine （SCr） was detected， and glomerular filtration rate （eGFR） were calculated. The 12-month renal replacement （dialysis or kidney transplantation）， progress （CKD4 to CKD5） and mitigation （CKD5 to CKD4 or CKD4 to CKD3） were recorded. Before and after treatment， levels of urea nitrogen （BUN）， hemoglobin （HB）， plasma albumin （ALB）， urine protein quantity （24 hUp） and blood uric acid （UA） levels were detected， deficiency of spleen kidney Qi was scored， and transforming growth factor-β1 （TGF-β1）， connective tissue growth factor （CTGF）， serum Klotho， tumor necrosis factor-α （TNF-α）， interleukin-6 （IL-6）， interleukin-1 （Lkn-1） and interleukin-12 （IL-12） were detected. And the safety was evaluated. Result:At the 3th and 6th after treatment， SCr in two groups increased （P<0.01）， while eGFR decreased （P<0.01）. Compared with control group， SCr was less than that in control group （P<0.01）， whereas eGFR was higher than that in control group （P<0.01）. During 12 months of observation， the reduction rate of CKD was 13.79% （8/58）， which was higher than 1.72% （1/58） in control group. The progress rate of CKD was 11.43% （4/35）， which was lower than 31.58% （12/38） in control group （P<0.05）. Levels of BUN， 24 hUp and UA were lower than those in control group （P<0.01）， while levels of Hb and ALB were higher than those in control group （P<0.01）. Effect in observation group was better than that in control group （Z=2.051， P<0.05）. And levels of TGF-β1， CTGF， TNF-α， IL-6， Lkn-1 and IL-12 were lower than those in control group （P<0.01）， and level of Klotho was higher than that in control group （P<0.01）. There was no adverse reaction relating to Shenwu Yishen Pian. Conclusion:Shenwu Yishenpian can delay the progress of renal function and CKD， reverse the progress of renal function in some patients， reduce the risk factors of disease progress， reduce the state of micro inflammation and resist RIF， and protect or improve renal function. Its clinical effect is better than placebo， and it is safe to use.