Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial / 中西医结合学报

BACKGROUND@#Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.@*OBJECTIVE@#This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium.@*DESIGN, SETTING, PARTICIPANTS AND INTERVENTION@#This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m@*MAIN OUTCOME MEASURES@#The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment.@*RESULTS@#A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group.@*CONCLUSION@#SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.@*TRIAL REGISTRATION NUMBER@#NCT02063100 on ClinicalTrials.gov.

Effects of Niaoduqing Particles () on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study / 中国结合医学杂志

OBJECTIVE@#To follow up the participants of the randomized clinical trial "Efficacy and Safety of Niaoduqing Particles () for Delaying Moderate-to-Severe Renal Dysfunction", and assess the long-term effects of Niaoduqing Particles on delaying the progression of renal dysfunction.@*METHODS@#Participants, who had previously been randomly assigned to receive Niaoduqing Particles or placebo for 24 weeks (146 cases in each group), were invited to follow-up and all were administered Niaoduqing Particles 5 g thrice daily and 10 g before bedtime for 24 weeks. The primary endpoints were changes in baseline serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) after completion of the open-label treatment period.@*RESULTS@#After the double-blind period, the median (interquartile range) changes in Scr were 1.1 (-13.0-24.1) and 11.7 (-2.6-42.9) μmol/L for the Niaoduqing Particle and placebo groups, respectively (P=0.008), and the median changes in eGFRs were-0.2 (-4.3-2.7) and-2.21 (-5.7-0.8) mL•min•1.73 m, respectively (P=0.016). There were significant differences in the double-blind period changes in renal function between groups. After the open-label period, the median changes in Scr were 9.0 (-10.0-41.9) and 17.5 (-6.0-50.0) μmol/L for the Niaoduqing Particle and placebo groups according to baseline grouping, respectively (P=0.214), and the median changes in eGFRs were-2.3 (-6.4-1.9) and-3.7 (-7.5-1.1) mL•min•1.73 m, respectively (P=0.134). There were no statistical differences in the open-label period changes in renal function between groups. The eGFR reduction of participants who accepted Niaoduqing Particle treatment for 48 weeks was projected to 2.5 mL•min•1.73 m per year.@*CONCLUSION@#Niaoduqing Particles appear to have long-term efficacy for patients with moderate-to-severe renal dysfunction. Although there was no statistical difference, the early use of Niaoduqing Paticles seems to ameliorate the worsening of renal function. (Trial registration No. ChiCTR-TRC-12002448).

Therapeutic Effects and Mechanism of Chinese Medicine Skin Dialysis for Chronic Renal Failure / 广州中医药大学学报

Objective To observe the influence of Chinese medicine skin dialysis on traditional Chinese medicine (TCM) syndrome scores and microinflammation in patients with chronic renal failure(CRF). Methods A total of 180 patients with CRF were divided into groups A, B and C, 60 cases in each group. All of the 3 groups were given conventional treatment, and additionally, group A was given Chinese medicine skin dialysis, and group B was given pure water dialysis. Meanwhile, 60 healthy volunteers served as normal control group (group D), and had no any medication. The course of treatment lasted for one month. Before and after treatment, we examined the scores of TCM syndromes and the levels of 24-hour urinary protein, serum creatinine (SCr), blood urea nitrogen (BUN), estimated glomerular filtration rate (eGFR), albumin (ALB), immunoglobulin A(IgA), immunoglobulin G (IgG) , immunoglobulin M(IgM), interleukin 6 (IL-6) , interleukin 1(IL-1), hyper-sensitive C reactive protein (hs-CRP), and tumor necrosis factor alpha (TNF-α). Results After treatment, the scores of TCM syndromes and the levels of 24-hour urinary protein, SCr, BUN, eGFR, IL-6, IL-1, hs-CRP, and TNF-α in the 3 groups were decreased (P < 0.05 compared with those before treatment), and were markedly lower in group A than those in group B and group C (P<0.05); serum levels of IgA, IgG, IgM and ALB in the 3 groups were increased(P < 0.05 compared with those before treatment), and the levels in group A were significantly higher than those in group B and group C (P < 0.05). However, the levels of observation indexes did not arrive to the levels of group D(P<0.05). Conclusion Chinese medicine skin dialysis is effective on relieving the symptoms of CRF patients and enhancing the therapeutic effect through decreasing inflammatory mediators, inhibiting micro-inflammation and improving nutritional status.

Biotransformation effect of Bombyx Mori L. may play an important role in treating diabetic nephropathy / 中国结合医学杂志

Compared with herbal drugs, medicine processed from animals (animal medicine) was thought to have more bioactive substances and higher activities. Biotransformation effect often plays an important role in their effect. However, researches about effect of animal medicine on diabetic nephropathy and applying animal medicine as natural bio-transformer were seldom reported. The purpose of this paper was to reveal the use of Bombyx Mori L. on diabetic nephropathy from ancient to modern times. The classical literature indicated that Saosi Decoction (), which contains Bombyx Mori L. or silkworm cocoon, was applied to treat disorders congruent with modern disease diabetic nephropathy from the Ming to Qing Dynasty in ancient China. Modern studies showed that Bombyx Mori L. contains four main active constituents. Among these, 1-deoxynojirimycin (1-DNJ) and quercetin showed promising potential to be new agents in diabetic nephropathy treatment. The concentrations of 1-DNJ and the activities of quercetin in Bombyx Mori L. are higher than in mulberry leaves, because of the biotransformation in the Bombyx Mori L. body. However, these specifific components need further human and mechanistic studies to determine their therapeutic potential for this challenging condition.

Management of chronic kidney disease in China calls for the implementation of expert patient program with traditional Chinese medical interventions / 中国结合医学杂志

Chronic kidney disease was closely related with unhealthy lifestyle; therefore a strategy focused both on daily life and medical process, like the Expert Patients Program, was of great value in the prevention and treatment of chronic kidney disease. In China, however, obstacles still existed in the process of implementing the program. Adding traditional Chinese medical interventions to the program assisted both patients and physicians to understand and to accept this new trend in management of chronic disease better. The combination with traditional Chinese medical interventions showed a solution for successfully implementing the Expert Patients Program and provided a new strategy for prevention and control of chronic kidney disease.

Colon may provide new therapeutic targets for treatment of chronic kidney disease with Chinese medicine / 中国结合医学杂志

Chronic kidney disease (CKD) has become a worldwide health and social problem. Retarding its progression to end-stage renal disease is beneficial both to the patients and the healthcare system. Plenty of clinical trials have indicated that enema with Chinese medicine could effectively prevent chronic renal failure, and was widely used in the clinical practice. However, studies on mechanism were still nearly blank, which may prevent further improvement of therapeutic efficacy. Recent studies had discovered that colon was an important organ where uremic toxins were generated. The uremic toxins involved could not only promote CKD progression, but also was closely correlated with CKD mortality. Reducing production and promoting excretion of toxins were confirmed to reduce renal tubule interstitial fibrosis and delay renal progression. On the basis of the theory of gut-kidney axis above, we had conducted pilot clinical researches to evaluate the effect of enema with Chinese medicine on the intestinal flora, gut barrier, enterogenous uremic toxins and renal protection. The preliminary results revealed that rheum enema through colon could accelerate intestinal dynamics, improve intestinal barrier function, regulate intestinal flora and reduce production and absorption of intestine-derived uremic toxins such as indoxyl sulfate, which may reduce renal fibrosis and delay renal progression. Further studies could provide more evidence for colon as a new therapeutic target for the treatment of CKD with Chinese medicine.

Progress on the application of aquaporins in Chinese medicine / 中国结合医学杂志

Aquaporins are a group of membrane proteins, which are known as the passages of water molecules transforming through the biological membrane lipid bilayer and distributing in almost all of the organs and tissues of living creatures. Aquaporins play important roles in maintaining water balance and internal environment stability. As a new entry point, aquaporins are involved in the researches on water metabolism, physiological regulation and pathological essence in viscera-state more and more widely in recent years. The literature on traditional Chinese medical studies, which related to aquaporins and were published in the last decade, was reviewed and the progress on application of aquaporin in Chinese medicine was summarized in this paper.

A survey and analysis of Chinese patent medicine for outpatients with chronic kidney disease / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To investigate the current state of oral administration of Chinese patent medicine in treatment of chronic kidney disease (CKD) in the Westem medicine hospitals.</p><p><b>METHODS</b>Outpatients of Department of Nephropathy, Peking University Third Hospital with diagnosed CKD confirmed by CKD diagnosis standard were surveyed by questionnaire in May 2009. The following patients' information was collected using the Questionnaire of the Current State of Oral Administration of Chinese Patent Medicine at CKD Clinics. (1) The present symptoms, tongue figure, pulse figure were syndrome typed referring to The Diagnosis, Syndrome Typing, and Efficacy Assessment of Chronic Renal Failure 2006 by Chinese Society of Renal Diseases, Chinese Society of Traditional Chinese Medicine. (2) Names of Chinese patent medicines and Western medicines patients use presently, the dose and dosage, names of hospitals responsible for prescriptions. (3) Patients' basic diseases including diabetes, hypertension, hyperuricemia, and so on at present. Irrational applications of Chinese patent medicines were classified according to the drug instruction and Guiding Principle of Clinical Application of Chinese Patent Medicines (issued by State Administration of Traditional Chinese Medicine). The irrationality was analyzed. Correlated factors such as age, sex, deficiency in origin syndrome, sthenia in superficiality syndrome, the nature and grade of hospitals responsible for prescriptions, total numbers of Chinese patent medicines, and primary diseases, etc. were analyzed using Logistic regression model. These factors might result in irrational application of Chinese patent medicines.</p><p><b>RESULTS</b>102 questionnaires were handed out, with 78 effective ones. Of them, 41 patients (41/78, accounting for 52.6%) were taking Chinese patent medicines. Of the 41 patients, irrational application happened to 24 patients (24/41, accounting for 58.5%), absolute discrepancy of medicines and syndromes to 5 (5/41, accounting for 12.2%), repeated medication to 7 (7/41, accounting for 17.1%), and interaction to 2 (2/41, accounting for 4.9%). Logistic regression model was analyzed. Variables were screened by Enter method. The number of Chinese patent medicines had statistic significance (P<0.05).</p><p><b>CONCLUSIONS</b>The occurrence rate of irrational application of Chinese patent medicines in CKD outpatients in Westem medicine hospitals was higher. They were mainly manifested as absolute discrepancy of medicines and syndromes and repeated medication. Increased numbers of Chinese patent medicines in recipes would increase the occurrence rate of irrational application of Chinese patent medicines.</p>

Analysis of Chinese medicine syndrome types in 156 patients undergoing maintenance peritoneal dialysis / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To analyze the Chinese medicine syndrome types of patients undergoing maintenance peritoneal dialysis to provide some clinical reference for the treatment based on syndromes.</p><p><b>METHODS</b>According to the criterion made by the Nephropathy Branch of China Association of Chinese Medicine in 2006, the syndrome type of 156 patients were differentiated, and the related laboratory parameters, including serum albumin (ALB), C-reactive protein (CRP), hemoglobin (HB), total urea clearance rate (KT/Vt), residual kidney urea clearance (KT/Vr), blood flow mediated vascular endothelial dilatation (FMD) and volume overload (OH) were measured.</p><p><b>RESULTS</b>Syndrome type presented in patients was different. Along with the progress of dialysis, it changed in the root syndromes from qi-deficiency to yang-deficiency and further to both yin-yang deficiency, while in the superficial syndromes it turned from turbid-damp to blood-stasis. ALB in patients with Pi-shen yang-deficiency type and both yin-yang deficiency type was significantly lower than that in patients with Pi-Shen qi-deficiency type and both qi-yin deficiency type (P < 0.05); KT/Vt in both yin-yang deficiency type was the lowest, significantly lower than that in Gan-Shen yin-deficiency type and both qi-yin deficiency (P < 0.05); OH in Pi-Shen yang-deficiency type and both yin-yang deficiency type was significantly higher than that in other types (P < 0.01). Comparison of patients' age showed that group of patients without superficial syndrome was the youngest and the group of patients with damp-heat syndrome type was the oldest (P < 0.01). CRP in damp-heat type was significantly higher than that in other types (P < 0.05); FMD was lower in blood-stasis type than in turbid-damp type and toxic heat type (P < 0.01); and OH was significantly higher in turbid-damp type than in other types (P < 0.01).</p><p><b>CONCLUSION</b>Some rules of syndrome type distribution could be seen in patients undergoing peritoneal dialysis, which is related with some laboratory parameters to a certain extent, so may provide a few references for clinical treatment based on syndrome type.</p>