Modified Sipjeondaebo-tang (JAROTANG) for Henoch-Schonlein purpura nephritis (HSPN): Two case reports.

INTRODUCTION: Henoch-Schönlein purpura (HSP) is a disease commonly manifesting purpura, joint pain, and gastrointestinal symptoms. It can lead to glomerulonephritis (Henoch-Schönlein purpura nephritis, HSPN), which is directly associated with mortality and progression to chronic kidney disease (CKD). While HSP occurs more commonly in children, deadly outcomes occur at a higher rate in adult patients. Previous studies have not reported effective treatment of HSPN by Western or traditional medicine. Here, we report two cases of adult HSPN patients treated with the herbal medicine Jarotang (JRT, modified Sipjeondaebo-tang, modified SJDBT). CASE SUMMARY: Two female patients (Cases 1 and 2), who were 26 and 27 years old, respectively, came to visit us complaining mainly of cutaneous purpura. Both women were diagnosed with HSP, and the results of urinalysis indicated that the HSP had already progressed to renal involvement (3+ proteinuria with 3+ urine occult blood in case 1; 100-120 RBC/HPF with 2+ urine occult blood in Case 2). Both patients were given modified SJDBT in the name of JRT, with some herbs added to disperse and circulate stagnant qi, relieve indigestion, and clear heat. After treatment, patient 1 showed only a trace level of urine occult blood, with disappearance of purpura and proteinuria. Patient 2 showed complete remission of purpura and hematuria. CONCLUSIONS: Modified SJDBT, namely, JRT was effective in treating 2 cases of adulthood HSP and subsequent nephritis. This may be due to the ability of this therapy to replenish qi and blood and/or its immunological effect on T cells. The medication can serve as an effective cure for HSPN.

The Curative Effect of Shuangshen Decoction Combined with Immunological Preparations in the Treatment of Pediatric Nephrotic Syndrome and Its Influence on the Rate of Complicated Infection and Recurrence.

BACKGROUND: To explore the curative effect of Shuangshen Decoction combined with immunological preparations in the treatment of pediatric nephrotic syndrome and its influence on concurrent infection and recurrence rate. METHODS: Ninety children with nephrotic syndrome were divided into the routine group and the combined group. The routine group received conventional treatment and immune agents, and the combined group was treated with Shuangshen Decoction on the basis of the routine group. The clinical indexes of the two groups were analyzed and followed up. The infection rate and recurrence rate were calculated. RESULTS: The TCM syndrome scores in the combined group were significantly lower than those in the routine group. The total effective rate of the combined group was significantly higher than that of the routine group. The recurrence rate and infection rate of the combined group were significantly lower than those of the routine group. The incidence of adverse reactions in the combined group was significantly lower than that in the routine group. CONCLUSION: Shuangshen Decoction combined with immune preparations is effective in treating pediatric nephrotic syndrome and can reduce the incidence of adverse reactions, infection rate, and recurrence rate.

Clinical efficacy and safety of Chinese herbal medicine for the treatment of patients with early diabetic nephropathy: A protocol for systematic review and meta-analysis.

BACKGROUND: Diabetic nephropathy (DN) is among the common and serious complications of diabetes and is also a major cause of end-stage kidney disease. Early DN is also called diabetic microalbumin period, the main treatment is in the control of blood sugar on the basis of kidney protection and urine lowering protein. There are few effective methods of western medicine treatment, and most of them are accompanied by adverse reactions. But some studies have shown that traditional Chinese medicine has achieved the curative effect and has certain superiority. However, there are few systematic reviews on the treatment of traditional Chinese herbal medicine for early DN currently. Therefore, this study conducted a systematic review of clinical efficacy and safety of Chinese herbal medicine for the treatment of patients with early DN, aim to comprehensively analyze the role of traditional Chinese herbal medicine in the treatment of early DN. METHODS AND ANALYSIS: The protocol of this systematic review and meta-analysis was registered on the INPLASY website (https://inplasy.com/inplasy-2020-4-0139/) and INPLASY registration number is INPLASY202040139. A systematic literature search will be conducted in 3 English database and 4 Chinese databases with a language limitation of English and Chinese. Search for clinical research literature on Chinese herbal medicine treatment of DN published in domestic and foreign biomedical journals. The time is limited from January 2010 to February 2020. We will investigate heterogeneity across studies and publication bias. To assess the risk of bias and quality of the included studies, we will use the Cochrane Collaboration's ROB tool. According to the relevant standards in the Cochrane Intervention System Evaluation Manual, it will be divided into low risk, high risk, and unclear. We will also use the RevMan 5.3 software and Stata 13.0 software for meta-analysis of the effectiveness and symptom scores of DN proteinuria. ETHICS AND DISSEMINATION: The ethical considerations are not required because the systematic review is based on published studies. The systematic review and meta-analysis will be published in a peer-reviewed Journal.

Effects of exercise training on proteinuria in adult patients with chronic kidney disease: a systematic review and meta-analysis.

BACKGROUND: Rehabilitation effects of exercise training on adults with chronic kidney disease (CKD) have been generally recognised; however, the effects of exercise training on proteinuria have been underexplored. Our aim was to explore the effects of exercise training on proteinuria in adult CKD patients without renal replacement therapy. METHODS: Randomised controlled trials (RCTs) and quasi-experimental studies examining the effects of exercise training on proteinuria in adults CKD patients without renal replacement therapy were searched in 10 electronic databases (MEDLINE, Embase, CINAHL, Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine Database, SPORTDiscus with full text, Web of Science, China Wan Fang Database, China National Knowledge Internet, China Science and Technology Journal Database) until June 2019. The quality of quasi-experimental studies was assessed using the Joanna Briggs Institute Checklist for non-randomised experimental studies. The Cochrane risk of bias tool was used to evaluate the RCT quality. RESULTS: We analysed 11 studies (623 participants). The 24-h urinary protein (24 h UP) level significantly decreased after exercise training in the within-group analysis (standard mean difference [SMD], 0.48; 95% confidence interval [CI], 0.08 to 0.88). There was a slight decrease in 24 h UP levels in the between-group analysis (SMD, 0.91; 95% CI, 0.00 to 1.82); however, the subgroup analysis showed that the change was insignificant (RCT: SMD, 0.24; 95% CI, - 0.44 to 0.92; quasi-experimental studies: SMD, 2.50; 95% CI, - 1.22 to 6.23). Exercise resulted in no significant differences in the urinary albumin-to-creatinine ratio in the between-group analysis (SMD, 0.06; 95% CI, - 0.54 to 0.67), but a significant decrease was found in the within-group analysis (SMD, 0.21; 95% CI, 0.04 to 0.38). No evidence of a decreased urinary protein-to-creatinine ratio was found after exercise (between-group analysis: SMD, 0.08 and 95% CI, - 0.33 to 0.48; within-group analysis: SMD, 0.04; 95% CI, - 0.25 to 0.32). CONCLUSION: Exercise training does not aggravate proteinuria in adult CKD patients without renal replacement therapy. Further research is warranted in the future to determine the effectiveness of exercise training on proteinuria and to explore the mechanisms by which exercise training influences proteinuria.

Attenuation of diabetic nephropathy by dietary fenugreek (Trigonella foenum-graecum) seeds and onion (Allium cepa) via suppression of glucose transporters and renin-angiotensin system.

OBJECTIVES: The aim of this study was to determine the effects of dietary fenugreek (Trigonella foenum-graecum) seeds and onion on the hyperglycemia-stimulated glucose transporters and activation of renin-angiotensin system-mediated cascade of events leading to renal lesions in diabetic animals. METHODS: The mechanistic aspects of nephroprotective influence of dietary fenugreek seeds (10%) and onion (3%) on diabetic renal lesions was investigated in streptozotocin diabetic rats. Renal damage was assessed by measuring proteinuria, enzymuria, expression of glucose transporters, renin-angiotensin system, and activities of polyol pathway enzymes. RESULTS: Diabetes resulted in an upregulation of glucose transporters in kidney tissue, which was countered by these dietary interventions. The upregulation of renal angiotensin-converting enzyme and its receptor was also countered by these dietary interventions. Dietary fenugreek and onion significantly reduced metabolites of polyol pathway, nitric oxide, and N-acetyl-ß-d-glucosaminidase activity. Markers of podocyte damage in kidney (nephrin, podocin, and podocalyxin) and their urinary excretion were normalized along with downregulation of the expression of kidney injury molecule-1 by these dietary interventions. Dietary fenugreek and onion effectively countered the diabetes-induced structural abnormalities of renal tissue. CONCLUSION: Feeding fiber-rich fenugreek seeds and sulfur compounds-rich onion produced a blockade in glucose translocation and renin-angiotensin system in the early stage of diabetic nephropathy. This involved a downregulation of the expression of polyol pathway enzymes, partial restoration of the podocyte damage, revival of renal architecture and functional abnormality. The present study also suggested that these two dietary interventions offer a higher renoprotective influence when consumed together.

Anti-interleukin-1 treatment among patients with familial Mediterranean fever resistant to colchicine treatment. Retrospective analysis.

BACKGROUND: Up to 5% of familial Mediterranean fever (FMF) cases are unresponsive to colchicine, through resistance, side effects and toxicity. Anakinra is an alternative treatment for FMF patients whose disease remains uncontrolled with colchicine. We aimed to evaluate anti-interleukin-1 treatment regarding clinical findings, laboratory parameters and quality of life (QoL) among FMF patients presenting resistance and toxicity towards colchicine. DESIGN AND SETTING: Descriptive observational study at the rheumatology clinic, Adnan Menderes University Medical School, Aydin, Turkey. METHODS: Among the patients included, age, sex, MEFV genotypes, acute-phase reactants, hepatic/renal function tests, average colchicine dose, disease duration, attack frequency, attack duration, disease severity, proteinuria, amyloidosis and QoL were evaluated. Colchicine resistance was defined as > 6 typical episodes/year or > 3 per 4-6 months. Kolmogorov-Smirnov, Friedman and two-way analysis of variance tests were used for statistical analyses. RESULTS: Between 2015 and 2017, 14 FMF patients receiving anakinra were enrolled. The mean colchicine dose was 1.7 ± 0.3 mg/day before use of anakinra. Ten patients were attack-free after treatment, while three showed reductions of at least 50% in attack frequency, attack duration and disease severity. Proteinuria levels in all patients with renal amyloidosis decreased after treatment. QoL among patients with renal amyloidosis differed significantly from QoL among non-amyloidosis patients. Mean visual analogue scale scores significantly improved in both groups after use of anakinra. CONCLUSIONS: Use of anakinra reduced attack frequency and proteinuria and acute-phase reactant levels, and improved QoL, with only a few uncomplicated side effects among colchicine-resistant or intolerant FMF patients. Injection-site reactions of severity insufficient to require discontinuation of treatment were seen.

Anti-interleukin-1 treatment among patients with familial Mediterranean fever resistant to colchicine treatment. Retrospective analysis

ABSTRACT BACKGROUND: Up to 5% of familial Mediterranean fever (FMF) cases are unresponsive to colchicine, through resistance, side effects and toxicity. Anakinra is an alternative treatment for FMF patients whose disease remains uncontrolled with colchicine. We aimed to evaluate anti-interleukin-1 treatment regarding clinical findings, laboratory parameters and quality of life (QoL) among FMF patients presenting resistance and toxicity towards colchicine. DESIGN AND SETTING: Descriptive observational study at the rheumatology clinic, Adnan Menderes University Medical School, Aydın, Turkey. METHODS: Among the patients included, age, sex, MEFV genotypes, acute-phase reactants, hepatic/renal function tests, average colchicine dose, disease duration, attack frequency, attack duration, disease severity, proteinuria, amyloidosis and QoL were evaluated. Colchicine resistance was defined as > 6 typical episodes/year or > 3 per 4-6 months. Kolmogorov-Smirnov, Friedman and two-way analysis of variance tests were used for statistical analyses. RESULTS: Between 2015 and 2017, 14 FMF patients receiving anakinra were enrolled. The mean colchicine dose was 1.7 ± 0.3 mg/day before use of anakinra. Ten patients were attack-free after treatment, while three showed reductions of at least 50% in attack frequency, attack duration and disease severity. Proteinuria levels in all patients with renal amyloidosis decreased after treatment. QoL among patients with renal amyloidosis differed significantly from QoL among non-amyloidosis patients. Mean visual analogue scale scores significantly improved in both groups after use of anakinra. CONCLUSIONS: Use of anakinra reduced attack frequency and proteinuria and acute-phase reactant levels, and improved QoL, with only a few uncomplicated side effects among colchicine-resistant or intolerant FMF patients. Injection-site reactions of severity insufficient to require discontinuation of treatment were seen.

Integrated therapy improve urinary total protein in patients with lupus nephritis: A case report.

OBJECTIVES: To report on the potential effectiveness of Chinese herbal medicine (CHM) as part of an integrated treatment for lupus nephritis. CLINICAL FEATURES AND OUTCOME: A 55-year-old female with systemic lupus erythematosus had experienced bilateral lower-limbs edema for half a year. Her urinary total protein (M-TP) was 1367.9 mg/24 h. Lupus nephritis (LN) was suspected by the Division of Rheumatology without a renal biopsy. Oral corticosteroid medication did not improve the edema; therefore, the patient requested CHM for integrated therapy, and was subsequently treated for seven months with a modified CHM prescription mainly composed of Zhi-Bo-Di-Huang-Wan, Gui-Shao-Zhi-Mu-Tang, and Zhu-Ling-Tang. After three days of CHM, her bilateral lower-limbs edema significantly improved, and after 143 days, her M-TP decreased from 1367.9 mg/24 h to 143.6 mg/24 h. CONCLUSIONS: Integrated therapy could significantly improve proteinuria by reducing this LN patients' urinary total protein, which further implies that CHM may have a protective effect against the progression of LN in this patient.

Dent disease in Poland: what we have learned so far?

PURPOSE: Dent disease (DD) is a rare tubulopathy characterized by proximal tubular dysfunction leading to chronic kidney disease (CKD). The aim of the study was to characterize patients with DD in Poland. METHODS: A retrospective analysis of a national cohort with genetically confirmed diagnosis. RESULTS: Of 24 males, all patients except one carried mutations in the CLCN5 gene; in one patient a mutation in the OCRL gene was disclosed. Molecular diagnosis was delayed 1 year on average (range 0-21 years). The most common features were tubular proteinuria (100%), hypercalciuria (87%), and nephrocalcinosis (56%). CKD (≤stage II) and growth deficiency were found in 45 and 22% of patients, respectively. Over time, a progression of CKD and persistence of growth impairment was noted. Subnephrotic and nephrotic proteinuria (20%) was found in most patients, but tubular proteinuria was assessed in only 67% of patients. In one family steroid-resistant nephrotic syndrome prompted a genetic testing, and reverse phenotyping. Five children (20%) underwent kidney biopsy, and two of them were treated with immunosuppressants. Hydrochlorothiazide and angiotensin-converting enzyme inhibitors were prescribed for a significant proportion of patients (42 and 37.5%, respectively), while supplemental therapy with phosphate, potassium, vitamin D (12.5% each), and alkali (4.2%) was insufficient, when compared to the percentages of patients requiring repletion. CONCLUSIONS: We found CLCN5 mutations in the vast majority of Polish patients with DD. Proteinuria was the most constant finding; however, tubular proteins were not assessed commonly, likely leading to delayed molecular diagnosis and misdiagnosis in some patients. More consideration should be given to optimize the therapy.

The questioning for routine monthly monitoring of proteinuria in patients with ß-thalassemia on deferasirox chelation.

BACKGROUND: Iron chelation therapy is one of the mainstays of the management of the patients with ß-thalassemia (BT) major. Deferasirox is an oral active iron chelating agent. Proteinuria is one of the potential renal adverse effects of deferasirox, and monthly follow-up for proteinuria is suggested by Food and Drug Administration and European Medicine Agency. METHODS: We aimed to investigate the necessity for monthly monitoring for proteinuria among patients with BT on deferasirox. A retrospective laboratory and clinic data review was performed for patients with BT major or intermedia who were treated with deferasirox chelation therapy. All patients were monitored for proteinuria for every 3 or 4 weeks after the initiation of deferasirox with serum creatinine and spot urine protein/creatinine ratios. RESULTS: The median follow-up time of the 37 (36 BT major and one BT intermedia) patients was 44 months. Seven patients (18.9%) developed significant proteinuria (ratio ≥0.8). Of the 1490 measurements, 12 tests (0.8%) were proteinuric. Urine proteinuria resolved in all of the patients during the follow-up. The risk of proteinuria was higher at ages below a cut-off point of 23 years (p = 0.019). Patients, who were on deferasirox at doses above a cut-off dose of 29 mg/kg/day, were found to have higher risk of proteinuria development (p = 0.004). CONCLUSION: Proteinuria resolves without any complication or major intervention according to our results. Potentially more risky groups (age below 23 years old and receivers above a dose of 29 mg/kg/day) might be suggested to be followed monthly, besides monitoring all of the patients.

Calcitriol in the treatment of IgA nephropathy with non-nephrotic range proteinuria: a meta-analysis of randomized controlled trials
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OBJECTIVE: The aim of the present study was to investigate the efficacy and safety of calcitriol for treating Chinese patients with IgA nephropathy presenting as non-nephrotic range proteinuria, and a comprehensive meta-analysis was conducted using the related randomized controlled trials (RCTs). METHODS: We searched for RCTs of calcitriol for the treatment of IgA nephropathy in the CNKI, CBM, Cochrane Central Register of Controlled Trials, PUBMED, and EMBASE databases. The studies included in our meta-analysis were strictly determined according to the inclusion and exclusion criteria. We evaluated the quality of the included studies using the Jadad score sheet and performed the meta-analysis using RevMan software (version 5.30). RESULTS: Our meta-analysis, which included 7 RCTs involving 310 Chinese participants, showed that calcitriol contributed to a decrease in proteinuria standard mean difference (SMD) -1.49, 95% CI (-2.37, -0.62); p = 0.0008). No significant differences were observed in serum creatinine (SMD -0.13, 95% CI (-0.53, 0.27); p = 0.52), serum calcium (SMD 0.28, 95% CI (-0.08, 0.65); p = 0.13), or serum phosphorus (SMD 0.03, 95% CI (-0.07, 0.14); p = 0.57) levels. All of the adverse reactions mentioned in these studies were mild. CONCLUSION: These data indicated that calcitriol is a promising treatment to reduce proteinuria in Chinese patients with IgA nephropathy presenting as non-nephrotic range proteinuria, and it has only mild side effects.
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Anemia in nephrotic syndrome: approach to evaluation and treatment.

Nephrotic syndrome is one of the most common glomerular diseases that affect in children. Complications may occur in nephrotic syndrome as a result of the disease itself as well as its treatment. Most of these complications result from excessive urinary protein losses, and control of proteinuria is the most effective treatment strategy. Anemia is one of the many complications seen in patients with persistent nephrotic syndrome and may occur as a result of excessive urinary losses of iron, transferrin, erythropoietin, transcobalamin and/or metals. This leads to a deficiency of substrates necessary for effective erythropoiesis, requiring supplementation in order to correct the anemia. Supplementation of iron and erythropoietin alone often does not lead to correction of the anemia, suggesting other possible mechanisms which need further investigation. A clear understanding of the pathophysiologic mechanisms of anemia in nephrotic syndrome is necessary to guide appropriate therapy, but only limited evidence is currently available on the precise etiologic mechanisms of anemia in nephrotic syndrome. In this review we focus on the current state of knowledge on the pathogenesis of anemia in nephrotic syndrome.

Keto-supplemented Low Protein Diet: A Valid Therapeutic Approach for Patients with Steroid-resistant Proteinuria during Early-stage Chronic Kidney Disease.

BACKGROUND AND OBJECTIVES: Low protein diets supplemented with keto acid (sLPD) are recommended for patients with stage 3-5 chronic kidney disease (CKD). This study assessed whether sLPD is beneficial for patients with steroid-resistant proteinuria during early-stage CKD. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: A 1-year randomized controlled trial was conducted from 2010 to 2012. In this study, 108 proteinuric patients who were steroid-resistant were assigned to a sLPD group (0.6 g/kg/d with 0.09 g/kg/d keto acids) or a normal protein diet group (NPD, 1.0 g/kg/d). Estimated dietary protein intake, urinary protein excretion, remission rate, renal function, nutritional status, and blood pressure were measured. RESULTS: Baseline characteristics were comparable between the sLPD group (47 patients) and the NPD group (49 patients). Urinary protein excretion significantly decreased in sLPD compared to NPD in months 6, 9, and 12 (P<0.05). Proteinuria reduction was higher in sLPD than in NPD (P<0.001) at the end of the study. Complete remission and partial remission rates were higher in sLPD than in NPD. Serum albumin and pre-albumin levels were higher in sLPD than in NPD in months 9 and 12 (P<0.05). Serum total cholesterol and triglyceride levels declined more significantly in sLPD than in NPD (P<0.01) at the end of the study. There were no differences in nutritional status, renal function, hemoglobin, or blood pressure between the two groups. CONCLUSIONS: sLPD is both nutritionally safe and beneficial, providing nephroprotective effects for early-stage CKD patients with steroid-resistant proteinuria.

Clinical decision support improves physician guideline adherence for laboratory monitoring of chronic kidney disease: a matched cohort study.

BACKGROUND: Guidelines exist for chronic kidney disease (CKD) but are not well implemented in clinical practice. We evaluated the impact of a guideline-based clinical decision support system (CDSS) on laboratory monitoring and achievement of laboratory targets in stage 3-4 CKD patients. METHODS: We performed a matched cohort study of 12,353 stage 3-4 CKD patients whose physicians opted to receive an automated guideline-based CDSS with CKD-related lab results, and 42,996 matched controls whose physicians did not receive the CDSS. Physicians were from US community-based physician practices utilizing a large, commercial laboratory (LabCorp®). We compared the percentage of laboratory tests obtained within guideline-recommended intervals and the percentage of results within guideline target ranges between CDSS and non-CDSS patients. Laboratory tests analyzed included estimated glomerular filtration rate, plasma parathyroid hormone, serum calcium, phosphorus, 25-hydroxy vitamin D (25-D), total carbon dioxide, transferrin saturation (TSAT), LDL cholesterol (LDL-C), blood hemoglobin, and urine protein measurements. RESULTS: Physicians who used the CDSS ordered all CKD-relevant testing more in accord with guidelines than those who did not use the system. Odds ratios favoring CDSS ranged from 1.29 (TSAT) to 1.88 (serum phosphorus) [CI, 1.20 to 2.01], p < 0.001 for all tests. The CDSS impact was greater for primary care physicians versus nephrologists. CDSS physicians met guideline targets for LDL-C and 25-D more often, but hemoglobin targets less often, than non-CDSS physicians. Use of CDSS did not impact guideline target achievement for the remaining tests. CONCLUSIONS: Use of an automated laboratory-based CDSS may improve physician adherence to guidelines with respect to timely monitoring of CKD.

Efficacy and safety of tangshen formula on patients with type 2 diabetic kidney disease: a multicenter double-blinded randomized placebo-controlled trial.

BACKGROUND: Persons with diabetes are at high risk of developing diabetic kidney disease (DKD), which is associated with high morbidity and mortality. Current drug therapies for DKD, such as angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), are not entirely satisfactory. This study aimed to evaluate the additional benefit and safety of the Chinese herbal granule Tangshen Formula (TSF) in treating DKD. METHODS: The study was designed as a six-center randomized, double-blind, placebo-controlled trial. From April 2007 through December 2009, 180 patients with DKD were enrolled. In addition to conventional treatment with ACEIs or ARBs, 122 participants were randomly assigned to receive TSF and 58 participants to receive placebo for 24 weeks. Primary outcome was urinary protein level, measured by urinary albumin excretion rate (UAER) for participants with microalbuminuria, 24-hour urinary protein (24h UP) for participants with macroalbuminuria. Secondary outcomes included renal function, serum lipids, quality of life, symptoms, and adverse events. FINDINGS: After 24 weeks of treatment, no statistically significant difference in UAER (TSF -19.53 µg/min compared with placebo -7.01 µg/min, with a mean difference of -12.52 µg/min; 95%CI, -68.67 to 43.63, P = 0.696) was found between TSF and placebo groups. However, TSF displayed a statistically significant decrease in 24h UP (TSF-0.21 g compared with placebo 0.36 g, with a mean difference of -0.57g; 95%CI, -1.05 to -0.09, P = 0.024). Estimated glomerular filtration rate (eGFR) was improved in both patients with microalbuminuria and macroalbuminuria, with a mean difference of 15.51 ml/min/1.73 m2 (95%CI, 3.71 to 27.31), 9.01 ml/min/1.73 m2 (95%CI, -0.10 to 18.13), respectively. Other secondary outcomes showed no statistically significant difference between groups or in the incidence of adverse events. CONCLUSIONS: Based on conventional treatments, TSF appears to provide additional benefits compared with placebo in decreasing proteinuria and improving eGFR in DKD patients with macroalbuminuria. Nevertheless, further study is needed to evaluate TSF treating patients with microalbuminuria. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-TRC-10000843.

Acute and subchronic (28 days) oral toxicity studies of Codonopsis lanceolata extract in Sprague-Dawley rats.

Codonopsis lanceolata is a perennial plant that has been used as a food and in traditional medicine for the treatment of cough, bronchitis, and inflammation in East Asia including Korea, Japan, and China. However, information regarding its toxicity is limited. Therefore, we performed a safety evaluation of aqueous C. lanceolata root extract (CLE) in Sprague-Dawley rats. Assessment of acute toxicity revealed that CLE did not influence mortality, clinical appearance, body weight gain, or necropsy findings at a dose of 5000 mg/kg body weight. In the subchronic oral toxicity, data revealed that several significant alteration in food consumption, water consumption, protein excretion, WBCs levels, TGs, BUN levels, and the absolute and relative weights in the liver, spleen and lungs. However, these changes were transient and were not considered treatment related because they showed no apparent dose dependent. These results suggest that CLE (1250, 2500, and 5000 mg/kg body weight/day) administered orally does not cause acute or subchronic toxicity to male or female rats. The 50% lethal dose (LD50) of CLE was determined to be greater than 5000 mg/kg.

[Protective effects and mechanism of congguiyishen capsules on diabetic nephropathy rats].

OBJECTIVE: To study the curative and protective effects of Congguiyishen Capsules on the diabetic nephropathy (DN) model rats. METHODS: Established the DN model rats by intraperitoneal injection of urea bacteria element (Streptozotocin, STZ). The rats were divided into six groups including normal control group, model group, positive control group, high-dosage group, medium-dosage group and low-dosage group. After oral administration for 4 weeks, determined the 24 h urinary protein, Cr, kidney mass/body mass, FBG, Ang II, AT1R, AGTRAP and CTGF in the kidney. Observed the pathological damage of kidney tissue with Masson staining. RESULTS: After treatment, Cr, kidney mass index, 24 h urine protein, FBG and Ang II were decreased signicantly (P < 0.05). And the treatment also alleviated the pathological damage of kidney tissue. CONCLUSION: Congguiyishen Capsules have protective effect for DN model rats. The mechanism may be related to the suppression of inflammatory response and down-regulating the expression of AT1R, AGTRAP and CTGF.

Effects of adjuvants for human use in systemic lupus erythematosus (SLE)-prone (New Zealand black/New Zealand white) F1 mice.

The safety of four different adjuvants was assessed in lupus-prone New Zealand black/New Zealand white (BW)F1 mice. Four groups of mice were injected intraperitoneally with incomplete Freund's adjuvant (IFA), complete Freund's adjuvant (CFA), squalene (SQU) or aluminium hydroxide (ALU). An additional group received plain phosphate-buffered saline (PBS) (UNT group). Mice were primed at week 9 and boosted every other week up to week 15. Proteinuria became detectable at weeks 17 (IFA group), 24 (CFA group), 28 (SQU and ALU groups) and 32 (UNT group). Different mean values were obtained among the groups from weeks 17 to 21 [week 17: one-way analysis of variance (anova) P = 0·016; weeks 18 and 19: P = 0·048; weeks 20 and 21: P = 0·013] being higher in the IFA group than the others [Tukey's honestly significant difference (HSD) post-test P < 0·05]. No differences in anti-DNA antibody levels were observed among groups. Anti-RNP/Sm antibody developed at week 19 in only one CFA-treated mouse. Mean mouse weight at week 18 was lower in the ALU group than the IFA (Tukey's HSD post-test P = 0·04), CFA (P = 0·01) and SQU (P < 0·0001) groups, while the mean weight in the SQU group was higher than in the IFA (P = 0·009), CFA (P = 0·013) and UNT (P = 0·005) groups. The ALU group weight decreased by almost half between weeks 29 and 31, indicating some toxic effect of ALU in the late post-immunization period. Thus, SQU was the least toxic adjuvant as it did not (i) accelerate proteinuria onset compared to IFA; (ii) induce toxicity compared to ALU or (iii) elicit anti-RNP/Sm autoantibody, as occurred in the CFA group.