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).

Electroacupuncture Reduces Body Fat by Down-regulating IL-6 and Vimentin in Abdominal White Adipose Tissue of Diet-induced Obesity Rats / 针刺研究

OBJECTIVE: To investigate the effect of electroacupuncture (EA) on IL-6 and vimentin protein expression in white adipose tissue (WAT) of diet-induced obesity (DIO) rats, so as to reveal its mechanism underlying losing weight. METHODS: Thirty-four Wistar rats were randomly divided into normal (control, n＝10), model, sham-EA and EA groups (n＝8 in each of the latter 3 groups). The obesity model was established by feeding the rats with high fat diet. EA (2 Hz/15 Hz, 1 mA) was applied to bilate-ral "Zusanli "(ST 36) and "Tianshu "(ST 25) for 30 min, 5 times per week for a total of 8 weeks. For sham-EA group, two sham points (about 5 mm lateral to ST 36 and to ST 25) were only punctured with filiform needles but without electrical stimulation. Du-ring EA treatment, all rats were fed with normal fodder, and their body weight were measured once a week. Histopathologic changes (diameters of adipose cells) of abdominal WAT were observed under microscope after sectioning and H．E. staining, and the expression levels of IL-6 and vimentin in the WAT were detected by Western blot. RESULTS: Compared with the control group, the body weight, diameter of fat cells and the expression levels of IL-6 and vimentin in the WAT were significantly increased in the model group (P0.05)．. CONCLUSION: EA intervention can effectively down-regulate the expression of IL-6 and vimentin in WAT of DIO rats, which may contribute to its action in reducing body fat by relieving chronic inflammation.

Electroacupuncture Relieves Obesity by Up-regulating PGC-1 α/UCP-1 Signaling in White Adipose Tissue in Diet-induced Obesity Rats / 针刺研究

OBJECTIVE: To observe the effect of electroacupuncture (EA) on the activities of peroxisome proliferator-activated receptor gamma coactivator-1 alpha/uncoupling protein-1 (PGC-1 α/UCP-1) signaling pathway in white adipose tissue(WAT)of diet-induced obesity (DIO) rats, so as to reveal its underlying mechanism in body weight loss. METHODS: Thirty-four male Wistar rats were randomly divided into normal diet (control, n＝10), high fat diet (model), sham EA-acupoint and EA groups (n＝8 in each of the latter 3 groups). The obesity model was established by feeding the rats with high fat diet containing lard oil, sugar, albumen powder, cholesterol, salt and sodium cholate for 12 weeks. EA (2 Hz/15 Hz, 1 mA) was applied to bilateral "Zusanli" (ST 36) and "Tianshu" (ST 25) or sham acupoints (about 5 mm beside ST 36 and ST 25) for 30 min, once daily, 5 times per week for a total of 8 weeks. During the treatment, all rats were fed with normal diet, and their body weight and length were measured once a week for calculating the Lee's index. The contents of serum total cholesterol (TC) and triglyceride (TG) were measured by using biochemical methods. The immunoactivity of PGC-1 α and UCP-1 in the abdominal WAT was detected by immunohistochemistry. RESULTS: After modeling, the Lee's index, serum TC and TG contents were significantly increased, and the levels of serum HDL-C, and PGC-1 α and UCP-1 immunoactivity in WAT considerably decreased in the model group relevant to the control group (P<0.05). Following the treatment, the Lee's index, TC and TG contents were significantly down-regulated while HDL-C and PGC-1 α and UCP-1 immunoactivity were obviously up-regulated in the EA-acupoint group relevant to the model group (P<0.05). CONCLUSION: EA can effectively reduce the body weight and adipose content in obesity rats, which may be closely related to its effect in up-regulating PGC-1 α/UCP-1 signaling in WAT, suggesting an efficacy of EA in promoting the browning of WAT.

Investigation of Evolution Rules of Phlegm and Blood Stasis Syndrome in Hyperlipidemia and Ath- erosclerosis by NMR-based Metabolic Profiling and Metabonomic Approaches / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To explore evolution rules of phlegm and blood stasis syndrome ( PBSS) in hyperlipidemia and atherosclerosis (AS) using NMR-based metabolic profiling and metabonomic approaches based on formulas corresponding to syndrome.</p><p><b>METHODS</b>Totally 150 SD rats were divided into the normal group, the model group, the Erchen Decoction (ED) group, the Xuefu Zhuyu Decoction (XZD) group, the Lipitor group, 30 in each group. The hyperlipidemia and AS rat model was duplicated by suturing carotid artery, injecting vitamin D3, and feeding with high fat diet. ED and XZD were used as drug probes. Blood samples were withdrawn at week 2, 4, and 8 after modeling. Blood lipids, blood rheology, histopathology and metabolomics were detected and analyzed. Results Results of blood lipids and pathology showed hyperlipidemia and early AS rat models were successfully established. At week 2 after modeling, levels of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) significantly increased, which reached the peak at week 4 and maintained at higher levels at week 8. ED exerted obvious effect in improving TC and LDL-C levels of early models, while XZD could greatly improve levels of TC and LDL-C of late models. Rheological results showed at week 2, there was no significant difference in whole blood viscosity, plasma viscosity, or hematocrit between the model group and the normal group (P > 0.05). At week 4 partial hemorheological indicators (such as plasma viscosity) were abnormal. Till week 8 whole blood viscosity, plasma viscosity, and hematocrit were significantly abnormal (P <0. 05, P < 0.01). As time went by, whole blood viscosity, plasma viscosity, and hematocrit showed gradual increasing tendency in the ED group, while they showed gradual decreasing tendency in the XZD group. Results of metabonomics showed significant difference in spectra of metabolites between the normal group and the model group. As modeling time was prolonged, contents of acetyl glucoprotein and glucose in the model group increased in late stage, which was in. line with results of blood lipids and hemorheology. ED showed more obvious effect in early and mid-term modeling (at week 2 and 4), and increased contents of partial metabolites (such as choline, phosphatidyl choline, glycerophosphocholine), but these changes in the XZD group were consistent with those of the model group. In late modeling (at week 8) XZD showed more obvious effect in improving contents of lactic acid, acetyl glycoprotein, LDL, creatine, choline, and glucose.</p><p><b>CONCLUSIONS</b>ED and XZD not only showed regulatory effects on lipid disorders, but also could improve dysbolism of Chos. In formulas corresponding to syndrome, damp-phlegm was main pathogenesis of hyperlipidema and AS in early and mid stages. Blood stasis syndrome began to occur along with it progressed. Phlegm can result in blood stasis and intermingles with stasis. Phlegm turbidity runs through the whole process.</p>

Effects of modified Sanhuang decoction () enema on serum tumor necrosis factor-α and colonic mucosa interleukin-1β, interleukin-6 levels in ulcerative colitis rats / 中国结合医学杂志

<p><b>OBJECTIVE</b>To investigate the effects of Modified Sanhuang Decoction (, MSD) enema on the serum tumor necrosis factor alpha (TNF-α) and colonic mucosa interleukin-1β (IL-1β), interleukin-6 (IL-6) levels in experimental ulcerative colitis (UC) rats.</p><p><b>METHODS</b>Forty-five male Wistar rats were randomly divided into 4 groups: normal group (n=12), model group (n=11), salazosulfapyridine (SASP) group (n=11) and MSD group (n=11). The UC model was induced by 2,4,6-trinitrobenzene sulfonic acid (TNBS)/ethanol solution. Rats in the normal group and model group were clystered with 0.9% normal saline, while in the SASP group and MSD group were clystered with SASP and MSD enema, respectively. After drug administration (10 mL/kg body weight, for 7 days), colonic gross changes and colonic mucosa histology were observed, serum TNF-α and colonic mucosa IL-1β, IL-6 levels were tested by enzyme linked immunosorbent assay and radioimmunoassay, respectively.</p><p><b>RESULTS</b>As compared with the normal group, the experimental UC rats, the colonic mucosal damage index scores (CMDIs), histopathological scores (HS) and the serum TNF-α and colonic mucosa IL-1β, IL-6 levels significantly increased (P<0.05 or P<0.01). In the MSD and SASP groups, the ulcer area significantly reduced, and edema disappeared. The CMDIs, HS, the serum TNF-α and colonic mucosa IL-1β, IL-6 levels in the MSD and SASP groups significantly decreased (P<0.05 or P<0.01) compared with the model group. The CMDIs in the MSD group were lower than that in the SASP group (P<0.05), but there were no significant differences in HS, serum TNF-α or colonic mucosa IL-1β, IL-6 levels between the MSD and SASP groups.</p><p><b>CONCLUSION</b>MSD enema can improve colonic mucosa impairment and decrease serum TNF-α and colonic mucosa IL-1β, IL-6 levels in experimental UC.</p>

Effects of comprehensive measures on prevention of children's Kashin-Beck disease in Aba state Sichuan province from 2007 to 2011 / 中国地方病学杂志

Objective To observe the effects of comprehensive measures of changing grain,selenium supplementation,off-site education and resettlement on prevention of children's Kashin-Beck disease in Aba state.Methods Fifty eight villages in Aba Kashin-Beck disease areas were chosen as intervention points in Aba state Sichuan province from 2007 to 2011.Based on the implementation of prevention and control measures,the villages were divided into off-site education + changing grain + selenium supplementation group and resettlement + off-site education + changing grain + selenium supplementation group,Geletuo town of Seda county,Ganzi state was selected as a control point,and right-hand anteroposterior X-ray examination(including the wrist) was carried out on children aged 6-13 from 2007 to 2011 annually.Clinical and X-ray diagnosis of Kashin-Beck disease was made in accordance with the Diagnostic Criteria of Kaschin-Beck Disease(GB 16003-1995).The effects of prevention and control measures were evaluated by comparing the child X-ray detection rate before and after the implementation of the measures.Results The average X-ray positive detectable rate of children in the intervention points was 2.07％(66/3181),2.72％ (69/2540),1.16％ (35/3017),0.56％ (19/3397) and 0.56％ (24/4273),respectively from 2007 to 2011,with a downward trend (x2trend =66.74,P ＜ 0.01).There was a downward trend in the average X-ray positive detectable rate of children in off-site education + changing grain + selenium supplementation group [1.60％(29/1809),2.63％ (39/1484),1.29％ (25/1941),0.64％ (15/2332),0.42％ (10/2379)] and resettlement + off-site education + changing grain + selenium supplementation group [2.70％ (37/1372),2.84％ (30/1056),0.93％(10/1076),0.38％ (4/1065),0.74％(14/1894)] (x2trend=30.97,35.19,all P ＜ 0.01).The average X-ray positive detectable rate of children in the intervention group was 0 from 2007 to 2010,and was 1.61％ (1/62) in 2011.The difference of X-ray positive detectable rate was not statistically significant in the control group in the 5 years from 2007 to 2011.The difference of children's X-ray positive detectable rate was not statistically significant between control group and intervention group.Conclusions The effect of taking changing grain,selenium supplementation,off-site education and resettlement comprehensive measures to prevent children's Kashin-Beck disease is not significant in those places where the state of Kaschin-Beck disease is not active.

Effect of changing grain and selenium supplementation on control of children's Kaschin-Beck disease in Qinghai province / 中国地方病学杂志

Objective To observe the effect of changing grain and selenium supplementation for 1-year on control of children's Kaschin-Beck disease in Qinghai province. Methods Epidemiology, clinical and right-hand X-ray examination were carried out on children aged 7 - 12 years in 2008. Patients were diagnosed and divided into 3 groups by village, control group from Xinjianping village in Guide county, changing grain group from Xiemalang village in Guide county and supplying salt with selenium and iodine group from Shanglujuan and Xialujuan villages in Xinghai county. One year before and after the treatment, right-hand X-ray photograph (including carpal bones)was taken and child hair samples were collected, selenium was detected by 2,3-diaminonaphthalene fluorescence spectrophotometry. Results After 1 year prevention and control, the detectable rate of X-ray in control group was raised from 4.88%(2/41) to 12.20%(5/41) , the detection rate in changing grain group was declined from 17.54%(10/57) to 5.26%(3/57), and from 13.51%(10/74) to 5.41%(4/74) in supplying salt with selenium and iodine group. In changing grain group, there were 10 patients, 7 cases were cured, 2 patients stable, 1 case progressed,no new case;in supplying salt with selenium and iodine group of 10 patients, 7 were cured, 3 patients stable, 1 new diagnosed case;in control group, 2 patients stable, 2 new diagnosed metaphysis cases, 1 new diagnosed metaphyseal case. Compared with control group, the difference was statistically significant between changing grain group and supplying salt with selenium and iodine group(x2 = 5.49,4.14, all P ＜ 0.05). After 1 year control and prevention,hair selenium contents in control group and changing grain group were increased from (107.15 ± 42.30), (125.30 ±40.30)μg/kg to (108.32 ± 35.67), (135.38 ± 65.24)μg/kg, the difference was statistically insignificant(t = 0.01,0.68, all P ＞ 0.05), and selenium contents in supplying salt with selenium and iodine group were obviously increased from (95.62 ± 43.42)μg/kg to (197.64 ± 97.08)μg/kg (t = 5.41, P ＜ 0.05). Conclusion Changing grain and supplying selenium can prevent and control children's Kaschin-Beck disease.