BackgroundRenal interstitial fibrosis (RIF) is an important manifestation of Diabetic nephropathy (DN) progression. Non-POU domain containing octamer-binding protein (NONO) is crucial in fibrosis in cardiovascular diseases, but its role in DN fibrosis remains unclear. This study explores the expression of NONO in DN and its correlation with Matrix Metalloproteinase-9 (MMP-9, as an important regulator of fibrosis), renal fibrosis, and prognosis.MethodsForty patients with type 2 diabetes mellitus (T2DM) with pathologically confirmed DN were included, divided into early DN group (n=20) and late DN group (n=20). 6 normal renal tissue as control group. HE, Masson staining, immunohistochemical staining and Immunofluorescence double staining were performed. The correlation between NONO expression levels and MMP-9 as well as clinical pathological data was analyzed. Cox regression analysis and Kaplan-Meier survival curves were used to evaluate the relationship between renal tissue NONO expression levels and DN prognosis.ResultsCompared with control group, NONO expression levels in renal tissues of DN patient were increased, and the late DN group was higher than the early DN group (P<0.05). NONO and MMP-9 expression were positively correlated with multiple clinical and Fibrosis-related pathological indicators, and NONO expression was positively correlated with MMP-9(P<0.05). Patients with high renal NONO expression had lower kidney progression-free survival rates.ConclusionsNONO expression levels correlate positively with MMP-9, collagen and renal damage indicators in renal tissues of DN patients. High NONO expression is linked to poor renal prognosis in DN. NONO may contribute to renal tissue fibrosis in DN by regulating MMP-9 levels.
This study examined whether plasma FXII levels reflect disease activity in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Plasma FXII levels were detected by ELISA in 127 patients with AAV, and their associations with disease activity and plasma myeloperoxidase (MPO)-ANCA titre were examined. Immunofluorescent co-staining of FXII and neutrophils was performed on the renal tissues of patients with AAV. MPO expression in renal biopsy tissues was determined by immunohistochemical staining. The association between plasma FXII levels and histological activity was assessed in 82 patients who underwent kidney biopsy. Plasma FXII levels were considerably increased in patients with clinically active AAV compared to those in clinical remission and healthy individuals. Plasma FXII levels correlated positively with creatinine (r = 0.377), CRP (r = 0.222), urine red blood cell (r = 0.203), serum MPO-ANCA titer (r = 0.353), white blood cell (r = 0.194), percentage of glomeruli with crescents (P = 0.001), capillary breaks (P = 0.001), interstitial inflammation (P < 0.001) and fibrinoid necrosis (p < 0.001) on kidney biopsy. The plasma FXII optimal cut-off value for evaluating AAV activity was 24.5 mu g/mL (sensitivity = 0.81, specificity = 0.82, P = 0.0001), which was superior to that achieved using conventional serologic biomarkers. Co-expression of FXII and neutrophils was higher, with increased MPO expression, in renal tissue with pathologically active AAV than that observed in pathologically inactive tissues. In conclusion, elevated plasma FXII levels reflect AAV clinical and histologic activity, and can serve as markers of active AAV.
糖尿病肾病(DN)发生肾纤维化是导致终末期肾脏病(ESRD)的关键原因.肾小管上皮细胞(RTEC)上皮-间充质转化(EMT)参与了DN肾组织纤维化的发生和发展.目前DN中EMT的发病机制仍不完全清楚,尚需进一步探索.本文将对DN中参与RTEC的EMT的多重机制做一综述,以期为通过抑制小管上皮细胞(TEC)的EMT治疗DN提供思路.
ObjectiveInflammation and thrombosis are recognized as interrelated biological processes. Both thrombomodulin (TM) and factor XIII-A (FXIII-A) are involved in inflammation and coagulation process. However, their role in the pathogenesis of diabetic nephropathy (DN) remains unclear. In vitro study, the liver X receptor (LXR) agonist T0901317 can up-regulate the expression of TM in glomerular endothelial cells. Now we evaluated the interaction between TM activation and FXIII-A and their effects against renal injury.MethodsWe first evaluated the serum levels of FXIII-A and TM and the expression of TM, LXR-α and FXIII-A in renal tissues of patients with biopsy-proven DN. We then analyzed the expression of TM, LXR-α and FXIII-A in renal tissues of db/db DN mice after upregulating TM expression via T0901317 or downregulating its expression via transfection of TM shRNA-loaded adenovirus. We also investigated the serum levels of Tumor necrosis factor (TNF)-α, Interleukin (IL)-6, creatinine, and urinary microalbumin level in db/db mice.ResultsOur study showed that elevations in serum levels of FXIII-A positively correlated to the serum levels of TM and were also associated with end-stage kidney disease in patients with DN. The number of TM+ cells in the renal tissues of patients with DN negatively correlated with the number of FXIII-A+ cells and positively correlated with the number of LXR-α+ cells and estimated glomerular filtration rate (eGFR), whereas the number of FXIII-A+ cells negatively correlated with the eGFR.ConclusionThrombomodulin activation with T0901317 downregulated FXIII-A expression in the kidney tissue and alleviated renal injury in db/db mice.
目的 探讨血液透析(HD)患者、腹膜透析(PD)患者及健康者肠道菌群的变化.方法 收集36例HD患者、27例PD患者及57例健康对照者的粪便,采用16SrRNA测序,评估其粪便微生物群组成的差异.结果 与对照组比较,PD组、HD组患者肠道菌群总数显著降低(P<0.01).PD组与对照组、HD组与对照组之间的chao指数比较,差异有统计学意义(P<0.001),HD组与对照组群落多样性差异有统计学意义(P<0.01),对照组的群落多样性更高.普雷沃特拉菌水平与透析患者生存时间呈负相关(P=0.04).结论 PD、HD患者的肠道菌群发生了改变,HD患者的肠道菌群变化较PD患者更为显著.
Background: Diabetic nephropathy (DN) is the most common complication of diabetes, and its pathogenesis is complex involving a variety of programmed cell death, inflammatory responses, and autophagy mechanisms. Disulfidptosis is a newly discovered mechanism of cell death. There are little studies about the role of disulfidptosis on DN.Methods: First, we obtained the data required for this study from the GeneCards database, the Nephroseq v5 database, and the GEO database. Through differential analysis, we obtained differential disulfidptosis-related genes. At the same time, through WGCNA analysis, we obtained key module genes in DN patients. The obtained intersecting genes were further screened by Lasso as well as SVM-RFE. By intersecting the results of the two, we ended up with a key gene for diabetic nephropathy. The diagnostic performance and expression of key genes were verified by the GSE30528, GSE30529, GSE96804, and Nephroseq v5 datasets. Using clinical information from the Nephroseq v5 database, we investigated the correlation between the expression of key genes and estimated glomerular filtration rate (eGFR) and serum creatinine content. Next, we constructed a nomogram and analyzed the immune microenvironment of patients with DN. The identification of subtypes facilitates individualized treatment of patients with DN.Results: We obtained 91 differential disulfidptosis-related genes. Through WGCNA analysis, we obtained 39 key module genes in DN patients. Taking the intersection of the two, we preliminarily screened 20 genes characteristic of DN. Through correlation analysis, we found that these 20 genes are positively correlated with each other. Further screening by Lasso and SVM-RFE algorithms and intersecting the results of the two, we identified CXCL6, CD48, C1QB, and COL6A3 as key genes in DN. Clinical correlation analysis found that the expression levels of key genes were closely related to eGFR. Immune cell infiltration is higher in samples from patients with DN than in normal samples.Conclusion: We identified and validated 4 DN key genes from disulfidptosis-related genes that CXCL6, CD48, C1QB, and COL6A3 may be key genes that promote the onset of DN and are closely related to the eGFR and immune cell infiltrated in the kidney tissue.
目的 观察羟苯磺酸钙胶囊联合贝那普利片治疗早期糖尿病肾病(diabe-tic nephropathy,DN)患者的临床疗效及安全性.方法 将108例早期DN患者随机分为对照组54例和试验组54例.对照组给予贝那普片每次10 mg,qd,口服;试验组在对照组治疗的基础上,给予羟苯磺酸钙胶囊每次0.5g,tid,口服.2组患者均治疗2个月.比较2组患者的临床疗效、血糖指标、肝肾功能和药物不良反应的发生情况.结果 治疗后,试验组和对照组的总有效率分别为82.69%(43例/52例)和60.00%(30例/50例),差异有统计学意义(P<0.05).治疗后,试验组和对照组的糖化血红蛋白分别为(6.06±0.62)%和(6.37±0.65)%,谷丙转氨酶分别 为(21.50±6.05)和(26.23±5.79)U·L1,谷草转氨酶分别为(19.71±3.63)和(21.91±3.27)U·L-1,血清肌酸酐分别为(92.06±9.36)和(102.71±9.28)μmol·L-1,尿素氮分别为(4.63±0.61)和(5.67±0.65)mmol·L-1,差异均有统计学意义(均P<0.05).试验组发生的药物不良反应主要有恶心和水肿,对照组发生的药物不良反应有水肿.试验组和对照组的总药物不良反应发生率分别为9.62%和6.00%,差异无统计学意义(P>0.05).结论 羟苯磺酸钙胶囊联合贝那普利片治疗早期DN患者的疗效比单用贝那普利片更佳,且不增加药物不良反应的发生率.
Introduction Virtual home visits may improve chronic disease management. However, whether they are suitable for peritoneal dialysis (PD) patients has not yet been fully investigated. This study aimed to compare the agreement and acceptance of virtual home visits and in-person home visits in PD patients.Methods This was a paired, single center, noninferiority trial. Participants received a virtual home visit and an in-person home visit simultaneously. A home visit checklist was built for standardization visits. The content was divided into three parts: domestic habits (57 items), bag exchange procedures (56 items), and exit site care (53 items). Satisfaction questionnaires for both patients and nurses were designed to assess attitudes toward home visits and socioeconomic effects.Results A total of 30 PD patients were enrolled in a single center. The information collected from virtual home visits and in-person home visits was found to be highly consistent. The perfect agreement was found in 52/57, 49/56, and 44/53 items (Cohen's kappa 0.81–1.00), substantial agreement in 4/57, 7/56, and 8/53 items (Cohen's kappa 0.61–0.80). Patients reported almost identical satisfaction for virtual home visits and in-person home visits (Z = 0.39, p = 0.70). PD nurses reported similar feasibility and patient cooperation for the two visit types (Z = 0.99, p = 0.33; Z = 1.65, p = 0.10, respectively). In addition, virtual home visits were found to be more cost-effective than in-person home visits.Conclusions Virtual home visits information collection was similar to in-person home visits in PD. There were no differences in participant satisfaction and feasibility between the two visit types.
目的 探讨显微镜下多血管炎(MPA)患者外周血髓样树突状细胞(mDC)、调节性T细胞(Treg)水平与伯明翰系统性血管炎活动评分(BVAS)、肾组织病理损伤之间的关系.方法 选择27例活跃期MPA患者(MPA活跃组)和18例缓解期MPA患者(缓解组),并以性别、年龄相匹配的健康志愿者15例为对照组,采用流式细胞技术三色分析法测定三组人群外周血中mDC占淋巴细胞的百分比、Treg细胞占CD4+细胞的百分比,其中mDC以Lin1-HLA-DR+CD11c+确定,Treg细胞以CD4+CD25high CD127low Treg细胞确定,将进行了肾穿刺的24例MPA患者分为局灶性12例,新月体性5例,混合性7例.结果 MPA活跃组外周血mDC占淋巴细胞的百分比及CD4+CD25high CD127low Treg细胞占CD4+细胞的百分比均较缓解组和健康对照组下降(P<0.05),mDC、CD4+CD25high CD127low Treg细胞占比均与BVAS评分负相关(P<0.05).新月体性组外周血mDC占淋巴细胞的百分比、CD4+CD25highCD127lowTreg细胞占CD4+细胞的百分比均较局灶性组、混合性组下降(P<0.05).结论 外周血mDC和CD4+CD25high CD127low Treg细胞下降与MPA患者疾病活跃度及肾组织急性病理损伤有关.
Objective To investigate the effect of modulating thrombomodulin (TM) expression on renal injury in a rat model of diabetic nephropathy (DN) and explore the possible mechanism. Methods We examined the expression of liver X receptor-α (LXR-α), TM, coagulation factor XⅢ-A (FXⅢ-A) and CD163 in 25 renal biopsy samples from patients with DN and in 6 normal renal tissue specimens using immunohistochemistry. Twenty-four 12-week-old male db/db mice with DN were randomly assigned into 4 equal groups and treated daily with intragastric administration of normal saline or LXR-α agonist T0901317, or with intravenous injection of an adenoviral vector carrying TM shRNA or the control adenoviral vector for 7 consecutive days; 6 wild-type C57BL6 mice with intragastric saline treatment served as the normal control group. Four weeks after the treatment, the expression of TM, LXR-α, FXⅢ-A and CD163 in the renal tissues of the mice were detected using Western blotting, the levels of tumor necrosis factor-α (TNF-α) and interleukine-6 (IL-6) were detected by ELISA, and the urinary microalbumin level was determined. Results The renal expression levels of TM and LXR-α were decreased (P < 0.05) and those of FXⅢ-A and CD163 were increased significantly (P < 0.05) in the kidney tissues of DN patients compared with normal kidney tissues. In db/db mouse model of DN, the expression levels of TM and LXR-α were positively correlated while those of FXⅢ-A and CD163 were negatively correlated with glomerular filtration rate (P < 0.05). Compared with the wild-type mice, the mouse model of DN showed significantly increased urinary microalbumin levels and serum levels of TNF-α and IL-6, lowered renal expressions of TM and LXR-α, and increased renal expression of FXⅢ-A and CD163; these changes were further exacerbated in the mice treated with Ad-TM shRNA (P < 0.05) but significantly improved in the mouse models treated with T0901317. Conclusion Upregulating TM expression can reduce urinary microalbumin level in db/db mouse model of DN by inhibiting the renal expression of FXⅢ-A and CD163 and downregulating blood levels of inflammatory mediators.
患者,女,25岁,因"双下肢水肿1周"于2020年7月14日收治入院.人院前1周患者无明显诱因出现双下肢可凹性水肿,伴乏力、纳差.我院门诊检查提示蛋白尿合并低蛋白血症,以"肾病综合征"收治人院.人院时体格检查提示,贫血貌,心率129次/分,腹肌较紧张,触诊不满意.双下肢中度对称性浮肿,余无明显阳性体征.检查结果提示:血红蛋白51 g/L;血清白蛋白12.5 g/L,血清肌酐、肝酶、胆红素结果正常;24小时尿蛋白定量11.862 g;抗核抗体(ANA),抗可提取的核抗原抗体谱(anti-ENAs),抗中性粒细胞胞浆抗体(ANCA)相关抗体、血清免疫固定电泳等结果均正常.
Chronic kidney disease (CKD) in diabetes mellitus includes diabetic kidney disease (DKD), non-diabetic kidney disease (NDKD) or a combination of NDKD and DKD. The clinical and renal pathological manifestations of DKD in type 1 diabetes are different from those in type 2 diabetes. Renal biopsy histopathology is the gold standard for distinguishing DKD from NDKD. However, based on the same pathological diagnosis, DKD patients may still have different disease progression and prognosis due to individual differences in molecular biological mechanisms. Metabonomics, proteomics, transcriptomics and artificial intelligence offer hope for biomarkers to diagnose and predict the progress of DKD.
目的 探讨血小板(platelet,PLT)、淋巴细胞(lymphocyte,L)联合评估狼疮性肾炎疾病活动度的价值.方法 选取近5年本院住院行肾活检的131例狼疮性肾炎(lupus nephritis,LN)患者纳入研究,根据系统性红斑狼疮疾病活动性指数2000(SLEDAI 2000)分为活动组和稳定组,收集患者的临床及病理资料,受试者工作特征曲线(ROC)评估PLT和L联合评估狼疮性肾炎疾病活动度的价值.结果 LN患者NLR与血清肌酐及尿素氮水平、SLEDAI均呈正相关,PLT、L与血清肌酐及尿素氮水平、SLEDAI呈负相关(P<0.05);PLT和L联合诊断LN疾病活动度准确性较各自诊断性能明显升高,其受试者工作特征曲线下面积(AUC)为0.701(95%CI:0.665~0.736),当最佳临界值为0.855时,灵敏度为71%,特异度为64%.结论 NLR、PLT、L与血清肌酐及尿素氮水平具有显著相关性,可一定程度上评估肾功能损害水平;PLT和L联合检测评估LN疾病活动度的AUC较各指标单独评估时明显升高.
The outbreak of coronavirus disease 2019 (COVID-19) is becoming a severe challenge to China and the whole world. By now, there is no report about medical support to peritoneal dialysis (PD) patient during COVID-19 pandemic. In this essay, we summed up our safety measures on how to protect PD patients and our staffs, and our experience on how to ensure the dialysis treatment of PD patients during the pandemic period. Using of telehealth has potential to improve patient care quality. As a result, by applying all the actions and efforts above, most of patients got enough medical support. According to the patient survey, 11 patients (3.3% of the total) reduced their treatment of dialysis exchange due to the shortage of PD solution or the affection of the pandemic. None of the PD patient and staff reported COVID-19. We successfully prevented COVID-19 transmission and ensured medical safety in our PD patients during the crisis.
Objective To determine the effects of liver X receptor (LXR) agonist T0901317 and thrombomodulin (TM) interfering RNA recombinant adenovirus Ad-TM shRNA on renal injury of db/db mice with diabetic nephropathy (DN). Methods A total of 36 male db/db mice (12 weeks old) were randomly assigned into 6 groups (n=6), DN group, Ad-ctrl+DN group, Ad-TMshRNA+DN group, T0901317+DN group, Ad-TMshRNA+T0901317+DN group and Ad-ctrl+T0901317+DN group. PBS, 2.5×109 pfu Ad-TM shRNA and Ad-ctrl were injected into mice through tail vein to corresponding mice, while 0.5 mg/(kg·d) T0901317 was intragastrically administered to the corresponding mice for 7 consecutive days. After treatment for 4 weeks, the kidney tissues were collected for detecting the expression of LXRα, LXRβ, VCAM-1 and ICAM-1 by Western blotting. The serum creatinine level was also detected in all the mice. Male wild-type C57BL/6 mice at the same age served as normal control. Results The expression of LXRα in kidney tissue was significantly lower in the DN group and Ad-ctrl+DN group than the wild-type mice (P < 0.05), but was obviously higher in the T0901317+DN group, the Ad-TMshRNA+T0901317+DN group and the Ad-ctrl+T0901317+DN group than the DN group, Ad-ctrl+DN group and the Ad-TM shRNA+DN group (P < 0.05). The expression of LXRβ in DN mice was notably lower than that in the wild-type mice (P < 0.05). T0901317 had no significant effect on the LXRβ expression in renal tissue of DN mice. The DN control group and Ad-ctrl+DN group had significantly higher serum level of creatinine and renal expression of VCAM-1 and ICAM-1, and aggravated renal pathological damages when compared with the wild-type mice (P < 0.05). When compared with the DN group, Ad-TMshRNA silenced mice groups had severer renal damages and elevated expression of VCAM-1 and ICAM-1 (P < 0.05), while the renal damages were alleviated and the expression of VCAM-1 and ICAM-1 were decreased in the T0901317+DN group and the Ad-ctrl+T0901317+DN group (P < 0.05). Conclusion T0901317 improves renal injury in db/db mice by activating LXRα to reduce the expression of VCAM-1 and ICAM-1.
目的 分析中性粒细胞胞浆抗体(ANCA)阳性的增殖型狼疮性肾炎(PLN,即WHO分类中的Ⅲ和Ⅳ型)患者的临床及病理特点,探究ANCA在PLN病理过程中的可能意义.方法 54例肾穿活检证实为PLN患者,据血清学ANCA检测分为p-ANCA阳性组及p-ANCA阴性组,比较两组实验室指标、病理表现、并发症、使用药物之间有无差异.结果 p-ANCA阳性组较p-ANCA阴性组有更高的抗ds-DNA水平和更低的补体C3水平(P<0.05).两组其他实验室指标、病理表现、并发症、使用药物比较,差异均无统计学意义(P>0.05).结论 p-ANCA阳性PLN患者更可能表现为狼疮活跃,p-ANCA或许参与了PLN的病理过程.
Objective To investigate the effects of liver X receptor(LXR) agonist T0901317 on the expressions and activities of liver X receptor (LXR) in the kidney of db/db mice.Methods We divided the 8-week old male db/db mice into db/db group and db/db+T0901317 group(7 in each group).At the same time,we took 7 male wild-type C57BL/6 as control group.The animals in the db/db group and the control group were administrated with 50 (l saline/animal by lavage for 7 days while the animals in the db/db +T0901317 group were given 12.5 mg T0901317/kg/day by lavage for 7 days.After 4 weeks,the expression levels of ABCA1 mRNA and LXR(and LXR(proteins in the kidney tissues were examined by using RT-PCR and Western blot analysis,respectively.Results Com-pared with the control group,the mRNA expression of ABCA1 and the expression of LXRα were significantly decreased in the db/db group (P <0.05).However,compared with the db/db group,the mRNA level of ABCA1 and the production of LXRα were significant-ly increased in the db/db +T0901317 group (P < 0.05).Compared with the db/db group,the expression of LXRβ in the db/db +T0901317 group was unchanged (P > 0.05) while in control group was decreased (P < 0.05).Conclusion LXR may activate the LXRα to increase the expression of ABCA1 that reduces the inflammatory injury in diabetic nephropathy.The results may provide a no-vel theoretical basis for anti-inflammatory target therapy of diabetic nephropathy.
ObjectiveTo 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.MethodsParticipants, 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.ResultsAfter 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) mol/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 center dot min(-1)center dot 1.73 m(-2), 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) mol/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 center dot min(-1)center dot 1.73 m(-2), 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 center dot min(-1)center dot 1.73 m(-2) per year.ConclusionNiaoduqing 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.
BACKGROUND:Chronic kidney disease (CKD) with moderate-to-severe renal dysfunction usually exhibits an irreversible course, and available treatments for delaying the progression to end-stage renal disease are limited. This study aimed to assess the efficacy and safety of the traditional Chinese medicine, Niaoduqing particles, for delaying renal dysfunction in patients with stage 3b-4 CKD. METHODS:The present study was a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial. From May 2013 to December 2013, 300 CKD patients with an estimated glomerular filtration rate (eGFR) between 20 and 45 ml·min-1·1.73 m-2, aged 18-70 years were recruited from 22 hospitals in 11 Chinese provinces. Patients were randomized in a 1:1 ratio to either a test group, which was administered Niaoduqing particles 5 g thrice daily and 10 g before bedtime for 24 weeks, or a control group, which was administered a placebo using the same methods. The primary endpoints were changes in baseline serum creatinine (Scr) and eGFR after completion of treatment. The primary endpoints were analyzed using Student's t-test or Wilcoxon's rank-sum test. The present study reported results based on an intention-to-treat (ITT) analysis. RESULTS:A total of 292 participants underwent the ITT analysis. At 24 weeks, the median (interquartile range) change in Scr was 1.1 (-13.0-24.1) and 11.7 (-2.6-42.9) μmol/L for the test and control groups, respectively (Z = 2.642, P = 0.008), and the median change in eGFR was -0.2 (-4.3-2.7) and -2.2 (-5.7-0.8) ml·min-1·1.73 m-2, respectively (Z = -2.408, P = 0.016). There were no significant differences in adverse events between the groups. CONCLUSIONS:Niaoduqing particles safely and effectively delayed CKD progression in patients with stage 3b-4 CKD. This traditional Chinese medicine may be a promising alternative medication for patients with moderate-to-severe renal dysfunction. TRIAL REGISTRATION:Chinese Clinical Trial Register, ChiCTR-TRC-12002448; http://www.chictr.org.cn/showproj.aspx?proj=7102.
Objective To evaluate the efficacy and safety of leflunomide (LEF) as an induction treatment for proliferative lupus nephritis (PLN). Methods In a single-center prospective study, 30 patients who had been confirmed with PLN by renal puncture biopsy in our hospital from Jan. 2013 to Dec. 2015 were selected and randomized into two groups, with 15 cases in each group. The two groups were treated with LEF combined with prednisolone (LEF group) and cytoxan (CTX) combined with prednisolone (CTX group), respectively, for 24 weeks. Urine routine, blood routine, blood biochemistry, quantitation of anti-ds-DNA, compliment C3, T-cell subsets and Systemic Lupus Erythematosus Dis-ease Activity Index (SLEDAI) scoring were periodically reviewed. In order to assess the efficacy and safety of LEF as an induction treatment for PLN, all adverse reactions were recorded for comparison between the two groups at different treatment stages. Results The 24-week treatment achieved significant improvement in both groups for 24-hour protein-uria, hemoglobinuria, serum albumin, renal function and lupus activity measurements (P<0.05). At 8 weeks (the middle stage) of treatment, the total proteinuria, serum albumin and lupus immunoregulation index of the CTX group were sig-nificantly better than those of the LEF group (P<0.05). However, at the end of treatment, there was no significant differ-ence in efficacy between the two groups (P>0.05). There no significant change in ALT, WBC and hemoglobin during the course of treatment (P>0.05) in either group, while T-cell subset was decreased in both groups (P<0.05) after treatment, with no significant difference between the two groups (P>0.05). Although the CTX group manifested higher adverse ef-fects in all measurements than the LEF group did, there was no statistical significance between the two groups (P>0.05). Conclusion LEF has a good efficacy in the induction treatment of PLN. Although it is slower than CTX, LEF has the equivalent efficacy to that of CTX at the end of the induction treatment but lower adverse reactions and better patient compliance than that of CTX, indicating its further use in the treatment of PLN patients.