Chronic kidney disease (CKD) is closely associated with gut microbiota dysbiosis and impaired intestinal barrier function, yet effective therapeutic strategies targeting the gut-kidney axis remain limited. This study aimed to develop a thiolated chitosan/sodium alginate-based nanoparticle system encapsulating emodin (TCS/ALG/Emodin-NPs), and to evaluate its therapeutic efficacy in CKD through modulation of gut microbiota and intestinal barrier protection. The nanoparticles were synthesized, characterized, and orally administered to CKD mice at varying doses, with irbesartan as a positive control. Our results showed that TCS/ALG/Emodin-NPs significantly improved renal function, reduced renal fibrosis, and restored gut microbiota balance, particularly increasing beneficial bacteria such as Lactobacillus. They also enhanced intestinal tight junction integrity and suppressed systemic inflammation. In a hydrogen peroxide-induced Caco-2 cell model, Emodin-NPs more effectively attenuated oxidative stress and apoptosis compared to free Emodin. The findings suggest that TCS/ALG/Emodin-NPs are a promising strategy for CKD treatment by reshaping gut microbiota and enhancing intestinal function.IMPORTANCEWhile the gut-kidney axis has emerged as a critical target in chronic kidney disease (CKD) management, therapeutic strategies leveraging this pathway remain limited. This study demonstrates that colon-targeted TCS/ALG/Emodin-NPs not only enhance drug bioavailability but also exert dual therapeutic effects by rectifying gut dysbiosis and reinforcing intestinal barrier function-key mechanisms implicated in CKD progression. The superior efficacy of TCS/ALG/Emodin-NPs over free Emodin underscores the transformative potential of nanoparticle delivery systems in overcoming the pharmacokinetic limitations of herbal medicines. This research opens new avenues for the development of microbiota-targeted, anti-inflammatory therapies that can complement existing CKD treatments and potentially slow disease progression in affected patients.
BACKGROUND:The impact of short-term atherogenic burden and long-term cumulative lipid exposure on the risk of incident T2DM with CKD remains unclear. This study examines the longitudinal associations between the Atherogenic Index of Plasma (AIP) and Cumulative Atherogenic Index of Plasma (CumAIP) with the development of T2DM complicated by CKD in middle-aged and older adults. METHODS:A total of 5,779 participants from the CHARLS cohort were included. AIP and CumAIP were used to represent short-term and long-term lipid burdens, respectively. Multivariable logistic regression and restricted cubic spline models were applied to assess the dose-response relationships, adjusting for 11 conventional covariates. ROC curve analysis was conducted to evaluate predictive performance. An exploratory analysis further evaluated incident CKD among participants with T2DM at baseline (n = 494). RESULTS:Both AIP and CumAIP were significantly associated with incident T2DM with CKD, with the highest quartiles showing modest but statistically significant associations with the outcome (AIP-Q4: OR: 1.013; 95% CI: 1.004-1.022; p < 0.05; CumAIP-Q4: OR: 1.017; 95% CI: 1.008-1.026; p < 0.001). Linear dose-response associations were observed across logistic regression and RCS regression models. ROC analysis showed that CumAIP demenstrated better discrimination than AIP (AUC 0.683 versus 0.650). In an exploratory analysis of participants with T2DM at the baseline (n = 494), both indices showed suggestive associations with incident CKD (AIP-Q4: OR: 1.050; 95% CI: 1.009-1.145; p = 0.025; CumAIP-Q4: OR: 1.081; 95% CI: 1.015-1.152; p = 0.016). CONCLUSION:AIP and CumAIP is significantly associated with incident T2DM with CKD among Chinese middle-aged and older adults. CumAIP demonstrated superior predictive performance over single AIP measurement. These findings support the potential value of long-term lipid monitoring for identifying indivuduals at increased risk of T2DM with CKD. An exploratory analyses also suggested a similar associations with progression from T2DM to CKD; however, these findings require confirmation in larger cohorts.
BACKGROUND:Previous clinical studies have confirmed that Bupi Yishen formula (BYF) can delay the progression of chronic kidney disease (CKD), and experimental studies have demonstrated that BYF exerts renoprotective effects in CKD models through anti-inflammatory and anti-fibrotic mechanisms. However, the fundamental pathways by which BYF produces these effects remain to be fully elucidated. PURPOSE:This study aims to investigate the potential of BYF to enhance intestinal barrier function through the modulation of gut microbiota and group 3 innate lymphoid cells (ILC3s), and to explore its effects on reducing systemic inflammation and alleviating renal fibrosis in CKD. METHODS:Mice with adenine-induced CKD were treated with oral BYF extract at two doses (15 or 30 g/kg/day). Irbesartan was used as a positive control. We examined the relationship between the renoprotective effects of BYF and changes in gut microbiota, ILC3s, retinoic acid levels, intestinal barrier function, and systemic inflammation. In addition, we conducted an antibiotic-induced gut microbiota depletion experiment to assess the dependence of BYF's effects on microbial presence. RESULTS:Oral BYF treatment reduced serum creatinine, blood urea nitrogen and urine protein levels in mice with adenine-induced CKD and alleviated renal tubular interstitial injury and fibrosis. 16S rRNA sequencing revealed that BYF modulated the gut microbiota composition, significantly enriching Akkermansia muciniphila and Barnesiella intestinihominis while suppressing Flavonifractor plautii and Turicibacter sanguinis. BYF also increased colonic ILC3 numbers, elevated retinoic acid levels, and upregulated interleukin22 (IL-22) expression, thereby improving intestinal barrier integrity and reducing serum levels of lipopolysaccharide (LPS), indoxyl sulfate, IL-1β, interferon gamma (IFN-γ), and tumor necrosis factor-α (TNF-α). However, in gut microbiota-depleted mice, BYF failed to improve kidney injury, fibrosis, ILC3s, retinoic acid, IL-22 expression, or intestinal barrier function. CONCLUSION:BYF may enhance intestinal barrier function by upregulating Akkermansia muciniphila and the ILC3s-IL-22 axis, thereby reducing toxin translocation, suppressing inflammation, alleviating renal fibrosis, and slowing CKD progression. These effects may involve activation of Akkermansia muciniphila-mediated retinoic acid synthesis, which modulates ILC3s-IL-22 signalling in mice with CKD. The breakthrough in our study lies in demonstrating that BYF, through its regulation of gut microbiota and immune cells, significantly impacts the gut-kidney axis to alleviate CKD progression.
Rationale & Objective:Hypokalemia is common and potentially life-threatening in patients undergoing peritoneal dialysis (PD). However, the current literature has produced varying results. This study aimed to evaluate the prevalence and adverse outcomes of hypokalemia and the role of potassium supplementation in patients receiving PD. Study Design:Systematic review and meta-analysis of randomized controlled trials and observational studies. Setting & Study Populations:Adults receiving maintenance PD. Selection Criteria for Studies:Studies that investigated the prevalence and adverse outcomes of hypokalemia and the effect of potassium supplementation. Data Extraction:Two independent reviewers evaluated studies for eligibility and extracted relevant data. Analytical Approach:Random effects meta-analysis was conducted to pool hazard ratios (HRs) and 95% CIs for the outcomes of interest. The certainty of findings was rated according to the Grading of Recommendations Assessment, Development and Evaluation criteria. Results:Of 3,632 reports identified, 24 studies involving 60,313 participants met the inclusion criteria. The prevalence of hypokalemia was 37.9% (95% CI, 27.2%-52.7%), 17.7% (95% CI, 12.0%-25.9%), and 4.4% (95% CI, 1.9%-10.2%) in patients with potassium level <4.0, 3.5, and 3.0 mmol/L, respectively. Hypokalemia, according to the study's definition, was associated with increased risks of all-cause mortality (HR, 1.49; 95% CI, 1.18-1.89), cardiovascular mortality (HR, 1.50; 95% CI, 1.19-1.88), and PD-associated peritonitis (HR, 1.42; 95% CI, 1.17-1.73). These associations were consistent but with low to very low certainty. The effect of correcting hypokalemia with potassium supplementation in patients undergoing PD remains uncertain. Limitations:Heterogeneity persisted across most of the examined subgroups, and observational studies preclude causation. Conclusions:Hypokalemia is common and portends poorer survival and a higher risk of peritonitis among patients undergoing PD. Further research into the optimal prevention and treatment strategies for hypokalemia is warranted to improve outcomes. Registration:Registered at PROSPERO with registration number CRD42022358236.
INTRODUCTION:Physical inactivity is prevalent and associated with adverse outcomes among patients with chronic kidney disease (CKD). Most previous studies have relied on subjective questionnaires to assess levels of physical activity (PA) and mainly focused on patients undergoing dialysis. Therefore, the Physical Activity Elements and Adverse Outcomes in Patients with Chronic Kidney Disease in Guangdong study aims to investigate the levels and types of PA elements and their association with adverse outcomes in Chinese non-dialysis CKD (ND-CKD) patients. METHODS AND ANALYSIS:In this prospective cohort study, 374 patients with ND-CKD will be recruited from Guangdong province, South of China. The primary exposure will be levels of PA assessed by ActiGraph GT3X+ accelerometer including the intensity, duration, frequency and type of PA. The traditional Chinese exercises such as tai chi and Baduanjin will also be assessed. The primary outcomes will be all-cause mortality. Other variables including demographics, comorbidities, medication and laboratory markers will be registered. All data will be updated annually for at least 5 years, or until the occurrence of death or initiation of renal replacement therapy. The Spearman correlation coefficient will be used to investigate the correlation between questionnaire-derived and accelerometry-derived PA. The Cox proportional hazards model will be used to investigate the association between level of PA and adverse outcomes. Non-linear associations between PA levels and outcomes, as well as the minimum desirable PA level, will be evaluated using restricted cubic splines. ETHICS AND DISSEMINATION:The ethical permission for this study was obtained from the ethics committee of Guangdong Provincial Hospital of Chinese Medicine in Guangzhou, China (B2015-152-02). Written informed consent is obtained from all participants. The results will be disseminated by publication in a peer-reviewed journal and presented at relevant conferences.
腹膜透析相关性腹膜炎(PDAP)是导致腹膜透析技术失败甚至患者死亡的首要并发症,尽早获得准确有效的病原学鉴定结果指导抗感染方案是影响PDAP临床疗效的关键环节。本文系统回顾了广东省中医院腹透中心PDAP病原微生物检测方法及现状,在梳理国际临床实践指南和标准操作规程等临床证据的基础上,从“标本留取”“标本预处理”“培养条件”及“首次培养阴性处理”四个方面归纳总结了影响PDAP培养阳性率的技术要点和潜在改进措施;并以省中医腹透中心为示例,展示了如何结合现有临床证据,从患者宣教、多学科协作、标本处理等方面对单中心的PDAP标本处理及送检流程进行完善及优化,提供可行的单中心经验,供国内其他腹膜透析中心参考。
BackgroundDiabetic kidney disease (DKD) has become the leading cause of kidney failure, causing a significant socioeconomic burden worldwide. The usual care for DKD fails to achieve satisfactory effects in delaying the persistent loss of renal function. A Chinese herbal medicine, Tangshen Qushi Formula (TQF), showed preliminary clinical benefits with a sound safety profile for people with stage 2-4 DKD. We present the protocol of an ongoing clinical trial investigating the feasibility, efficacy, and safety of TQF compared to placebo in delaying the progressive decline of renal function for people with stage 2-4 DKD.MethodsA mixed methods research design will be used in this study. A randomized, double-blind, placebo-controlled pilot trial will evaluate the feasibility, efficacy, and safety of TQF compared to placebo on kidney function for people with stage 2-4 DKD. An embedded semi-structured interview will explore the acceptability of TQF granules and trial procedures from the participant’s perspective. Sixty eligible participants with stage 2-4 DKD will be randomly allocated to the treatment group (TQF plus usual care) or the control group (TQF placebo plus usual care) at a 1:1 ratio for 48-week treatment and 12-week follow-up. Participants will be assessed every 12 weeks. The feasibility will be assessed as the primary outcome. The changes in the estimated glomerular filtration rate, urinary protein/albumin, renal function, glycemic and lipid markers, renal composite endpoint events, and dampness syndrome of Chinese medicine will be assessed as the efficacy outcomes. Safety outcomes such as liver function, serum potassium, and adverse events will also be evaluated. The data and safety monitoring board will be responsible for the participants’ benefits, the data’s credibility, and the results’ validity. The intent-to-treat and per-protocol analysis will be performed as the primary statistical strategy.DiscussionConducting a rigorously designed pilot trial will be a significant step toward establishing the feasibility and acceptability of TQF and trial design. The study will also provide critical information for future full-scale trial design to further generate new evidence supporting clinical practice for people with stage 2-4 DKD.Trial registration numberhttps://www.chictr.org.cn/, identifier ChiCTR2200062786.
Context A Chinese herbal formula, Tiaopi Xiezhuo decoction (TXD), is developed from a classical Chinese prescription Sanhuang Xiexin decoction.Objective To investigate the regulatory effect of TXD on gut dysbiosis, as a treatment of constipation in patients with peritoneal dialysis (PD).Materials and methods The chemical content of TXD was assessed by high-performance liquid chromatography. A total of 29 PD patients were enrolled and treated with TXD orally (3 g crude drug/each/twice/day) for 3 months. Blood and faecal samples were collected at the beginning and end, to determine the changes in biochemical characteristics and gut microbial composition. The stool conditions were asked to be scored. Additional 30 healthy individuals were recruited as a control for the analysis of gut microbiota.Results Although having no significant effects on serum biochemical characteristics, 3-month TXD intervention improved constipation in PD patients: decreased 80% abdominal distention (p < 0.01), increased 2.6-fold sloppy stools (p < 0.05) and eliminated hard stool completely (p < 0.01). The analysis of gut microbiota showed that, compared to the healthy group, the microbial richness was reduced in PD patients. After a 3-month TXD treatment, this reduced richness was raised, and Paraprevotella clara, Lachnospiraceae bacterium 2-146FA, Phascolarctobaterium succinatutens, Lachnospiraceae bacterium 2-1-58FAA, Fusobacterium mortiferum, and Prevotella copri were accumulated in the intestinal flora. Furthermore, the bacterial species enriched by TXD correlated with the improvement of constipation.Discussion and conclusions TXD treatment may improve constipation by modulating gut dysbiosis in PD patients. These findings provide data to support the further application of TXD in the adjuvant treatment of PD.
Chronic kidney disease (CKD) is characterized by abnormal urine test or progressive kidney function decline. Patients with CKD are at a higher risk of COVID-19 infection with higher conversion and mortality rates after infection for their reduced kidney function, long-term use of immunosuppressive agents or combination of underlying diseases. Therefore, rational drug use is particularly important for CKD patients combined with COVID-19 infection. This article summarizes special considerations for the use of relevant medications in patients with CKD by integrating the current evidence of medications for the treatment of COVID-19 infection, including antiviral drugs, anti-inflammatory drugs, antithrombotic drugs, convalescent plasma and neutralizing monoclonal antibodies, as well as commonly used symptomatic drugs of respiratory system (such as antfebrile, antisputum and cough medicine and anti-allergic drugs), high lighting the modified medication regiments according to kidney function levels, in order to provide a reference for clinical professionals, assist in clinical decision-making and rational drug use, and ensure clinical efficacy and safety.
Review question / Objective: The objective of the proposed work is to evaluate the efficacy and safety of moxibustion as a treatment in improving fatigue in dialysis patients.Condition being studied: Fatigue is a highly prevalent and debilitating symptom in patients undergoing dialysis and is associated with impaired quality of life, cardiovascular disease, and mortality.The causes of fatigue in patients receiving dialysis are complex and multifactorial.Uremia, anemia, depression, quality of sleep and physical deconditioning can lead to fatigue in dialysis patients.There is evidence suggested that specific non-pharmaceutical interventions were potentially effective in improving dialysis related-fatigue, such as cognitive behavioral therapy, exercise, reflexology, aromatherapy, acupressure and moxibustion.By far, how to relieve fatigue in dialysis patients remained controversial.
目的:分析目前中西医结合治疗糖尿病肾病(DKD)的随机对照试验(RCT)中结局指标的选择现状,为今后研究提供参考.方法:检索10个中英文数据库,纳入中西医结合治疗DKD的RCT,提取结局指标做频数分析.结果:纳入了3 038项中西医结合治疗DKD的RCT共报告了 199个结局指标,73.4%为生化指标,硬终点或临床结局仅0.1%,不良事件报告率为25.6%.使用频率>50%的指标包括复合疗效(有效率)、血肌酐和空腹血糖,其中,有效率的判断标准各研究间不一致.84%的指标使用率<5%.结论:中西医结合治疗DKD的RCT结局指标选择以替代指标为主,极少选择硬终点或临床结局,且忽视安全性结局的报告.今后同类试验可参考现有肾病领域的核心指标集,结合中医药干预措施确切或可能的作用途径来选择相应的系列效应指标.
Background: IgA nephropathy (IgAN) is the most common type of glomerulonephritis in Asia. Its pathogenesis involves higher expression of galactose-deficient IgA1 (Gd-IgA1) and dysregulated intestinal mucosal immunity. The objective of this study was to explore whether specific gut microbiota and associated enzymes affect Gd-IgA1 in IgAN. Methods: This study carried out shotgun metagenomic sequencing with Illumina on fecal samples collected from 20 IgAN patients (IgAN group) and 20 healthy controls (HCs group) who were recruited from January 2016 to December 2018 at the Second Clinical College of Guangzhou University of Chinese Medicine. Differences analysis in gut microbiota was performed to determine the overall microbiota composition, the representative enterotypes, and the microbiota abundance. Correlations between gut microbiota and clinical indicators were assessed by Spearman's analysis. Moreover, the functional prediction of microbial communities and the quantitative calculation of enzymes encoded by microbiome were performed using the MetaCyc pathway and the bioBakery three platform, respectively. Results:Bacteroides plebeius and Bacteroides vulgatus levels were higher, while Prevotella copri and Alistipes putredinis levels were lower in the IgAN group compared to HCs group. Enterotype I characterized by Bacteroides was closely related to the IgAN patients. Moreover, Bacteroides fragilis, Flavonifractor plautii and Ruminococcus gnavus were characteristic bacteria enriched in IgAN patients. Spearman's correlation analysis found that Eggerthella lenta and Ruminococcus bromii were positively correlated with urine protein-creatinine ratio, while Ruminococcus gnavus showed a direct association with red blood cells in urine, and Bacteroides vulgatus and Ruminococcus gnavus were positively correlated with eGFR. These results indicated that intestinal dysbacteriosis occurred in IgAN patients and was associated with clinical and biochemical features. In addition, MetaCyc pathway analysis predicted microbiota-related metabolic pathways, including the biosynthesis of amino acids and glycans, were associated with the IgAN group. Microbial enzymes analysis highlighted that Gd-IgA1-associated α-galactosidase and α-N-acetyl-galactosaminidase secreted by Flavonifractor plautii were enriched in IgAN patients. Conclusion: These findings suggested that α-galactosidase and α-N-acetyl-galactosaminidase secreted by Flavonifractor plautii might be related to the production of Gd-IgA1, indicating that enzymes originated from abnormal intestinal microbiota may contribute to the production of Gd-IgA1 and play an important role in the pathogenesis of IgAN.
目的:调查分析原发性膜性肾病常见的中医证型分布特点.方法:以系统整理文献资料为基础,结合临床专家及方法学专家意见,制作原发性膜性肾病中医证型专家调查问卷,采取线上发放问卷、线上回收的方式进行调查.结果:文献调研发现膜性肾病多为本虚标实证,本证以脾肾阳虚证为主,标证以湿热证居多.专家调查共发放问卷72份,回收71份,回收率为98.61%(71/72),常见证型本证以脾肾气虚证、脾肾阳虚证为主,标证以水湿证、湿热证、湿浊证为主.专家所在单位按照地理干湿区域划分为湿润区和半湿润区,两组水湿证和湿热证比较,差异无统计学意义(P>0.05).湿润地区湿浊证频率(77.97%)高于半湿润地区(50.00%),水气证频率(22.03%)低于半湿润区(50.00%),差异均有统计学意义(P<0.05).结论:原发性膜性肾病属于本虚标实之证,虚以脾肾气(阳)虚证为主,实以湿证为主,在湿润区尤以湿浊证为典型表现,提示了三因制宜的重要性.
Objective: Diabetic kidney disease (DKD) has become the major cause of end-stage renal disease (ESRD) associated with the progression of renal fibrosis. As gut microbiota dysbiosis is closely related to renal damage and fibrosis, we investigated the role of gut microbiota and microbiota-related serum metabolites in DKD progression in this study.Methods: Fecal and serum samples obtained from predialysis DKD patients from January 2017 to December 2019 were detected using 16S rRNA gene sequencing and liquid chromatography-mass spectrometry, respectively. Forty-one predialysis patients were divided into two groups according to their estimated glomerular filtration rate (eGFR): the DKD non-ESRD group (eGFR ≥ 15 ml/min/1.73 m2) (n = 22), and the DKD ESRD group (eGFR < 15 ml/min/1.73 m2) (n = 19). The metabolic pathways related to differential serum metabolites were obtained by the KEGG pathway analysis. Differences between the two groups relative to gut microbiota profiles and serum metabolites were investigated, and associations between gut microbiota and metabolite concentrations were assessed. Correlations between clinical indicators and both microbiota-related metabolites and gut microbiota were calculated by Spearman rank correlation coefficient and visualized by heatmap.Results: Eleven different intestinal floras and 239 different serum metabolites were identified between the two groups. Of 239 serum metabolites, 192 related to the 11 different intestinal flora were mainly enriched in six metabolic pathways, among which, phenylalanine and tryptophan metabolic pathways were most associated with DKD progression. Four microbiota-related metabolites in the phenylalanine metabolic pathway [hippuric acid (HA), L-(−)-3-phenylactic acid, trans-3-hydroxy-cinnamate, and dihydro-3-coumaric acid] and indole-3 acetic acid (IAA) in the tryptophan metabolic pathway positively correlated with DKD progression, whereas L-tryptophan in the tryptophan metabolic pathway had a negative correlation. Intestinal flora g_Abiotrophia and g_norank_f_Peptococcaceae were positively correlated with the increase in renal function indicators and serum metabolite HA. G_Lachnospiraceae_NC2004_Group was negatively correlated with the increase in renal function indicators and serum metabolites [L-(−)-3-phenyllactic acid and IAA].Conclusions: This study highlights the interaction among gut microbiota, serum metabolites, and clinical indicators in predialysis DKD patients, and provides new insights into the role of gut microbiota and microbiota-related serum metabolites that were enriched in the phenylalanine and tryptophan metabolic pathways, which correlated with the progression of DKD.
Background: In clinical practice, Chinese herbal medicine (CHM) purportedly has beneficial therapeutic effects for chronic kidney disease (CKD), which include delaying disease progression and dialysis initiation. However, there is a lack of high-quality evidence-based results to support this. Therefore, this study aimed to evaluate the efficacy of CHM combined with Western medicine in the treatment of stage 5 CKD.Methods: This was a prospective nonrandomized controlled study. Stage 5 CKD (nondialysis) patients were recruited form 29 AAA class hospitals across China from July 2014 to April 2019. According to doctors’ advice and the patients’ wishes, patients were assigned to the CHM group (Western medicine + CHM) and the non-CHM group (Western medicine). Patient demographic data, primary disease, blood pressure, Chinese and Western medical drugs, clinical test results, and time of dialysis initiation were collected during follow-up.Results: A total of 908 patients were recruited in this study, and 814 patients were finally included for further analysis, including 747 patients in the CHM group and 67 patients in the non-CHM group. 482 patients in the CHM group and 52 patients in the non-CHM group initiated dialysis. The median time of initiating dialysis was 9 (7.90, 10.10) and 3 (0.98,5.02) months in the CHM group and non-CHM group, respectively. The multivariate Cox regression analysis showed that patients in the CHM group had a significantly lower risk of dialysis [adjusted hazard ratio (aHR): 0.38; 95% confidence interval (CI): 0.28, 0.53] compared to those in the non-CHM group. After 1:2 matching, the outcomes of 160 patients were analyzed. The multivariate Cox regression analysis showed that patients in the CHM group had a significantly lower risk of dialysis (aHR: 0.32; 95% CI: 0.21, 0.48) compared to patients in the non-CHM group. Also, the Kaplan-Meier analysis demonstrated that the cumulative incidence of dialysis in the CHM group was significantly lower than that in the non-CHM group (log-rank test, P<0.001) before and after matching.Conclusions: This study suggest that the combination of CHM and Western medicine could effectively reduce the incidence of dialysis and delay the time of dialysis initiation in stage 5 CKD patients.
Chinese herbal medicine (CHM) might have benefits in patients with non-diabetic chronic kidney disease (CKD), but there is a lack of high-quality evidence, especially in CKD4. This study aimed to assess the efficacy and safety of Bupi Yishen Formula (BYF) vs. losartan in patients with non-diabetic CKD4. This trial was a multicenter, double-blind, double-dummy, randomized controlled trial that was carried out from 11-08-2011 to 07-20-2015. Patients were assigned (1:1) to receive either BYF or losartan for 48 weeks. The primary outcome was the change in the slope of the estimated glomerular filtration rate (eGFR) over 48 weeks. The secondary outcomes were the composite of end-stage kidney disease, death, doubling of serum creatinine, stroke, and cardiovascular events. A total of 567 patients were randomized to BYF (n = 283) or losartan (n = 284); of these, 549 (97%) patients were included in the final analysis. The BYF group had a slower renal function decline particularly prior to 12 weeks over the 48-week duration (between-group mean difference of eGFR slopes: −2.25 ml/min/1.73 m2/year, 95% confidence interval [CI]: −4.03,−0.47), and a lower risk of composite outcome of death from any cause, doubling of serum creatinine level, end-stage kidney disease (ESKD), stroke, or cardiovascular events (adjusted hazard ratio = 0.61, 95%CI: 0.44,0.85). No significant between-group differences were observed in the incidence of adverse events. We conclude that BYF might have renoprotective effects among non-diabetic patients with CKD4 in the first 12 weeks and over 48 weeks, but longer follow-up is required to evaluate the long-term effects. Clinical Trial Registration: http://www.chictr.org.cn, identifier ChiCTR-TRC-10001518.
通过对历代中医综合方书中与蚕茧相关的古籍文献进行了全面收集梳理,系统归纳了历代医家对蚕茧功效应用和配伍用法的经验认识,发现蚕茧在古代主要应用于血证、消渴、外科痈疮、痔疮痔漏、杀虫、妇科、骨伤、皲裂等病症,为今后蚕茧的药用研究提供参考方向.
目的:借助数据挖掘分析的方法,探讨刘伟胜教授治疗肝癌的处方用药规律.方法:收集于刘伟胜教授肿瘤专科门诊治疗的患者病案,筛选出456份肝癌病案处方,构建病案处方数据库,经数据整理后,进行频数分析和聚类分析.结果:刘伟胜教授治疗肝癌的常用药物包括柴胡、女贞子、白芍、预知子、全蝎等,多为苦寒之药.对使用频率较高的前30味中药依照主治功效分类,可得出疏肝健脾、化瘀抑瘤的核心治法.基于聚类分析结果,可得出刘伟胜教授治疗肝癌1个核心处方(柴胡、白芍、甘草、女贞子、预知子、全蝎、党参、黄芪、茯苓)以及4组核心中药组合.结论:刘伟胜教授辨治肝癌以"辨病-辨证-辨症"思路贯穿诊治过程,辨病以攻毒散结药物进行抑瘤,辨证选用疏肝理气、健脾化湿、活血化瘀药物,并辅佐利湿退黄、健胃消食等药物.