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Background: Chinese patent medicine is commonly used in China as an important treatment mechanism to thwart the progression of chronic kidney disease (CKD) stages 3-5, among which Niaoduqing granules are a representative Chinese patent medicine; however, its long-term efficacy on CKD prognosis remains unclear. Methods: Patients were grouped according to Niaoduqing granule prescription duration (non-Niaoduqing granule (non-NDQ) group vs Niaoduqing granule (NDQ) group). Serum creatinine (SCr) variation was compared using a generalized linear mixed model (GLMM). Multivariate Cox regression models were constructed, adjusting for confounding factors, to explore the risk of composite outcomes (receiving renal replacement therapy (RRT) or having an estimated glomerular filtration rate (eGFR)<5 mL/min/1.73 m2, ≥50% decline in the eGFR from the baseline, and doubling of SCr) in individuals consuming Niaoduqing granules. Results: A total of 1,271 patients were included, with a median follow-up duration of 29.71 (12.10, 56.07) months. The mean SCr Z-scores for the non-NDQ group and NDQ group were -0.175 and 0.153, respectively, at baseline (p = 0.015). The coefficients of the NDQ group from visit 1 to visit 5 were -0.207 (95% CI: -0.346, -0.068, p = 0.004), -0.214 (95% CI: 0.389, -0.039, p = 0.017), -0.324 (95% CI: 0.538, -0.109, p = 0.003), -0.502 (95% CI: 0.761, -0.243, p = 0.000), and -0.252 (95% CI: 0.569, 0.065, p = 0.119), respectively. The survival probability was significantly higher in the NDQ group (p = 0.0039). Taking Niaoduqing granules was a significant protective factor for thwarting disease progression (model 1: HR 0.654 (95% CI 0.489-0.875, p = 0.004); model 2: HR 0.646 (95% CI 0.476, 0.877, p = 0.005); and model 3: HR 0.602 (95% CI 0.442, 0.820, p = 0.001)). Conclusion: The long-term use of Niaoduqing granules improved SCr variation and lowered the risk of CKD progression by 39.8%.

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Diabetic kidney disease (DKD) is one of the most severe chronic microvascular complications of diabetes and the leading cause of end-stage kidney disease worldwide. The mechanism of inflammation underlying DKD has been attracting attention over recent years, but effective therapeutic strategies have remained elusive. Niaoduqing (NDQ) granules are one of the most commonly used drugs for the treatment of DKD in China, and it has therapeutic effects against inflammation in DKD. Therefore, the aim of the present analysis was to evaluate the inflammatory response outcomes and safety of NDQ granules for the treatment of DKD. The following databases were searched from their inception to 31st of May 2023 to obtain published accounts of relevant randomized controlled trials: China National Knowledge Infrastructure, China Science and Technology Journal, Wanfang, The Chinese Biomedicine, PubMed, Web of Science and Cochrane Library. The 'risk of bias' evaluation tool produced by the Cochrane Collaboration Handbook was used for evaluating the quality, whereas Revman software (version 5.3) was used for meta-analysis. In total, 16 studies were included into the present study according to criteria, with a total of 1,526 patients. Compared with those in the control group, the results of the meta-analysis revealed that the combination of conventional treatment and NDQ granules may further decrease C-reactive protein [standardized mean difference (SMD), -1.33; 95% confidence interval (CI), -1.76, -0.91; P<0.00001], TNF-α (SMD, -1.90; 95% CI, -2.35,-1.45; P<0.00001) and IL-6 (SMD, -1.72; 95% CI, -2.52,-0.91; P<0.0001) levels, whilst increasing the clinical effective rate (risk ratio, 1.22; 95% CI, 1.14,1.29; P<0.00001), in patients with DKD. In terms of safety, a total of 34 and 39 patients included in the intervention and in the control group, respectively, developed adverse reactions. Results from the present analysis suggest that NDQ granules may be beneficial in suppressing inflammation caused by DKD when used in combination with conventional treatment, potentially guiding future directions in clinical practice. However, further high-quality studies are needed to confirm the anti-inflammation response in the future.

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Background: Diabetic nephropathy (DN) is the main cause of chronic kidney disease (CKD) and end-stage renal failure (ESRF), and the control of disease progression and adverse events during treatment needs to be improved. Objective: This study aimed to systematically evaluate the clinical efficacy and safety of Niaoduqing granules (NDQG) in the treatment of diabetic kidney disease (DKD). Method: Randomized controlled trials (RCTs) of NDQG for DKD from Chinese and English databases up to 31 August 2022 were included. The quality of the literature was assessed using the risk of bias tool of the Cochrane Handbook. At a 95% confidence interval (CI), relative risk (RR) and Cohen's d were used for the categorical and continuous variables, respectively, and Stata 16.0 software was used for statistical analysis. A funnel plot and Egger's tests were used to assess publication bias. Result: A total of 4,006 patients were included in 52 RCTs, including 1,987 cases in the control group and 2,019 cases in the treatment group. Compared with conventional treatment (CT), combined NDQG therapy is more effective in improving clinical efficiency [RR = 1.23, 95% confidence interval (1.17, 1.29), p < 0.001, I 2 = 53.17%], kidney function (urinary albumin excretion rate [SMD = -0.90, 95% CI (-1.14, -0.66), p < 0.001, I 2 = 78.19%], 24hUTP levels [SMD = -0.81, 95% CI (-1.08, -0.55), p < 0.001, I 2 = 87.08%], blood urea nitrogen [SMD = -0.54, 95% CI (-0.69, -0.39), p < 0.01, I 2 = 77.01%], SCr [SMD = -0.68, 95% CI (-0.90, -0.45), p < 0.001, I 2 = 89.97%], CCr [SMD = 0.76, 95% CI (0.10,1.42), p = 0.02, I 2 = 95.97%], and Cys-C [SMD = -1.32, 95% CI (-2.25, -0.40), p = 0.01, I 2 = 93.44%]), the level of glucose metabolism (fasting blood glucose [SMD = -0.18, 95% CI (-0.38, 0.03), p = 0.10, I 2 = 71.18%] and HbA1c [SMD = -0.42, 95% CI (-0.86, -0.02), p = 0.06, I 2 = 81.64%]), the level of lipid metabolism (total cholesterol [SMD = -0.70, 95% CI (-1.01, -0.39), p < 0.001, I 2 = 86.74%] and triglyceride [SMD = -0.61, 95% CI (-0.87,-0.36), p < 0.001, I 2 = 80.64%]), inflammatory factors (Hs-CRP [SMD = -1.00, 95% CI (-1.54, -0.46), p < 0.001, I 2 = 86.81%], IL-18 [SMD = -1.25, 95% CI (-1.58, -0.92), p < 0.001, I 2 = 0], and TNF-α [SMD = -1.28, 95% CI (-1.64, -0.91), p < 0.001, I 2 = 75.73%]), and indicators of oxidative stress (malondialdehyde [SMD = -0.88, 95% CI (-1.22, -0.54), p < 0.001, I 2 = 66.01%] and advanced oxidation protein products [SMD = -0.92, 95% CI (-1.85, 0.00), p < 0.001, I 2 = 90.68%]). In terms of improving uric acid [SMD = -1.59, 95% CI (-3.45, 0.27), p = 0.09, I 2 = 94.67%], 2hPG [SMD = -0.04, 95% CI (-0.61, 0.53), p = 0.89, I 2 = 84.33%], HDL-C [SMD = 0.71, 95% CI (0.02, 1.40), p = 0.04, I 2 = 87.43%], Hb [SMD = 0.11, 95% CI (-0.10, 0.32), p = 0.32, I 2 = 0.00]), and superoxide dismutase [SMD = 1.32, 95% CI (0.44, 2.20), p < 0.001, I 2 = 93.48%], the effect is not obvious. Adjuvant treatment with NDQG did not increase the incidence of adverse reactions in the control group [SMD = 0.98, 95% CI (0.71, 1.34), p = 0.89, I 2 = 1.59%]. Obvious publication bias was detected by funnel plot and Egger's test. Conclusion: Our meta-analysis showed that adjuvant treatment with NDQG has more advantages than conventional treatment alone in the DKD treatment, which could improve clinical efficiency, kidney function, the level of glucose metabolism, the level of lipid metabolism, inflammatory factors, and oxidative stress indicators. At the same time, it also showed that NDQG are relatively safe. However, more high-quality studies are needed to provide more reliable evidence for clinical use. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022373726, identifier CRD42022373726.

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BACKGROUND: The therapeutic benefits of Niaoduqing granules (NDQG) in kidney diseases has been comprehensively studied, but its adverse drug reactions remain unexplored. OBJECTIVE: To evaluate the safety of NDQG in kidney disease treatment. METHODS: The literature was searched in Embase, Medline via PubMed, Cochrane Library database, Wanfang database, Chinese National Knowledge Infrastructure, SinoMed, and Chinese VIP Database from inception to January 15, 2022, for randomized controlled trials (RCTs) and observational studies. The ClinicalTrials.gov website was searched for ongoing trials. The frequency and characteristics of adverse drug reactions (ADRs) were the primary and secondary outcomes, respectively. Subgroup analysis were conducted to explore the effects of clinical trial types, different kidney diseases, drug combinations and dosage on the safety of NDQG. RESULTS: This review included 132 trials comprising 115 RCTs and 17 cohort studies. Additionally, 118 studies reported ADR rates with complete data, including 10381 participants. Regarding ADR frequency, no significant difference was observed between NDQG (7.26%) and control (8.39%) groups (RR = 0.890, 95% confidence interval (CI): 0.788-1.007); with no heterogeneity among the studies (I2 = 0.0%, P = 0.958). ADR frequency in patients with chronic kidney disease (65 trials, n = 5823) was significantly lower in the NDQG treatment group than in the control group (RR = 0.810, 95% CI: 0.67-0.969, I2 = 0.0%, P = 0.993); however, for patients with diabetic nephropathy there was no difference between both groups (26 trials, n = 2166, RR = 1.077, 95% CI: 0.802-1.446, I2 = 0.0%, P = 0.611). Similarly, the incidence of ADR in patients on dialysis and patients with pyelonephritis and nephrotic syndrome was the same for both groups, with 95% CI overlapping the line. For different interventions, including NDQG monotherapy or its combination with other commonly used drugs (including angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, statin drugs, and compound α-keto acid) or dialysis, the incidence of ADR showed no significant difference between the experimental and control arms. The ADR in the NDQG group primarily affected the gastrointestinal system (64.74%), central and peripheral nervous system (9.07%), whole body (5.79%), and skin and appendages (4.53%). The most common clinical manifestations were diarrhea, nausea, and vomiting. CONCLUSIONS: Our meta-analysis showed that compared with supportive therapy, the incidence of ADR was similar when NDQG was added. However, current evidence is not definitive and more well-designed and conducted RCTs are warranted to definitively establish the reliable evidence. PROTOCOL REGISTRATION NUMBER: PROSPERO CRD 42018104227.

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Objective To observe the effect of Niaoduqing granules on chronic renal failure in patients with blood lipid and blood homocysteine.Methods Patients with chronic renal failure were divided into observation group and control group by number table method,two groups of patients were both given low salt,low fat and high quality low protein diet,controlling blood pressure and blood sugar,correcting anemia,correcting calcium and phosphorus meta-bolic disorders,correcting of acidosis,while patients with combined infection were given positive anti infection treat-ment.Observation group was treated with Niaoduqing granules on that basis.The changes of triglyceride(TG),total cholesterol( HDL-C) ,total cholesterol( CHO) ,low-density lipoprotein( LDL-C) ,and plasma homocysteine( Hcy) were observed before and after treatment in the two groups.Results After treatment,CHO,TG,HDL-C,LDL-C, Hcy in the control group were respectively (4.83 ±0.22)mmol/L,(2.21 ±0.30)mmol/L,(0.69 ±0.11)mmol/L, (4.30 ±0.32)mmol/L,(24.35 ±7.05)μmol/L,that threre was no significant changes before and after treatment.In the observation group,TG,LDL-C,Hcy were (1.38 ±0.18)mmol/L,(3.29 ±0.13)mmol/L,(14.54 ±3.56)umol/L respectively after treatment,and which were significantly lower than that before treatment ( t=1.45,2.13,4.28,all P<0.05).HDL-C (1.42 ±0.31)mmol/L,were significantly increased after treatment as compared with that before treatment (t=3.88,P<0.05).The difference of Hcy,TG,LDL-C,HDL-C and CHO after treatment was statisti-cally significantin between the two groups (t=1.34,2.08,1.10,3.88,all P<0.05).Conclusion Niaoduqing gran-ules can improve lipid metabolism disorders in patients with chronic renal failure,and can reduce the serum homocys-teine.