1.Oxidative Stress of Qidan Tangshen Granules (芪丹糖肾颗粒) in Treatment of 95 Patients with Early Diabetic Kidney Disease with Qi Deficiency,Blood Stasis,and Kidney Deficiency Syndrome:A Double-Blind,Double-Simulated,Randomized Controlled Trial
Jie ZHANG ; Yilei CONG ; Tengfei WU ; Qin LIU ; Yue YUAN ; Shilei CUI ; Hua YANG
Journal of Traditional Chinese Medicine 2025;66(7):695-703
ObjectiveTo evaluate the clinical efficacy and safety of Qidan Tangshen Granules (芪丹糖肾颗粒, QTG) in the treatment of early diabetic kidney disease (DKD) with qi deficiency, blood stasis, and kidney deficiency syndrome, and to explore its mechanism. MethodsA double-blind, double-simulated method was used to enroll 200 patients with early DKD and qi deficiency, blood stasis, and kidney deficiency syndrome. Patients were randomly assigned in a 1∶1 ratio to the treatment group (100 cases) and the control group (100 cases). The treatment group received QTG plus a valsartan capsule simulant, while the control group received valsartan capsules plus a QTG simulant, both for 12 weeks. The primary outcome was the urinary albumin-to-creatinine ratio (UACR). Secondary outcomes included estimated glomerular filtration rate (eGFR), fasting blood glucose (FBG), 2-hour postprandial blood glucose (PBG), glycated hemoglobin (HbA1c), and traditional Chinese medicine (TCM) syndrome scores (including individual symptom scores for fatigue, dull complexion, soreness and weakness of the waist and knees, headache and chest pain, irritability, spontaneous sweating, thirst and polydipsia, polyphagia, polyuria, numbness of the limbs, and the total TCM syndrome score). Oxidative stress markers including serum 8-hydroxy-2'-deoxyguanosine (8-OHDG), 3-nitrotyrosine (3-NT), and superoxide dismutase (SOD) were also assessed. Clinical efficacy and TCM syndrome efficacy were evaluated after treatment, and routine blood tests, urinalysis, and liver function tests were conducted and adverse reaction during the tria was recorded to assess safety. ResultsA total of 191 patients completed the study (95 in the treatment group and 96 in the control group). The treatment group showed significant reductions in UACR, FBG, PBG, and HbA1c levels after treatment (P<0.05 or P<0.01). The single TCM symptom scores except for polyphagia and total TCM syndrome scores significantly decreased (P<0.05 or P<0.01). Compared to the control group, the treatment group had signi-ficantly lower UACR, FBG, PBG levels, and total TCM syndrome scores, sinlge symptoms scores except for polyphagia and limb numbness (P<0.05 or P<0.01). Among 40 randomly selected patients (21 cases in the treatment group and 19 cases in the control group) for oxidative stress analysis, there were no significant differences in SOD, 3-NT, and 8-OHDG levels before and after treatment within or between groups (P>0.05). The overall effective rate in the treatment group was 64.2% (61/95) and 39.6% (38/96) in the control group, while the TCM syndrome efficacy rates were 80.0% (76/95) and 24.0% (23/96), respectively, with the treatment group showing superior efficacy (P<0.01). No significant differences were observed in routine blood tests, urinalysis, or liver function indices before and after treatment in either group (P>0.05). The incidence of adverse reactions was 8.4% (8/95) in the treatment group and 9.4% (9/96) in the control group, with no statistically significant difference (P>0.05). ConclusionQTG can effectively reduce UACR and blood glucose levels, alleviate clinical symptoms, and improve clinical efficacy in patients with early DKD with qi deficiency, blood stasis, and kidney deficiency syndrome. The treatment is well-tolerated and safe, with no significant impact on oxidative stress markers.
2.Efficacy of Fufang Lingjiao Jiangya Pills with Different Proportions of Goat Horn Replacing Antelope Horn on Spontaneous Hypertensive Rats
Tengjian WANG ; Wanlu ZHAO ; Yang YU ; Yan LIU ; Kun CAO ; Zheyuan LIN ; Yue WU ; Lilan LUO ; Weizhi LAI ; Zhaohuan LOU ; Qiaoyan ZHANG ; Quanlong ZHANG ; Luping QIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):68-78
ObjectiveTo investigate the optimal ratio of goat horn replacing antelope horn in Fufang Lingjiao Jiangya pills and the blood pressure-lowering mechanism of this medicine. MethodsThe blood pressure-lowering efficacy of Fufang Lingjiao Jiangya pills with varying proportions of goat horn replacing antelope horn was evaluated on spontaneous hypertensive rats (SHR). In this experiment, 50 SHR rats were randomly grouped as follows: model (n=8), captopril (0.01 g·kg-1) (n=6), low-dose blank Fufang Lingjiao Jiangya pills (0.342 g·kg-1) (n=6), high-dose blank Fufang Lingjiao Jiangya pills (0.684 g·kg-1) (n=6), low-dose antelope horn-containing Fufang Lingjiao Jiangya pills (0.378 g·kg-1) (n=6), high-dose antelope horn-containing Fufang Lingjiao Jiangya pills (0.756 g·kg-1) (n=6), low-dose goat horn-containing Fufang Lingjiao Jiangya pills (0.378 g·kg-1) (n=6), and high-dose goat horn-containing Fufang Lingjiao Jiangya pills (0.756 g·kg-1) (n=6). Additionally, 8 WKY rats were used as the normal group. Drugs were administered by gavage for 4 weeks while an equal volume of distilled water was administered for the normal and model groups. Blood pressure was measured before administration, 3 h post administration, and biweekly thereafter. In the experiment for Fufang Lingjiao Jiangya pills with goat horn replacing antelope horn in different proportions, 48 SHR rats were randomly grouped as follows: model, blank Fufang Lingjiao Jiangya pills (0.684 g·kg-1), antelope horn-containing Fufang Lingjiao Jiangya pills (0.756 g·kg-1), 2× goat horn-containing Fufang Lingjiao Jiangya pills (0.824 g·kg-1), 4× goat horn Fufang Lingjiao Jiangya pills (0.969 g·kg-1), and 6× goat horn Fufang Lingjiao Jiangya pills (1.112 g·kg-1). The normal group included 8 WKY rats, and the normal group and model group received an equal volume of distilled water. The treatment lasted for 2 weeks, and blood pressure was recorded at various time points (pre-administration, 3 h post administration, and on days 4, 7, 10, and 14 of administration). Serum levels of angiotensin-converting enzyme (ACE), angiotensin Ⅱ(Ang Ⅱ), renin, and interleukin-6 (IL-6) were measured by enzyme-linked immunosorbent assay. Histopathological changes in the heart, kidney, and thoracic aorta were observed by hematoxylin-eosin staining. The protein levels of ACE2, angiotensin Ⅱ type 1 receptor (AT1R), and angiotensinogen (AGT) in the kidney tissue were determined by Western blot, while the expression of nuclear factor (NF)-κB p65 and Toll-like receptor 4 (TLR4) in the thoracic aorta tissue was assessed by immunohistochemistry. ResultsCompared with the model group, all treatment groups showed lowered blood pressure (P<0.05, P<0.01), and the 6× goat horn-containing Fufang Lingjiao Jiangya pills group showed consistent blood pressure-lowering effect with the antelope horn-containing Fufang Lingjiao Jiangya pills group. Compared with the normal group, the model group showed elevated serum levels of ACE, Ang Ⅱ, renin, and IL-6, while the elevations were declined in the Fufang Lingjiao Jiangya pills groups (P<0.05, P<0.01). Pathological changes in the heart, kidney, and thoracic aorta were alleviated in all the treatment groups, with the 6× goat horn- and antelope horn-containing Fufang Lingjiao Jiangya pills groups exhibited the best effect. Western blot and immunohistochemistry results showed that all the treatment groups exhibited down-regulated protein levels of AT1R, AGT, NF-κB p65, and TLR4 and up-regulated protein levels of ACE2 (P<0.05, P<0.01) compared with model group, with the 6×goat horn- and antelope horn-containing Fufang Lingjiao Jiangya pills groups showcasing the best effect. ConclusionReplacing antelope horn with 6×goat horn in Fufang Lingjiao Jiangya pills can achieve consistent blood pressure-lowering effect with the original prescription. The prescription may exert the effect by inhibiting the renin-angiotensin-aldosterone system (RAAS) and TLR4/NF-κB signaling pathways.
3.Analysis of human parvovirus B19 nucleic acid detection in blood products in China
Yue WANG ; Xiaobei ZHENG ; Qin GONG ; Ying ZHAO ; Yuanxiu LUO ; Dandan YANG ; Linlin ZHANG ; Zheng JIANG ; Gan PENG ; Jin ZHANG ; Bingbing KE
Chinese Journal of Blood Transfusion 2025;38(7):950-957
Objective: To analyze the nucleic acid load of human parvovirus B19 in major commercially available blood products in China, including human albumin, human intravenous immunoglobulin, human rabies immunoglobulin and various coagulation factor products, aiming to provide evidence for improving blood product manufacturing processes and quality control of source plasma. Methods: A total of 98 batches of coagulation factor products were tested for human parvovirus B19 nucleic acid using real-time fluorescent quantitative PCR, including 42 batches of human prothrombin complex, 35 batches of human coagulation factor Ⅷ, and 21 batches of human fibrinogen. Additionally, 6 batches of human albumin, 6 batches of human intravenous immunoglobulin, and 38 batches of human rabies immunoglobulin were tested for human parvovirus B19 nucleic acid. Results: Human parvovirus B19 nucleic acid were undetectable in human albumin, human intravenous immunoglobulin and human rabies immunoglobulin. Among the 98 batches of coagulation factor products tested for human parvovirus B19 nucleic acid, B19 nucleic acid reactivity rate was 69.0% (29/42) for human prothrombin complex batches, but nucleic acid concentration were all significantly lower than 10
IU/mL. The reactivity rate of B19 nucleic acid in 35 batches of human coagulation factor Ⅷ was 48.6% (17/35), with nucleic acid concentration all below 10
IU/mL. The reactivity rate of B19 nucleic acid in 21 batches of human fibrinogen was 61.9% (13/21), with nucleic acid concentration all below 10
IU/mL. Conclusion: No human parvovirus B19 has been detected in human albumin, human intravenous immunoglobulin, or human rabies immunoglobulin. Human parvovirus B19 nucleic acid may exist in commercially available coagulation factor products, highlighting the need for enhanced screening of human parvovirus B19 nucleic acid in these products. It is also recommended that B19 viral nucleic acid testing be conducted on source plasma, particularly for coagulation factor products.
4.Analysis of human parvovirus B19 nucleic acid detection in blood products in China
Yue WANG ; Xiaobei ZHENG ; Qin GONG ; Ying ZHAO ; Yuanxiu LUO ; Dandan YANG ; Linlin ZHANG ; Zheng JIANG ; Gan PENG ; Jin ZHANG ; Bingbing KE
Chinese Journal of Blood Transfusion 2025;38(7):950-957
Objective: To analyze the nucleic acid load of human parvovirus B19 in major commercially available blood products in China, including human albumin, human intravenous immunoglobulin, human rabies immunoglobulin and various coagulation factor products, aiming to provide evidence for improving blood product manufacturing processes and quality control of source plasma. Methods: A total of 98 batches of coagulation factor products were tested for human parvovirus B19 nucleic acid using real-time fluorescent quantitative PCR, including 42 batches of human prothrombin complex, 35 batches of human coagulation factor Ⅷ, and 21 batches of human fibrinogen. Additionally, 6 batches of human albumin, 6 batches of human intravenous immunoglobulin, and 38 batches of human rabies immunoglobulin were tested for human parvovirus B19 nucleic acid. Results: Human parvovirus B19 nucleic acid were undetectable in human albumin, human intravenous immunoglobulin and human rabies immunoglobulin. Among the 98 batches of coagulation factor products tested for human parvovirus B19 nucleic acid, B19 nucleic acid reactivity rate was 69.0% (29/42) for human prothrombin complex batches, but nucleic acid concentration were all significantly lower than 10
IU/mL. The reactivity rate of B19 nucleic acid in 35 batches of human coagulation factor Ⅷ was 48.6% (17/35), with nucleic acid concentration all below 10
IU/mL. The reactivity rate of B19 nucleic acid in 21 batches of human fibrinogen was 61.9% (13/21), with nucleic acid concentration all below 10
IU/mL. Conclusion: No human parvovirus B19 has been detected in human albumin, human intravenous immunoglobulin, or human rabies immunoglobulin. Human parvovirus B19 nucleic acid may exist in commercially available coagulation factor products, highlighting the need for enhanced screening of human parvovirus B19 nucleic acid in these products. It is also recommended that B19 viral nucleic acid testing be conducted on source plasma, particularly for coagulation factor products.
6. Nuclear factor-KB signaling pathway and gender differences in alcoholic liver fibrosis
Xiao-Rain HONG ; San-Qiang LI ; Qin-Yi CUI ; Run-Yue ZHENG ; Meng-Li YANG ; Ren-Li LUO ; Qian-Hui LI ; San-Qiang LI
Acta Anatomica Sinica 2024;55(1):55-61
Objective To investigate the relationship between nuclear factor(NF)-κB signaling pathway and gender differences in alcoholic liver fibrosis. Methods C57BL/6 N mice at 7-8 weeks of age were randomly divided into: male normal group, male model group, female normal group and female model group of 20 mice each. The normal group was fed with control liquid diet for 8 weeks, and the model group was fed with alcoholic liquid diet for 8 weeks combined with 31.5% ethanol gavage (5g/kg twice a week) to establish an alcoholic liver fibrosis model. The mice were executed at the end of 8 weekends, and the alanine aminotransferase (ALT), aspartate aminotransferase (AST) activity, estradiol (E
7.Research progress in clinical application and mechanism of Sijunzi Decoction in the treatment of gastric cancer
Jingtao ZHAO ; Bo NING ; Meng XIAO ; Yue QIN ; Yanan LI ; Qiuyan YANG ; Haijuan XIAO
International Journal of Traditional Chinese Medicine 2024;46(3):395-399
As a classic prescription for invigorating spleen and replenishing qi, Sijunzi Decoction has a good clinical efficacy in the treatment of gastric cancer. It can improve chemotherapy resistance, reduce the toxic and side effects of chemotherapy, promote postoperative recovery, enhance immunity, improve the nutritional status of patients, improve the quality of life of patients and prevent precancerous lesions. Network pharmacology studies have shown that Sijunzi Decoction exerts anti-gastric cancer effects through multiple active ingredients, multiple targets and multiple pathways, and quercetin may be the main active component in Sijunzi Decoction to exert anti-gastric cancer effects. The main mechanisms of Sijunzi Decoction in the treatment of gastric cancer include regulating the expression of cell cycle and apoptosis-related gene proteins, and inhibiting the proliferation, migration, invasion and gastric cancer stem cell characteristics of gastric cancer cells.
8.The application of low-dose test method combined with variable helical pitch technology in CT angiography of lower extremity arteries
Jigang GENG ; Xiaoshi LI ; Dayong JIN ; Yadi YANG ; Lu LU ; Yue QIN
Journal of Practical Radiology 2024;40(4):646-649,669
Objective To evaluate the application efficacy of low-dose test method combined with variable helical pitch(VHP)technology in computed tomography angiography(CTA)of lower extremity arteries.Methods Eighty patients with CTA imaging of bilateral lower extremity arteries were selected and divided into group A and group B on average.VHP technology was used in group A,and conventional fixed pitch scanning was used in group B.The objective and subjective image quality of the two groups were compared,and the radiation dose and contrast agent dosage of the two groups were recorded and compared.Results The subjective image quality evaluation of group A was significantly better than that of group B,and the difference was statistically significant(Kappa test,P<0.05).In the objective image quality evaluation,the CT value and signal-to-noise ratio(SNR)value of the common iliac artery,popliteal artery and anterior tibial artery in group A were higher than those in group B at the same level,and the differences were statistically significant(P<0.05);The effective dose(ED)value in group A was(6.74±1.20)mSv,and that in group B was(7.93±1.78)mSv(P<0.05).The dosage of contrast agent in group A was significantly lower than that in group B[(73.97±12.15)mL in group A,(82.50±2.61)mL in group B](P<0.05).Conclusion Low-dose test method combined with VHP technology not only can reduce the radiation dose and contrast agent dosage,but also can effectively improve the success rate and image quality of lower extremity arteries examination,which is worthy of clinical application.
9.The effectiveness of fluorescence labeling-based assay bundle intervention in the prevention and control of multidrug-resistant organism infection
Ting-Zheng QIN ; Yun LIU ; Yue-Wei HAO ; Na YANG ; Ya-Teng SONG ; Xiao-Qun WANG ; Wei-Guang LI
Chinese Journal of Infection Control 2024;23(2):225-230
Objective To observe the effectiveness of fluorescence labeling-based assay bundle intervention in the prevention and control of multidrug-resistant organism(MDRO)infection.Methods Patients who were detected MDRO in a hospital from January to December 2022 were selected as the research subjects.MDRO monitoring data and implementation status of prevention and control measures were collected.Fluorescence labeling assay was adopted to monitor the cleaning and disinfection effectiveness of the surrounding object surface of the bed units.Based on the bundled prevention and control measures as well as management mode of the pre-intervention group,the post-intervention group implemented enhanced rectification measures for the problems found by the pre-interven-tion group.Changes in relevant indicators between January-June 2022(before intervention)and July-December 2022(after intervention)were compared.Results There were 136 MDRO-infected patients in the pre-intervention group,208 MDRO strains were detected and 10 healthcare-associated infection(HAI)occurred.There were 128 MDRO-infected patients in the post-intervention group,198 MDRO strains were detected and 9 HAI occurred.Af-ter intervention,the total detection rates of methicillin-resistant Staphylococcus aureus(MRSA),carbapenem-re-sistant Acinetobacter baumannii(CRAB),and total MDRO from patients decreased significantly compared to before intervention(all P<0.05).After intervention,the detection rates of MRSA,carbapenem-resistant Pseudomonas aeruginosa(CRPA),CRAB,and total MDRO from the surrounding object surface were all lower than those before intervention(all P<0.05).The detection rate of MDRO from surrounding object surface before intervention was 34.52%,which showed a decreased trend after intervention(P<0.05).The clearance rate of fluorescent labeled markers before intervention was 41.84%,which showed an upward trend after implementing intervention measures(from July to December),and increased to 85.00%at the end of intervention(November-December).The comp-liance rates of issuing isolation medical orders,placing isolation labels,using medical supplies exclusively,and cor-rectly handling medical waste after intervention have all increased compared to before intervention(all P<0.05).Conclusion Adopting fluorescence labeling-based assay bundle intervention can effectively improve the effectiveness of MDRO infection prevention and control.
10.Establishment and methodological validation of a nucleic acid detection method for human parvovirus B19
Yue WANG ; Xiaobei ZHENG ; Yajing ZHENG ; Yu SUN ; Qin GONG ; Linlin ZHANG ; Ying ZHAO ; Dandan YANG ; Yi YANG ; Lin LI ; Boran LI ; Jin ZHANG
Chinese Journal of Blood Transfusion 2024;37(11):1234-1240
[Objective] To establish a real-time fluorescence quantitative PCR nucleic acid detection method of human parvovirus B19 and validate the method systematically. [Methods] Specific primers and probes for the highly conserved regions of the three genotypes of B19 virus were designed, and B19 quantitative amplification standard curves were established. The accuracy, precision (repeatability and intermediate precision), linear range, quantification limit, detection limit, specificity, anti cross contamination, genotyping and anti-interference ability of this method were verified. [Results] When the quantitative reference range for B19 virus was 2.0×101 to 1.0×108 IU/mL, a double logarithmic regression analysis was performed between the measured values and the theoretical values, and the regression equation R2≥0.98 showed good linear correlation. The quantification limit was 20 IU/mL, with a detection rate of 100%. The detection limit was 10 IU/mL, and the detection rate is 95.23%. Three genotypes of B19 virus samples can be effectively detected. The plasma of seven non B19 pathogens, including hepatitis A virus, hepatitis B virus, hepatitis C virus, human immuno-deficiency virus, human cytomegalovirus, hepatitis E virus and Treponema pallidum, was non reactive and has good species specificity. Simultaneously, in the presence of seven other concurrent pathogens, positive samples with a weak positive concentration of E3 IU/mL could be stably detected, and the B19 nucleic acid testing method was not interfered with. When the hemoglobin concentration was 431 mg/dL, triglycerides (1 269 turbidity) and unconjugated bilirubin concentration was 20 mg/dL, this method was non reactive for all three common plasma interfering substances. In the presence of three common plasma interfering substances, positive samples with a weak positive concentration of E3 IU/mL could be stably detected, and the B19 nucleic acid testing method was not interfered with. The deviation between the detection values of standard substances at two concentration levels of S1 (E5 IU/mL) and S2 (E4 IU/mL) and the target values were≤±0.5 log value. The CV values of positive sample 1 (concentration level E5 IU/mL) and positive sample 2 (concentration level E4 IU/mL) for daily precision confirmation and continuous 5-day intra-day precision confirmation were both≤5%. [Conclusion] This method has strong specificity, high sensitivity, wide linear range, stability, reliability and high accuracy, and can be used for the detection of human parvovirus B19 nucleic acid in plasma.

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