2.Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial.
Jie WU ; Shu-Wei DUAN ; Hong-Tao YANG ; Yue-Yi DENG ; Wei LI ; Ya-Ni HE ; Zhao-Hui NI ; Yong-Li ZHAN ; Shan LIN ; Zhi-Yong GUO ; Jun ZHU ; Jing-Ai FANG ; Xu-Sheng LIU ; Li-Hua WANG ; Rong WANG ; Nian-Song WANG ; Xiao-Hong CHENG ; Li-Qun HE ; Ping LUO ; Shi-Ren SUN ; Ji-Feng SUN ; Ai-Ping YIN ; Geng-Ru JIANG ; Hong-Yu CHEN ; Wen-Hu LIU ; Hong-Li LIN ; Meng LIANG ; Lu MA ; Ming CHEN ; Li-Qun SONG ; Jian CHEN ; Qing ZHU ; Chang-Ying XING ; Yun LI ; Ji-Ning GAO ; Rong-Shan LI ; Ying LI ; Hao ZHANG ; Ying LU ; Qiao-Ling ZHOU ; Jun-Zhou FU ; Qiang HE ; Guang-Yan CAI ; Xiang-Mei CHEN
Journal of Integrative Medicine 2021;19(2):111-119
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.
3.Gender Differences in the Relationships between Pubertal Stages and the Perpetration of Self-inflicted and Interpersonal Violence among Middle School Students in China.
Pu Yu SU ; Geng Fu WANG ; Hao Yang REN ; Li Ru CHEN ; Guo Bao ZHANG ; Ying SUN
Biomedical and Environmental Sciences 2020;33(6):464-469
4.Comparison of minimal residual disease in multiple myeloma patients detected by 8-color panels and next generation flow cytometry.
Xian Feng WANG ; Tong Tong WANG ; Zhi Yao ZHANG ; Hui Xing ZHOU ; Yan Ru ZHANG ; Wen Ming CHEN ; Chuan Ying GENG
Chinese Journal of Hematology 2019;40(6):512-517
Objective: To compare the sensitivity of 8-color panels and next generation flow cytometry (NGF) for detecting minimal residual disease of multiple myeloma patients. Methods: 8-color-membrane antigens (8C-Mem) panel was built including CD45, CD38, CD138, CD19, CD56, CD81, CD27 and CD117 to identify the plasma cells, while 8-color-cytoplasmic antigens (8C-Cyto) panel was built including CD45, CD38, CD138, CD19, CD56, CD81, cKappa (cK) and cLambda (cλ) , and 8-color-two-tubes (8C-2tubes) panel were built including 8C-Mem and 8C-Cyto panels, the data of three groups was analyzed by Diva software. NGF uses Infinicyt software to fuse 8C-2tubes data to further analyze the expression of plasma antigens. Bone marrow aspiration obtained from 20 controls and 76 multiple myeloma patients who achieved complete remission were measured and analyzed. Results: Positive MRD samples were discriminated in 88.2% of the specimen evaluated through either abnormal plasma cells (aPCs) or clonal plasma cells (cPCs) by NGF antigens panel, Among of them, consistency was 94.7%. The median percentage of cPCs was 0.3530%, The lowest sensitivity of NGF was 0.0003%. In 8-color panels, the positive MRD rates of 8C-Mem, 8C-Cyto and 8C-2tubes panels were 84.2%, 85.5% and 86.8%, respectively, which lower than that of NGF (P<0.001) . The positive MRD rate of 8C-Mem and 8C-Cyto panels were lower than that of 8C-2tubes panel (P<0.001) , and the positive MRD rate of 8C-Mem panel was lower than that of 8C-Cyto panel (P<0.001) . Sensitivity and specificity of NGF was higher than that of 8-color panels. 8C-2tubes panel has the best sensitivity, accuracy, negative predicted value, positive predicted value and specificity than other 8-color panels. However, huge data and low efficiency for analysis is the disadvantage. 8C-Cyto panel was the second choice, and 8C-Mem panel was the last. Conclusions: Membrane and cytoplasmic light chain is a better method for multiple myeloma-MRD detection and NGF panel is an ideal approach. 8C-Cyto panel is recommended in 8-MFC groups.
Bone Marrow
;
Flow Cytometry
;
Humans
;
Immunophenotyping
;
Multiple Myeloma/diagnosis*
;
Neoplasm, Residual
;
Plasma Cells
5.Prediction of Antiviral and Anti-inflammatory Mechanisms of Major Compounds from Flowers of Trollius Chinensis Based on Molecular Docking Technology
Ming-Yue FANG ; De-Li LI ; Shuang-Yue LIU ; Qing-Qing WANG ; Di GENG ; Chao MA ; Ru-Feng WANG
Chinese Journal of Information on Traditional Chinese Medicine 2018;25(7):57-61
Objective To predict the antiviral and anti-inflammatory mechanisms of major compounds from the flowers of Trollius chinensis, namely, vitexin, orientin, 2"-O-β-L-galactopyranosylvitexin, 2"-O-β-L-galactopyranosylorientin, veratric acid, and trolline, by using the molecular docking technique. Methods Discovery Studio 2.5 software and Chinese Medicine Chemistry Database were employed for docking between the ligands including 6 compounds and the proteins including Toll-like receptors (TLRs) and neuraminidase (NA). The docking results and interactions of their functional domains were obtained by simulation analysis. Results Vitexin, orientin, 2"-O-β-L-galactopyranosylvitexin, veratric acid, and trolline were applied to one or more TLR, whereas 2"-O-β-L-galactopyranosylorientin could interact with neither of the proteins investigated. Flavonoids, namely vitexin, orientin, 2"-O-β-L-galactopyranosylvitexin and 2"-O-β-L-galactopyranosylorientin were applied to NA, whereas veratric acid and trolline could not interact with NA. Conclusion Five out of the 6 compounds have influence on the signaling pathways mediated by TLRs, and TLR3, 4, and 7 are their potential targets for antivirus and anti-inflammation. Four flavonoids can affect the activity of influenza virus by interacting with NA. This study can provide a basis for the investigation of the antiviral and anti-inflammatory effective compounds of the flowers of Trollius chinensis and the further development.
6.Prevalence of knee osteoarthritis in the middle-aged and elderly in China:a Meta-analysis
Xiao-Jia TIE ; Ru-Geng ZHENG ; Meng ZHAO ; Ya-Jun HAN ; Hong-Liang GUO ; Zhi-Zhou WANG ; Guo-Ju MA
Chinese Journal of Tissue Engineering Research 2018;22(4):650-656
BACKGROUND: Investigation on epidemiologic features of knee osteoarthritis in many areas of China has been much reported. However, multicenter studies with large samples have been rarely reported. The published papers cannot give a good description about the epidemiologic features of knee osteoarthritis. OBJECTIVE: To evaluate the epidemiologic features of knee osteoarthritis in the patients aged over 40 years in China. METHODS: Meta-analysis was used to evaluate the data extracted from papers published 2001-2016 on the epidemiology of knee osteoarthritis in the middle-aged and elderly in China. The prevalence rate of knee osteoarthritis in the patients over 40 years of age was summarized, with every 10 years as group, and then analyzed on Stata 12.0 software. RESULTS AND CONCLUSION: Twenty-six articles were included, involving 42 199 people aged more than 40 years old. The total prevalence rate of knee osteoarthritis at the age above 40 years old in China was 17.0% (95% CI:16.7%-17.4%),the prevalence rate was 12.3% in male and 22.2% in female(P<0.05).Noticeably,the prevalence rate increased with age.The total prevalence rate in northern China was 16.1%(95% CI:15.6%-16.6%),12.2% in male and 21.4% in female;the total prevalence in southern China was 18.0%(95%CI:17.5%-18.5%), 12.3% in male and 23.1% in female. There was no significant difference in the prevalence rate between northern and southern China(P>0.05).The total prevalence rate in rural China was 23.6%(95%CI:16.7%-30.4%),with 15.4% in male and 28.1% in female;and the total prevalence in urban China was 20.0%(95% CI:16.2%-23.9%),with 13.7% in male and 24.3% in female. There was no significant difference in the prevalence rate between rural and urban China (P > 0.05). These results suggest that knee osteoarthritis in China is a common disease, characterized by increased prevalence with age, relatively significant difference between male and female, but no difference between northern and southern China as well as between rural and urban China. It is of great significance to timely propagate and perform interventional strategies for prevention and treatment of knee osteoarthritis in China.
7.Safety, Effectiveness, and Manipulability of Peritoneal Dialysis Machines Made in China: A Randomized, Crossover, Multicenter Clinical Study.
Xue-Ying CAO ; Ya-Ni HE ; Jian-Hui ZHOU ; Shi-Ren SUN ; Li-Ning MIAO ; Wen CHEN ; Jing-Ai FANG ; Ming WANG ; Nian-Song WANG ; Hong-Li LIN ; Jian LIU ; Zhao-Hui NI ; Wen-Hu LIU ; Yu NA ; Jiu-Yang ZHAO ; Zhi-Yong GUO ; Hong-Guang ZHENG ; Wei SHI ; Geng-Ru JIANG ; Guang-Yan CAI ; Xiang-Mei CHEN
Chinese Medical Journal 2018;131(23):2785-2791
Background:
Automated peritoneal dialysis (APD) can cater to individual needs, provide treatment while asleep, take into account the adequacy of dialysis, and improve the quality of life. Currently, independent research and development of APD machines made in China are more conducive to patients. A randomized, multicenter, crossover study was conducted by comparing an APD machine made in China with an imported machine. The safety, effectiveness, and manipulability of the two machines were compared.
Methods:
Two hundred and sixty patients who underwent peritoneal dialysis (PD) on a regular basis in 18 centers between August 2015 and February 2016 were included. The inclusion criteria include age ≥18 years and PD ≥30 days. The exclusion criteria were as follows: hemodialysis; exit site or tunnel infection; and peritonitis ≤30 days. The patients were randomly divided into Group A, who were first treated with a FM machine made in China, then changed to an imported machine; and Group B, who were treated using the reverse sequence. APD treatment was performed with 10 L/10 h and 5 cycles of exchange. After 72 h, the daily peritoneal Kt/V, the accuracy of the injection rate, accuracy of the injection temperature, safety, and manipulability of the machine were assessed. Noninferiority test was conducted between the two groups.
Results:
The daily peritoneal Kt/V in the APD machine made in China and the imported APD machine were 0.17 (0.14, 0.25) and 0.16 (0.13, 0.23), respectively. There was no significant difference between the groups (Z = 0.15, P = 0.703). The lower limit of the daily Kt/V difference between the two groups was 0.0069, which was greater than the noninferiority value of -0.07 in this study. The accuracy of the injection rate and injection temperature was 89.7% and 91.5%, respectively, in the domestic APD machine, which were both slightly better than the accuracy rates of 84.0% and 86.8% in the imported APD machine (89.7% vs. 84.0%, P = 0.2466; 91.5% vs. 86.8%, P = 0.0954). Therefore, the APD machine made in China was not inferior to the imported APD machine. The fuselage of the imported APD machine was space-saving, while the APD machine made in China was superior with respect to body mobility, man-machine dialog operation, alarm control, and patient information recognition.
Conclusions:
The FM machine made in China was not inferior to the imported APD machine. In addition, the FM machine made in China had better operability.
Trial Registration
Clinicaltrials.gov, NCT02525497; https://clinicaltrials.gov/ct2/results?cond=&term=NCT02525497&cntry=& state=&city=&dist=.
Adult
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China
;
Cross-Over Studies
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Female
;
Humans
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Male
;
Middle Aged
;
Multicenter Studies as Topic
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Peritoneal Dialysis
;
adverse effects
;
instrumentation
;
methods
;
Quality of Life
;
Temperature
8.CK19 can be used to predict the early recurrence and prognosis of HBV-related hepatocellular carcinoma patients with low AFP serum concentration after R0 radical hepatectomy.
Zu-sen WANG ; Li-qun WU ; Xin YI ; Chao GENG ; Yu-jun LI ; Ru-yong YAO ; Wei-yu HU ; Bing HAN
Chinese Journal of Oncology 2012;34(10):753-758
OBJECTIVETo investigate the expression of CK19 in HBV-related hepatocellular carcinoma (HCC) tissues in patients with low serum AFP concentration and the relationship between them and the recurrence and prognosis of HCC after R0 radical hepatectomy.
METHODSThe expressions of CK19 and Ki67 in HCC tissues of 235 cases were examined using tissue microarray and two-step methods of PV-6000 immunohistochemistry. The expression of CK19 mRNA in 20 frozen HCC specimens was examined by RT-PCR. The correlation between gene expressions and tumor recurrence and prognosis was analyzed.
RESULTSAmong the 235 HBV-related HCC patients after R0 radical hepatectomy, the median disease-free survival (DFS) was 31.2 months in the patients with serum AFP < 400 µg/L and 13.8 months in the patients with serum AFP ≥ 400 µg/L (P = 0.041), the overall survival (OS) was 84.0 and 58.6 months in the two subgroups (P = 0.125), and the tumor recurrence within one year was in 43 cases (27%) and 37 cases (49.3%), respectively, (P = 0.001). The DFS was 11.6 months in the CK19-positive cases and 27.0 months in the CK19-negative cases (P > 0.05). The OS was significantly lower in the CK19-positive cases than that in the CK19-negative cases (P = 0.023). Both DFS and OS in the CK19-positive cases with AFP < 400 µg/L were significantly lower than those in the CK19-negative cases with AFP < 400 µg/L (both P < 0.05). The CK19 expression was significantly correlated with histological differentiation (P = 0.023), number of tumor foci (P = 0.044), vascular tumor embolism (P = 0.005), regional lymph node metastasis (P = 0.023), and 1-year recurrence (P = 0.006). Among the patients with AFP < 400 µg/L, the 1-year recurrence was 53% in the CK19-positive cases and 23% in the CK19-negative cases (P < 0.001), the median DFS was 11.3 months in CK19-positive cases and 34.0 months in CK19-negative cases (P = 0.010), and the median OS was 19.5 months in the CK19-positive cases, significantly lower than 84.0 months in the CK19-negative cases (P = 0.001). Cox regression analysis showed that CK19-positive expression was an independent factor affecting early HCC recurrence and prognosis.
CONCLUSIONIn HBV-related HCC patients after radical hepatectomy with AFP < 400 µg/L, positive expression of CK19 indicates a higher proliferation and invasiveness of HCC, and is an important factor of early recurrence and poor prognosis.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Carcinoma, Hepatocellular ; metabolism ; pathology ; surgery ; virology ; Disease-Free Survival ; Female ; Hepatectomy ; methods ; Hepatitis B virus ; Humans ; Keratin-19 ; genetics ; metabolism ; Liver Neoplasms ; metabolism ; pathology ; surgery ; virology ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; RNA, Messenger ; metabolism ; Survival Rate ; Young Adult ; alpha-Fetoproteins ; metabolism
9.Development of three-dimensional visual neurosurgical station and its preliminary clinical practice
Yi-Zhao CHEN ; Da-Yong HUANG ; Ru-Xiang XU ; Yong-Geng NIE ; Xiang-Yu WANG ; Shi-Zhong ZHANG ; Yi-Quan KE
Chinese Journal of Neuromedicine 2012;11(9):891-894
Objective To develop a three-dimensional visual neurosurgical tool enjoying simple,fast and accurate characteristics at moderate cost for visual positioning and imaging information storage and processing. Methods Seven patients with epidural hematoma or depressed fracture resulted from severe craniocerebral trauma, 8 patients with hypophysoma, 5 with glioma and 3 with meningeoma were chosen in our study; CT three-dimensional reconstruction of their imaging data were performed and used for preoperative planning before surgery assisted by neurosurgical station.According to CT three-dimensional reconstruction results, appropriate neurosurgical approach was planned and patients were treated by surgery. Results Neurosurgical station performed three-dimensional reconstruction could show three-dimensional quantitative relationship between the above lesions and anatomical landmarks directly,which could help direct positioning and designing the best-individualized approach to improve the surgical accuracy and efficacy. Neurosurgical station could improve the efficiency of scientific research and clinical work by managing,storing,editing and using the imaging and video of the patients. Conclusion Neurosurgical station, which can show three-dimensional quantitative relationship between the above lesions and anatomical landmarks directly, is a simple, fast and accurate preoperative planning and information processing tool for clinical neurosurgical practice.
10.Comparisons of efficacy and safety of tolterodine and oxybutynin in children with idiopathic overactive bladder.
Yong-Ji DENG ; Geng MA ; Yun-Fei GUO ; Zheng GE ; Ru-Gang LU ; Li-Xia WANG ; Hao-Bo ZHU ; Chen-Jun CHEN
Chinese Journal of Contemporary Pediatrics 2011;13(1):26-28
OBJECTIVETo compare the efficacy and safety of tolterodine and oxybutynin in the treatment of idiopathic overactive bladder in children.
METHODSA total of 204 children with idiopathic overactive bladder were randomly divided into three groups (n=68 each): placebo, tolterodine-treated and oxybutynin-treated. The efficacy and safety were evaluated two weeks after treatment.
RESULTSThe effective rate was 25% in the placebo group, 89% in the tolterodine-treated group, and 92% in the oxybutynin-treated group. The effective rate in the two treatment groups was significantly higher than that in the placebo group (P<0.05). There was a similar efficacy between the two treatment groups. The incidence of adverse events in the tolterodine-treated group (28%) was significantly lower than that in the oxybutnin-treated group (57%) (P<0.05).
CONCLUSIONSTolterodine has a similar efficacy to oxybutynin in the treatment of idiopathic overactive bladder in children, with better safety in pharmacotherapy.
Adolescent ; Benzhydryl Compounds ; adverse effects ; therapeutic use ; Child ; Child, Preschool ; Cresols ; adverse effects ; therapeutic use ; Female ; Humans ; Male ; Mandelic Acids ; adverse effects ; therapeutic use ; Muscarinic Antagonists ; therapeutic use ; Phenylpropanolamine ; adverse effects ; therapeutic use ; Tolterodine Tartrate ; Urinary Bladder, Overactive ; drug therapy

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