Objective To study how to promote the rational use of clinical data and orderly conduct health care Big data research by establishing a broad informed consent system and an effective implementation path.Methods The research methods of Document retrieval and expert interviews were mainly used to formulate management rules and regulations,clarify work processes and department responsibilities of the broad informed consent,and draw up patient informed consent forms.Results and Conclusion Based on the current implementation status of broad informed consent in domestic medical institutions,Peking University First Hospital has identified an effective path for obtaining clinical data in the implementation of broad informed consent in medical institutions,laying a preliminary foundation for the pilot implementation of related work.At the same time,discussions were conducted on the protection of patient rights,policy promotion and interpretation,information system support capabilities,and effective data application after the implementation of the broad informed consent system for clinical data,which will help promote and apply the work of broad informed consent for clinical data acquisition in China.

Objective: To investigate the functional changes of key gut microbiota (GM) that produce lipopolysaccharide (LPS) in atrial fibrillation (AF) patients and to explore their potential role in the pathogenesis of AF. Methods: This was a prospective cross-sectional study. Patients with AF admitted to Beijing Chaoyang Hospital of Capital Medical University were enrolled from March 2016 to December 2018. Subjects with matched genetic backgrounds undergoing physical examination during the same period were selected as controls. Clinical baseline data and fecal samples were collected. Bacterial DNA was extracted and metagenomic sequencing was performed by using Illumina Novaseq. Based on metagenomic data, the relative abundances of KEGG Orthology (KO), enzymatic genes and species that harbored enzymatic genes were acquired. The key features were selected via the least absolute shrinkage and selection operator (LASSO) analysis. The role of GM-derived LPS biosynthetic feature in the development of AF was assessed by receiver operating characteristic (ROC) curve, partial least squares structural equation modeling (PLS-SEM) and logistic regression analysis. Results: Fifty nonvalvular AF patients (mean age: 66.0 (57.0, 71.3), 32 males(64%)) were enrolled as AF group. Fifty individuals (mean age 55.0 (50.5, 57.5), 41 males(82%)) were recruited as controls. Compared with the controls, AF patients showed a marked difference in the GM genes underlying LPS-biosynthesis, including 20 potential LPS-synthesis KO, 7 LPS-biosynthesis enzymatic genes and 89 species that were assigned as taxa harbored nine LPS-enzymatic genes. LASSO regression analysis showed that 5 KO, 3 enzymatic genes and 9 species could be selected to construct the KO, enzyme and species scoring system. Genes enriched in AF group included 2 KO (K02851 and K00972), 3 enzymatic genes (LpxH, LpxC and LpxK) and 7 species (Intestinibacter bartlettii、Ruminococcus sp. JC304、Coprococcus catus、uncultured Eubacterium sp.、Eubacterium sp. CAG:251、Anaerostipes hadrus、Dorea longicatena). ROC curve analysis revealed the predictive capacity of differential GM-derived LPS signatures to distinguish AF patients in terms of above KO, enzymatic and species scores: area under curve (AUC)=0.957, 95%CI: 0.918-0.995, AUC=0.940, 95%CI 0.889-0.991, AUC=0.972, 95%CI 0.948-0.997. PLS-SEM showed that changes in lipopolysaccharide-producing bacteria could be involved in the pathogenesis of AF. The key KO mediated 35.17% of the total effect of key bacteria on AF. After incorporating the clinical factors of AF, the KO score was positively associated with the significantly increased risk of AF (OR<0.001, 95%CI:<0.001-0.021, P<0.001). Conclusion: Microbes involved in LPS synthesis are enriched in the gut of AF patients, accompanied with up-regulated LPS synthesis function by encoding the LPS-enzymatic biosynthesis gene.
Aged ; Atrial Fibrillation/complications* ; Cross-Sectional Studies ; Gastrointestinal Microbiome ; Humans ; Lipopolysaccharides ; Male ; Middle Aged ; Prospective Studies

OBJECTIVE: To evaluate the effects of a 48-week course of adefovir dipivoxil (ADV) plus Chinese medicine (CM) therapy, namely Tiaogan Jianpi Hexue () and Tiaogan Jiedu Huashi () fomulae, in hepatitis B e antigen (HBeAg)-positive Chinese patients. METHODS: A total of 605 HBeAg-positive Chinese CHB patients were screened and 590 eligible participants were randomly assigned to 2 groups in 1:1 ratio including experimental group (EG, received ADV plus CM) and control group (CG, received ADV plus CM-placebo) for 48 weeks. The major study outcomes were the rates of HBeAg and HBV-DNA loss on week 12, 24, 36, 48, respectively. Secondary endpoints including liver functions (enzymes and bilirubin readings) were evaluated every 4 weeks at the beginning of week 24, 36, and 48. Routine blood, urine, and stool analyses in addition to electrocardiogram and abdominal B scan were monitored as safety evaluations. Adverse events (AEs) were documented. RESULTS: The combination therapy demonstrated superior HBeAg loss at 48 weeks, without additional AEs. The full analysis population was 560 and 280 in each group. In the EG, population achieved HBeAg loss on week 12, 24, 36, and 48 were 25 (8.90%), 34 (12.14%), 52 (18.57%), and 83 (29.64%), respectively; the equivalent numbers in the CG were 20 (7.14%), 41 (14.64%), 54 (19.29%), and 50 (17.86%), respectively. There was a statistically significant difference between these group values on week 48 (P<0.01). No additional AEs were found in EG. Subgroup analysis suggested different outcomes among treatment patterns. CONCLUSION Combination of CM and ADV therapy demonstrated superior HBeAg clearance compared with ADV monotherapy. The finding indicates that this combination therapy may provide an improved therapeutic effect and safety profile (ChiCTR-TRC-11001263).
Adenine ; analogs & derivatives ; therapeutic use ; Adult ; Antiviral Agents ; therapeutic use ; Double-Blind Method ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Hepatitis B e Antigens ; immunology ; Hepatitis B, Chronic ; drug therapy ; immunology ; Humans ; Male ; Medicine, Chinese Traditional ; Organophosphonates ; therapeutic use ; Young Adult

BACKGROUNDThe domestic prevalence of chronic hepatitis B (CHB) in China is 7.18% in 2006, imposing great societal healthcare burdens. Nucleot(s)ide analogues (NUCs) anti-hepatitis B virus (HBV) therapies are widely applied despite the relatively low rate of seroconversion and high risk of drug-resistant mutation. More effective treatments for CHB deserve further explorations. Combined therapy of NUCs plus Chinese herbal medicine (CHM) is widely accepted in China, which is recognized as a prospective alternative approach. The study was primarily designed to confirm the hypothesis that Tiaogan-Yipi Granule (, TGYP) or Tiaogan-Jianpi-Jiedu Granule (, TGJPJD) plus entecavir tablet (ETV) was superior over ETV monotherapy in enhancing HBeAg loss rate.

METHODSThe study was a nationwide, large-scale, multi-center, double-blind, randomized, placebo-controlled trial with a designed duration of 108 weeks. A total of 16 hospitals and 596 eligible Chinese HBeAg positive CHB patients were enrolled from November 2012 to September 2013 and randomly allocated into 2 groups in 1:1 ratio via central randomization system: experimental group (EG) and control group (CG). Subjects in EG received CM formulae (TGYP or TGJPJD, 50 g per dose, twice daily) plus ETV tablet (or ETV placebo) 0.5 mg per day in the first 24 weeks (stage 1), and CHM granule plus ETV tablet (0.5 mg per day) from week 25 to 108 (stage 2). Subjects in CG received CHM Granule placebo plus ETV tablet (0.5 mg per day) for 108 weeks throughout the trial. The assessments of primary outcomes (HBV serum markers and HBV-DNA) were conducted by a third-party College of American Pathologists (CAP) qualified laboratory. Adverse effects were observed in the hospitals of recruitment.

DISCUSSIONThe study was designed to compare the curative effect of CM plus ETV and ETV monotherapy in respect of HBeAg loss, which is recognized by the European Association for the Study of the Liver as "a valuable endpoint". We believe this trial could provide a reliable status for patients' "journey" towards durable responses after treatment discontinuation. The trial was registered before recruitment on Chinese Clinical trial registry (No. ChiCTR-TRC-12002784, Version 1.0, 2015/12/23).

OBJECTIVETo investigate the feasibility and reliability on the quantitative evaluation of Colles' fracture by multislice CT (MSCT) multiplanner reconstruction (MPR).

METHODSA total of 36 patients with Colles' fracture from July 2011 to July 2014 were investigated in this study. There were 11 males and 25 females with a mean age of (42.5 ± 5.4) years old (ranged 35 to 72 years). All the patients underwent anteroposterior and lateral X-ray films and MSCT scans on wrist joints within 2 days after trauma. Images were sent to the workstation through picture archiving and conserving system (PACS). One associate chief physician independently and respectively measured the dorsal intercalation depth of distal fracture block, palmar angle and dislocation degree of wrist articular surface collapse on anteroposterior and lateral X-ray film and MSCT-MPR. The time interval between the two measurements was 2 weeks. All the data between the first and second measurement on X-ray and MPR and the mean value between the X-ray and MPR was examined with paired t-test. The pearson analyzed their correlation.

RESULTSAmong the 35 cases, 35 cases of palmar angle, 21 cases of intercalation depth and 16 cases of dislocation of wrist articular surface collapse could be measured on both X-ray and MPR. For the above parameters, the first measurement results were (12.5 ± 3.6)°, (4.5 ± 2.1) mm, (3.7 ± 1.6) mm and the second measurement results were (4.8 ± 2.2)°, (6.4 ± 3.6) mm, (2.5 ± 1.2) mm on X-ray films respectively. The first measurement results on MPR were (14.5 ± 5.3)°, (4.2 ± 1.2) mm, (5.7 ± 2.3) mm, and the results were (13.2 ± 2.6)°, (4.7 ± 2.2) mm, (4.6 ± 2.1) mm for the second measurement respectively. The three parameters between the first and second measurement on plain film had statistical difference and low correlation (r = 0.681, 0.640, 0.345, P < 0.05). The data between the first and second measurement on MPR showed that the dislocation degree of wrist articular surface collapse had statistical difference (P < 0.05) and no statistical significance was found for the other two parameters (P > 0.05), with the moderate correlation (r = 0.954, 0.854, 0.642). The three parameters had low or moderate correlation with each other on X-ray (r = 0.454, 0.532, 0.378, P < 0.05), compared with the mean value on MPR.

CONCLUSIONUsing MSCT MPR images may carry on the multiple parameter measurement of Colles fracture, to make quantitative evaluation, and repeated measurement is better reliability.

Adult ; Aged ; Colles' Fracture ; diagnostic imaging ; Feasibility Studies ; Female ; Humans ; Image Processing, Computer-Assisted ; Male ; Middle Aged ; Multidetector Computed Tomography ; methods

Forearm ; innervation ; Ganglion Cysts ; surgery ; Humans ; Male ; Middle Aged ; Muscle, Skeletal ; innervation ; surgery ; Tendons ; surgery ; Ulnar Nerve ; surgery

Objective:To investigate the feasibility and reliability on the quantitative evaluation of Colles' fracture by multislice CT (MSCT) multiplanner reconstruction (MPR). Methods:A total of 36 patients with Colles'fracture from July 2011 to July 2014 were investigated in this study. There were 11 males and 25 females with a mean age of (42.5±5.4) years old (ranged 35 to 72 years). All the patients underwent anteroposterior and lateral X ray films and MSCT scans on wrist joints within 2 days after trauma. Images were sent to the workstation through picture archiving and conserving system (PACS). One associate chief physician independently and respectively measured the dorsal intercalation depth of distal fracture block ,pal-mar angle and dislocation degree of wrist articular surface collapse on anteroposterior and lateral X ray film and MSCT-MPR. The time interval between the two measurements was 2 weeks. All the data between the first and second measurement on X ray and MPR and the mean value between the X ray and MPR was examined with paired t test. The pearson analyzed their correla-tion. Results:Among the 35 cases,35 cases of palmar angle,21 cases of intercalation depth and 16 cases of dislocation of wrist articular surface collapse could be measured on both X ray and MPR. For the above parameters,the first measurement results were (12.5±3.6)°,(4.5±2.1) mm,(3.7±1.6) mm and the second measurement results were (4.8±2.2)°,(6.4±3.6) mm,(2.5± 1.2) mm on X ray films respectively. The first measurement results on MPR were (14.5±5.3)°,(4.2±1.2) mm,(5.7±2.3) mm, and the results were(13.2±2.6)°,(4.7±2.2) mm,(4.6±2.1) mm for the second measurement respectively. The three parameters between the first and second measurement on plain film had statistical difference and low correlation (r=0.681,0.640,0.345,P<0.05). The data between the first and second measurement on MPR showed that the dislocation degree of wrist articular surface collapse had statistical difference (P<0.05) and no statistical significance was found for the other two parameters (P>0.05), with the moderate correlation (r=0.954,0.854,0.642). The three parameters had low or moderate correlation with each other on X ray (r=0.454,0.532,0.378,P<0.05),compared with the mean value on MPR. Conclusion:Using MSCT MPR images may carry on the multiple parameter measurement of Colles fracture,to make quantitative evaluation,and repeated measurement is better reliability.

OBJECTIVETo evaluate the impacts of three different surgical approaches to urethral stricture on the erectile function of the patients.

METHODSThis study included 126 male patients with urethral stricture, 35 treated by substitution urethroplasty (group A), 52 by anastomotic urethroplasty (group B), and 39 by internal urethroplasty (group C). We evaluated the pre- and postoperative erectile function of the patients using IIEF-5 scores by telephone calls and interviews. We also monitored their nocturnal penile tumescence (NPT).

RESULTSThe IIEF-5 scores in groups A, B and C were 13.5 +/- 4.5, 11.1 +/- 4.8 and 14.5 +/- 4.41 respectively after surgery, all significantly decreased as compared with 17.1 +/- 2.6, 17.1 +/- 3.0 and 17.6 +/- 2.2 preoperatively (P < 0.05).

CONCLUSIONAll the three surgical approaches can reduce IIEF-5 scores in patients with urethral stricture, but anastomotic urethroplasty may induce a higher incidence of erectile dysfunction than the other two approaches.

Adult ; Aged ; Humans ; Intraoperative Period ; Male ; Middle Aged ; Penile Erection ; physiology ; Urethral Stricture ; surgery ; Urologic Surgical Procedures, Male ; methods ; Young Adult

OBJECTIVETo study the toxicity features of high glucose on the endothelial cell cycle and the influence of Dan Gua-Fang, a Chinese herbal compound prescription, on the reproductive cycle of vascular endothelial cells cultivated under a high glucose condition; to reveal the partial mechanisms of Dan Gua-Fang in the prevention and treatment of endothelial injury caused by hyperglycemia in diabetes mellitus (DM); and offer a reference for dealing with the vascular complications of DM patients with long-term high blood glucose.

METHODSBased on the previous 3-(4,5)-dimethylthiahiazo (z-y1)-3-5-diphenytetrazoliumromide (MTT) experiment, under different medium concentrations of glucose and Dangua liquor, the endothelial cells of vein-304 (ECV-304) were divided into 6 groups as follows: standard culture group (Group A, 5.56 mmol/L glucose); 1/300 herb-standard group (Group B); high glucose culture group (Group C, 16.67 mmol/L glucose); 1/150 herb-high glucose group (Group D); 1/300 herb-high glucose group (Group E); and 1/600 herb-high glucose group (Group F). The cell cycle was assayed using flow cytometry after cells were cultivated for 36, 72 and 108 h, respectively.

RESULTS(1) The percentage of cells in the G0/G1 phase was significantly increased in Group C compared with that in Group A (P<0.05), while the percentage of S-phase (S%) cells in Group C was significantly reduced compared with Group A (P<0.05); the latter difference was dynamically related to the length of growing time of the endothelial cells in a high glucose environment. (2) The S% cells in Group A was decreased by 30.25% (from 40.23% to 28.06%) from 36 h to 72 h, and 12.33% (from 28.06% to 24.60%) from 72 h to 108 h; while in Group C, the corresponding decreases were 23.05% and 21.87%, respectively. The difference of S% cells between the two groups reached statistical significance at 108 h (P<0.05). (3) The percentage difference of cells in the G2/M phase between Group C and Group A was statistically significant at 72 h (P<0.01). (4) 1/300 Dan Gua-Fang completely reversed the harmful effect caused by 16.67 mmol/L high glucose on the cell cycle; moreover it did not disturb the cell cycle when the cell was cultivated in a glucose concentration of 5.56 mmol/L.

CONCLUSIONSHigh glucose produces an independent impact on the cell cycle. Persistent blocking of the cell cycle and its arrest at the G0/G1 phase are toxic effects of high glucose on the endothelial cell cycle. The corresponding variation of the arrest appears in the S phase. 1/300 Dan Gua-Fang completely eliminates the blockage of high glucose on the endothelial cell cycle.

Cell Cycle ; drug effects ; physiology ; Cells, Cultured ; Culture Media ; pharmacology ; Cytoprotection ; drug effects ; Dose-Response Relationship, Drug ; Drug Evaluation, Preclinical ; Drugs, Chinese Herbal ; pharmacology ; Endothelial Cells ; drug effects ; physiology ; Flow Cytometry ; Glucose ; adverse effects ; Humans

OBJECTIVETo investigate the cellular effects of Pien Tze Huang (PZH) in the HT-29 human colon carcinoma cell line.

METHODSThe viability of HT-29 cells was determined by MTT assay. A fluorescence-activated cell sorting (FACS) analysis with annexin-V/propidium iodide (PI) and JC-1 staining were performed to determine cell apoptosis and the loss of mitochondrial membrane potential, respectively. Activation of caspase 3 was evaluated by a colorimetric assay. The mRNA expression levels of Bcl-2 and Bax were measured by reverse transcription polymerase chain reaction (RT-PCR).

RESULTSPZH, in a dose- and time-dependent manner, reduced viability and induced apoptosis of HT-29 cells. Moreover, PZH treatment resulted in the collapse of the mitochondrial membrane potential, activation of caspase 3, and an increase in the Bax/Bcl-2 ratio.

CONCLUSIONPZH inhibits the growth of HT-29 cells by inducing cancer cell apoptosis via regulation of the Bcl-2 family and activation of caspase 3, which may, in part, explain its anticancer activity.

Apoptosis ; drug effects ; Caspase 3 ; metabolism ; Cell Proliferation ; drug effects ; Cell Survival ; drug effects ; Colonic Neoplasms ; enzymology ; pathology ; Drug Screening Assays, Antitumor ; Drugs, Chinese Herbal ; pharmacology ; Enzyme Activation ; drug effects ; HT29 Cells ; Humans ; Membrane Potential, Mitochondrial ; drug effects ; Proto-Oncogene Proteins c-bcl-2 ; metabolism ; bcl-2-Associated X Protein ; metabolism