OBJECTIVE: The aim of this study is to explore the clinical efficacy and safety of endocrinotherapy combined with Shenqi Pills on hormone-sensitive prostate cancer (HSPC). METHODS: Eighty patients who were diagnosed with HSPC and renal-yang deficiency at the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine and the Hospital of Traditional Chinese Medicine of Mayang Miao Autonomous County from 1st April 2021 to 30th April 2024 were randomly divided into 2 groups. The patients in the control group were treated with androgen deprivation therapy (ADT). And the patients in treatment group were treated with Shenqi Pills orally on the basis of the control group. The baseline data of the two groups were analyzed. After 36 months of treatment, the differences between the two groups were compared in terms of overall survival (OS), prostate-specific antigen (PSA) level, PSA response rate, Functional Assessment Scale for Prostate Cancer Therapy (FACT-P), Chinese medicine evidence scores, testosterone level and safety. RESULTS: A total of 80 study subjects were included in this study, including 42 cases in the treatment group and 38 cases in the control group. There was no statistical difference in the baseline data between the two groups before treatment (P>0.05). At the end of the observation period, a statistically significant difference in OS was found in the treatment group compared to the control group in the subgroup of patients with a disease duration ranged of 0-6 months (P<0.05). There was no statistically significant difference in PSA levels in the treatment group at 3 months (P>0.05). And the differences in the proportion of PSA50 (98.1% vs 91.4%), PSA90 (92.9% vs 84.6%) and the proportion of decrease in PSA (56.7% vs 33.8%) in the treatment group were found compared to those in the control group after 6 months of tre atment. After 12 months of treatment, the scores of FACT-4 and renal-yang deficiency in the treatment group were (95.28±7.93) and (15.73±5.70) respectively, compared to the scores in the control group (［85.46±10.12］ and ［18.20±4.27］ (P<0.05). However, there was no significant difference in serum testosterone (［0.60±0.24］ nmol/L vs ［1.09±2.10］ nmol/L) between the two groups (P>0.05). After 24 months of treatment, there were significant differences in in the FACT-4 total score (［97.95±7.54］ vs ［80.33±8.58］), renal-yang deficiency syndrome score (［14.64±5.15］ vs ［24.94±8.75］) between the treatment group and the control group (P<0.05). However, there was no significant difference in serum testosterone ( ［0.73±1.01］ nmol/L vs ［0.59±0.25］ nmol/L) between the two groups (P> 0.05). Better therapeutic results were showed in the treatment group in terms of total FACT-P score, physical situation score, social and family situation score, emotional state score, functional state score, additional score and renal-yang deficiency symptom score (P<0.05). After treatment, there was no serious adverse reaction in the course of treatment, and no obvious abnormality was found in the liver and kidney function of the patients from two groups. CONCLUSION Endocrinotherapy combined with Shenqi Pills is safe and effective in HSPC and can reduce the risk of death in HSPC patients, and the earlier the intervention, the longer the overall survival of the patients. In addition, this treatment regimen can increase the PSA response rate, improve patients' quality of life, and reduce the renal-yang deficiency syndrome score without the risk of elevating serum testosterone levels.
Humans ; Male ; Drugs, Chinese Herbal/therapeutic use* ; Prostatic Neoplasms/drug therapy* ; Androgen Antagonists/therapeutic use* ; Prostate-Specific Antigen/blood* ; Aged ; Middle Aged ; Treatment Outcome ; Testosterone

Objective To explore the severity of loneliness among the elderly in communities in Shanghai,and to identify factors associated with social and emotional loneliness respectively.Methods A cross-sectional study was conducted in older adults aged 65 years or above in Pudong New Area,Jing'an District and Huangpu District in Shanghai from Mar to Jun 2021.In Pudong New Area,multi-stage stratified random sampling was conducted based on the age and gender distribution of Shanghai,while in Huangpu District and Jing'an District convenience sampling was conducted.A total of 635 samples were included in the study.Loneliness was assessed using the De Jong Gierveld Loneliness Scale with social and emotional loneliness subscales.Logistic regression analyses were conducted to identify factors associated with social and emotional loneliness.Results Among the 635 participants,only 53 older adults(8.4%)were not lonely.Female(OR=0.46,95%CI:0.31-0.70),higher self-efficacy(OR=0.97,95%CI:0.94-1.00),more objective social support(OR=0.96,95%CI:0.93-0.99)were associated with less severe social loneliness.Meanwhile,higher level of education(secondary education,OR=0.56,95%CI:0.34-0.95;college or above,OR=0.30,95%CI:0.11-0.83)and higher self-efficacy(OR=0.96,95%CI:0.93-0.99)were associated with less severe emotional loneliness,while depression(OR=3.41,95%CI:1.76-6.60)and worse social capital(OR=2.02,95%CI:1.29-3.16)were associated with more severe emotional loneliness.Conclusion Up to 91.6%of the elderly in our study sample were moderately lonely or above.The factors associated with social loneliness include self-efficacy,gender and social support.The factors associated with emotional loneliness are self-efficacy,education level,depression,and social capital.

BackgroundFunctional dyspepsia (FD) is a common upper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and safety of Qi-Zhi-Wei-Tong granules in patients with postprandial distress syndrome (PDS)-predominant FD.

MethodsThe study was conducted as a randomized, double-blinded, multicenter, placebo-controlled design in 197 patients with PDS. All participants received placebo treatment for 1 week. Patients whose total symptom score decreased by <50% after the placebo treatment were recruited into the 4-week treatment period, in which they were randomly assigned to be treated with either Qi-Zhi-Wei-Tong granules or placebo. The patients were then followed for 2 weeks without any treatment. Dyspeptic symptoms were scored at weeks 2 and 4 during the random treatment period and 2 weeks after the treatment. Anxiety and depression symptoms were also scored and compared.

Results(1) The total effective rates in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 during the random treatment period and 2 weeks after treatment were all significantly higher than those in the placebo group (38.82% vs. 8.75%, P < 0.001; 69.14% vs. 16.25%, P < 0.001; 77.65% vs. 21.25%, P < 0.001). (2) The total dyspeptic symptoms scores in the Qi-Zhi-Wei-Tong granules group at weeks 2 and 4 and 2 weeks after treatment were significantly lower than those in the placebo group. (3) The severity and frequency of each dyspeptic symptom at weeks 2 and 4 and the follow-up period were all significantly lower than those in the placebo group. (4) The anxiety scores in the Qi-Zhi-Wei-Tong granules group were significantly lower than those in the placebo group. (5) Qi-Zhi-Wei-Tong granules did not have more adverse effects than the placebo.

ConclusionQi-Zhi-Wei-Tong granules offer significant symptomatic improvement in PDS with no more adverse effects than placebo.

Trial Registrationhttps://clinicaltrials.gov/, NCT02460601.

Objective:To study the influences of Mycoplasma penumoniae capsular polysaccharide (CPS) on the phagocytosis and membrane molecules expression of the human peripheral blood mononuclear cells derived dendritic cells by binding to dendritic cell-specific intercellular adhesion molecule-3-grabbing nonintegrin (DC-SIGN),so as to know the effect of CPS on the maturation of dendritic cells.Methods:M.pneumoniae strain was cultivated and CPS was extracted.Human peripheral blood mononuclear cells were separated and induced to dendritic cells,then identified the cells by flow cytometry and observation under the microscope.CPS was used to treat dendritic cells or cells pretreated with DC-SIGN monoclonal antibody,and then FITC-dextran phagocytosis and surface markers CD83,HLA-DR,CD80 and CD86 were detected by flow cytometry.Results:The dendritic cells tended to form colony groups.The positive rate of CD11c molecule in the cultured dendritic cells was about 86.27％.After stimulated by CPS,the FITC-dextran fluorescence mean intake by dendritic cells were increased (P＜0.05),while the cell surface membrane molecules CD83,HLA-DR,CD80 and CD86 were decreased significantly when compared with the PBS treated control cells(P＜0.05).When blocked DC-SIGN with the monoclonal antibody,the FITC-dextran fluorescence mean and membrane molecules expression had no statistical difference with the control cells(P＞0.05).Conclusion:M.pneumoniae CPS can promote the phagocytic function of DC and inhibit the expression of CD83,HLA-DR,CD80 and CD86.

OBJECTIVE: To study the metabolic characteristics of 5-bromo-2-fluorobenzonitrile in vitro and compare the differences between rats and human,and for the purpose of providing data for poison effect research and extrapolating poison effect of 5-bromo-2-fluorobenzonitrile from animals to human being. METHODS: Equilibrium dialysis method was used to analyze the protein binding ratio of 5-bromo-2-fluorobenzonitrile in the plasma of rats and humans in the groups of low dose,medium dose and high dose which were treated with mass concentration of 5-bromo-2-fluorobenzonitrile at 500,5 000 and 50 000 μg / L respectively. Metabolic incubation systems of SD rat microsomes and human liver microsomes were established in vitro. When the mass concentration of 5-bromo-2-fluorobenzonitrile in the systems was 800 μg / L,the concentration of liver microsome was 0. 5 g / L; after being incubated for 0,10,30,60 and 90 min with the involvement of the regeneration system of nicotinamide-adenine dinucleotide phosphate in the incubation systems,the metabolic reaction was stoped. The residual amounts of 5-bromo-2-fluorobenzonitrile were analyzed and metabolic half-life of 5-bromo-2-fluorobenzonitrile incubating with liver microsomes in vitro was figured out. RESULTS: Protein binding ratio of 5-bromo-2-fluorobenzonitrile in the groups of low dose,medium dose and high dose were( 83. 5 ± 0. 9) %,( 88. 8 ± 0. 3) % and( 88. 6 ± 0. 3) % in rats plasma,and( 85. 2 ± 0. 1) %,( 89. 0 ± 0. 1) % and( 91. 1 ± 0. 4) % in human plasma. Both in rat plasma and human plasma,the protein binding ratio of 5-bromo-2-fluorobenzonitrile in the groups of medium dose and high dose were significantly increased than that in the low-dose group( P < 0. 01). In human plasma,the protein binding ratio of 5-bromo-2-fluorobenzonitrile in the high-dose group significantly increased than that in the medium-dose group( P < 0. 01). In the groups of low dose and high dose,the protein binding ratio of 5-bromo-2-fluorobenzonitrile in human plasma significantly increased than that in rats plasma( P < 0. 01). Absolute differences in protein binding ratio of 5-bromo-2-fluorobenzonitrile between the rat plasma and the human plasma were no more than 2. 5% in the same dose groups. Metabolic half-life of 5-bromo-2-fluorobenzonitrile incubating with rats and human liver microsomes and control solution in vitro were respectively( 58. 6 ± 1. 6),( 59. 2 ± 1. 5) and( 65. 0 ± 6. 3) min,which shows no significant differences( P < 0. 05). CONCLUSION: The potein binding ratio and metabolism of 5-bromo-2-fluorobenzonitrile in liver microsomes in rat plasma is similar to those in human plasma. Both in the plasmas of rats and humans,5-bromo-2-fluorobenzonitrile has high protein binding ratio,and 5-bromo-2-fluorobenzonitrile is not metabolized in liver microsomes of either rats or humans.

Establishment of quality management system (QMS) plays a critical role in the clinical data management (CDM). The objectives of CDM are to ensure the quality and integrity of the trial data. Thus, every stage or element that may impact the quality outcomes of clinical studies should be in the controlled manner, which is referred to the full life cycle of CDM associated with the data collection, handling and statistical analysis of trial data. Based on the QMS, this paper provides consensus on how to develop a compliant clinical data management plan (CDMP). According to the essential requirements of the CDM, the CDMP should encompass each process of data collection, data capture and cleaning, medical coding, data verification and reconciliation, database monitoring and management, external data transmission and integration, data documentation and data quality assurance and so on. Creating and following up data management plan in each designed data management steps, dynamically record systems used, actions taken, parties involved will build and confirm regulated data management processes, standard operational procedures and effective quality metrics in all data management activities. CDMP is one of most important data management documents that is the solid foundation for clinical data quality.
Clinical Trials as Topic ; Data Collection ; standards ; Database Management Systems ; standards ; Information Storage and Retrieval ; standards

OBJECTIVETo study the change of intestinal mucosa barrier in chronic severe hepatitis B patients and clinical intervention.

METHOD(1) 30 normal healthy controls and 60 chronic severe hepatitis B patients were enrolled in this study. The change of intestinal permeability was determined by urine lactulose/ mannitol ratio (L/M), and the serum diamine oxidase (DAO) was measured. (2) 60 chronic severe hepatitis B patients were randomly divided into two groups: the control group and the treated group, each group has 30 cases. Patients in the control group received standard treatment for 2 weeks, however, in addition to standard treatment, patients in the treated group also received glutamine 10g tid. Endotoxin (ET), DAO and L/M were compared between the two group.

RESULTS(1) Compared to healthy controls, the level of L/M and DAO was significantly increased in chronic severe hepatitis B patients (t = 2.762, P less than 0.01 or t = 6.326, P less than 0.01). (2) Compared to the control group, ET, DAO and L/M were significantly lower 2 weeks after treatment (F = 11.662, P less than 0.01; F = 12.699, P less than 0.01; F = 19.981, P less than 0.01).

CONCLUSION(1) There is an early intestinal mucosa barrier damage in chronic severe hepatitis B patients. (2) Compared to standard treatment, adding glutamine can reverse intestinal mucosa barrier damage.

Administration, Oral ; Adolescent ; Adult ; Amine Oxidase (Copper-Containing) ; blood ; Antiviral Agents ; pharmacology ; therapeutic use ; Child ; Endotoxins ; blood ; Female ; Glutamine ; pharmacology ; therapeutic use ; Hepatitis B, Chronic ; drug therapy ; metabolism ; physiopathology ; Humans ; Intestinal Mucosa ; drug effects ; metabolism ; physiopathology ; Intestine, Small ; Lactulose ; urine ; Male ; Mannitol ; urine ; Middle Aged ; Permeability ; Treatment Outcome ; Young Adult

OBJECTIVETo compare the clinical effects and graft outcomes of 4 surgical approaches for nephrectomy in living related kidney donors.

METHODSBetween June, 2004 and June, 2007, 119 living related kidney donors underwent nephrectomy via different surgical approaches, and their clinical data were retrospectively analyzed. Of these donors, 22 received retroperitoneal open nephrectomy, 21 had retroperitoneoscopic nephrectomy, 13 had hand-assisted laparoscopic nephrectomy, and 63 underwent transperitoneal open nephrectomy. The operating time, warm ischemia time of the graft, renal graft artery and vein lengths, reduction rate of recipient serum creatinine in the first 3 days after renal transplantation, mean hospital stay and complications of the donors were compared between the 4 surgical approaches.

RESULTSOpen surgeries were associated with significantly shorter operating time (P=0.0033) and warm ischemia time of the graft (P=0.0001), longer hospital stay (P=0.0000), higher hospital expenses (P=0.0000), faster postoperative reduction of recipient serum creatinine (P=0.0001), and longer renal artery and vein lengths (P=0.0000 on the left and P=0.0001 on the right) than laparoscopic surgeries. In the laparoscopic surgery group, subcutaneous emphysema occurred in 1 case, DGF in 2 cases, and lumbar vein hemorrhage in 2 cases for which open surgery was performed. In the open surgery group, only one case required reoperation due to adrenal gland hemorrhage. All the kidney grafts were successfully harvested without other complications observed in the donors.

CONCLUSIONSBoth open and laparoscopic surgeries are safe for nephrectomy in living related kidney donors, and the selection of the surgical approaches depends on the kidney and donor conditions and the surgical proficiency of the surgeons.

Adult ; Female ; Humans ; Kidney Transplantation ; Laparoscopy ; methods ; Living Donors ; Male ; Middle Aged ; Nephrectomy ; methods ; Retrospective Studies ; Tissue and Organ Harvesting

OBJECTIVETo explore the feasibility of using a nonreactive, permanent endoskeletal scaffold to create the prothesis in special shape which is covered with tissue-engineered cartilage.

METHODSPorcine BMSCs and articular chondrocytes were isolated and expanded respectively in vitro. Porcine BMSC of passage 1 in the concentration of 10 x 10(7)/ml were seeded onto a cylinder-shaped PGA (1 mm in thickness)/Medpor (3mm in diameter and 5mm in highness) scaffold as the experimental group. After the cell-scaffold constructs were cultured for 5 days, the primary medium, high-glucose DMEM medium with 10% fetal bovine serum (FBS), was replaced by chondrogenically inductive medium for 4 weeks. BMSCs and chondrocytes of the same concentration were seeded respectively onto the scaffold as the negative control group and the positive control group. After cultured in vitro for 4 weeks, the cell-scaffolds construct were implanted into subcutaneous pockets on the back of nude mice. Four and eight weeks later, the formed cartilage prosthesis were harvested and then evaluated by gross view, histology, immunohistochemistry and glycosamino-glycan (GAG) content.

RESULTSCells in all groups had fine adhesion to the scaffold and could secrete extracellular matrix. All specimens in experimental group and positive control group formed mature cartilage with collagen II expression.The mature catrtilage wraped HDPE compactly and grown into the gap of HDPE. Mature lacuna structures and metachromatic matrices were also observed in these specimens. GAG contents in experimental group were (5.13 +/- 0.32) mg/g (4 weeks), (5.37 +/- 0.12) mg/g (8 weeks). In contrast, specimens in BMSC group showed mainly fibrous tissue.

CONCLUSIONIt indicates that it is feasible to create special shaped tissue-engineering cartilage with the permanent internal support using BMSCs as seed cell.

Animals ; Bone Marrow Cells ; cytology ; Cartilage ; cytology ; Cell Culture Techniques ; Cell Differentiation ; Cells, Cultured ; Mice ; Mice, Nude ; Stromal Cells ; cytology ; Swine ; Tissue Engineering ; methods ; Tissue Scaffolds

Objective To discuss the diagnostic value of DSA for massive hemorrhage in lower gastrointestinal tract resulting from tumour. Methods 24 patients with massive lower gastrointestinal hemorrhage were performed DSA and then operated as tumour. Results Among 24 patients, 17 cases demonstrated direct signs of hemorrhage, 9 cases visible turnout vessels; 24 patients all showed clumping tumour-specifie dyeing. Conclusion DSA is of great value to determining the location and qualitation of the massive lower gastrointestinal hemorrhage resuhing from tumours.