Drug clinical trial is an important link in the chain of new drug research and development. The results of drug discovery and development directly depend on the extent of standardization of clinical trials. Therefore, improving the quality of drug clinical trials is of great importance, and drug clinical trial institutions play a crucial role in the quality management of drug clinical trials. After years of development, the overall level of drug clinical trials has advanced rapidly in China, and a large number of clinical trials of traditional Chinese medicine have also been carried out. However, there is still a big gap between our country and developed countries. Therefore, for the construction and management of Chinese drug clinical trial institutions, there is still a long way to go. This study aims to analyze the current development of drug clinical trial institutions in China and explore the existing problems from three aspects, including current situations of institutional organization and management, regional and professional distributions, and quality control. And some suggestions are put forward finally, including support of traditional Chinese medicine, introduction of drug-risk management system, and construction of information management.
China ; Clinical Trials as Topic ; standards ; Drug Evaluation ; Drug Therapy ; standards ; trends ; Drugs, Chinese Herbal ; standards ; therapeutic use ; Humans ; Quality Control ; Research

Objective:To express human dentin sialoprotein (hDSP) gene in COS-7 cells. Methods:hDSP gene was subcloned into mammalian expression vector pcDNA3. The recombined plasmids were transfected into COS-7 cells using lipofectamune PLUS TM kit for transient expression. Western blot analysis and immunohistochemical staining were used to examine the gene products. Results:The constructed vectors were confirmed by digestion with restriction enzyme. An immuno-reaction positive band with relative molecular mass of 60 000 was found by Western blot analysis in culture supernatant and cytoplasms of COS-7 cells. Immunohistochemical staining showed strong positive particles in the cytoplasms. Conclution:hDSP gene can be expressed in COS-7 cells.

Serum cystatin C (Cys-C) is a cysteine protease inhibitor and has been used as an indicator of early renal function damage.The recent studies have found that Cys-C is closely related to the occurrence,development and prognosis of heart failure.This article reviews the recent research progress on the association between Cys-C and heart failure.

Objective To observe the growth and differentiation of the cultured mouse bone marrow stromal cells in vitro into neural like cells. Methods Bone marrow stromal cells (BMSCs) isolated from mice were cultured according to the routine method, and induced to differentiate by basic fibroblast growth factor b (bFGF), retinoic acid (RA), nerve growth factor (NGF), and dimethylsulfoxide (DMSO). Expressions of neural microfilament protein (NF 200), glial fibrillary acidic protein (GFAP), and fibronectin at 72 h after inductin were determined by immunoflurenscence and immunocytochemicalmethod. Results At 72 h after inductin, neural like changes were found in BMSCs. Immunohistochemical stain showed that 60% BMSCs differentiated into NF 200 positive cells, and about 50% BMSCs into GFAP positive cells. Fibronectin expression was significantly lower as compared with that in the control group. Conclusion Combined action of RA, bFGF, NGF, and DMSO can induce BMSCs to differentiate into neural like cells in vitro .

China ; Humans ; Pulmonary Medicine

Objective To explore the effect of participatory humanistic nursing on the quality of life and psychology of patients with gastric cancer. Methods From May 2015 to May 2016, 68 patients with gastric cancer were enrolled in the study. All patients were divided into the experimental group and the control group with 34 patients in each group according to the principle of double-blind randomization. Patients in the control group were given routine clinical nursing, and patients in the experimental group were given the participatory humanistic nursing care. The quality of life and psychological state were evaluated by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and Symptom Checklist 90 edited by Derogatis and compared before nursing and after 6 months of nursing. Results There was no significant difference in the quality of life before nursing between two groups (P >0.05). After nursing, the scores of physical function, role function, emotional function, cognitive function, social function of the quality of life were 57.85±4.64, 68.43±5.23, 61.43±4.97, 58.47± 6.12, 53.57±5.54 in the experimental group and 43.56±4.56, 54.67±4.67, 56.34±4.74, 51.34±4.13, 50.46± 4.27 in the control group,and there were significant differences (t=2.593-12.808,P<0.01 or 0.05). There was no significant difference in the psychological state before nursing between two groups (P>0.05). After nursing, the scores of interpersonal sensitivity, depression, anxiety, hostility, terror, paranoia, psychosis of the psychological state were 1.65 ± 0.17, 1.40 ± 0.15, 1.45 ± 0.14, 1.46 ± 0.12, 1.52 ± 0.16, 1.54 ± 0.10, 1.43 ± 0.11 in the experimental group and 1.75±0.21, 1.72±0.24, 1.63±0.21, 1.75±0.23, 1.71±0.24, 1.65±0.10, 1.56 ± 0.12 in the control group, and there were significant differences (t=2.158-6.593, P<0.05 or 0.01). Conclusions Participating humanistic care can improve the quality of life and improve the psychological state, and the clinical effect is significant, it is worthy of being popularized and applied.

Benzene ; poisoning ; Chronic Disease ; Female ; Humans ; Middle Aged ; Occupational Diseases

ObjectiveTo study the utility of multi-modal guiding in transrectal ultrasound-guided prostate biopsies.MethodsA total of 115 consecutive patients suspicious for prostate cancer due to elevated serum prostate specific antigen level were enrolled in this prospective study. All patients underwent transrectal ultrasound (TRUS), transrectal real-time elastography (TRTE) and contrast-enhanced transrectal ultrasound (CETRUS). Both positive sites on above imaging studies and 6 core-systematic biopsy sites were included in transrectal biopsy. The impact of targeted biopsies on the prostate cancer detection rate was analyzed in comparison with prostate biopsy pathology.Results The overall prostate cancer detection rate was 55% (63/115). TRTE and CETRUS had a higher sensitivity, specificity and accuracy of 71% (45/63), 81% (42/52), 76% (87/115), and 65% (41/63), 83% (43/52), 73% (84/115), respectively. Compared with TRUS, TRTE and CETRUS guided targeted biopsy improve the sensitivity of prostate cancer (χ2=14.950, 10.754,P=0.002, 0.013), specificity (χ2=0.256, 20.021,P=0.006, 0.009), accuracy (χ2=5.735,10.361, P=0.020, 0.011). Targeted biopsy could improve the detection rate of prostate cancer (χ2=9.021, 23.176,P=0.042, 0.000). On the operating characteristic (ROC) curve of TRTE, the area under the curve was 0.834 with a 95% confidence interval of 0.742-0.926.ConclusionCombined with the application of new technology of ultrasound to improve positive rate of prostate cancer, improving the multi-mode ultrasound-guided prostate biopsy positive rate, and has important clinical significance for early screening and diagnosis of prostate cancer.

Objective:To analyze the clinical features of the patients with drug-induced liver injury ( DILI) combined with hepati-tis B to improve the awareness and attention to the disease by medical workers. Methods:Using retrospective analysis, the patients di-agnosed with DILI combined with hepatitis B from a tertiary-hospital were analyzed from January 2013 to January 2014. Results:Total-ly 30 cases of DILI combined with hepatitis B were collected, the number of male patients was higher than that of female patients, and most of them were elderly patients. The symptoms included weak, anorexia, yellow skin and sclera, tired of the oil, nausea, abdominal distension and so on. The patients with severe liver damage accounted for 80. 0%, 16. 7% was with moderate liver damage, and 3. 3%was with mild liver damage. Thirteen cases were mixed type, ten cases were hepatocellular type, and seven cases were cholestatic type. Conclusion:Middle-aged men may be prone to the disease, and the clinical manifestations are complex and diverse. Severe liver damage is majority, and often shows as mixed liver injury.

Objective To investigate the causes and mechanism of preterm birth through analysis of the relationship between histological chorioamnionitis (HCA) in placental tissue and preterm birth.Methods Totally,327 preterm birth cases with report of placental pathologic examination were retrospectively collected from those women who delivered from December 1,2009 to December 1,2012 in Peking University First Hospital.According to the etiology of preterm birth,three groups were assigned:iatrogenic group (n=106),spontaneous contraction group (n=56) and premature rupture of membranes (PROM) group (n=165).According to the gestational age at delivery,three subgroups were further divided:early-preterm group (≥ 28-＜ 32 weeks),mid-preterm group(≥ 32-＜ 34 weeks) and late-preterm group (≥ 34-＜ 37 weeks).HCA was confirmed when ≥ 5 neutrophil infiltration identified on the chorionic plate and amniotic membrane under high power light microscope after HE staining.The relationship between HCA and the different types of preterm birth and the different delivery gestational age were analyzed.Besides,the consistency between clinical chorioamnionitis and HCA was also analyzed.Chi-square test was applied for statistics.Results The incidence of HCA in the spontaneous contraction group was significantly higher than in the iatrogenic group and PROM group [66.1％ (37/56) vs 25.5％ (27/106) and 33.3％ (55/165),x2=25.27 and 18.44,both P ＜ 0.01],but no significant difference was found between the latter two groups (P ＞ 0.05).Among the three subgroups,the early-,midand late-preterm subgroup,the incidence of HCA in the iatrogenic group was 24.0％ (6/25),33.3％ (8/24) and 22.8％ (13/57) (P ＞ 0.05),and 13/17,5/7 and 59.4％ (19/32) in the spontaneous contraction group (P ＞ 0.05).However,significantly higher incidence of HCA was shown in the early-preterm subgroup than in the mid-and late-preterm subgroup [70.0％ (20/29) vs 41.2％ (14/34) and 20.6％ (21/102),X2=4.87 and 24.58,both P ＜ 0.05] in the PROM group.Among the subjects in PROM group,those with the latency ≥ 72 h after the rupture of membranes had a higher incidence of HCA than those with the latency less than 72 h [68.6％ (24/35) vs 23.8％ (31/130),x2=24.82,P ＜ 0.01].For all 327 cases in this study,the incidence of clinical chorioamnionitis was 15.9％ (52/327),among which 31 cases [59.6％ (31/52)] were diagnosed as HCA.Conclusions The occurrence of HCA is closely associated with spontaneous contraction preterm.Some iatrogenic preterm birth might cause HCA.The earlier the preterm birth and the longer the latency after PROM,the higher the incidence of HCA.Differential diagnosis is necessary as the inconsistency between clinical chorioamnionitis and HCA.