Evidence-Based Medicine ; Humans ; Occupational Diseases ; prevention & control ; Occupational Medicine ; methods

Data is the basis and soul of clinical trials. To obtain accurate data, strict and standard data management is essential, which can be effectively supported by quality control in statistical analysis. In this paper, we briefly introduce the concept of the quality control in clinical trials, and describe its contents and methods. We hope that this work will be helpful to the application of statistical quality control in data management of clinical trials.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Quality Control ; Statistics as Topic

A new and effective method to produce transgenic animals was established. Without a surgical incision, the recombinant plasmid containing green fluorescence protein (GFP) cDNA was repeatedly injected into male mouse testis at multi-sites. After few weeks of the final injection, the injected male was mated with normal oestrus female to produce transgenic mice. The presence of the GFP cDNA in F1 transgenic individuals were detected by polymerase chain reaction and Southern blot hybridization, which showed that the transgenic rate of mouse F1 offspring was 41%. The transferred gene was integrated into the host genome and could be transmitted to its offspring. When the positive F1 individuals were mated with the wild type ICR mice, the F2 individuals had a transgenic rate of 37%. The results indicate that the high efficiency of gene transfer and the limited number of manipulations make the method suitable for creating a large number of transgenic animals, especially, for producing domestic animals.

Objective To investigate the distribution pattern of the ADAS-Cog scores among the elderly in Beijing and to evaluate the application of ADAS-Cog in distinguishing patients with mild Alzheimer's disease (AD) and healthy elderly. Methods In total, 1616 healthy elderly (NC), 125 elderly patients with non-AD disorders (ND), and 310 patients with probable AD including 201 patients with mild AD and 109 patients with moderate AD (by NINCDS-ADRDA criteria) were recruited in the study and their cognitive performance was measured by the ADAS-Cog.Results In NC group, those older than 80 years and those with less than 5 years schooling scored highest. There was statistically significant correlation between the total scores of the ADAS-Cog and age and duration of schooling in NC group (F=14.34, 113.27,both P<0.01). No correlation was suggested in the mild AD group. The total score of ADAS-Cog was significantly associated with duration of schooling in both moderate AD and ND groups (F=4.18, 8.72, both P<0.05). The total score of ADAS-Cog differentiated the patients with mild AD from NC healthy elderly with AUC ranging from 0.69 to 0.82 in each subgroup by age, and from 0.75 to 0.88 in subgroups by durations of schooling with the highest AUC of 0.88 in the subgroup having more than 15 years of schooling education. Conclusions The ADAS-Cog score in the healthy elderly is significantly associated with age and duration of schooling education. The ADAS-Cog can be applied in the cognitive assessment of Chinese AD patients. The total score of ADAS-Cog could efficiently differentiate patients with mild AD from healthy elderly, especially in subjects with higher education level.

The connotations of "du-fu" and "Sanli" in "Sanli acupoint for du-fu diseases" are discussed in this paper, which can provide theoretical foundation for the clinical application of "Sanli acupoint for du-fu diseases". Based on ancient literature combined with related theories in the Huangdi Neijing (Yellow Emperor's Canon of Internal Classic), a deep discussion is performed through the relationship between Zusanli (ST 36) and stomach, indication and mechanism of Zusanli (ST 36) on du-fu diseases and comparison between Zusanli (ST 36) and Shousanli (LI 10). It is believed that "du" should be pronounced as "dŭ", meaning stomach, and it indicates that Zusanli (ST 36) is closely related to stomach and spleen when it is used for du-fu diseases; "fu" means abdomen area, including liver-gallbladder, spleen, stomach-intestine, kidney, uterus, triple energizer; "sanli' means exclusively the acupoint of Zusanli (ST 36).
Abdominal Cavity ; anatomy & histology ; Acupuncture Points ; Acupuncture Therapy ; history ; Books ; history ; China ; History, Ancient ; Humans ; Medicine in Literature ; Meridians

Objective Recent researches find that endoplasmic reticulum is a new target for the treatment of cardiovascular disease and its stress response plays an important role in the hypertension-induced cardiovascular remodeling.The study built up the apoptosis model of endoplasmic reticulum stress ( ERS) in human umbilical vein endothelial cells ( HUVECs) and investigated the im-pact of 17β-estradiol ( E2) on the ERS apoptosis of HUVECs induced by tunicamycinand(TM)/dithiothreitol(DTT). Methods HUVECs incubated for 10 h in 10μmol/L TM or 8 h in 2 mmol/L DTT were the best concentration and time for ERS apoptosis.E2 of 10-8 mol/L was prominent in protecting ERS.According to the application of TM/DTT, E2, estrogen antagonists (ICI182, 780 and G15), there were 6 groups:control group, TM/DTT group, TM/DTT+E2 group, TM/DTT+E2 +G15 group, TM/DTT+E2 +ICI+G15 group.Western blot was applied to detect the expressions of biomarkers for ERS in-duced apoptosis (GRP78, cleaved caspase-12 and CHOP).Hochest staining was used to observe the changes of the apoptosis cell number. Results Compared with control group, the expressions of GRP78, caspase-12 and CHOP significantly increased(P<0.05).In comparison with TM group, the expressions of GRP78, caspase-12 and CHOP in TM+E2 group significantly decreased (6.80 ±1.07 vs 4.01 ±0.46, 1.54 ±0.32 vs 0.88 ±0.10, 1.91 ±0.37 vs 0.91 ± 0.02, P<0.05).In comparison with TM +E2 group, the CHOP expression in TM +E2 +ICI group increased(0.91 ±0.02 vs 0.96 ±0.02, P<0.05), and the expressions of GRP78 and caspase-12 in TM+E2 +G15 group increased(4.01 ±0.46 vs 5.25 ± 0.80, 0.88 ±0.10 vs 1.02 ±0.07, P<0.05), and the expressions of GRP78, caspase-12 and CHOP in TM+E2 +ICI+G15 group increased (P<0.05).Compared with DTT group, the expressions of GRP78 and CHOP in DTT+E2 group decreased (1.81 ± 0.08 vs 1.30 ±0.14, 1.00 ±0.13 vs 0.51 ±0.01, P<0.05).In comparison with DTT+E2 group, the expressions of GRP78 and CHOP in DTT+E2 +ICI group decreased(P <0.05), and the expression of GPR78 in DTT+E2 +G15 group increased(P<0.05), and the expressions of GRP78, caspase-12 and CHOP in DTT+E2 +ICI+G15 group increased(P<0.05).The change of the apop-tosis cell number observed by hochest staining was in consistence with the result of western blot. Conclusion E2 can protect human endothelial cells from ERS induced apoptosis caused by TM and DTT.Estrogen maintains homeostasis by regulating ERS estrogen re-ceptors, thereby protecting the cardiovascular system.

Objective To understand the environmental estrogens contamination of tap water and source water. Methods Environmental estrogens in the water samples were concentrated by macroporous adsorption resin H103. The effect of environmental estrogens in concentrated samples was assessed by the recombinant yeast system. Results The results showed that some source water and tap water really contained environmental estrogens. The activity of environmental estrogens in concentrated samples of some source water increased as the volume of concentrated sample increased. The concentrate of 100 ml water sample could show the estrogenic effect. Conclusion Some source waters and tap waters in China have been contaminated by environmental estrogens. Environmental estrogens in source water can not be removed completely by drinking water treatment system of city.

Objective To evaluate the changes in the expression of acetylated histone H3 (Ac-H3) and deacetylase silent information regulator 1 (SIRT1) in dorsal root ganglions in a rat model of negative phenotype neuropathic pain.Methods Forty-eight male Sprague-Dawley rats,weighing 250-300 g,were randomly divided into 2 groups (n =24 each):sham operation group (group S) and C-fiber dysfunction group (group CFD).The rats were anesthetized with 10％ chloral hydrate 3 ml/kg.C-fiber dysfunction was induced by exposing sciatic nerve to 8％ capsaicin for 30 min in group CFD.The thermal withdrawal latency (TWL) and mechanical withdrawal threshold (MWT) were measured before and on 1,3,7 and 14 days after CFD.Six rats were then sacrificed at each time and the lumbar segments (L5) of the dorsal root ganglions were removed for detection of SIRT1 mRNA expression (by RT-PCR) and Ac-H3 and SIRT1 protein expression (by Western blot).Results Compared with group S,TWL was significantly increased at 1,3,7 and 14 days after CFD,SIRT1 mRNA and protein expression was up-regulated and Ac-H3 expression was down-regulated at 3,7 and 14 days after CFD (P ＜ 0.05),while no significant change was found in MWT at each time point in group CFD (P ＞ 0.05).Conclusion The mechanism of negative phenotype neuropathic pain is related to up-regulation of deacetylase SIRT1 expression and decreased acetylation of histone H3 in rat dorsal root ganglions.

Objective To screen for the potential protein biomarkers in serum for the diagnosis of idiopathic Parkinson's disease (PD) using proteomic fingerprint technology. Methods Proteomic fingerprint technology combining weak cation exchange (WCX) magnetic beads with MALDI-TOF-MS was used to identify and compare the serum proteins from 61 patients with idiopathic PD, 29 patients with other neurodegenerative diseases (OND) and 30 healthy blood donors. Model of biomarkers and proteomics patterns associated with PD was analyzed by Biomarker Patterns Software. The model also was validated by 40 newly recruited PD cases. Results A total of 17 discriminating M/Z peaks which were related to PD were identified ( nonparametric test, Z:-4.039--2.633, P<0.01 ). Five biomarkers with M/Z of 6121, 5234, 2961,4309 and 8170 respectively generated an excellent model of distinguishing between PD and healthy groups. The sensitivity was 98.4% and the specificity was 83.1%. Blind testing in 40 newly recruited cases demonstrated a sensitivity of 85.0% (17 of 20 PD) and a specificity of 70. 0% (14 of 20 controls). Conclusions Combination of WCX magnetic beads with MALDI-TOF-MS is a useful method in establishing proteomic patterns associated with PD. It also may be used to construct a diagnostic model with PD Biomarkers. Although this model of biomarkers fails to distinguish between PD and OND controls, it is able to differentiate PD from healthy controls.

Objective To investigate the expressions of protein gene product 9.5 (PGP 9.5),cathepsin D(CAD) and S-100 protein(S100) and their significance in the colon of the patients with hirschsprung′s disease(HD).Methods Thirty stenotic segments from children with HD and 35 controls were stained for PGP 9.5 and CAD and S100 by immunohistochemistry.The expressions were observed by imaging analysis system.Results 1.In the controls,CAD was only positive to ganglionic cells,which could be observed in myenteric and submucosal plexuses.Schwann cells and perineural satellite cells and nerve fibers were positive to PGP 9.5 and S100,ganglionic cells were positive to PGP 9.5,and were stained negative to S100,which left "cells-like blank area" in the plexuses.2.In the stenotic segments of HD,neither CAD-positive and PGP 9.5-positive neurons nor "cell-like blank area" in S100 staining were found in the plexus.The PGP 9.5 and S100 positive fibers were proliferated obviously in number.There were obvious differences in the density of the S100 stained nerve fibers and the fiber sizes between the controls[169.25?9.53;(23.15?5.56) ?m ] and the stenotic segments of HD[146.70?10.87;(57.81?14.99) ?m](all P