OBJECTIVETo investigate the dosage-efficacy/toxicity relationship of prepared rhubarb, in order to explore the bidirectional effects in hepatoprotection and hepatotoxicity of prepared rhubarb and the objective authenticity for attenuating toxicity by processing.

METHODNormal and pathological animals were adopted simultaneous to investigate the effect of total extracts from prepared rhubarb within a high dose range (2.0, 5.4, 14.7, 40.0 g x kg(-1) x d(-1)) on normal state, biochemical index and histopathology of experimental animals. The factor analytic approach was used to analyze the dosage-efficacy/toxicity relationship of prepared rhubarb.

RESULTThe factor analytic approach was used to extract two common factors from the nine biochemical indexes. The firs common factor was mainly dominated by HA, LN and TGF-β1, and could be explained as fibrotic factors. The second common factor was mainly dominated by ALT, AST and ALP, and could be explained as cellular factor. The results of the factor analysis suggested that prepared rhubarb showed significant bidirectional effects in hepatoprotection and hepatotoxicity, which could protect liver in CC14 injured chronic hepatic injury, but had a certain hepatotoxic effect to normal animals. The pathological examination showed consistent results with the factor analysis. Under comparable dosages, prepared rhubarb showed a stronger liver protecting effect than crude rhubarb, with a lower toxicity.

CONCLUSIONAlthough prepared rhubarb has a certain hepatotoxic effect to normal animals, it has also a significant therapeutic effect to animals with liver injury. The results proved the symptom-based prescription theory and the scientificity of the symptom-based medication. The symptom-based prescription theory is important to correctly realize the dosage-efficacy/toxicity relationship of traditional Chinese medicines and guide the symptom-based medication.

Animals ; Dose-Response Relationship, Drug ; Drug Prescriptions ; Drugs, Chinese Herbal ; pharmacology ; toxicity ; Female ; Fibrosis ; Liver ; drug effects ; metabolism ; pathology ; Male ; Rats ; Rats, Sprague-Dawley ; Rheum ; chemistry ; Toxicity Tests

Adenocarcinoma ; pathology ; surgery ; Aged ; Carcinoma, Signet Ring Cell ; pathology ; surgery ; Cell Differentiation ; Female ; Follow-Up Studies ; Gastrectomy ; methods ; Humans ; Male ; Middle Aged ; Paneth Cells ; pathology ; Stomach Neoplasms ; pathology ; surgery

Humans ; Lead ; toxicity ; Male ; Reproduction ; drug effects ; Sperm Count ; Sperm Motility ; drug effects

Objective To evaluate prourodynamic study and somatosensory evoked potentials(SEPs)before and after operation of children with lipomyelomeningocele(LMMC)and its clinical significance.Methods Urodynamic study(UDS)and SEPs in 31 cases of LMMC who underwent microsurgical release within 1 week preoperatively and 3 months postoperatively were conducted.The 4 parameters used for UDS evaluation were bladder volume,compliance,detrusor activity and residual urine;parameters used for SEPs evaluation were latent period and amplitude.Results There was a statistics significant difference between operation and control group;the similar result was attented in the comparison of before and after operation,also in the comprison of the improved group and the group without improvement after operation.Conclusions UDS and SEPs investigation can provide guidance for the treatment of tethered cord syndrome(TCS)and evaluate clinical prognosis.These cases with the severity changing in UDS and somatosensory shall be avoided unnecessary action in operation.

Objective:To investigate the expression and prognostic significance of CD19 in patients with Acute myelogenous leukemia with AML1-ETO positive. Methods: Clinical data of 66 patients AML with AML1-ETO positive who were newly diagnosed from Jan 2010 to Dec 2015 were collected. To retrospectively analyze the relationship between clinical characteristics and expression of CD19,so dose the prognosis. Results:The positive rate of CD19 expressing in AML with AML1-ETO positive was 50. 0%. There were no statistically significant differences in terms of age,gender,hemoglobin,platelet,percentage of bone marrow blasts,accompanied with chromosome ,gene mutations between patients with and without CD19 expression(P>0. 05). The white blood cell count(WBC) of the CD19 negative group was higher than CD19 positive group,while showed significant difference(P=0. 027). Although the relapse-free survival (RFS) of patients with CD19 expression was higher than those without,no significant difference was calculated (P=0. 105). Patients with CD19 expression had superior overall survival ( OS ) compared to those without CD19 expression ( P = 0. 030 ) . Multivariable analysis for OS identified CD19 positivity as an independent predictor associated with better prognosis. Conclusion: The expression of CD19 in AML with AML1-ETO positive may be an indicator associated with better prognosis.

Objective:To study the effect of nerve growth factor(NGF)on bone fracture healing of inflicted T_(10)spinal cord injury(SCI)complicated with tibia fracture in rats.Methods:Totally 120 rats were randomly divided into tihia fracture group (F group,n=40),T_(10)SCI+tibia fracture group(FS group,n=40),and T_(10)SCI+tibia fracture+NGF group(FSN group,n=40).Four weeks later,the fracture sites in the 3 groups were subjected to CT scanning;the maximum transverse diameter of the fracture ends and the gray scales of non-osseous area were measured;the changes of biomechanics property of the fracture ends were determined by three-point bending test;the bone morphometry,bone density,and histomorphology of callus were determined;the expression of OCN was detected by immunohistochemical method;the osteoblast ultrastructure was observed by TEM and the expression ofⅠ,Ⅱtype collagen were examined by Western blotting.Results:The maximum transverse diameter of F group was less than those of FS group(P

0.05. Conclusion The tumour chemosensitivity test in vitro gave some prediction and guidances for the clinic chemotherapy,and it could discover the drug resisting cases.The combined chemotherapy should be selected for gastric carcino- ma patients.

Objective To apply Estimation and Projection Package (EPP) and Spectrum models for the estimation and projection on HIV/AIDS epidemics in areas with relatively low HIV/AIDS prevalence in China,and to explore the influences of antiretroviral therapy (ART) on the outputs of the models.Methods Taizhou prefecture in Zhejiang province was selected as the study site.Social and demographic data as well as all the information on HIV/AIDS epidemics in Taizhou prefecture were collected,managed,input to EPP and Spectrum models to estimate and project the HIV/AIDS epidemic in Taizhou prefecture.Impact of ART on the HIV/AIDS epidemic was also assessed.Results According to the estimates from both EPP and Spectrum model,the HIV/AIDS epidemic in Taizhou prefecture was at a relatively low level.HIV prevalence rates among men having sex with men (MSM) and injection drug users (IDU) were relatively high and rapidly increasing.It was estimated that 1773 (1384-2449) people were living with HIV in 2010 in Taizhou prefecture,with an overall HIV prevalence of 0.03％ (0.02％-0.04％).ART had reduced and would continue to reduce new HIV infections and AIDS deaths,but had no significant impact on the overall HIV prevalence and the numbers of people living with HIV and adults who were in need of ART.Conclusion EPP and Spectrum models seemed to be suitable and useful tools for estimation and projection on HIV/AIDS in Taizhou prefecture,and the results could provide reference for the further studies in other areas with a relatively low epidemic level of HIV/AIDS.ART appeared effective for HIV/AIDS prevention and control.

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

BACKGROUND/AIMS: Healthcare-associated infections (HAIs) in critically ill patients with prolonged length of hospital stay and increased medical costs. The aim of this study is to assess whether daily chlorhexidine gluconate (CHG) bathing will significantly reduce the rates of HAIs in adult intensive care units (ICUs). METHODS: PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials were systematically searched until December 31, 2014 to identify relevant studies. Two authors independently reviewed and extracted data from included studies. All data was analyzed by Review Manager version 5.3. RESULTS: Fifteen studies including three randomized controlled trials and 12 quasi-experimental studies were available in this study. The outcomes showed that daily CHG bathing were associated with significant reduction in the rates of primary outcomes: catheter-related bloodstream infection (risk ratio [RR], 0.44; 95% confidence interval [CI], 0.32 to 0.63; p < 0.00001), catheter-associated urinary tract infection (RR, 0.68; 95% CI, 0.52 to 0.88; p = 0.004), ventilator-associated pneumonia (RR, 0.73; 95% CI, 0.57 to 0.93; p = 0.01), acquisition of methicillin-resistant Staphylococcus aureus (RR, 0.78; 95% CI, 0.68 to 0.91; p = 0.001) and vancomycin-resistant Enterococcus (RR, 0.56; 95% CI, 0.31 to 0.99; p = 0.05). CONCLUSIONS: Our study suggests that the use of daily CHG bathing can significantly prevent HAIs in ICUs. However, more well-designed studies are needed to confirm these findings.
Adult* ; Baths* ; Chlorhexidine* ; Critical Care* ; Critical Illness ; Enterococcus ; Humans ; Intensive Care Units* ; Length of Stay ; Methicillin-Resistant Staphylococcus aureus ; Non-Randomized Controlled Trials as Topic ; Pneumonia, Ventilator-Associated ; Urinary Tract Infections