Objective To evaluate the application and efficacy of 6S quality management methods in drug clinical trials of oncology department.Methods By using 6S (Seiri,Seiton,Seiso,Seiketsu,Shitsuke,Safety) quality management methods,quality about mastering level of good clinical practice (GCP) knowledge,sample collection and drug management etc.were controlled,and efficacy after the quality control was evaluated.Results After implemention of 6S quality management,rate of achieving GCP certificate was increased to 77.80％,accuracy rate of sample collection and accuracy rate of medicine preparation were increased to 100.00％,and the rate of relearning study protocol was increased to 100.00％,and subjects' satisfaction was improved significantly.Conclusion The implementation of 6S quality management methods could effectively enhance the quality of drug clinical trials in oncology department.

This paper reviewed the common ethical issues in oncology drug clinical trials implementation of one hospital, such as the auditing and implementation of research protocols were not strict, the quality of research-ers needed to be improved, the hardware facilities for drug clinical trial was lacking, the informed consent signature was not standard, and the professional quality control was lacking. After corresponding countermeasures had been taken, such as the strict examination of research programs, strengthening the research team construction, taking the focus of GCP and SOP training, equipping hardware facilities for drug clinical trials, standardizing of ICF signa-ture, and the joint implementation of the quality control in hospital and departments, the researchers′ professional quality was further improved, which established a good foundation for better implementation of the drugs clinical tri-als and protection of the participants′interests.

OBJECTIVETo analyze the electrical activity property changes in nucleus accumbens (NAc) of heroin-induced conditioned place preference (CPP) rats during different stages of heroin dependence and to explore NAc's roles in the formation of drug dependence.

METHODSRecording electrodes were bilaterally embedded into the NAcs of rats with the aid of stereotaxic apparatus, followed by establishment of heroin-dependent rat model. The NAc electrical activity during 3 different stages of heroin dependence, including heroin pre-exposure, immediate post-exposure and heroin withdrawal, were respectively recorded using EEG wireless telemetry techniques. The frequency distribution (ranging from 0.5 to 30 Hz) and the amplitude of NAc electrical activity were analyzed and measured.

RESULTSHeroin-dependent rat models were successfully established and their withdrawal symptoms were evident. All rats showed a conditioned place preference (CPP) for the white box after 5-10 days of heroin-exposure, and displayed a maximum withdrawal symptoms on 2d after heroin- withdrawal. During all statges of heroin-dependence, the NAc electrical activity contained the highest proportion of delta rhythm and the lowest proportion of alpha2 rhythm. The discharge frequence band was similar across different stages. There was a significantly increased ratio of low-frequency discharges (delta rhythm) and decreased ratio of high-frequency discharges (beta rhythm) in NAc of rats during the immediate post- heroin exposure stage when compared with that during pre-exposure and heroin withdrawal stages. During the withdrawal stage, the ratio of at rhythm was significantly lower than during pre- and post-heroin exposure stages (P < 0.01). Further, the mean discharge amplitude in NAcs during immediate post-exposure and withdrawal stages was significantly increased relative to pre-exposure stage. However, the mean discharge amplitude during heroin withdrawal stage was significantly lower than during immediate post-exposure stage.

CONCLUSIONThe electrical activity properties in rat NAcs showed a significant change during different stages of heroin-dependence, which suggested that neuronal activities in NAcs might contribute to the modulation of drug-dependence.

Animals ; Conditioning, Operant ; Heroin ; pharmacology ; Heroin Dependence ; physiopathology ; Male ; Nucleus Accumbens ; physiopathology ; Rats ; Rats, Sprague-Dawley ; Telemetry

The aim of this study was to establish a diagnostic method for ABO genotyping and to investigate the distribution of ABO genotype in Beijing Han population so as to understand the distribution characteristics and regularity of ABO genotype. An ABO genotyping method was established by using multiplex-PCR-RFLP and PCR-SSP techniques, and the ABO allele frequency in Beijing Han population was investigated. The results showed that A102, O1 and B allele were more common genes in Beijing Han individuals. And A102 allele was predominant in the phenotype A group in this population. Three O2 alleles were found and no A201 allele was found while gene frequency investigation was performed. No A101A101, A101O2, A102O2, BO2 and O2O2 in this population were discovered. It is concluded that the primary regularity of ABO allele distribution in Beijing Han population is found through this study. It provides basic reference for further study of ABO types.
ABO Blood-Group System ; genetics ; Adult ; Alleles ; Asian Continental Ancestry Group ; genetics ; China ; ethnology ; Female ; Gene Frequency ; Genotype ; Humans ; Male ; Middle Aged ; Polymerase Chain Reaction ; methods ; Polymorphism, Genetic ; Young Adult

OBJECTIVETo investigate the clinical characteristics and prognosis of different breast cancer molecular subtypes.

METHODSClinicopathological and follow-up data of 1153 cases of operable breast cancer were analyzed retrospectively. Their molecular subtypes were categorized as luminal A, luminal B, Her-2 over-expressing and basal-like subtypes, based on detection of ER, PR, Her-2 expression. The correlation of prognosis of different molecular subtypes with age, tumor size, lymph node status and clinical staging was analyzed.

RESULTSAmong the 1153 cases, 791 cases (68.6%) were of luminal A subtype, 50 cases (4.3%) luminal B subtype, 53 cases (4.6%) Her-2(+)subtype, and 259 cases (22.5%) basal-like subtype. There were no statistically significant differences among different molecular subtypes regarding the age, tumor size, lymph node status, and clinical stage. 1006 cases had complete follow-up data and the analysis showed that distant metastasis of Her-2 over-expressing subtype was significantly higher than that in other subtypes (P = 0.005), but the differences of local recurrence rate in different molecular subtypes was not statistically significant (P > 0.05). Kaplan-Meier method was used to analyze the survival prognosis of different molecular subtypes, showing both DFS rate and OS rate of Her-2 over-expressing subtype were the lowest, with a statistically significant difference (Log rank test, P < 0.05). Univariate and multivariate analyses showed that molecular typing and lymph node status were independent prognostic factors affecting both DFS and OS.

CONCLUSIONSHer-2 over-expressing subtype has the worst prognosis. Molecular subtypes may provide important information to predict the prognosis of breast cancer and might be an important basis for individualized treatment of breast cancer in future.

Adult ; Aged ; Aged, 80 and over ; Breast Neoplasms ; classification ; metabolism ; pathology ; therapy ; Carcinoma, Ductal, Breast ; classification ; metabolism ; pathology ; therapy ; Chemotherapy, Adjuvant ; Disease-Free Survival ; Female ; Follow-Up Studies ; Humans ; Lymphatic Metastasis ; Mastectomy ; methods ; Middle Aged ; Neoplasm Metastasis ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Proportional Hazards Models ; Radiotherapy, Adjuvant ; Receptor, ErbB-2 ; metabolism ; Receptors, Estrogen ; metabolism ; Receptors, Progesterone ; metabolism ; Retrospective Studies ; Survival Rate ; Young Adult

Limitations of polyacrylamide gel or agarose gel electrophoretic methods in genotyping research affect the interpreting of detection results. In order to develop a simple and reliable method for appraising results of ABO genotyping detection, the microfluidic chip analysis system was established by using microfluidic chip to replace the gel electrophoresis and combining with multiplex-PCR-RFLP technique. 150 blood samples were tested by this microfluidic chip analysis system with multiplex-PCR-RFLP technique to evaluate its stability and accuracy. The results showed that all the testing results were consistent with serologic ABO genotyping results and 1 blood sample with decrease of B antigen caused by CML was identified. In conclusion, the established microfluidic chip analysis system is stable and reliable technique. Application of this technique enables the ABO genotyping results to be more objective and accurate.
ABO Blood-Group System ; genetics ; Blood Grouping and Crossmatching ; methods ; DNA Primers ; genetics ; Genotype ; Humans ; Microfluidic Analytical Techniques ; Microfluidics ; Oligonucleotide Array Sequence Analysis

BACKGROUNDDifficult airway remains not only a challenge to the anesthesiologists, but also a life-threatening event to the patients. Awake intubation is the principal choice to deal with difficult airway, and a key point for awake intubation is airway topical anesthesia. Yet, so far there is no ideal topical anesthesia approach for awake intubation. This study aimed at evaluating the effect of pressure-driven (by 10 L/min oxygen flow) lidocaine spray on airway topical anesthesia in order to find a powerful and convenient method for airway topical anesthesia for conscious sedation intubation.

METHODSThirty adult patients referred for elective surgery under general anesthesia, aged 18 - C60 years and Mallampati class I or II, were recruited for the study. Before topical anesthesia, the observer's assessment of alert and sedation (OAA/S) scale was controlled between 3 and 4 by intravenous midazolam (0.03 mg/kg), propofol (2 mg×kg(-1)×h(-1)) and remifentanil (0.05 µg×kg(-1)×min(-1)). Ten minutes after sedation, topical anesthesia was performed with the pressure-driven lidocaine spray; the driving pressure was achieved by an oxygen flow of 10 L/min. After topical anesthesia, tracheal intubation was performed and the intubation condition was assessed with modified the Erhan's intubation condition score by an experienced anesthesiologist, and a score of less than 10 was considered to be satisfactory. Attempts to intubate the patient were recorded, and the complications such as local anesthetic toxicity, mucosa injury, and respiration depression were also recorded. The mean arterial blood pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded at different time points before and after intubation. Patients were asked 24 hours after the operation whether they could recall the events during intubation.

RESULTSAll patients were intubated at the first attempt, the average intubation condition score was 7.0 ± 1.1, from 6 to 10, satisfied intubation condition. MAP and HR increased significantly but mildly immediately after the tracheal intubation (P < 0.05), and decreased to the pre-intubation level soon after intubation. There were no related complications and patients had no recall of the intubation procedures.

CONCLUSIONSTopical anesthesia with pressure driven 2% lidocaine spray, where pressure is achieved by 10 L/min oxygen flow, can offer satisfactory intubation conditions for conscious sedation intubation.

Adolescent ; Adult ; Anesthesia, Local ; methods ; Conscious Sedation ; methods ; Female ; Humans ; Intubation, Intratracheal ; methods ; Lidocaine ; administration & dosage ; therapeutic use ; Male ; Middle Aged ; Young Adult

Objective: To investigate the prevalence and associated factors of eating out among children and adolescents aged 6-17 in Hebei Province, and to explore the association between eating out and overweight/obesity. Methods: Data came from Children and Nurse Nutrition Health Monitoring of China during 2016-2017. Questionnaire surveys and anthropometric measures was conducted among 3 330 children aged 6-17 in 12 survey sites. Multivariate Logistics stepwise regression model was used to analyze the influencing factors of eating out and the relationship between eating out and overweight/obesity. Results: The proportion of eating out was 16.19%, and the rate of overweight and obesity was 29.43%. Multivariate analysis showed that the older children (junior high school students:OR=1.36; high school students:OR=3.57, both P<0.05) and adolescents from highincome families (10 000~<20 000 CNY:OR=1.48; ≥20 000 CNY:OR=2.93, both P<0.05) were more likely to eat out. Children and adolescents living in rural areas (OR=0.20, P<0.01), nononlychild (OR=0.76, P=0.02), day school students (OR=0.21, P<0.01), and the primary caregivers of the elderly (OR=0.69, P=0.03) were less likely to eat out. In addition, eating out was statistically associated with an increased risk of overweight and obesity (OR=1.31, P<0.01). Conclusion Eating out is common among children and adolescents aged 6-17 in Hebei Province. Residency, age, household income, onechild family, boarding and and eating out behaviors of primary caregivers are associated with eating out among children and adolescents. Eating out may increase the risk of overweight/obesity in children.

Objective:To investigate the effects of intravascular hypothermia combined with early post-pyloric feeding on the neurological function and prognosis in patients with severe ischemic stroke, and to provide a theoretical basis for clinical decision-making on the optimal nutritional support strategy for patients with severe ischemic stroke during intravascular hypothermia treatment.Methods:This was a retrospective, non-randomized, controlled study. A total of 78 patients with first severe ischemic stroke who were admitted to the ICU of Neurology Department, Xuanwu Hospital, Capital Medical University from January 2018 to December 2021 were selected. General information and clinical data of the patients were collected and grouped according to intrvascular hypothermia combined with nutritional support. Patients were divided into early post-pyloric feeding group of 52 cases and early parenteral nutrition group of 26 cases. The neurological prognosis, disease prognosis, nutritional status and complications related to nutritional support of the two groups were retrospectively analyzed.Results:The Glasgow score at 30th day after intravascular hypothermia in the early postpyloric feeding group was (11.25 ± 4.92) points, which was higher than that in the early parenteral nutrition group (8.40 ± 5.53), and the difference was statistically significant ( t=-2.45, P<0.05). After treatment, the serum total protein and hemoglobin of early postpyloric feeding group were (59.56 ± 5.09) g/L and (131.06 ± 19.58) g/L, respectively, which were higher than those of early parenteral nutrition group (56.52 ± 7.94) g/L and (122.07 ± 17.72) g/L. The difference was statistically significant ( t=-2.03, -1.91, P<0.05). The clinical pulmonary infection score of the early postpyloric feeding group was (7.33 ± 0.96) points, which was lower than that of the early parenteral nutrition group (9.42 ± 2.11). The mechanical ventilation time and ICU stay time were (17.46 ± 10.47) days and (28.89 ± 12.59) days, respectively. Compared with the early parenteral nutrition group (25.77 ± 15.20) days and (37.07 ± 17.15) days, the differences were statistically significant ( t=3.28, 2.83, 2.52, all P<0.05). There were no significant differences in catheter-associated bloodstream infection and ICU hospitalization mortality between the two groups (both P>0.05). Conclusions:Intravascular hypothermia combined with early post-pyloric feeding can improve the nutritional status of patients with severe ischemic stroke, effectively control pulmonary infection, shorten mechanical ventilation and hospital stay, and promote neurological repair.

OBJECTIVETo investigate the incidence of Philadelphia chromosome (Ph) in adult B-lineage acute lymphoblastic leukemia (B-ALL).

METHODSOne hundred and twelve adult patients with previously untreated B-ALL were prospectively investigated by interphase dual-color dual-fusion fluorescence in situ hybridization (DD-FISH) with two-color break apart probe BCR-ABL and the results were compared with that of conventional cytogenetics (CC).

RESULTSThe incidence of Ph chromosome was 17.98% (16/89) and 31.25% (35/112) by CC and DD-FISH, respectively. The mean positive rate of Ph+cells by FISH was 66.23% (ranging 18.5%-99%). Of the 35 Ph+ALL patients by FISH, 25 were successfully karyotyped by CC which included 5 normal karyotypes, 20 abnormal karyotypes including 16 Ph chromosome and 13 complex abnormalities.

CONCLUSIONThe incidence of Ph chromosome was 31.25% in adult with B-ALL. DD-FISH with BCR-ABL probe provides a powerful technique for the diagnosis of Ph+B-ALL. It is an important supplement to the CC analysis. DD-FISH technique should be used as a routine method for the diagnosis for adult acute B-ALL.

Adolescent ; Adult ; Aged ; B-Lymphocytes ; metabolism ; pathology ; Chromosome Aberrations ; Color ; Female ; Humans ; In Situ Hybridization, Fluorescence ; methods ; Interphase ; Karyotyping ; Male ; Middle Aged ; Philadelphia Chromosome ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; genetics ; pathology