International Standard for Medical Laboratories Accreditation demanded monitoring the quality of the total testing process (TFP).Recently, the errors in the analysis phase had been effectively controlled, while the errors in pre-and post-analytical phases still remained comparably high, and became the major factors influencing the TTP quality.Thus, monitoring and improving the quality of the extraanalytical phases became the major challenge.Monitoring the TTP quality required the laboratory staff to extend the quality management to the influential elements outside the laboratory.In addition, it also prompted the organizers of external quality assessment (EQA) in China to provide a quality assurance program for extra-analytical phases.The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) had developed a model of quality indicators.The Q-Probes and Q-Tracks programs of the College of American Pathologists provided a good practice of monitoring and improving quality for the extraanalytical phases.Based on the related international guidelines, the QIs system was established for quality management and control in clinical laboratory, so as to manage EQA of extra-analytical phases.

BACKGROUND: Cigarette smoking has been recognized as one of the high risk factors in carcinogenesis of lung cancer. Early diagnosis of lung cancer may be of clinical therapy value.OBJECTIVE: To explore the mutation of K-ras oncogene in bronchoalveolar lavage fluid(BALF) in order to reveal its relationship with cigarette smoking in lung cancer patients.DESIGN: Randomized controlled trial based on the patients.SETTING: Department of Toxicology, College of Radiology and Public Health of a university, and Department of Respiratory Medicine of a university hospital.PARTICIPANTS: The out-patients and inpatients in the Second Affiliated Hospital of Soochow University between June 1999 and September 2001 were included. The patients were confirmed to have lung cancer or innocuous diseases by fiber bronchoscopy through bronchoalveolar lavage(BAL) and cytological or pathological examination.METHODS: BALF samples were obtained from 37 smoking patients with lung cancer and 25 nonsmoking patients with lung cancer, and 20 with benign pulmonary diseases in the Second Affiliated Hospital of Soochow University. They were detected for K-ras codon 12 mutations using polymerase chain reaction with restriction fragment length polymorphism(PCR-RFLP).MAIN OUTCOME MEASURES: Codon 12 mutations of K-ras gene.RESULTS: K-ras mutation in patients with lung cancer was found to have an average frequency of 36% (22/62)but no K-ras gene mutation was detected in patients with benign pulmonary diseases. The mutation frequency in heavy smokers(69% ) was higher than that in moderate smokers(31%), mild smokers (25%) and nonsmokers (20%). The mutation was related to age and history of smoking, but not to sex and TNM classification.CONCLUSION: Cigarette smoking may be correlated with the mutation of K-ras gene. Early detection of K-ras mutation in BALF may be of clinical value, which helps the identification and diagnosis of smoking-related lung cancer.

Objective To investigate endoscropic assist in rat orotracheal intubation.Methods 40 rats were randomly divided into two groups.The procedure time, total time, intubation frequency,the success rate of the first intubation and the survival rate in 24h were compared between the conventional group and the endoscropic group.Results The total time in two groups were nearly the same.But the procedure time and frequency of intubation were significantly less in the endoscropic group than those in the conventional group.The success rate of the first intubation in the endoscropic group was obviously higher than that of the conventional group.There was no obviously difference between the survival rate after extubation in 24h between groups.Conclusion Endoscropic assist is superior to the conventional method and worth promoting.

Objective To investigate the relationship between the leptin level and neonatal weight and the expression of leptin in placenta. Methods The concentrations of leptin in 100 maternal blood and umbilical blood of the term pregnant women were examined by radioimmunoassay (RIA). According to the neonatal weight to divide into the large for gestational age (LGA) group 19 cases, the appropriate for gestational age (AGA) group 65 cases, the small for gestational age (SGA) 16 cases. The level of leptin mRNA in 41 placental tissue was examined by Reverse transcription polymerase chain reaction (RT PCR). Results (1) The expression level of leptin mRNA in placenta was 0 97?0 04, which was positively related to the neonatal weight significantly ( r =0 43, P 0 05).(3)The concentration of leptin in umbilical blood was (7 58? 5 15) ?g/L, which was positively related to the neonatal weight ( r =0 57, P

Objective To observe the impact of DPP4 inhibitor Saxagliptin on body weight of type 2 diabetes patients. Methods In this randomized and parallel study,50 patients were given either Saxagliptin(n=25)or Glimepiride(n=24). The changes of body weight, HbA1c and hypoglycemic events were observated in 12 weeks. Results There were no significant difference in gender,age and body weight between 2 groups(P>0. 05). After 12 weeks treatment,body weight has significant changed in both group,and the weight changes were sig-nificant differet in two groups:an average of 0. 4 kg weight was increased in Glimepiride group and 0. 4 kg weight was decreased in Saxagliptin group (P<0. 05). The change of HbA1c level has no statistical difference in two groups (P>0. 05). Hypoglycemia event was happened four times in Glimepiride group,while no hypoglycemia event was happened in Saxagliptin group. Conclusion Compared with Glimepiride,Saxa-gliptin provides similar hypoglycemic action with less hypoglycemia,at the same time,Saxagliptin yields better results in lowering weight.

In type 2 diabetes mellitus,the levels of leptin were higher in female and obese subjects compared with male and non-obese subjects.There was negative relationship in female between leptin and HbA_1c,and negative relationship between leptin and HDL-C in male.Gender and obesity had no effect on TNF-? and NP Y.

In order to optimize extraction process conditions of tannins from Geranium orientali-tibeticum by supercritical CO2, the content of tannins was determined by phosphomolybdium tungsten acid-casein reaction, with extraction pressure, extraction temper- ature and extraction time as factors, the content of tannins from extract of G. orientali-tibeticum as index, technology conditions were optimized by orthogonal test. Optimum technology conditions were as follows: extraction pressure was 25 MPa, extraction temperature was 50 °C, extracted 1.5 h. The content of tannins in extract was 12.91 mg x g(-1), extract rate was 3.67%. The method established could be used for assay the contents of tannin in G. orientali-tibeticum. The circulated extraction was an effective extraction process that was stable and feasible, and that provides a way of the extraction process conditions of tannin from G. orientali-tibeticum.
Carbon Dioxide ; chemistry ; Chemical Fractionation ; methods ; Drugs, Chinese Herbal ; chemistry ; Geranium ; chemistry ; Tannins ; isolation & purification

With the advantage of clear target and little side effect, antibody drug has attracted widely attention of worldwide pharmaceutical companies. However, large scale mammalian cell culture and antibody quality analysis are the bottlenecks of antibody drug industrialization in China. Especially due to the significant effect of cell culture conditions on antibody heterogeneity. Therefore, it is extremely urgent to optimize cell culture conditions to favor the demands of antibody drug development. This review summarized the most recent advances in the effect of cell culture conditions on antibody quality, followed by addressing the key issues that might be strategically important for domestic antibody drug development.
Animals ; Antibodies, Monoclonal ; biosynthesis ; isolation & purification ; Antibody Formation ; Cell Culture Techniques ; methods ; trends ; Genetic Heterogeneity ; Protein Stability ; Quality Control

In this paper, a qualitative and quantitative analysis method was established for the scopoletin in herba Artemisiae hedinii hy HPLC. The chromatographic column was Agilent TC-C18 (4.6 mm×250 mm, 5μm);the tem-perature of column was 30℃, eluted with a mobile phase consisted of methanol and 0.3%phosphoric acid solution and gradient elution at a flow rate of 1.0 mL·min-1. The detection wavelength was 344 nm. The results showed that the mass concentration and peak area of scopoletin had a good linear relationship within the range of measurement (r=0.999 9). The reproducibility was good;and the RSD was 1.51%. The average sample recovery rate was 101.42%. It was concluded that the established method was stable, reliable and simple. It provided theoretical evidences for the quality evaluation and quality control of herba A. hedinii.

Objective • To investigate the effects of bisphenol A (BPA) on the development and neurobehavior of zebrafish. Methods • The zebrafish fertilized eggs that developed to 4 hpf (hours post-fertilization) were treated with different concentrations of BPA (0, 2.5, 25, 250, and 2 500 μg/L). Survival rates, malformation rates, hatching rates, 24 hpf autonomic movement, and 48 hpf heart rates in the groups were observed and recorded. And the neurobehavioral test of larval zebrafish that developed to 144 hpf was performed. Results • The BPA exposure did not affect the survival rates, malformation rates and hatching rates of zebrafish. Compared with the control group, the autonomic movement in 24 hpf and heart rate in 48 hpf of zebrafish embryos that exposed to 2 500 μg/L BPA decreased (P=0.000), and the total distance and average speed of larval zebrafish that developed to 144 hpf also decreased (P=0.000). The behavior of larval zebrafish exposed to 250 μg/L and 2 500 μg/L BPA changed on light-evoked startle escape response activity, mainly including the decrease of total distance under strong light stimulation (P<0.05). Conclusion • BPA exposure during embryonic phase has developmental toxicity and neurotoxicity on zebrafish.