OBJECTIVE:To analyze and compare the congruity between Maria and DDW-J standard and Roussel uclaf causali-ty assessment method(RUCAM)for diagnosing drug-induced liver injury(DILI),and evaluate its application. METHODS:In ret-rospective analysis,the clinical data of 122 patients with DILI with RUCAM ≥3 scores was quantitatively scored by Maria and DDW-J standard,χ2 test was conducted for statistical analysis. RESULTS:Among the 122 cases,120 cases(98.4%)were classi-fied as“likely and possible”by DDW-J standard,which was significantly higher than the 58 cases(47.5%)that classified as“pos-sible”by Maria standard,with statistical significance;and compared with Maria standard,DDW-J standard was more closer to RU-CAM scoring results. CONCLUSIONS:DDW-J standard is superior to Maria standard,and close to RUCAM scoring results for DI-LI;RUCAM is still the DILI diagnostic evaluation system with high accuracy and operability.

Based on the principles of the in vitro staining technique, hypotonic swelling test, and water test, the Eosin Y-water test method was developed to simultaneously detect the integrity of the sperm head and tail and sperm membrane structure and function. As a widely used method in clinical laboratories in China, the Eosin Y-water test is methodologically characterized by three advantages. Firstly, both the sperm head and tail can be detected at the same time, which allows easy and comprehensive assessment of membrane damage in different parts of sperm. Secondly, distilled water is used instead of the usual formula solution to simplify and standardize the test by eliminating any potential effects on the water molecules through the sperm membrane due to different osmotic pressure or different sugar proportions and electrolyte solutions. Thirdly, the test takes less time and thus can be repeated before and after treatment. This article focuses on the fundamental principles and modification of the Eosin Y-water test and its application in sperm function examination and routine semen analysis for male infertility, assessment of the quality of sperm retrieved by testicular fine needle aspiration, semen cryopreservation program development, and evaluation of sperm membrane integrity after microwave radiation.
Cell Membrane ; China ; Cryopreservation ; Eosine Yellowish-(YS) ; Fluorescent Dyes ; Humans ; Infertility, Male ; diagnosis ; Male ; Osmotic Pressure ; Semen Analysis ; methods ; Sperm Head ; Sperm Motility ; Sperm Tail ; Spermatozoa ; Staining and Labeling ; Water

Aim To study and compare the pharmaco-kinetic parameters of roxithromycin under normoxic and hypoxic rats. Methods A highly effective and rapid ultra-performance liquid chromatography with tandem mass spectrometry ( UPLC-MS/MS) method with posi-tive electrospray ionization source was successfully de-veloped and validated for quantification of roxithromy-cin in rat plasma. Sprague-Dawley rats were randomly divided into the hypoxia and normoxic groups. Each rat obtained a single dose of roxithromycin with 10 mg · kg-1 via intragastric administration. The pharmacoki-netic parameter comparison between normoxic and hy-poxic groups was calculated by SPSS software using in-dependent sample t test method. Results The main pharmacokinetic parameters of roxithromycin between the normoxic and hypoxic rats were:the AUC(0-t) 7 576 and 3 761 μg·h·L-1 , MRT(0-t) 5. 6 and 7. 7 h, T1/2 3. 4 h and 3. 9 h, CL 1. 5 and 3. 0 L · h-1 · kg-2 , tmax3. 1 and 3. 4 h, Cmax 1 116 and 372 μg·L-1 , re-spectively. The levels of Cmax and AUC of roxithromy-cin in hypoxic rats were statistically lower than those in normoxic rats. Conclusion The exposure level of rox-ithromycin in hypoxic rats markedly decreased. Our re-sults may provide an important experimental basis to adjust the dosage for roxithromycin in hypoxic clinical practice.

Objective To analyze the sensitivity of clinical isolates of Candida albicans to flucona- zole,to detect mutations in their ERG11 genes,and to investigate the correlation between ERG11 gene mutation and resistance to fluconazole.Methods Candida albicans was identified from clinical isolates of Candida spp..The sensitivity to fluconazole was detected in vitro by microdilution-basesd method and Rosco tablets method.Three pairs of primers were designed to amplify three fragments of ERG11 gene(483 bps, from 295 bp to777 bp;482bps,from 723 bp to 1204 bp;489 bps,from 1179 bp to 1667 bp)after the extracting of genomic DNA.PCR products were sequenced.Results Eighty clinical isolates of Candida spp.were collected,which included 52 isolates of Candida albicans,all of which were sensitive to flucona- zole.Nineteen mutations were detected in ERG11 gene of 5 fluconazole-sensitive clinical isolates.Of the 19 mutations,14 were samesense mutations,and the remaing 5 missense mutations(T495A,A530C, G640A,A945C and G1609A),resulting in amino acid substitution D116E,K128T,E165K,E266D and V488I,respectively in lanosterol 14 alpha-demethylase.E165K was a novel mutation.Conclusions The clinical isolates of Candida albicans were highly sensitive to fluconazole;E165K and V488I might not lead to the resistance of Candida albicans to fluconazole.

Objective To investigate the clinical indicators which can predict esophageal varices in patients with primary biliary cirrhosis (PBC).Methods A total of 351 patients with PBC from the First Affiliated Hospital of Xinjiang Medical University from January 2013 to December 2016 were retrospectively analyzed, including 173 patients with esophageal varices and 178 patients without varicose veins.The alanine aminotransferase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), γ-glutamyl transpeptadase (γ-GT), total bilirubin (TBil), albumin (Alb), prothrombin time (PT), platelet (PLT), AST to ALT ratio (AAR), fibrosis index based on the 4 fator (FIB-4), AST to PLT ratio index (APRI) and Mayo scores were compared between two groups.Group t test or rank sum test was used to compare the two groups.Relation between the indicators mentioned above and esophageal varices were tested by univariate analysis.Multivariate unconditional Logistic regression was used to screen these indicators to independently predict esophageal varices in PBC patients.Results Age, PT, TBil, AAR, FIB-4, APRI and Mayo scores of PBC patients with esophageal varices were all higher than those of patients without esophageal varices ([60.3±10.6] years old vs [51.9±10.9] years old, [13.31±3.12] s vs [11.17±2.42] s, 28.06 [18.05, 60.06] mmol/L vs 15.39 [10.64, 33.63] μmol/L, 1.69±0.91 vs 1.23±0.95, 6.18 [4.05,9.16] vs 1.80 [1.10,2.74], 1.95 [1.12,3.08] vs 0.69 [0.38,1.57], 6.45±1.52 vs4.62±1.53, respectively).Whereas ALT, γ-GT, Alb and PLT levels were all lower than those without varicose veins (36.60 [19.88, 74.28] U/L vs 59.32 [23.58, 132.70] U/L, 71.00 [38.36, 165.38] U/L vs 125.00 [37.50, 336.21] U/L, [29.78±6.33] g/L vs [39.51±25.16] g/L, [103.43±52.84]×109/L vs [234.44±90.40]×109/L, respectively).The differences were all statistically significant (t=-7.25, t=-7.18, Z=-5.823, t=-4.60, Z=-8.427, Z=-12.661, t=-11.25, Z=-3.218, Z=2.987, t=4.94, t=16.63, respectively;all P<0.01).Multivariate unconditional logistic regression analysis showed that PLT<149×109/L (OR=0.966, 95% CI: 0.957-0.974), PT>11.95 s (OR=0.705, 95%CI: 0.569-0.874), TBil>17.19 μmol/L (OR=0.99, 95%CI: 0.982-0.999), FIB-4>3.02 (OR=0.868, 95% CI: 0.807-0.932) and Mayo score>4.88 (OR=6.053, 95%CI: 2.388-15.342) were independent clinical indicators for the prediction of esophageal varicose veins.Conclusions PLT, PT, TBil, FIB-4, and Mayo scores can be used as predictors of esophageal varices in patients with PBC.

The recombinant plasmid pCI-TSLC1 carrying TSLC1 gene was stably transfected into human hepatocellular carcinoma cell line HepG2. Cell proliferation was analyzed by MTT assay. The ability of migration was determined by transwell and FACSort flow cytometry was used to detect the cell cycle distribution and apoptosis. Western blotting revealed that H4 expressed higher amounts of TSLC1 protein than H15 and H0 did. The growth of TSLC1-transfected cells was significantly suppressed in vitro, and the ability of migration was reduced as well. The re-expression of TSLC1 could induce cell apoptosis. It was concluded that TSLC1 strongly inhibited the growth and ability of migration of HepG2 cell line in vitro and also induced apoptosis, suggesting that TSLC1 could reduce the tumorigenicity of human hepatocellular carcinoma cell line HepG2 in vitro, which provided a basis for further exploring the roles of TSLC1 in hepatocellular cellular carcinoma.
Apoptosis/*genetics ; Cell Adhesion Molecules/*genetics ; Cell Proliferation ; Hep G2 Cells ; Immunoglobulins/*genetics ; Neoplasm Invasiveness/genetics ; Transfection ; Tumor Suppressor Proteins/*genetics

Objective To investigate the conventional ultrasound characteristics of VX2 tumors in fatty liver and normal liver of rabbits,furthermore,to analysis the blood flow characteristics of them with contrast-enhanced ultrasound (CEUS).Methods Rabbit model of fatty liver and normal liver with implanted VX2 tumors were established,and examined using conventional and CEUS.QontraXt quantitative software of CEUS was used.Results The fatty liver models with 20 VX2 tumors and normal liver models with 23 VX2 tumors were successfully developed in rabbits.In conventional ultrasonography,hyperechoic VX2 tumor lesions in fatty liver were far less than them in normal liver (P =0.008).No significant difference was found in iso-echoic and hypoechoic VX2 tumor lesions between two groups (P ＞ 0.05).Compared with normal liver parenchyma,arrival time of fatty liver parenchyma was later,peak intensity was lower (P ＜0.05).There was no significant difference in arrival time,peak intensity,sharpness,area under curve between the VX2 tumors of normal liver and fatty liver (P ＞ 0.05).Conclusions There is a significant difference characteristic in conventional ultrasonography between VX2 tumors in fatty liver and normal liver.Fatty liver blood perfusion effects are lower than normal liver in CEUS.Quantitative parameters of CEUS are more objective and accurate for hemodynamic of VX2 tumors and fatty liver.

Objective To analyze hepatic inflammatory pseudoneoplasm with fatty liver and normal liver perfusion blood characteristics and quantitative parameters using real-time contrast-enhanced ultrasound (CEUS) and time intensity curve.Methods Twenty rabbits (including ten with fatty liver and ten with normal liver) with thirty-nine inflammatory pseudoneoplasm of the liver (IPL) were studied by low mechanical index CEUS with bolus injection of SonoVue via peripheral auricular vein and QontraXt quantitative analysis software.IPL contrast-enhanced ultrasound blood perfusion characteristics with two different liver background were analyzed.Results ①According to the different pathological elements,IPL showed four kinds of CEUS types:one lesion showed absent contrast enhancement pattern (type Ⅰ),nineteen lesions showed iso-enhancement pattern (type Ⅱ),six lesions showed hypo-enhancement pattern (type Ⅲ),thirteen lesions showed fast-in and fast-out pattern (type Ⅳ).②Compared with normal liver,arrival time of fatty liver was later and its peak intensity was lower.②Compared with peripheral parenchyma,arrival time of IPL was later,peak intensity was lower and its sharpness was sharper (P ＜0.05).④Between IPL lesions with two different liver background,there was no significant difference about parameters of the time-intensity curve (P ＞0.05).Conclusions Due to different pathological elements,IPL lesions have multiform perfusion patterns in CEUS.CEUS and time intensity curve could provide enough perfusion information for IPL and liver parenchyma more accurately.

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.

Objective For selecting and developing the excellent Bupleurum chinense to mass-produce seedlings and seeds in high quality.Methods B.chinense was picked from eight different areas,such as Lingchuan and Wanrong county in Shanxi Province,Longxi county in Gansu Province,and Shangluo in Shaanxi Province,etc.Rapid propagation was done.The testa of Zhongchai No.1 was scrapped or seeds were soaked in different phytohormones.The effects on germination rates of seeds were compared.ResultsThe optimum medium for bud propagation was B5supplemented with 1.0 mg/L 6-BA and 0.2 mg/L KT.The optimum medium for root induction of test-tube plantlets was 1/2 MS added with 0.1 mg/L NAA,0.5 mg/L IBA,and 1.0 mg/L DSC.The annual propagation coefficient of B.chinense plants was more than 1?108,and the survival rate of transplantation reached to 94%—97%.The phytohormone has little effect on seed germination of B.chinense,but scraping the testa could increase the germination percentage of seeds to 20% and shorten the germinating time greatly.Conclusion By tissue culture of excellent B.chinense,a great deal of plants and seeds could be produced in short time.By scrapping testa in a certain extent,the germination of seeds could be increased.