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 search a new,safe and effective method to obtain semen using rectal Drobe electroejaculation(RPE).Methods RPE procedures were performed in 8 men with psychological ejaculatory failure,used the electrical stimulate instrument(CGS model,made in Italy).The average age was 26 years.Seminal vesicle was normal by B Uhrasonography or CT examination.Except for 1 case of diabetes,the other 7 cases found no hormones,blood,biochemical and nervous system abnormalities.Three cases had nocturnal emission,but no sexual intercourse ejaculation.Results Adequate sperm was successfully taken out from the 8 patients.Mean seminal fluid volume was 2.3 ml,mean total sperm count was 67×106/ml and mean total motile sperm was 21.3%.Three patients felt abdominal distension during the RPE course.Conclusion RPE is a safe,reliable,non-in-vasive,repeatable method to obtain semen.

OBJECTIVEThe purpose of the present study was to investigate the in vitro effects of baicalin on induction of apoptosis in human prostate cancer cell line DU145.

METHODHuman prostate cancer cell line DU145 was treated with different concentration of baicalin in vitro. The apoptosis rate was determined by FACS analysis, cell cycle distribution was detected by flow cytometry, morphological changes and protein analysis were determined by means of electron microscope techniqueand immunohistochemical techniquerespectively.

RESULT50micromol x L(-1) and 125 micromol x L(-1) of baicalin dose-dependently induced apoptosis and inhibited the proliferation of prostate cancer cell DU145 in a dose and time-dependent manner. DNA flow cytometric analysis indicated that baicalin induced a arrest in G1 phase, showing a typical apoptosis peak. Electron microscopy detected a characteristic appearance of the apoptotic cells morphology. Immunohistochemical analysis revealed that induction of apoptosis by ways of inhibition of the bcl-2, loss of the Bax, and upregulation of Fas.

CONCLUSIONThe results indicate that baicalin may induce apoptosis and inhibit proliferation of prostate cancer cells, and has direct anti-tumor effects on human prostate cancer cells.

Antineoplastic Agents, Phytogenic ; pharmacology ; Apoptosis ; drug effects ; Cell Line, Tumor ; Cell Proliferation ; drug effects ; Dose-Response Relationship, Drug ; Flavonoids ; isolation & purification ; pharmacology ; G1 Phase ; Humans ; Male ; Plants, Medicinal ; chemistry ; Prostatic Neoplasms ; metabolism ; pathology ; Proto-Oncogene Proteins c-bcl-2 ; metabolism ; Scutellaria ; chemistry ; bcl-2-Associated X Protein ; fas Receptor ; metabolism

Protamine (PRM) is one of the most abundant arginine-rich nucleoproteins in sperm and plays an important role in spermatogenesis. In the late stage of spermatogenesis, the replacement of PRM by histone prompts the closer combination between the nuclear matrix of sperm and nucleoprotein in order for high enrichment and condensation of nuclear chromatin in addition to preventing the sperm genome from mutation induced by internal and external factors. With the development of DNA sequencing techniques, researches on the association between PRM polymorphisms and male fertility are surfacing as a hot field. Many studies show that rs2301365 polymorphism is a risk factor for male infertility and increases the risk of male infertility by 27 - 66%, that rs737008 polymorphism of PRM1 and rs1646022 polymorphism of PRM2 are protective factors against Asian infertility, and that the ratio of PRM1 to PRM2 is intensively associated with male infertility. This review presents an update on the association between PRM gene polymorphisms and male infertility.
Asian Continental Ancestry Group ; Humans ; Infertility, Male ; genetics ; Male ; Mutation ; Polymorphism, Single Nucleotide ; Protamines ; genetics ; Risk Factors ; Spermatogenesis ; Spermatozoa

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 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.

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.