Objective To evaluate the bioequivalence and safety of two pyrazinamide tablets in healthy Chinese subjects.Methods An open,randomized,single-dose,two-sequence,two-cycle,double-cross trial design was used.All 48 healthy subjects(24 in fasting and 24 in fed trial)were randomized to receive a single oral dose of a 0.5 g pyrazinamide tablet(test or reference)per cycle.The plasma concentration of the drug was determined by liquid chromatography coupled to tandem mass spectrometry method.The pharmacokinetic parameters were calculated by WinNonlin v8.2,and the bioequivalence was evaluated by SAS 9.4.Results In the fasting group,the Cmax of the test and reference preparation of pyrazinamide tablets were(13.28±2.82)and(12.88±4.49)μg·mL-1,the AUC0-t were(139.17±26.58)and(138.63±28.92)h·μg·mL-1,the AUC0-∞ were(148.96±33.65)and(148.71±36.97)h·μg·mL-1 respectively.In the fed group,the Cmax of the test and reference preparation of pyrazinamide tablets were(11.89±1.96)and(11.99±1.92)μg·mL-1,the AUC0-t were(138.22±37.21)and(141.68±25.80)h·μg·mL-1,the AUC0-∞ were(152.20±32.41)and(151.04±28.05)h·μg·mL-,respectively.The 90％confidence intervals of Cmax,AUC0-t and AUC0-∞ geometric mean ratios of the test and reference preparation were all within 80.00％to 125.00％.The incidence of adverse events was 16.70％for both the test and reference preparation in the fasting group and 8.30％for both the test and reference preparation in the fed group,all of which were mild in severity.Conclusion The test and reference preparation of pyrazinamide tablets were bioequivalent,safe and well tolerated in healthy Chinese subjects under fasting and fed conditions.

Objective To compare the diagnosis value of double-balloon endoscopy (DBE) and single-balloon endoscopy (SBE) in diagnosing small intestinal diseases. Methods 117 cases with suspected small intestinal diseases from Jul 2014 to Aug 2016 were divided into DBE group (n = 68) and SBE group (n = 49) according to the treatment methods. These indexes as followed were compared between the two groups: procedure duration, intubation depth, detection rate, endoscopic treatment rate, and the detection rates in different chief complaints and diseases. The safety assessment was analyzed. Results Through the mouth and the anus examinations, DBE and SBE groups produced no significant differences in procedure duration, intubation depth, detection rate, and endoscopic treatment rate (P > 0.05). The unknown causes gastrointestinal bleeding, abdominal pain, diarrhea and other detection rate of small intestine disease compare differences had no statistical significance (P > 0.05), none in crohn's disease, malignant tumor, benign tumor, small enteritis, ulcers, polyps, diverticulum and tuberculosis (P > 0.05). There were no serious complications occurred in both groups. Conclusion DBE and SBE have the similar detection rate of small intestine diseases.

Near infrared spectroscopy combined with chemometrics methods was used to distinguish Ganoderma lucidum samples collected from different origins, and a prediction model was established for rapid determine polysaccharides contents in these samples. The classification accuracy for training dataset was 96.87%, while for independent dataset was 93.33%; as for the prediction model, 5-fold cross-validation was used to optimize the parameters, and different signal processing methods were also optimized to improve the prediction ability of the model. The best square of correlation coefficients for training dataset was 0.965 4, and 0.851 6 for validation dataset; while the root-mean-square deviation values for training dataset and validation dataset were 0.018 5 and 0.023 6, respectively. These results showed that combining near infrared spectroscopy with suitable chemometrics approaches could accuracy distinguish different origins of G. lucidum samples; the established prediction model could precious predict polysaccharides contents, the proposed method can help determine the activity compounds and quality evaluation of G. lucidum.
Fungal Polysaccharides ; analysis ; Geography ; Least-Squares Analysis ; Reishi ; chemistry ; Spectroscopy, Near-Infrared

Based on the reviewing of development and disadvantages of Chinese medicine formula granules, the concept of standard decoction of traditional Chinese medicine was proposed in this study, and it was used as the standard mode of Chinese medicine formula granules to standardize the production process and quality standards of formula granules. The standard was unified according to the principles of "standardization of medicinal materials, standardization of process, intellectualization of production, standardization of quality, normalization of packaging, and informatization of storage"; and consistency evaluation was carried out by the analysis of chemical components, pharmacological activities and clinical efficacy of the standardized decoction and the traditional decoction, interpreting the scientific questions to ensure the stability and uniformity of Chinese medicine formula granule as well as the safety and effectiveness of its clinical application.

OBJECTIVETo investigate the change of indicators of oxidative stress in serum and NF-kappaB in peripheral blood mononuclear cells of patients with silicosis, and explore the mechanism of the development of silicosis.

METHODSThe subjects were divided into (1) 200 workers exposed to SiO2 for at least 1 years in a foundry served as the dust-exposure group; (2) 130 cases with silicosis (I phase silicosis 64 cases, II phase 46 cases III phase 20 cases) served as the silicosis group; (3) 32 cases with 0+ phase silicosis in the foundry served as the observed group,(4)100 subjects from a hotel served as the control group. The serum including superoxide dismutase (SOD), nitric oxide (NO), serum glutathione peroxidase (GSH-Px), total antioxidant capacity (T-AOC), nitric oxide synthase (NOS), lipid malondialdehyde (MDA) and NF-kappaB protein levels in peripheral blood mononuclear cells were determined, respectively.

RESULTSCompared with the control group, NO levels in dust-exposed group and silicosis group significantly increased, and SOD decreased significantly (P < 0.05 or P < 0.01). Compared with the control group and dust-exposed group, T-AOC, NOS, MDA levels in silicosis group significantly increased (P < 0.05 or P < 0.01). GSH-Px in dust-exposed group and silicosis group were (231.164 +/- 36.484) and (270.469 +/- 39.228)U/ml, respectively which were significantly than that [(223.360 +/- 46.838) U/ml] in control group (P < 0.05 or P < 0.01), and there was significant difference of GSHPx between the silicosis group and the dust-exposed group significantly (P < 0.01) . GSH-Px level [(290.750 +/- 39.129) U/ml] in III phase silicosis group were significantly higher than those [(256.906 +/- 21.41) and (259.594 +/- 34.79) U/ml] in observation group and I phase silicosis group (P < 0.05). NF-kappaB levels [(72.06 +/- 9.12) and (85.25 +/- 11.64) ng/L] in dust-exposed group and silicosis group were significantly higher than that [(59.71 +/- 9.27) ng/L] in control group (P < 0.01), and there was significant difference of between the silicosis group and the dust-exposed group (P < 0.01). There was a positive correlation between serum GSH-Px level and the silicosis stages (r = 0.507, P < 0.01). Also there was a positive correlation between NF-kappaB level and silicosis stages, age, GSH-Px or NO levels (r = 0.376, 0.243, 0.233, 0.221, P < 0.01).

CONCLUSIONThe imbalance of oxidative and anti-oxidation system and the activation of NF-kappaB are related with the occurrence and development of silicosis. The monitoring of oxidative stress indicators and NF-kappaB is beneficial to the prediction and prognosis assessment of silicosis.

Adult ; Aged ; Case-Control Studies ; Glutathione Peroxidase ; metabolism ; Humans ; Leukocytes, Mononuclear ; metabolism ; Malondialdehyde ; metabolism ; Middle Aged ; NF-kappa B ; metabolism ; Nitric Oxide ; metabolism ; Oxidative Stress ; Silicosis ; blood ; Superoxide Dismutase ; metabolism ; Young Adult

This is a case report of mediastinal fungal granuloma in an immunocompetent host. The definite diagnosis was made by pathological biopsy via video-assisted thoracoscopy and silver methenamine staining showed aspergillus hyphae and spores in the epithelioid granuloma. In conclusion, opportunistic pathogenic fungi can cause granulomatous inflammation in mediastinal lymph nodes in an immunocompetent host, as it can do in an immunocompromised host. More attention should be paid on tissue biopsy and pathological examination to ensure a correct diagnosis for these kinds of cases.
Adolescent ; Fungi ; immunology ; pathogenicity ; Granuloma ; diagnostic imaging ; immunology ; microbiology ; Humans ; Immunocompromised Host ; immunology ; Lymph Nodes ; diagnostic imaging ; immunology ; microbiology ; Male ; Mediastinum ; diagnostic imaging ; Radiography

OBJECTIVETo develop a loop-mediated isothermal amplification (LAMP) method for rapidly diagnosing of Escherichia coli (EHEC) O157:H7 in pathogen detection department or small-scale laboratories.

METHODSPrimers for LAMP test were designed by targeting the antigen coding rfbE of EHEC O157:H7, the Shiga-like toxin stx2 and the fliC encoding gene of H7 flagella antigen, respectively. The reaction condition and reaction system of LAMP were optimized. 2 EHEC O157:H7 type strains, 17 local strains and 33 other enterobacteria were analyzed to evaluate the LAMP's specificity and sensitivity. The results of the LAMP reaction were also compared with routine PCR method.

RESULTSThe amplification products of O157 which had the corresponding target genes turned green by visual inspection and had ladder-like pattern on the gel, but products of other enterobacteria remained orange by visual examination and had no band on the gel. The detection results of LAMP were the same as of routine PCR method. The reaction time of the LAMP method was only 1.5 hours and the detection limit of LAMP assay was 26 CFU/reaction. In addition, the LAMP results could be determined only by visual inspection.

CONCLUSIONLAMP assay is rapid, specific, and sensitive for the detection of EHEC O157:H7. This method might not only reduce the dependence of complicated equipments but also be a potential method for wider use in pathogen detection department, small-scale laboratory, emergency motor vehicle or field survey.

Environmental Monitoring ; methods ; Escherichia coli O157 ; genetics ; isolation & purification ; Nucleic Acid Amplification Techniques ; methods ; Sensitivity and Specificity

Objective To develop a loop-mediated isothermal amplification (LAMP) method for rapid diagnosing of Legionella pneumophila in the Pathogen Detection Department(PDD) or in small-scale laboratory. Methods Five primers (2 Inner Primers, 2 Outer Primers and a Loop Primer) for the LAMP test were designed by targeting the mip gene of Lpneumophila and reaction system of LAMP reaction was optimized. 12 strains of L.pneumophila, 45 local strains, 6 non-L.pneumophila strains, 11 other strains and 59 environmental water samples were analyzed to evaluate the specificity and sensibility of the LAMP amplification. At the same time, the results of the LAMP were also compared with biochemical culture and quantitative PCR methods. Results The amplification products of L.pneumophila turned green by visual inspection and had ladder-like pattern on the gel, but non-L.pneumophila and other products from the strains remained orange by visual examination and had no band on the gel. The detection rate of LAMP was higher than the biochemical culture and the real-time PCR methods. Reaction time of the LAMP method was only 1.5 h and the detection limit of LAMP assay was 5 cfu/reaction. In addition, the LAMP results could be determined only by visual inspection. Conclusion LAMP assay targeting the mip gene of L.pneumophila appeared to be rapid, specific, and sensitive for the detection of L.pneumophila. This method not only reduced the dependence of complicated equipment but also had a potential for wider use in the PDD, small-scale laboratory, emergency motor vehicle or for field survey.

We have obtain a steady and reliable dyeing methods for the uniuncleate and dicaryotic hyphae of Pleurotus tuber-regium by using different foster hyphae way, comparing two kinds of fastness liquid and three dye stuff on the hyphae nuclear stain effect, and then optimization grouping.

Anti-Inflammatory Agents ; pharmacology ; Capsules ; China ; Coronary Disease ; prevention & control ; Drugs, Chinese Herbal ; administration & dosage ; pharmacology ; Humans