Implementation of information technology in clinical research has resulted in revolutionary changes in drug development. Based on the good clinical practice (GCP) requirements on data, processes and documentations, and the era of fast growth in clinical studies using up-to-date information technology, we explore an integrated e-clinical solution in clinical studies in China.
China ; Clinical Trials as Topic ; Data Collection ; methods ; Medical Informatics ; methods

OBJECTIVETo discriminate and determine of the artificial bear bile of the compound bile capsule.

METHODTaking the pharmacopoeia as reference, the artificial bear bile was discriminated and determined by HPLC.

RESULTThe compound bile capsule and the control sample had chromatographic peak at the same time from HPLC. The content of the artificial bear bile was above 10 mg per tablets.

CONCLUSIONThe artificial bear bile of compound bile capsules can be discriminated effectively and determined accurately by HPLC method.

Animals ; Bile ; chemistry ; Capsules ; analysis ; Chromatography, High Pressure Liquid ; methods ; Discriminant Analysis ; Medicine, Chinese Traditional ; Taurochenodeoxycholic Acid ; analysis ; Ursidae

Hospital Restructuring ; Hospitals ; Occupational Health Services

Objective:To investigate the application of drug utilization evaluation( DUE) as a kind of clinical pharmacy work model in the antibacterial drug special rectification. Methods: Following the steps of DUE schedule,retrospective method was conducted to collect the data of the use of vancomycin in one institution and the model of clinical drug use was improved by the evaluation result. Re-sults:The rationality of vancomycin use was improved in the institution. The index of drug use reasons and key disease course indica-tors was improved significantly. The qualification rate of indications and drug indications was increased from 79. 5% to 95. 0%,and the qualification rate of antibacterial drugs classification management was increased from 63. 3% to 92. 7%. The qualification rate of dosing frequency was increased from 72. 5% to 96. 0%. Conclusion:As a program for continual improvement of new clinical pharmacy work mode and medical care quality,the mode plays an important role in the institution and improves the rational use of vancomycin.

Asingleparticle-inductivelycoupledplasmamassspectrometric(SP-ICP-MS)methodwas established to detect the size distribution and number concentrations of silver nanoparticle ( AgNPs) in dilute aqueous solution. The optimal dwell time was 3 ms to reduce possibility of two or more particles entering into detector simultaneously. An iterative algorithm was applied to distinguish AgNPs as outliers from baseline and dissolved metal ion signal if the measured intensity was beyond five time standard deviation of whole data. Size distribution and number concentration of three commercial silver nanoparticle dispersions ( nominal diameters of 30, 50, 100 nm) were determined using SP-ICP-MS. The result of SP-ICP-MS is accurately similar to the transmission electron microscopy ( TEM) , indicating that SP-ICP-MS is able to size silver nanoparticles. The particle size detection limit is 25 nm and the limit of number concentration is 8 × 104 particles/L in dilute solution. Tap water added with silver nanoparticle was tested to obtain a similar size distribution and number concentration. This method is simple, fast and highly sensitive, which can be used to investigate risk assessment of silver nanoparticle in aqueous environment and monitor silver nanoparticle in drinking water.

Objective: To observe the effects of interferon-induced protein 204 (p204) over-expression on apoptosis, proliferation and migration of aortic vascular adventitial ifbroblast (VAFs) in experimental rats.
Methods: Our research included in 3 groups: Iif204-Lv group, in whichVAFs were infected by Iif204-recombined lentivirus, Con-Lv group, in which VAFs carried the empty vector without virus, Blank control group, in which VAFs were untreated. VAFs proliferation was examined by MTT method, cell apoptosis was measured by lfow cytometry and the migration was detected by scratching assay and transwell chamber method. The mRNA and protein expressions of p204, p53 and p21were evaluated by real-time q RT-PCR and Western blot analysis respectively.
Results: Compared with Con-Lv and Blank control groups, Iif204-Lv group had decreased VAFs proliferation (by OD value) at 48 hours: (0.53 ± 0.05) vs (0.66±0.03) and (0.63 ± 0.06), at 72 hours: (0.89 ± 0.06) vs (1.02 ± 0.06) and (1.01 ± 0.07); distance of cell migration (by pixel): (61.00 ± 1.83) vs (74.50 ± 6.25) and (75.50 ± 7.85); number of cell migration: (61.75 ± 10.69) vs (155.25 ± 10.21) and (153.75 ± 9.40), allP<0.05. VAFs apoptosis rates were similar among different groups. Compared with Con-Lv and Blank control groups, Ifi204-Lv group presented up-regulated mRNA expressions of p204 (3.45 ± 0.15) vs (2.09 ± 0.10) and (2.06 ± 0.09); p53 (3.41 ± 0.09) vs (2.06 ± 0.07) and (2.10 ± 0.06); p21 (3.01 ± 0.08) vs (2.05 ± 0.06) and (2.11 ± 0.08), allP<0.05.
Conclusion: p204 over-expression inhibits VAFs proliferation and migration which might be partly related to the activation of p53 and p21 expression in experimental rats.

Objective:To study interferon alpha (IFN-α) inhibition of proliferation and apoptosis induction of human brain vascular adventitial fibroblasts(HBVAFs)via IFI16.Methods:Cultured HBVAFs were treated with transfection IFI16 siRNA and/or IFN-α in vitro instantaneously.The protein and mRNA levels of IFI16,P53,P21 were measured by Western blot and Real-time PCR.MTT was used to detect the cell proliferation of the HBVAFs.Cell cycle and apoptosis were analyzed by flow cytometry.Results:IFN-α with terminal concentration of 2 000-5 000 kU/L induce significantly expression of IFI16 in HBVAFs,without any significant difference.Stimulated with 2 000 kU/L IFN-α up-regulated the expression of P53,P21 at protein and mRNA levels,and inhibited the cell proliferation and promote cells apoptosis in HBVAFs.Such effect was restrained by transfection with IFI16 siRNA into HBVAFs.Conclusion:IFN-α inhibits HBVAFs proliferation and induces apoptosis may partly relate to the increased IFI16 expression.

Objective·To investigate the clinicopathologic characteristics and prognosis of adult rhabdomyosarcoma (RMS).Methods·The clinical and pathological data,immunohistochemical test results of 9 RMS were analyzed retrospectively.Results·The information of 6 males and 3 females were collected in this research,whose average age was (46.89+20.09) years old.The tumors had a wide range distribution.The subtypes of histology included 6 cases of embryonal RMS,1 case of alveolar RMS,1 case of spindle cell RMS and 1 case of pleomorphic RMS.Immunohistochemically study showed that 6 cases were myogenin positive,4 cases were MyoDl positive and 8 cases were desmin positive.During the follow-up period of the 7 cases,only 2 patients survived free of tumors,2 patients presented with tumor recurrence and metastasis after the operations,and 3 patients died of tumor.Conclusion·In this study,embryonaI RMS is the most common type,and immunohistochemistry test is helpful to diagnosis of RMS.

AIM: To establish the quality standard for Zhike Pingchuan Capsule (Radix Panacis Quinquefolii, Semen Pruni Armeniacae, Radix Scutellariae, Radix Glycyrrhizae, Bulbus Fritillariae Cirrhosae, etc.). METHODS: Radix Panacis Quinquefolii, Radix Glycyrrhizae, Bulbus Fritillariae Cirrhosae in Zhike Pingchuan Capsule were identified by TLC and ginsenoside Rb_1 was determined by HPLC. The analysis was carried out on C_~18 column by HPLC. The mobile phase was CH_3CN-H_2O(34∶66). The flow rate was 1.2 mL?min~-1 and the detection wavelength was at 203 nm. The column temperature was at 40.0 ℃ and sensitivity was 0.02 AUFS. RESULTS:The average recovery was 97.20% and RSD was 2.25% and the linear range of ginsenoside Rb_1 was in 0.612-~6.120 ?g. CONCLUSION:This method is simple, rapid with a good reproducibility. This method can be used for the quality control of Zhike Pingchuan Capsule.

Objective To study the difference in clinical characteristics and experimental profiles of primary Sj gren's syndrome(pSS)with a different onset age.Methods The clinical and laboratory data of 136 pSS patients were retrospectively analyzed.Results The prevalence of anti-SSA and anti-SSB antibodies de- clined with later onset.As compared with patients with disease onset older than 45,patients with disease onset younger than 45 had higher rheumatoid factor,circulating immune complex and lower C3.The prevalence of parotitis was higher in patients with disease onset younger than 45 than those with disease onset older than 45. The two groups had similar extra-glandular involvement.Conclusion The younger onset pSS patients have more abnomlalities in inmmnological parameters,and more parotiditis,implying that young onset pSS have more strong immune responses.