Aim To show the performance of the weighted modification method in the clinicaldesign of combination drug therapy. Methods A scheme combined by Drug1, Drug2and Drug3 was used to treat infants with iron deficiency anemia for 2 wk in a hypo-thetical clinical trial. Thirty-six infants were randomly into 6 compound groups. Threedrugs in the scheme were divided into 6 dose levels, which were evenly distributed to the6 groups according to the weighted modification method. The increased Hb (?Hb) wasrecorded at 2, 3, 4 wk after the treatment (po ). The dose-effect data at 4 wk wereanalyzed by the method, and then the doses in scheme were modified by the analyticresult. The modified doses in the scheme would be further demonstrated. ResultsDrug1 and Drug2 were principal drugs, but Drug1 had larger contribution to the com-bined effect (△Hb) than Drug2. Drug3 had little effect. There was a strong synergismbetween Drug1 and Drug2 with the weighted coefficient (b1) = 2. 636 (P

In clinical and experimental therapeutics, the quantitative analysis of drug interaction will supply a tool for optimizing and evaluating a combination in the study of compound drug, the design of combination drug therapy, and the evaluation of traditional medicine formulae. This paper listed the systematic methods of the quantitative analysis, including the weighted modification method for optimizing constituents, doses and ratio in combination, the parameter method and the reflection method for dynamic analysis of drug interaction, and a comprehensive method for multiple response indexes. The software CoDrug about these methods also was introduced.

Qualitative data are often converted to quantitative data by ranking in pharmacodynamical statistics. Some common questions were listed and discussed with examples in this paper, including ranking method and the selection of statistical method.

The principle of the relative operating characteristic (ROC) curve, along with constructing curve, a cutoff value between therapeutic and non-therapeutic concentration, formula for calculation, and statistic analysis, was introduced. Illustrated by an example, ROC was an important tool in analysis of the fixed effect model. It can beapplied to determine the relationship between a blood concentration and its action, probability of certain concentration producing therapeutic action, and high or low limit of therapeutic window, etc.

On the basis of analyzing the transition and development trend of current medical and pharmaceutical mode,this article proposed that in the process of pharmacy talents training,not only biological,but also the construction of natural drugs knowledge should be stressed.In addition,the necessity of natural drugs knowledge construction as well as its practice and future blueprint in our university were illuminated intensively,in order to provide reference for the training of pharmacy talents in local colleges.

Aim To set up a novel animal model of intra-abdominal adhesion and to determine whether the tissue plasminogen activator activity (PAA) in exudate can be taken as an indicator to judge the formation of the adhesion. Methods　Rats were randomly divided into 2 groups. Each animal in both groups was opened the abdominal cavity via midline laparotomy without any disinfectant measures. 2-cm section from the cecal end was clamped and ligated, 1-cm cecum of the section was cut, and another 1-cm end from the ligated site was kept. After the content in the end was extruded, the cecum was put back without using any antibacterial agent. Before the skin closure, an effective combination AMD (allantoin, metronidazole and dexamethasone in combination), was given (ip) according to 1.5 ml per 100 g body weight (60.6 mg·kg-1). The control group was injected (ip) the same volume of normal saline. After 6 h, the exudate was extracted from drainage-tube, with the rats varying posture, and after 1 kw, the rats were killed for examining the intra-abdominal adhesion. The values of PAA of exudate in both groups were analyzed by the relative operating characteristic curve (ROC). Results　In the control group, all 20 rats formed the adhesions, the amount of exudate=(1.25±0.09) ml, the number of WBC(×103)=(23.1±6.6) mm3 and PAA=(0.9±0.4) IU·ml-1 in the exudate of abdominal cavity. In AMD group, however, there was not the adhesion formations (0/20), the amount of exuade was (0.52±0.04) ml (P<0.01), the number of WBC (×103) (10.6±4.2) mm3 (P<0.01), and PAA (23.1±6.6) IU·ml-1(P<0.01) in exuade.ROC analysis indicated that if PAA >1.24 IU·ml-1 in the exuade, the adhesion was difficult to form, and vice versa. Conclusion　This animal model can be taken as an effective tool to evaluate the human adhesion related to multi-links on the pathogenesis, and the PAA in exudate an indicator to judge intra-abdominal adhesion formation.

AIM: To investigate the therapeutic effect of tea polyphenols (TP) on cationic bovine serum albumin (C BSA) glomerulonephritis. METHODS: C BSA glomerulonephritic model was induced in rabbits. TP in three different doses (30, 100 and 300 mg?kg -1 ) was administered (ig) once daily for 14 days. RESULTS: TP not only significantly reduced the urinary protein excretion, decreased blood urea nitrogen (BUN) and plasma creatinine (Cr) levels, but also significantly relieved gloermular lesions in the rabbits treated and there was a significant dose dependent relationship between high dosage (300 mg?kg -1 ) and low dosage ( 30 mg?kg -1 ). CONCLUSION: TP can reduce proteinuria, suppress the development of glomerular impairments, and ameliorate the kidney function of rabbits with C BSA glomerulonephritis.

Due to a great amount of data in clinical trials, the data cleansing needs to adopt a variety of measures, including the latest developed visual check approach. According to the different types of clinical data and the different stages in the course of clinical data management, this study reviews 8 types of visual graphics that show the relevance and trend among the data. The series of graphics can rapidly detect abnormal data, monitor clinical research in real-time, make the data management process much easier and improve the clinical trial efficiency and data quality.

Electronic case report forms (eCRFs) instead of the traditional paper case report forms (pCRFs) are increasingly used by investigators and sponsors of clinical research. We include a total of 14 phase III studies (8 pCRF, 6 eCRF) to compare paper and electronic data documentation both quantitatively and qualitatively in clinical studies. The result suggests that adaptions of electronic data capture (EDC) in clinical trials have the advantages in optimization of data capture process, improvement of data quality and earlier clinical decision compared to paper-based methods. Furthermore, the successful implementation of EDC requires accouplements with corresponding data management processes and reallocation of resources.

Objective To investigate the effect of multidrug resistance protein 4 (MRP4) overexpression on lipopolysaccharide (LPS)-induced vascular endothelial hyperpermeability of rat pulmonary micro-vascular endothelial cells (PMVECs) and its molecule mechanism. Methods Three to six passages of PMVECs were cultured in vitro, and they were divided into three groups: the cells in LPS group were only challenged by LPS 10 μg/mL after being cultured in serum-free medium for 24 hours; the cells in Ad-shRNA and Ad-MRP4 groups were infected with the empty virus control or recombinant adenovirus expressing MRP4 for 2 hours, and then were cultured in serum-free medium for 24 hours followed by stimulation of LPS 10 μg/mL. Endothelial permeability was assayed by the Transwell chamber models at 2, 6, 12, and 24 hours after LPS stimulation. Intracellular cyclic adenosine monophosphate (cAMP) levels were detected by enzyme-linked immunosorbent assay (ELISA). The morphological characteristics and distribution of F-actin was determined by laser confocal fluorescence microscope. The protein expressions of MRP4,β-catenin, vascular endothelium-cadherin (VE-cad) and ZO-1 were measured by Western Blot. Results ① After LPS stimulation, endothelium permeability and intracellular cAMP levels in PMVECs were significantly increased, peaked at 12 hours, and then decreased after 24 hours. Compared with LPS group and Ad-shRNA group, PMVECs of Ad-MRP4 group were exhibited a significant increase in endothelial permeability [12-hour permeability (A value):1.88±0.06 vs. 1.12±0.17, 1.10±0.18] and a significant decrease in intracellular cAMP level [12-hour cAMP (μg/L):2.39±0.02 vs. 2.97±0.01, 3.00±0.02, all P < 0.05]. There was no significant difference in endothelium permeability and intracellular cAMP levels at all time points between the LPS group and the Ad-shRNA group (all P > 0.05).② Under laser confocal fluorescence microscope, after LPS stimulation, the stress fiber formation was induced in three groups. But there were pronounced irregular aggregation of fiber in PMVECs of Ad-MRP4 group. ③ Furthermore, compared with LPS group and Ad-shRNA group, protein expression of MRP4 in Ad-MRP4 group was dramatically increased (gray value: 0.76±0.03 vs. 0.44±0.02, 0.43±0.02, both P < 0.05), and the protein expressions of β-catenin, VE-cad, and ZO-1 were significantly decreased [β-catenin (gray value): 0.14±0.03 vs. 0.23±0.04, 0.23±0.03);VE-cad (gray value): 0.21±0.01 vs. 0.34±0.02, 0.35±0.04; ZO-1 (gray value): 0.14±0.02 vs. 0.37±0.06, 0.33±0.07, all P < 0.05]. There was no significant difference in all protein expressions between the LPS group and Ad-shRNA group (all P > 0.05). Conclusion MRP4 overexpression can decrease intracellular cAMP levels, reduce intercellular junction protein expression, and then exaggerate LPS-induced vascular endothelial hyperpermeability.