Safety assessment in clinical trials is dependent on an in-depth analysis of the adverse events to a great extent. However, there are difficulties in summary classification, data management and statistical analysis of the adverse events because of the different expressions on the same adverse events caused by regional, linguistic, ethnic, cultural and other differences. In order to ensure the normative expressions, it's necessary to standardize the terms in recording the adverse events. MedDRA (medical dictionary for regulatory activities) has been widely recommended and applied in the world as a powerful support for the adverse events reporting in clinical trials. In this paper, the development history, applicable scope, hierarchy structure, encoding term selection and standardized query strategies of the MedDRA is introduced. Furthermore, the practical process of adverse events encoding with MedDRA is proposed. Finally, the framework of statistical analysis about adverse events is discussed.
Adverse Drug Reaction Reporting Systems ; standards ; statistics & numerical data ; Databases, Pharmaceutical ; standards ; Humans

Adolescent ; Cough ; complications ; Fatal Outcome ; Female ; Fever ; complications ; Humans ; Pulmonary Fibrosis ; complications ; diagnosis

Objective To investigate the influence of enteral nutrition (EN) emulsion containing slowrelease starch on blood sugar level in patients with craniocerebral injury. Methods Totally 120 patients with severe craniocerebral injury complicated with hyperglycemia joined this open study and were randomized into control group and study group. Study group was given EN emulsion containing slow-release starch ( Fresubin Diabetes)and control group was given routine EN emulsion ( Fresubin), both for 15 days. Fasting blood glucose (FBG),2-hour postprandial glucose (2hPG), and glycosylated hemoglobin (HbA1c) were examined before EN support and 7 days and 15 days after EN support. Results In the study group, the levels of 2hPG before EN support and on the seventh and fifteenth day after EN support were ( 12.26 ± 2. 36 )mmol/L, (9.76 ± 2.90 ) mmol/L, and (9.78 ± 1.86) mmol/L, respectively. The levels of 2hPG after EN support were both significantly lower than that before EN support (P ＜ 0. 05). However, the levels of FBG and HbA1c in the study group were not significantly different before and after EN support ( P ＞ 0. 05 ). In the control group, the levels of 2hPG on the seventh and fifteenth day after EN support were ( 11.70 ± 2. 80) mmol/L and ( 11.39 ± 2. 44 ) mmol/L, respectively, which were significantly higher than those in study group ( P = 0. 033, P = 0. 020). The levels of FBG and HbA1c werenot significantly different between the study group and the control group ( P ＞ 0. 05 ). Conclusion EN emulsion containing slow-release starch may promote the control of blood sugar in patients with craniocerebral injury complicated with hyperglycemia and improve the level of postprandial blood sugar in those patients.

Objective To screen thyroid function among planned pregnant women in Chongqing, to guide prenatal and postnatal care. Methods Proportional multi-stage stratified cluster random sampling method was adopted to enroll 11 953 planned pregnant women for questionnaire, physical examination, and serum samples collection. Results The median TSH was 2. 04 mIU/ L, P25 = 1. 36 mIU/ L,P75 = 2. 99 mIU/ L. TSH levels being normal, higher, and lower than the reference were 91. 47% , 6. 20% , and 2. 33% , respectively. In Northeast Chongqing, the proportions of median TSH level and TSH level above the upper limit were higher than those in other regions(P<0. 05). With improved education, proportions of TSH above the upper limit and below the lower limit declined(P<0. 05). With the increase in body mass index, the proportion of those whose TSH was above the upper limit showed elevated trend(P<0. 05). In women with history of adverse pregnancy outcomes, their median TSH was higher than that in the control group, and those, whose TSH level exceeded the upper limit, yield higher results than those in the control group(P<0. 05). In women with higher fasting blood glucose The median TSH level was lower than that in normal blood glucose group( P<0. 05), with the fasting plasma glucose concentration and TSH negatively correlated(P<0. 05). Conclusion The abnormal rate of TSH level in planned pregnant women was 8. 53% in Chongqing. The abnormal rate varies by different regions, education levels, body mass indexes, and blood glucose levels. Previous history of adverse pregnancy outcomes was related to elevated TSH levels. It is necessary to take pre-pregnancy thyroid function screening investigation.

Antigens ; analysis ; Cervical Intraepithelial Neoplasia ; metabolism ; Citric Acid ; Cyclin-Dependent Kinase Inhibitor p21 ; analysis ; Edetic Acid ; Formaldehyde ; Hot Temperature ; Humans ; Hydrogen-Ion Concentration ; Immunohistochemistry ; Intestinal Mucosa ; immunology ; Ki-67 Antigen ; analysis ; Microwaves ; Palatine Tonsil ; metabolism ; Proto-Oncogene Proteins c-bcl-6 ; analysis

Objective To observe the different effects of iodine excess on inducing two strain mice thyroiditis. Methods NOD and Balb/c mice, each having 14 mice, were divided into NaI and control group. The mice were given 0.05% NaI water for 8 weeks in NaI group. RIA and ELISA were used respectively to detect TT4, TgAb, TPOAb and TSH level in serum. Morphology changes of thyroid and apoptosis of thyrocytes stained by immunohistochemistry were observed under light microscope. Lymphocytic proliferation of cervical lymph node and spleen to responding to Tg were detected by MTr method. Results After intake of iodine water for 8 weeks, NOD and Balb/c mice showed relative quality of thyroid in Nal group[(104.83±14.52), (155.79±20.77)mg/kg]obviously increased compared with control group[(71.80±20.42), (105.15±21.98)mg/kg, t values:-3.293,-4.429, all P< 0.01)], enlarged follicular lumen with colloid accumulation were observed in thyroid. Serum level of TT4 in Nal group [(29.52±4.42), (19.53± 2.35)nmol/L]to control group[33.40±5.38), (23.47±6.22)nmol/L]of NOD and Balb/c mice showed a decreasing tendency(t values: 1.374,1.567, all P > 0.05). TSH of Nal group showed an increasing tendency in Balb/c mice[(4.14±1.71)μg/L, compared with control [(3.55±1.41)μg/L, t values:-0.705, P > 0.05]and obviously increased in NOD mice [(6.98±0.66)μg/L, compared with control[(555±056)μg/L, t values:-3.562, P< 0.01], but no change of TgAb and TPOAb level in Nal group(1281,1364 cpm, 2.50×103, 0.14×103U/L were observed, compared with control(1297,1220 cpm, 3.17×103,0.03×103 U/L; Zvalues:-0.081,-0.703, -0.244,-1.293, all P > 0.05). In NOD mice NaI group, apoptosis of thyrocytes was more intense than Balb/c mice, obvious infiltration of lymphoeytes, disorganization and focus fibrosis was seen in thyroid. The cell amount of NaI group increased in NOD mice lymph node and spleen cells[(1.100±0.014), (1.076±0.033)]were more than that in the control group [(0.993±0.011), (1.005±0.003), t value:-11.672,-4.314, P < 0.01). Conclusions Iodine leads to enlargement of thyroid and malfunction of thyroid in Balb/c mice. Besides, NOD mice have generate inflammatory reaction in thyroid and produced sensitized lymphocytes to Tg. Iodine excess can induce NOD mice to occur autoimmune thyroiditis.

Objective To investigate the expression of cyclooxygenase-2 (COX-2) and epidermal growth factor receptor (EGFR) in astrecytomas, as well as the correlation between them. Methods The expression of COX-2, EGFR and PCNA were respectively detected by immunohistochmical (S-P) method in 68 astrocytomas and 5 cases normal brain tissue. Proliferation index (PI) was calculated and the correlation of COX-2, EGFR and PI was analyzed. Results COX-2 and EGFR were negative expression in normal brain tissue. The positive expression rate of COX-2 and EGFR in high grade astrocytomas was significantly higher than that in low grade astrocytomas(73.53% vs 44. 18% ,67.65% vs 38.24%, P <0. 01 ), and the PI was significantly higher than that in low grade astrocytumas as well as normal brain tissue(46.11 ± 10. 68vs 23. 04±6. 25,4. 52±0. 95, P <0. 01 ). The PI in COX-2 positive group was higher than that in negative group( P <0. 01 ). The positive expression rate of COX-2 in the group with EGFR positive expression was higher than that in the negative group. Conclusions The expression of COX-2 and EGFR was related to pathological feature of astrocytomas. COX-2 may promote the proliferation of tumor cells. There was a static correlation between the expression of EGFR and COX-2 in astrocytomas. EGFR signal transduction probably modulated the expression of COX-2 in astrocytomas cells.

Combining the structural features of picotamide and linotroban, a series of N,N'-bis-(halogenophenyl)-4-methoxybenzene-1, 3-disulfonamides were designed and synthesized on the basic principles of drug design. The structures of target compounds were confirmed by IR, 1H NMR and HR-MS, and the in vitro antiplatelet aggregation activity was evaluated by Born turbidimetric method with adenosine diphosphate (ADP) as the platelet aggregation inducers. The assay results showed that twelve compounds (4b, 4f, 4l, 5b, 5d-5g, 5j, 5k, 5m and 5n) were found to have superior anti-platelet aggregation activities than the positive drug picotamide. The preliminary structure-activity relationship (SAR) has been explored.
Adenosine Diphosphate ; Drug Design ; Phthalic Acids ; Platelet Aggregation ; Platelet Aggregation Inhibitors ; chemical synthesis ; chemistry ; Structure-Activity Relationship ; Sulfonamides ; chemical synthesis ; chemistry

Cassiae Semen is a common traditional Chinese medicine, and contents of anthraquinones of Cassiae Semen different significantly from area to area. According to Chinese Pharmacopoeia (2010 edition), only contents of aurantio obtusin and chrysophanol were used to evaluate the quality of Cassiae Semen, another data could be added later. Ten batches of Cassiae Semen from different areas were determined, and total anthraquinones, total free anthraquinones and total combined anthraquinones contents were assessed by ultraviolet visible spectrophotometer, contents of aurantio obtusin, rhein, aloe emodin, emodin, chrysophanol and physcion were determined by HPLC. After that, principal components analysis was used to evaluate these data determined previous by dimension reduction analysis. At last, the result suggests that three main components were found out, it shows that content of aloe emodin could be used to evaluate the quality of Cassiae Semen as well as contents of aurantio obtusin and chrysophanol. And Cassiae Semen from Hebei province posseses higher quality than Cassiae Semen from other different areas. All these results can provide a good reference for quality evaluating of Cassiae Semen medicinal materials at a certain extent.
Anthraquinones ; analysis ; Cassia ; chemistry ; Chromatography, High Pressure Liquid ; Principal Component Analysis

Breast Neoplasms ; genetics ; pathology ; Chromosome Aberrations ; Chromosome Deletion ; Chromosomes, Human, Pair 1 ; Chromosomes, Human, Pair 17 ; Chromosomes, Human, Pair 9 ; Female ; Genome, Human ; Humans ; Nucleic Acid Hybridization ; methods ; Phyllodes Tumor ; genetics ; pathology