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

Objective To observe the effects of berberine on ICAM-1, VCAM-1 expression and inflammatory cells exudation in mice with viral pneumonia caused by influenza virus, and explore its anti-injury effect. Methods Totally 108 BALB/c mice were randomly divided into control group, model group, and berberine group. 25 μL 50 LD50 influenza virus, mouse lung-adapted strain, was intranasally inoculated to model group and berberine group. 1 h after infection, control and model group were intragastrically given 25 μL distilled water, berberine group was treated by intraperitoneal injection with berberine at a dose of 0.005 g/(kg·d) for 5 days, twice per day. On day 2, 4 and 6 after infection, immunocytochemical method was used to detect ICAM-1 and VCAM-1 expression, and sorting cell count of leukocytes in bronchoalveolar lavage fluid (BALF) were counted. Results The expression of ICAM-1 and VCAM-1 in model group increased obviously on day 2, 4, 6, and which in berberine group decreased compared with model group (P<0.01). WBC, mononuclear cell, eosinophile cell and neutrophil cell number in model group increased significantly. WBC and neutrophil cell number decreased in berberine group on day 6 (P<0.01), and the mononuclear cell number decreased on day 4 (P<0.01). Conclusion Berberine inhibited the expression of ICAM-1 and VCAM-1, and decreased the inflammatory cells exudation in lung of mice with viral pneumonia caused by influenza virus. Berberine has protective effect on inflammatory injury of lung tissue in mice with viral pneumonia caused by influenza virus.

Objective To discuss the relationship between c-reactive protein and prognosis of acute coronary syndrome.Methods C-reactive protein of 60 acute coronary syndrome aged patients was evaluated.The patients were divided into two groups:one group with higher CRP level and another group with normal CRP level.The following-up duration was 6 months.After correct therapy,the morbidity of re-angina,arrbythmia,heart failure,re-infarction and cardiac death was compared.Results The morbidity of re-angina,arrhythmia,heart failure,re-infarction,cardiac death was 46.3%(19/41),43.9%(18/41),9.8%(4/41),22.0%(9/41),7.3%(3/41)respectively in higher Clip levd group;The morbidity of re-angina,arrhythmia,heart failure,re-infarction was 15.8%(3/19),10.5%(2/19),5.3%(1/19),5.3%(1/19)respectively in normal CRP group and there was no cardiac death accident.There was significant difference between the two groups.Conclusion CRP plays an important role in the onset of acute coronary syndrome,and its level is related with the higher morbidity of re-angina,arrbythmia,heart failure,re-infarction and cardiac death.

Objective: To investigate the epidemiological characteristics of genital Chlamydia trachomatis infections in Shaoxing City from 2012 to 2021, so as to provide the evidence for improving the control strategy of genital C. trachomatis infections. Methods: Data pertaining of patients with genital C. trachomatis infections in Shaoxing City from 2012 to 2021 were retrieved from Chinese Disease Prevention and Control Information System, and the incidence of genital C. trachomatis infections was calculated. The trends in incidence of genital C. trachomatis infections were analyzed using annual percent change (APC), and temporal, human and temporal distributions of genital C. trachomatis infections were descriptively analyzed. Results: A total of 18 235 cases with genital C. trachomatis infection were reported in Shaoxing City from 2012 to 2021, and the annual average incidence was 36.36/105. The incidence of genital C. trachomatis infections appeared a tendency towards a rise in Shaoxing City from 2012 to 2021 (APC=4.51%, t=2.663, P=0.029). The reported incidence of genital C. trachomatis infections was significantly higher among females than among males (60.46/105 vs. 12.50/105; χ2=7 935.467, P<0.001), and 76.04% infections (13 866 cases) occurred at ages of 20 to <40 years, while a high incidence rate of genital C. trachomatis infections was seen among patients at ages of 25 to <30 years (154.23/105). In addition, high incidence rates were seen in Keqiao District (57.93/105) and Yuecheng District (51.78/105). Conclusions The incidence of genital C. trachomatis infections appeared a tendency towards a rise in Shaoxing City from 2012 to 2021, and the infection predominately occurred among women and young individuals.

The study evaluates the lipolysis rate and extent of type Ⅲ lipid formulations using testosterone undecanoate as a model drug after digestion with in vitro lipolysis model, and studies the digestive regularity with optical microscope and electrical conductivity. The results showed that for testosterone undecanoate type Ⅲ lipid formulations with castor oil as oil phase and Transcutol HP as latent solvent, the lipolysis rate and extent were increased with the increase of oil phase proportion and were decreased with excessive proportion of surfactant, in which can see liquid crystal phase during lipolysis process. The lipolysis rate of type ⅢB lipid preparations with different surfactant were ordered as Labrasol > Tween 80 > Cremophor EL, but the rate of type ⅢA is different in quick digestion phase and slow digestion phase. The lipolysis extent of type Ⅲ lipid formulations with different surfactant were ordered as Cremophor EL > Tween 80 > Labrasol. These may be related to the digestive effect of pancreatic lipase on different surfactants. This study implied that the lipolysis rate and extent of type Ⅲ lipid formulations are greatly influenced by the proportion of oil phase and surfactant, and the surfactant structure. These factors will affect the in vivo digestion and should be taken into account when screening type Ⅲ lipid formulations.

Human ScFv against botulinum neurotoxin serotype A(BoNTa) was modified by fusing human IgG1 Fc to C terminal of ScFv. ScFv-Fc fusion protein was expressed at high level over 30% of total host cell proteins in E.coli. Recombinant protein existed in inclusion body form. Renatured ScFv-Fc was purified to 90%~95% by Protein G Sepharose column. In vitro ScFv-Fc could bind specific to toxiod BoNTa in ELISA. Recombinant ScFv-Fc had similar relative affinity to parent ScFv and had improved stability.

OBJECTIVE: To analyze the long-term efficacy of nasal endoscopic opticnerve decompression for traumatic optic neuropathy(TON) and to explore its possible influencing factors. METHOD: To summarize the clinical data of 39 cases underwent transnasal decompression, which were followed-up for more than 1 year. The data, including optic canal CT scanning, flashed-elicited visual-evoked potential (FVEP), preoperational vision and visual field examination were reviewed. Nasal endoscopic optic nerve decompression was preformed. Whether or not optic nerve sheath incision decided to perform was according to preoperative CT and situations in operation. Postoperative follow-up including vision, visual field, funduscopy, nasal endoscopy were performed. RESULT: Total efficacy rate was 30. 77% (12/39), inefficacy rate was 69. 23%(27/39). The efficacy rate was 85. 71% with better than nolight perception, and the efficacy rate was 18. 75% with nolight perception, the clinical effect in the group of preoperative better than nolight perception was better than that of nolight perception, the difference was statistically significant (P<0. 05). The efficacy rate was 34. 38% with duration of less than 7 days from the traumatic point to the operation point, and the efficacy rate was 14. 29% for more than 7 days, but the difference was not statistically significant (P> 0. 05). The efficacy rate was 26. 32% with optic nerve sheathincision, while the efficacy rate was 35. 00% without optic nerve sheath incision, and there was no statistically significant difference (P>0. 05); Postoperative vision tended to stabilize until about 6 months post-operation, without complications. CONCLUSION The long-term efficacy of nasal endoscopic opticnerve decompression for TON was certain; The efficacy with preoperative residual vision was better than that of nolight perception, the factor of long or short duration from the trauma point to the operation point and the factor of optic nerve sheath incision didn't influence long curative effect. To avoid the secondary damage to the optic nerve after trauma was the key to increase long curative effect in TON.
Decompression, Surgical ; Endoscopy ; Humans ; Neurosurgical Procedures ; Nose ; surgery ; Optic Nerve ; surgery ; Optic Nerve Injuries ; surgery ; Postoperative Period ; Tomography, X-Ray Computed ; Treatment Outcome ; Visual Acuity

The effect of water temperature, stocking density and feeding cycle on the growth of Poecilobdella manillensis juvenile was conducted P. manillensis was conducted respectively under different conditions: water temperatures(18, 22, 26, 30,34, 38 degrees C and CT), stocking density (75, 125, 200, 275, 350 individual/L) and feeding cycle(2, 4, 6, 8, 12, 16 d). After 30 days, survival rate, weight gain rate, specific growth rate were measured. There was a significant correlation between water temperature and specific growth rate (γ = -0.066x2 + 3.543 1x -38.09, R2 = 0.837 9). Based on the regression equation, the specific growth rate of P. manillensis achieved the maximum (9.461 4) at 26.84 degrees C. And the most optimal water temperature was 26-30 degrees C. Meanwhile, the survival rates of P. manillensis was 0 at 38 degrees C in 3 d. There was significant negative correlation between density and specific growth rate (γ = -0.005 7x + 9.197 3, R2 = 0.998 3) and between feeding cycle and specific growth rate (γ = -0.468 2x + 10.574, R2 = 0.998 8).
Animals ; Annelida ; growth & development ; physiology ; Body Size ; Feeding Behavior ; Temperature ; Water ; chemistry

Objective To study the anatomic data of the first metatarsal dorsal artery and to provide anatomical basis for clinical tissue transplantation based on the first metatarsal dorsal artery.Methods The 16 adult cadaver specimens with 32 feet were dissected and meas-ured by vernier caliper.Then the anatomic data of the first metatarsal dorsal artery were analyzed.Results Through the examinations of 32 feet sample,the first metatarsal dorsal artery were classified into 5 types.Type Ⅰ:the first metatarsal dorsal artery runs at the surface of the first dorsal interosseous muscle (13 sides,40.6%).Type Ⅱ:the first metatarsal dorsal artery runs in the interior of the first dorsal interosse-ous muscle (11sides,34.4%).Type Ⅲ:the first metatarsal dorsal artery runs underneath the first dorsal interosseous muscle (6 sides, 18.8%).Type Ⅳ:the first metatarsal dorsal artery is slender (1 side,3.1%).TypeⅤ:the first metatarsal dorsal artery is absent (1 side, 3.1%).Distance relationship was measured between the first metatarsal bone and the first metatarsal dorsal artery:the vertical distance be-tween the origin of the posterior branch of the first metatarsal dorsal artery and base of the first metatarsal bone was (2.4 ±0.3)mm,the ver-tical distance between the origin of the posterior branch of the first metatarsal dorsal artery and head of the first metatarsal bone was (10.1 ±1.0)mm;the vertical distance between the origin of the anterior branch of the first metatarsal dorsal artery and the first metatarso-phalangeal joint was (7.6 ±2.7)mm.Conclusion The first metatarsal dorsal artery has clinical reference significance for the hands and feet’s trauma and skin flap transplantation such as thumb reconstruction.

Diagnosis, Differential ; Humans ; Neoplasms, Glandular and Epithelial ; diagnosis ; Thymus Neoplasms ; diagnosis