1.Key activities involved in conduct of clinical trials
Ai-Jian LI ; Ning-Ning XIONG ; Xiu-Qin WANG ;
Chinese Journal of Clinical Pharmacology and Therapeutics 2000;0(03):-
Key trial activities include: development of the trial protocol;development of standard operating procedures;development of support systems and tools;generation and approval of trial information documents;selection of trial sites and the selection of properly qualified,trained,and experienced investigators and study personnel;ethics committee review and approval of the protocol;review and approval by applicable regulatory authorities;enrollment of subjects into the study: recruitment,eligibility,and informed consent;the investigational product(s): quality,handling,and accounting;trial data acquisition: conducting the trial;trial data acquisition: conducting the trial; safety management and reporting;monitoring the trial;managing trial data;quality assurance of the trial performance and data;reporting the trial.
2.The changes of three endogenous hormones during flower bud differentiation of Schisandga chinensis.
Jun AI ; Ying-ping WANG ; Chang-yu LI ; Xiu-wu GUO ; Ai-min LI
China Journal of Chinese Materia Medica 2006;31(1):24-26
OBJECTIVETo reveal the relation between endogenous hormones and the flower bud differentiation in Schisandga chinensis.
METHODTop buds of extremely short branch and axillary buds of long branch in the same plant of S. chinensis were used as material and the contents of endogenous hormones were measured during different periods of the flower bud differentiation with HPLC.
RESULTThe result showed that flower bud differentiation and the formation of female flower were inhibited by high concentration of GA3 and were promoted by high concentration of ABA or ZT. Low ratio of GA3/ABA has the same result.
CONCLUSIONThere was a correlation between endogenous hormones and the flower bud differentiation of S. chinensis.
Abscisic Acid ; metabolism ; Flowers ; growth & development ; Germination ; Gibberellins ; metabolism ; Plant Growth Regulators ; metabolism ; Plants, Medicinal ; growth & development ; metabolism ; Schisandra ; growth & development ; metabolism ; Zeatin ; metabolism
4.Effects of interleukin-1 receptor antagonist on photoreceptor apoptosis in inherited retinal degeneration rat
Ai-jun, LI ; Jun, FANG ; Xiu-an, ZHU ; Wen-zhen, YU ; Chun-hui, DI ; Li-ping, YANG
Chinese Journal of Experimental Ophthalmology 2013;(1):23-27
Background Inherited retinal degeneration,one of the major causes of blindness worldwide,comprises a large number of disorders characterized by a slow and progressive retinal degeneration.Interleukin-1 (IL-1)was recognized to be involved in inherited retinal degeneration.Whether IL-1 receptor antagonist (IL-1ra) can arrest retinal degeneration is worthy of investigation.Objective This study was to investigate the effects of IL-1ra on photoreceptor apoptosis in Royal College of Surgeons (RCS) rats.Methods The use of the animals complied with the Regulations for the Administration of Affairs Concerning Experimental Animals by State Science and Technology Commission.The SPF RCS rats aged 9,15,16,25,30,35,40,50 and 60 postnatal days were collected,with 9 rats for each age group.Retinal sections were used for the TdT-mediated biotin-dUTP nick-end labeling (TUNEL) cell apoptosis assay.1 μl of IL-1ra (1.8 g/L) was intravitreally injected in the right eyes of 9 RCS rats aged 15 postnatal days and PBS was used in the same way in the fellow eyes.The injection procedure was repeated on the 20 th and 25 th day,respectively.The rats were sacrificed on the 30 th day and retinal sections were prepared for the TUNEL assay.The differences in the percentage of the positive cellular nuclei area among different ages of rats were compared by one-way ANOVA,and the differences in retinal layer thickness between IL-1ra injection group and PBS injection group were assessed by paired t test.Results Photoreceptor apoptosis appeared in 20-day-old RCS rats and progressed and peaked in 30 and 35-day-old rats and then reduced,showing a significant difference among rat of various age groups (F=28.020,P<0.01).Images from TUNEL assay showed a weaker and less TUNEL staining in the IL-1ra injected eyes than the PBS injected eyes in 30-day-old rats.The total area and relative area of TUNEL positive nuclei were (223.052±153.092) μm2 and (2.206±1.531) % in the IL-1ra injected group,and those in PBS injected group were (1235.050±359.767) μm2 and (7.269± 1.624) %,with a significant difference between them (t =4.370,t=3.250,P<0.01).The cone and rod thickness was (15.324±9.035) μm in the IL-1ra injected group and (49.566±4.605)μm in the PBS injected group,showing a significant difference (t =22.674,P<0.01).However,no significant difference was seen in the outer nuclear layer thickness between the two groups (t =0.268,P>0.05).Conclusions IL-1 participates in the pathogenesis and development of inherited retinal degeneration of RCS rats.The use of IL-1ra might be a potential approach in the treatment of inherited retinal degeneration.
5.Effects of low calcium and high fluoride on expressions of receptor activator of nuclear factor-kappa B ligang mRNA in spleens of rats
Chun-hong, WANG ; Xiu-li, WANG ; Ai-ping, LU ; Hui, XU ; Guang-sheng, LI ; Ling, JING
Chinese Journal of Endemiology 2010;29(2):127-129
Objective To study the different expressions of receptor activator of nuclear factor-kappa B ligang(RANKL) mRNA in spleens of rats fed with diet of low calcium and high fluoride. Methods A 2× 2×2 factorial design was used and the factors were calcium, fluoride and action time. In the design, 40 Wistar rats [average body mass(118.9±13.5)g] were divided into four groups randomly by weight: control with normal diet (0.790%, calcium), low calcium group with low calcium intake(0.063%, calcium), high fluoride group with normal diet and high fluoride intake(100 mg/L, fluoride) and low calcium and high fluoride group with low calcium and high fluoride intake. After 4 and 8 months, 5 rats of each group were sacrificed and total RNA was extracted from spleen. And the expression levels of RANKL mRNA were determined by reverse transcription polymerase chain reaction (RT-PCR). Results At time of 4 months, the expression level of RANKL mRNA was 0.13± 0.05,0.13± 0.03,0.17±0.02,0.27± 0.05 and at time of 8 months, it was 0.11 ± 0.01,0.16 ± 0.02,0.16± 0.03,0.36 ± 0.07 in control group, low calcium group, high fluoride group, low calcium with high fluoride group, repectively. The factorial design AVONA showed that low calcium and high fluoride had significant effects on RANKL mRNA expression(F = 40.224,56.679, all P < 0.05) while action time had not(F = 2.850, P > 0.05 ). The interactions of low calcium with high fluoride or high fluoride with action time were signifieant(F = 7.247, 18.789, all P < 0.05) while the interaction of high fluoride with action time was not(F = 1.751, P > 0.05). Conclusions Low calcium alone or high fluoride alone or low calcium with high fluoride or low calcium with action time can increase the the RANKL mRNA expression level. High fluoride does not affect the RANKL mRNA level as the action time is prolonged.
7.Prognosis and Etiological Treatment of Cardiogenic Syncope in Children
xiu-lan, SHI ; zi-pu, LI ; shun-lan, WAN ; ai-ling, WANG
Journal of Applied Clinical Pediatrics 1986;0(01):-
Objective To explore the prognosis and etiological treatment of cardiogenic syncope in children.Methods The cause,clinical manifestation,treatment and prognosis of 45 children with syncope were made in affiliated hospital of Qingdao medical university were su mmarized and analyzed.They were divided into arhythmia group and other groups,the former included myocarditis,dilated cardiomyopathy,and post-operation of congenital heart disease and the latter included tetralogy of fallot,pulmonary stenosis,hypertrophic cardiomyopathy,pericarclial effusion,and right atrial myxoma.Results There were 29 cases(64.44%) with arrhythmia in this group,of which there were 18 cases with complete atrioventricular block(CAVB),2 cases with second degree type Ⅱ atrioventricular block,3 cases with ventricular tachycardia,2 cases with bradycardia,2 cases with atrial flutter,1 case with supraventricular tachycardia,and 1 case with nonconducting atrial premature.There were 16 cases(35.56%) with other etiologies,of which there 8 cases with tetralogy of Fallot,2 cases with pulmonary stenosis,hypertrop-hic cardiomyopathy,pericardial effusion,and right atrial myxoma,respectively.Children with CAVB,bradycardia,or ventricular tachycardia resulted from viral myocarditis were given anti-virus medicine,protecting myocardium,neoepinephrine,and intravenous vitamin C 100-200 mg/(kg?d).Dexamethasone 1-2 mg/(kg?d) was given in earlier period for short course,and some children were given human ?-globulin.Eight cases were placed temporary pacemaker because of unsatisfactory therapeutic efficacy,and 1 case was placed permanent pacemaker.In all,38 cases(84.44%)were cured,1 case(2.22%)was improved,and 4 cases(8.88%) died.Conclusions Cardiogenic syncope is pediatric emergency and shall be treated immediately.Temporary pacemaker shall be placed at the right moment.
8.Effects of ?-3 fish oil fat emulsion combined with total parenteral nutrition on the release of pro-inflammatory cytokines in patients with systemic inflammatory response syndrome
Xiu-Li ZOU ; Tie-Jun WU ; Ai-Jun QU ; Hui TIAN ;
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2006;0(05):-
Objective To explore the effect of?-3 fish oil fat emulsion on the release of pro-inflam- matory cytokines in patients with systemic inflammatory response syndrome(SIRS).Methods Forty patients with SIRS in the intensive care unit(ICU)from June 2006 to June 2007 were randomly divided into routine total parenteral nutrition(TPN)group(group A,20 cases)and?-3 fish oil fat emulsion+TPN treatment group(group B,20 cases).All the patients received treatment of parenteral nutrition with equal nitrogen content and calories.The caloric value given was 83.68 kJ?kg~(-1)?d~(-1),with 0.2 g?kg~(-1)?d~(-1)of nitrogen. Group A patients received routine TPN,and group B patients received TPN with?-3 fish oil fat emulsion 1-2 ml?kg~(-1)?d~(-1),and both regimes lasted for 7 days.The levels of serum tumor necrosis factor-?(TNF-?),interleukin-1(IL-1)and IL-6 were checked before the treatment,and on the 1st,3rd and 7th day after the beginning of the treatment.The duration in ICU,the incidence of multiple organ dysfunction syndrome(MODS)and the mortality rates in 28 days of the two groups were also assessed.Results Compared with the routine treatment group,the levels of serum TNF-?,IL-1,and IL-6 in the?-3 fish oil fat emulsion+TPN treatment group were lower markedly(P0.05).Conclusion The emulsion of?-3 fish oil fat seems to have a protective effect on patients with SIRS through decreasing the levels of serum TNF-?,IL-1 and IL-6,thus reducing the incidence of MODS,shortening the ICU stay, and increasing the survival rate of serious patients.
9.Molecular mechanism of Cigu Xiaozhi formula interfering with HSC-T6 cell activation by regulating HIF-1α signaling pathway based on computer aided drug design
Zhen REN ; Shuo YIN ; Ai-di WANG ; Li WANG ; Xiu-ping ZHAO ; Yan-hua MA
Acta Pharmaceutica Sinica 2023;58(10):3049-3058
In this study, we investigated the effect of Cigu Xiaozhi formula on HSC-T6 activity in hypoxic microenvironment based on network pharmacology and computer-aided drug design, and predicted and verified its possible targets and related signaling pathways. The potential active components and targets of Cigu Xiaozhi formula were screened by searching Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP), Encyclopaedia of Traditional Chinese Medicine (ETCM) and Bioinformatics Analysis Tool for Molecular Mechanism of Traditional Chinese Medicine (BATMAN-TCM) databases, and the liver fibrosis related targets retrieved from Gene Cards and Pharm GK database were integrated to obtain the potential targets of Cigu Xiaozhi formula in the treatment of liver fibrosis. GO enrichment analysis and KEGG signaling pathway enrichment analysis were performed on Omic Share platform, and Cytoscape software was used to construct the "potential active ingredient-key target-pathway" network. The active components and target proteins were subjected to molecular docking analysis by Auto Dock software. According to the results of molecular dynamics simulation and binding free energy calculation, the top 5 active components with degree were scored. The active components stigmasterol and
10.Combination of EMPs and BMSCs in promoting regeneration of periodontal tissue
zhong-chen, SONG ; rong, SHU ; yu-feng, XIE ; xiu-li, ZHANG ; bin, ZHANG ; ai-mei, SONG ; chao-lun, LI
Journal of Shanghai Jiaotong University(Medical Science) 2006;0(06):-
Objective To evaluate the feasibility of reconstructing horizontal periodontal bone defects by tissue engineering based on bone marrow stromal cells(BMSCs)as seed cells and enamel matrix proteins(EMPs)as growth factors. Methods Two healthy rhesus monkeys were selected, and BMSCs were isolated from iliac marrow and serial subcultivation was conducted. The cells of induced BMSCs at passage 3 were harvested and mixed with Bio-oss collagen. The models of horizontal periodontal bone defects were established surgically in each buccal side of the posterior teeth, and were divided into four groups (blank control group, material group, cells/material group and cells/material/EMPs group). The histological and Micro-CT observation were carried out 8 weeks later. Results In the blank control group, the defects were filled with fibrous connective tissue. There was newly-formed alveolar bone in the material group. In the cells/material group, periodontal regeneration could be observed, while the newly-formed cementum was irregular and less in quantity. In the cells/material/EMPs group, the amount of newly-formed alveolar bone was larger, and the newly-formed cementum was continuous and regular. Conclusion The tissue engineering technique of BMSCs as seed cells in combination with EMPs induction can significantly promote the regeneration of periodontal tissue.