OBJECTIVE:To provide reference for food & drug regulatory authorities in China to disclose government information.METHODS:In the light of the development and status quo of the disclosure of information in US FDA,the access,content and procedure for the disclosure of information in FDA were discussed.RESULTS & CONCLUSIONS:There are many similarities between US and China in the disclosure of information.In view of the practical situation of governmental information disclosure in food and drug regulatory authorities in China,Chinese government should be able to find out such key issues as the human and financial support is much needed in FDA information disclosure,the disclosure level should be in line with our national condition,a three-dimensional publicity system of government information at different level should be established and emphasis should be laid to the key disclosed information etc based on the research on the development,access,content and procedure of information disclosure in FDA.

AIM:To study the effect of panax notoginseng saponins on the left atrial appendage(LAA)of the guinea pigs.METHODS:Standard microelectrode intracellular recording technique was used to record the LAA action potential(AP)and the effective refractory period(ERP)in the guinea pigs during the pouring with different density of PNS.RESULTS:The effect of PNS in concentration of 0.7,7,70,700 mg/L was significant at 20 min,the APD50 and APD80 of the pouring at 20 min,30 min,40 min of the 70 mg/L was longer than the reference group(P

Mid-ventricular hypertrophic obstructive cardiomyopathy (MVHOCM) is a rare type of cardiomyopathy thatcan be accompanied by apical aneurysm.We presented here a case report of MVHOCM with cornary artery disease.The sixty-fouryears old man was sent to hospital because of ventricular tachycardia.Large inversion T wave was showed on electrocardiography in the presence of abnormal coronary arteries and normal cardiac enzyme.Echoeardiogmphy showed an hourglass appearance of the leftventricle with an aneurysm in the apex and a pressure gradient between the outflow tract of left ventricle and the middle of the leftventricle was revealed by left-heart catheterization.

Objective:To evaluate the effects of maxillary protraction with or without rapid maxillary expansion in the treatment of Class Ⅲ malocclusion by Meta-Analysis.Methods:The randomized controlled trail,quasi-randomized controlled trail and the clinical controlled trail about the treatment of Class Ⅲ malocclusion by protraction with or without expansion were searched in the database of Cochrane Library,Embase,PubMed,Medline,CBM,Wan Fang,CNKI,VIP.2 authors qualified and extracted the data independently.Then the Meta-analysis was performed by using the RevMan 5.3 software.Results:7 studies with 228 cases were included,114 cases were treated by maxillary protraction with expansion and the other 114 cases by maxillary protraction without expansion.The Meta-analysis showed that:there was no significant difference in SNA,SNB,ANB and SN-PP except ANS-Me,U1-NA,SN-MP.A favorable improvement of the sagittal relationship between maxillary and mandibular was observed by using protraction whether with expansion or not.The expansion did not shorten the course of treatment,but it lowered the inclination of upper incisors,resulting in more clockwise rotation of mandibular plane and increase of the facial vertical dimension.Conclusion:Maxillary protraction with rapid maxillary expansion can be used in the treatment of class Ⅲ malocclusion with incisor labioclination.

Objective To investigate the applicability of zebra fish thrombosis model in antithrombotic activity screening of Chinese materia medica.Methods The living zebra fish thrombosis model was induced by adrenaline hydrochloride. Zebra fish were randomly divided into blank control group, model group, positive medicine group and medication group. Each group was given the corresponding medicine or embryo culture water. O-anisidine staining solution was used to stain and calculate the staining intensity of erythrocytes in zebra fish heart, and quantitative analysis was carried out. The platelet aggregation of transgenic zebra fish was observed and under qualitative analysis. Results Compared with the model group, 100μg/mL salvianolic acid B, 300, 900μg/mL aqueous extract of Salvia miltiorrhiza, 45μg/mL 95% ethanol extract and 400, 1200μg/mL hypothalamus could significantly inhibited the formation of zebra fish thrombosis (P<0.01).ConclusionZebra fish thrombosis model has good applicability in antithrombotic activity screening of Chinese materia medica.

Objective To explore the clinical efficacy and indications of kyphoplasty with movement and secondary en?largement of balloon for the compression fracture of vertebral body with ruptured posterior wall. Methods A retrospective analy?sis was carried out on the data of 29 patients (10 males, 19 females;age range:55-86 years old;mean age:71 years old;29 verte?bral bodies in total) who suffered from compression fracture of the thoracolumbar spine and below, and underwent kyphoplasty through the movement and secondary enlargement of balloon within the vertebral body and were followed up from January 2011 to November 2014. These patients had backache, accompanied by lowered support, limitation of movement, no symptom of nervous lesion on both lower extremities and no past history of balloon kyphoplasty. All fractured vertebral bodies were at T 11 or below, in?cluding 1 case at T11, 4 cases T12, 11 cases L1, 9 cases L2 and 4 cases L3. The causes of injury included fall (19 cases), car accident (8 cases) and unknown reasons (2 cases). All patients underwent kyphoplasty with the movement and secondary enlargement of bal?loon within the vertebral body. Photos were taken immediately after the surgery, at 1 month, 3 months, 6 months and 12 months, and these patients were assessed and analyzed in terms of vertebral height, Cobb angle, visual analogue score (VAS) and Oswestry disability index (ODI). Results The operation time (including the formation and solidification of bone cement) of 29 patients was 40 to 65 min and the mean time was 55 ± 7 min;the blood loss during operation was 2 to 15 ml and the mean blood loss was 5 ± 2 ml;the injected volume of bone cement was 2.5-7.5 ml and the mean volume was 5.5±0.5 ml. Post?operative pain was relieved and ambulation was performed under the protection of lumbar orthosis brace. Statstical analysis was conducted on VAS, ODI, vertebral height and Cobb angle before operation and at 1 month, 3 months, 6 months and 12 months after operation, showing statistically significant differences. X ray examination found that there was no alternation or displacement of bone cement location, and no change in vertebral morphology, the vertebral height and cobb angle remained the post?operative status, and posterior wall rupture of the vertebral body was recovered well. CT revealed that the morphology of bone cement was irregular and closely integrated with bone substance, and no cavity or fissure was seen. Conclusion Kyphoplasty with movement and secondary enlargement of bal?loon within the vertebral body has a good, definite clinical efficacy in treating compression vertebral fracture with incomplete pos?terior wall of the vertebral body without obvious displacement of fractured bone and symptom of nervous lesion on both lower ex?tremities. This surgery is easy to operate, and has an immediate analgesic effect, which could recover vertebral height as well as re?duce kyphosis deformity and improve patient’s prognosis.

Objective To evaluate the clinical effectiveness of double balloon dilation in percutaneous kyphonplasty on curing vertebral?compression fractures. Methods From January 2009 to September 2013, 84 patients (94 vertebral bodies) with vertebral compression were treated by percutaneous kyphonplasty. All were fresh fractures and were injured or obvious low back pain 1 month, accompanied by local tenderness, kowtow attack painful, lumbar mobility, but no lower extremity injury numbness, activities and defecation disorders. After randomization, the double balloon dilation in percutaneous kyphonplasty method was used to treat 44 patients (49 vertebrae). In the process of performing percutaneous unilateral pedicle puncture and balloon dilata?tion of the vertebral body, the balloon has been moved some distance in the vertebral body. Then completed the perfusion of bone cement, vertebral body forming. 40 cases (45 vertebrae) were used conventional unilateral percutaneous kyphonplasty to vertebtal compression fractures. Recorded the operation time, amount of bleeding, bone?cement injection volume. Used visual analogue scale (VAS), the height of the vertebral body and Cobb angle to evaluated the curative effect. Results All 84 patients completed the operation, follow?up time was 22 months (18-24 months). In two mobile open expansion group, the operation time was about 48 min. The amount of bleeding was 8-15 ml. The average bone?cement injection volume was 5.1 ml. No patients quit the study and no bone cement?leakage cases or other side effects were observed , and no clinical accidents occurred. In a single stretching group, 40 cases (45 vertebrae) completed conventional vertebroplasty, the time of 44 min, bone cement average injection rate 3.2 ml, bleeding 10-15 ml. In two mobile open expansion group, the VAS score was 8.5 points, the height of the vertebral body height was 2.1cm, and the Cobb angle was 34°. After operation, the VAS score 2.9 points, the height of the vertebral body 2.8 cm, and Cobb 20° . In the other group, the pain was significantly relieved and the relief was satisfactor after operation.Vertebral height of 2 cm turned to the last follow?up of 2.4 cm. The Cobb angle was 32°, and the last follow?up was 27°. The VAS score, operation time and bleeding volume of the two groups were not statistically significant, and a statistically significant difference of the average bone ce?ment injection volume, postoperative vertebral height and cobb angle improved with statistical significance. A single open group were 2 cases of bone cement leakage and leakage, 1 cases of bone cement tail, the complication rate was 5.6%. Conclusion The application of double balloon dilation in percutaneous kyphonplasty to vertebral?compression fractures improve relocation of verte?bral compression fractures, increase recovery of vertebral height, and more effectively strengthen and stiffen pathological vertebral bodies, while improving kyphosis. Moreover, it can reduce pressure during bone?cement injections, minimizing the chance of over?flow and leakage, as well as the related side effects, but it will also result in an increase of bone cement?injection volume.

Objective To investigate the inhibitory effect of a disintegrin and metalloprotease 12 silenced by shR?NA on self-renewal capacity of CD133 positive giloma cells. Methods The shRNA recombinant lentivirus aimed at si?lencing ADAM12 was prepared. Human glioma cells U87 were employed in this study and assigned into three groups:shRNA-ADAM12, shRNA-NCandshRNA-C. ADAM12 expression was detected at mRNA and protein level using Re?al-time quantitative-PCR and western bloting, respectively. U87 cells were cultured with stem cell culture medium, to obtain cell sphere formation in which CD133 positive glioma cells were enriched. Immunofluorescence was employed to detect the expression of ADAM12 and CD133 in cell spheres and U87 cells; Self-renewal was tested by using tumor sphere formation assay. Molecular markers for differentiated or undifferentiated cells (CD133,GFAP and Tuj1) were de?tected at protein using western blotting. Western blotting was employed to test protein expression of HES1. Results AD?AM12 shRNA significantly down-regulated the mRNA and protein expression levels of ADAM12. Compared with shRNA–C group, the relative expression levels of mRNA in shRNA-ADAM12 group and shRNA-NC group were 0.22 ± 0.03 and 0.98 ± 0.06 (F=425.37,P<0.01). The relative expression levels of protein in shRNA-ADAM12 group, shRNA-NC group and shRNA-C group were 28.72%±2.36%, 69.21%±3.92%and 69.04%±3.57%, respectively (F=145.42,P<0.01). Immunofluorescence staining showed that expression levels of ADAM12 and CD133 in cell spheres were significantly higher than those in normal cells. The number of spheres in three groups were 45.5±2.3、104.2±5.8 and 109.6±6.2, tumor sphere formation ability of shRNA-ADAM12 group was lower than that of shRNA-NC group and shRNA-C group (F=147.03,P<0.01). Compared with the shRNA-NC group and shRNA-C group, the protain expression of GFAP and Tuj1 were increased up to 166% and 146% (P<0.01) whereas the protein expression levels of CD133 and HES1 were down-regulated by 54% and 50% (P<0.01). Conclusion Knockdown of ADAM12 may suppress self-renewal ability of CD133 positive glioma cells by inhibiting the Notch pathway activity.

Objective:To investigate the effects of fluoride exposure on proliferation, apoptosis and osteogenic differentiation of bone marrow mesenchymal stem cells (BMSCs) in mice.Methods:BMSCs were isolated and cultured from femur bone marrow of C57BL/6 mice (6 - 8 weeks). The cells in passage 3 were used to detect the surface markers of stem cells by flow cytometry. The cells were cultured in media with a final fluoride concentration of 0.0, 0.1, 1.0, 5.0, 10.0, 15.0, 20.0 and 40.0 mg/L, respectively. The effects of different fluoride concentrations on BMSCs cell proliferation (CCK8 method), apoptosis (flow cytometry analysis), osteogenic differentiation ability [alizarin red and alkaline phosphatase (ALP) staining] were detected. Western blot was applied to detect the levels of apoptosis-related proteins [poly ADP-ribose polymerase (PARP)], mitogen-activated protein kinase (MAPK) pathway member proteins [extracellular regulated protein kinase 1/2 (ERK1/2), c-Jun amino-terminal kinase (JNK), p38 and phosphorylated ERK, JNK, p38 (p-ERK, p-JNK, p-p38)], osteogenic differentiation-related protein [Runt-related transcription factor 2 (Runx2), ALP] and Wnt/β-catenin pathway member proteins [glycogen synthase kinase-3β (GSK3β), phosphorylated GSK3β (p-GSK3β) and β-catenin]. Immunocytofluorescense staining was applied to evaluate the expression levels of p-GSK3β and β-catenin. The two pathways (MAPK and Wnt/β-catenin) were blocked by SP600125 and DKK-1, respectively, to testify their involvement in mechanisms of apoptosis and osteogenic differentiation.Results:The mouse BMSCs were successfully isolated and cultured. Flow cytometry analysis showed that the mesenchymal stem cell surface biomarkers (CD73, CD90 and CD105) were positively expressed. The comparison of cell proliferation at three time points (24, 48 and 72 h) in each concentration group was statistically significant ( F = 65.36, 160.04 and 365.32, P < 0.001), and the comparison of early apoptosis (24 h) in each concentration group was statistically significant ( F = 214.04, P < 0.001); compared with the 0.0 mg/L group, the cell proliferation in 15.0, 20.0 and 40.0 mg/L groups decreased, and the early apoptosis rate in 10.0, 15.0 and 20.0 mg/L groups increased ( P < 0.05). When cells were treated with 15.0 mg/L fluoride for 0 - 24 h, the p-JNK/JNK ratio was higher at 2, 4, 8, 12, 18 and 24 h compared with that at 0 min ( P < 0.05); compared with the fluoride group (15.0 mg/L), the early apoptosis rate of cells after SP600125 block decreased ( P < 0.05), and the protein expression levels of PARP and p-JNK decreased ( P < 0.05). After osteogenic induction, compared with the 0.0 mg/L group, in 0.1 and 1.0 mg/L groups ALP staining was enhanced and the number of calcified nodules increased, and the protein expression levels of Runx2 and ALP in the 0.1 and 1.0 mg/L groups were higher ( P < 0.05). After osteogenic induction, compared with the 0.0 mg/L group, the p-GSK3β/GSK3β ratio and β-catenin protein level were significantly higher in the 0.1 and 1.0 mg/L groups ( P < 0.05); and compared with the fluoride group (1.0 mg/L), addition of DKK-1 significantly decreased the protein expression levels of p-GSK3β and β-catenin and reduced the nuclear entry of β-catenin, and ALP staining decreased and the number of calcified nodules decreased. Conclusions:High concentration of fluoride (> 10.0 mg/L) inhibits the proliferation and promotes apoptosis of BMSCs, while low concentration of fluoride (0.1, 1.0 mg/L) promotes osteogenic differentiation. The MAPK/JNK pathway and the classical Wnt pathway are involved in the above cellular processes, respectively.

Objective:To evaluate the relationship between preoperative SARS-CoV-2 vaccination and postoperative delirium(POD) in the patients.Methods:A total of 938 participants of either sex, aged 50-90 yr, weighing 50-90 kg, of American Society of Anesthesiologists Physical Status classificationⅠorⅡ, with preoperative Mini-Mental State Examination score ≥24, without communication barriers, undergoing elective knee or hip joint replacement under combined spinal-epidural anesthesia from June 2020 to June 2022 in Qingdao Municipal Hospital, were enrolled. The vaccination with SARS-CoV-2 inactivated vaccine within 6 months before operation was recorded. The cerebrospinal fluid 2 ml was extracted after the puncture needle was successfully inserted into the subarachnoid space for determination of the concentrations of Aβ42, total tau protein (t-tau), and phosphorylated tau protein (p-tau) by enzyme-linked immunosorbent assay (by enzyme-linked immunosorbent assay). The Aβ42/t-tau and Aβ42/p-tau ratios were calculated. POD was assessed using the Confusion Assessment Method twice a day within 7 days after surgery or before discharge.The patients were divided into POD group and non-POD group according to whether they developed POD. The risk factors of which P values were less than 0.20 in the univariate logistic regression would enter the multivariate logistic regression analysis to investigate the relationship between SARS-CoV-2 vaccine and level of cerebral spinal fluid (CSF) biomarkers and POD. Results:Eight hundred and seventy-four patients were finally enrolled in the analysis, of which 169 patients developed POD, with an incidence of 19.3%.The results of logistic regression showed that vaccination with SARS-CoV-2 inactivated vaccine within 6 months before operation, preoperative concentrations of Aβ42 in CSF, and increase in Aβ42/t-tau and Aβ42/p-tau ratios were protective factors for POD, and preoperative elevated concentrations of t-tau and p-tau in CSF were risk factors for POD ( P<0.05). After gender, age, preoperative Mini-Mental State Examination score, years of education, history of drinking, hypertension, diabetes mellitus and coronary heart disease were added to eliminate the influence of confounding factors, the results still showed that vaccination with SARS-CoV-2 inactivated vaccine within 6 months before operation was a protective factor for POD. Conclusions:Vaccination with SARS-CoV-2 inactivated vaccine within 6 months before operation is a protective factor for POD in patients.