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Objective:This study was to explore the effect of HBM-based education and to help establish the measures on improving oral health status in deaf-dumb students. Methods:A total of 152 students aged 9-18 from two deaf-mute schools in Jing'an District， Shanghai were selected. The study subjects were randomly assigned to either experimental or control group. Students in the control group received oral health education with sign language every 6 months， and students in the experimental group received oral health education based on HBM. Before and two years after the intervention， data were collected by oral examinations and questionnaires. SPSS 22.0 software package was used for statistical processing of the data. Results:Before the intervention， there was no significant difference between the control group and the experimental group in caries rate， soft scale detection rate， calculus detection rate， caries average， debris index and calculus index. After the intervention， the caries rate （47.3% vs 68.5%）， soft scale detection rate （77.0% vs 91.8%）， and calculus detection rate （37.8% vs 58.9%） in the experimental group were all significantly （P<0.05） lower than those in the control group. After the intervention， caries average， debris index and calculus index in the experimental group were 1.93±2.25， 0.55±0.45， and 0.37±0.50， respectively， while the corresponding values in the control group were 2.82±3.24， 1.17±0.47， and 0.41±0.44. The difference in debris index between two groups was statistically significant （P<0.05）. Conclusion:Oral health education for deaf-mute students based on Health Belief Model（HBM）shows a good effect on improving the oral health. Further oral health education as well as the implementation of intervention measures such as using local fluoride， pit and fissure sealing， and early dental caries filling， are needed to effectively control the occurrence and development of dental caries in deaf-mute students.
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OBJECTIVE: To compare the applicability of two risk assessment methods for occupational health risk assessment in enterprises with 1-bromopropane(1-BP) production and utilization. METHODS: Three enterprises with 1-BP production and utilization were selected as the research subjects by a typical sampling method. The exposure concentration of time-weighted average of 1-BP-exposed in worker was detected. The non-carcinogenic health risk of 1-BP was assessed using the USA Environmental Protection Agency(EPA) inhalation risk(EPA assessment model) and the Ministry of Manpower of Singapore(MOM assessment model), and the results were compared. RESULTS: When the EPA method was used for the assessment, the risk assessment results of the four posts in the manufacturing enterprises were all negligible. In the enterprises that use 1-BP, the posts of cleaning machine B and clamping were of medium risk and the other four posts were of low risk based on the occupational exposure limit(OEL) in China used as the reference exposure concentration(RfC). When the 24-hour minimal risk level of USA Agency for Toxic Substances and Disease Registry was used as the RfC, the posts of cleaning machine B and clamping were of extreme high risk; the posts in cleaning machine A and checking were of high risk; the post in the cleaning machine D was of medium risk and the post of cleaning machine C was of low risk. When the MOM assessment model was used for evaluation, the four posts were of low risk in the 1-BP production enterprises. In the enterprises that use 1-BP, the posts of cleaning machine B and clamping were of high risk; the posts of cleaning machine A, cleaning machine D and checking were of medium risk; and the post of cleaning machine C was of low risk. CONCLUSION: When the OEL value is used for risk assessment, the MOM assessment method is more suitable than the EPA assessment method to assess occupational health risks of 1-BP.
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Alzheimer's disease(AD) is a chronic progressive neurodegenerative disease with recent memory impairment as the main clinical manifestation and senile plaques and neurofibrillary tangles as the main pathological changes. In recent years, the effect of microRNAs on AD has attracted widespread attention. Patients with AD have abnormal expression of miRNA, which is closed related to regulation of AD pathophysiology-related genes. Therefore, this paper first elaborated neuroprotective and toxic effects of microRNA in AD, and then explored relevant traditional Chinese medicines that can regulate miRNA in the treatment of AD, so as to provide basis for revealing the pathogenesis relationship between miRNA and AD and provide ideas for further development of anti-AD traditional Chinese medicine.
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Humans , Alzheimer Disease/genetics , Medicine, Chinese Traditional , MicroRNAs/genetics , Neurodegenerative DiseasesABSTRACT
Objective To investigate dental caries in 3-year-old children in Jing′an District of Shanghai and analyze the influence of oral cleaning behavior on caries in children. Methods Six hundread 3-year-old children from 12 kindergartens in Jing′an District, Shanghai were randomly selected by cluster sampling method for oral examination, and a self-administered questionnaire survey on children′s oral cleaning behavior was completed by parents.SPSS 22.0 software package was used for statistical analysis. Results Among the 600 children, the prevalence of dental caries was 42.50%, and the average dmft index was 1.76±2.92.Children who did not brush their teeth had a statistically significant increase in rate of dental caries(χ2=29.995, P < 0.001).Children who brushed their teeth for more than three minutes each time had a statistically significant lower rate of caries(χ2=3.918, P=0.048).Children whose parents helped their children brush their teeth every day had a lower rate of caries than those who brushed teeth by themselves, and the difference was statistically significant (χ2=8.718, P=0.013).Logistic regression analysis showed that age of beginning brushing teeth, times of brushing teeth per day and length of brushing teeth per time were all influence factors for caries in children (P < 0.05). Conclusion For the prevention and control of dental caries in 3-year-old, proper oral cleaning behavior is very important.We should make parents as a priority group for doing oral hygiene in children.Schools should strengthen oral health education for parents.Medical institutions should guide and monitor the effectiveness of oral hygiene in children.It is important to reduce the rate of dental caries in preschool children from three aspects:family, school and medical institutions.
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OBJECTIVE: To summarize the structural design strategy and safety assessments of rAAV packaging systems. METHODS: Based on the research progress and international review experience of commercial rAAV products, the design strategy and safety assessments of rAAV packaging systems were summarized. The design strategy and safety assessments of rAAV packaging systems were summarized. RESULTS: The scientific evaluation of the pharmaceutical design of rAAV for human should cover multiple aspects, because various types of AAVs differ in tissue selectivity, viral assembly, transgene expression. Meanwhile, the packaging system is diverse, and the production process is complex. CONCLUSION: The considerations referring to the rAAV structure and mechanisms of producing replication-competent AAV are proposed, and we hope to improve the communications between developers and regulators.
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In recent years, the number of clinical trials of stem cell products has increased, and the research and development technology and evaluation system have developed rapidly. Human pluripotent stem cell (hPSC)-derived cellular products are in the phase I/II stage of clinical trials. Related products include hPSC-derived neurons, retinal pigment epithelial cells, pancreatic beta cells, etc. They are generally used for the repair and replacement of functional cells related to degenerative diseases and genetic diseases via local transplantation. So far, no similar products have been officially approved on market. As hPSC possesses multi-directional differentiation potential and the ability to form teratoma in vivo, compared with other stem cell products, hPSC-derived cellular products have relatively higher risk of tumorigenicity, longer differentiation induction cycle, more complex production process, together with the rapidly updating quality characterization methods, which pose challenges to the scientific evaluation of their human applications. Based on the problems in the recent review and communication of clinical trial applications of stem cell products, and with reference to the relevant technical guidelines, this paper proposes the chemistry, manufacturing, and controls review considerations on the manufacturing process and quality study of hPSC-derived cellular products. We hope to improve the communications between developers and regulators.
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The number of clinical trials for mesenchymal stem cell (MSC) products ranked the top among all stem cell products, with more than 900 trials ongoing or completed by 2018. In China, many MSC clinical trials have started as "the third type of medical technique" and the dossiers of MSC products have been submitted to National Medical Products Administration (NMPA). The biological function and therapeutic effect of MSCs are constantly being recognized in scientific communities. However, the observed functions of MSCs in vitro are not fully reproduced in the living microenvironment in vivo. There are substantial variations among tissue origins, cellular phenotypes and biological functions. Different formulations, delivery methods, manufacture processes or doses all greatly affect the clinical efficacy. It is difficult for MSCs to maintain the naive state due to the differences between in vitro culture conditions and in vivo microenvironment. Meanwhile, there is no widely accepted scientific definition for MSCs until now, due to the complexity of manufacturing process and variable sources. Consequently, the regulation of MSC products is a challenge for drug administrative agencies. In this article, we review the research progress of MSC products around the world, and summarize the considerations in evaluating the chemistry, manufacturing and controls (CMC) section of MSC product applications, with respect to raw materials, manufacture processes and quality control. We hope that the information summarized here will provide insights for the development and evaluation of MSC products.
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As a living cell product, chimeric antigen receptor (CAR)-T cell therapy displays multiple characteristics including the diversity of raw materials, the complexity of manufacturing process and the complementarity of quality control set. Pharmaceutical research and evaluation of CAR-T cell therapy are fundamentally different from small molecule and macromolecular recombinant proteins. Chemistry manufacturing and controls (CMC) review of investigational new drug (IND) submission for CAR-T therapy should especially pay attention to above unique characteristics and focus on potential risks to ensure clinical safety. Based on questions and concerns from recent CMC review practice and workshop on CAR-T cell therapy IND application, the critical points to consider for CMC study is proposed, and questions related to supplementation are also discussed in this review to accelerate the clinic translation of CAR-T therapy.
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<p><b>OBJECTIVE</b>To investigate changes in endogenous bactericidal/permeability-increasing protein (BPI) levels and their significance in patients with surgical sepsis.</p><p><b>METHODS</b>In the prospective study, 19 surgical patients with infection were involved. The plasma BPI, lipopolysaccharide-binding protein (LBP) and interleukin-6 levels were measured on post-infected days 1, 3, 5, 7 and 14 by an enzyme-linked immunosorbent assay (ELISA). Plasma endotoxin concentrations were determined by the modified chromogenic Limulus Amebocyte Lysate (LAL).</p><p><b>RESULTS</b>Compared with normal controls, significant lower plasma BPI/LBP ratios were observed in septic patients on days 1 to 5 after infection (P < 0.01), and in severe septic patients on days 1 to 7 (P < 0.01). Moreover, plasma BPI/LBP ratios were much lower in severe sepsis than those in sepsis on days 1 to 3 after infection (P < 0.05).</p><p><b>CONCLUSIONS</b>Plasma BPI and LBP levels increased rapidly after infection, but BPI/LBP ratios were significantly decreased during sepsis. Plasma BPI/LBP ratios appear to be closely related to the severity of sepsis in patients complicated by surgical infection.</p>
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Adolescent , Adult , Female , Humans , Male , Middle Aged , Acute-Phase Proteins , Antimicrobial Cationic Peptides , Blood , Blood Proteins , Carrier Proteins , Blood , Enzyme-Linked Immunosorbent Assay , Interleukin-6 , Blood , Membrane Glycoproteins , Blood , Postoperative Complications , Blood , Microbiology , Prognosis , Prospective Studies , Sepsis , BloodABSTRACT
<p><b>OBJECTIVE</b>To investigate the potential role of high mobility group-1 protein (HMG-1) in the pathogenesis of sepsis-induced multiple organ dysfunction syndrome in rats.</p><p><b>METHODS</b>Using a sepsis model by cecal ligation and puncture (CLP), 80 male Wistar rats were randomly divided into four groups: normal control (n = 10), sham operation (n = 10), CLP (subdivided into 2, 6, 12, 24, 48, 72 h post-CLP, n = 60), and sodium butyrate treatment (subdivided into 12, 24 h post-CLP, n = 20). At serial time points in each group, animals were sacrificed, and blood as well as tissue samples from the liver, lung, kidney and small intestine were harvested to measure organ function parameters and HMG-1 mRNA expression by the reverse transcription polymerase chain reaction (RT-PCR) taking GAPDH as an internal standard. Also, additional experiments were performed to observe the effect of treatment with sodium butyrate on survival rate in septic rats (n = 57).</p><p><b>RESULTS</b>HMG-1 mRNA levels significantly increased in various tissues during 6 - 72 h after CLP (P < 0.05 or 0.01), and were markedly inhibited by sodium butyrate at 12 h and 24 h (P < 0.05 or 0.01). Early treatment with sodium butyrate also could markedly reduce serum alanine aminotransferase, creatinine levels at 12 h post-CLP and pulmonary myeloperoxidase activities at 24 h. Furthermore, treatment with sodium butyrate could significantly improve the 1- to 6-day survival rates in animals subjected to CLP (P < 0.05 or 0.01).</p><p><b>CONCLUSIONS</b>HMG-1 might play an important role in the development of excessive inflammatory response and subsequent multiple organ dysfunction syndrome.</p>