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The pricing and reimbursement of orphan drugs are related to the accessibility of patients,and are of great significance to the prevention and guarantee of rare diseases.European countries have formed special standards and paths for health technology evaluation,and established special payment funds and diversified risk-sharing agreements,which have effectively improved the accessibility of orphan drugs.Based on this,it selected typical European countries to compare the orphan drug pricing and reimbursement methods.Then,it put forward some suggestions"building orphan drug health technology evaluation accelerated program,exploring the health of orphan drug classification security mechanism,and attaining supply incentives and development incentives through orphan drug pricing and adjustment",to optimize the basis for the orphan drug market access mechanism to provide reference.
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OBJECTIVE To systematically introduce the supply guarantee system of orphan drugs in South Korea, and to provide reference for improving the accessibility of orphan drugs in China. METHODS The basic characteristics and practical experience of supply guarantee system of orphan drugs in South Korea were summarized by studying the marketing incentive mechanism, reserve supply mechanism and emergency use mechanism. Then, based on the research on the current situation and existing problems of orphan drug supply in China, specific suggestions were put forward to improve the accessibility of orphan drugs in China. RESULTS & CONCLUSIONS South Korea has effectively improved the accessibility of orphan drugs through orphan drug identification channels and supporting incentive policies, relying on the reserve supply mechanism and the import route for emergency use. Therefore, it is suggested that China should guarantee the normal supply of orphan drugs from three aspects: improving the recognition and incentive policy of orphan drugs, building a full-time management department of orphan drugs, and optimizing the temporary import path.
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Objective:To identify the core genes related to the disease severity of respiratory syncytial virus (RSV) bronchiolitis in children using RNA sequencing (RNA-seq) and weighted gene co-expression network analysis (WGCNA), aiming to provide reference for predicting the condition of RSV infection.Methods:Twenty-two patients admitted to the Second Affiliated Hospital of Wenzhou Medical University with RSV bronchiolitis from October 1, 2019 to February 29, 2020 were enrolled as the case group. They were divided into three groups based on the severity of the disease: mild group, moderate group and severe group. Twenty-two healthy children were selected as the control group. Total RNA was extracted from whole blood leukocytes and analyzed by RNA-seq to compare the differentially expressed genes (DEGs) between children with RSV bronchiolitis and healthy children. The gene co-expression modules related to disease severity and biological indicators for disease severity assessment were identified.Results:The median age of the 22 patients (19 males and 3 females) was 3 months. The median age of the 22 healthy children (14 males and 8 females) was 4 months. There was no significant difference in age or gender between the two groups. There were 8 cases in the mild group, 7 cases in the moderate group and 7 cases in the severe group. Through significance analysis, 416 DEGs were found in the mild group, 586 in the moderate group and 846 in the severe group. According to WGCNA analysis, 10 co-expression modules were found, among which brown module ( r=0.62, P<0.001) was significantly correlated with disease severity. The protein-protein interaction network of DEGs in brown module was constructed and the top 30 core genes were selected according to the connectivity of gene nodes, among which the genes with high correlation were RBX1 and PSMA7. The expression of RBX1 and PSMA7 genes was up-regulated in the severe group, but their expression in the mild and moderate groups was not significantly different from that in the control group. Conclusions:RBX1 and PSMA7 genes might be biological predictors of disease severity in RSV bronchiolitis.
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Objective:To investigate the developmental behavior of early term infants at 6 months and its difference from that of complete full-term infants.Methods:A healthy maternal and infant birth cohort in maanshan city, established in Maanshan Maternal and Child Health Hospital from June 2015 to June 2016. Birth outcomes were copied from the hospital electronic medical record system after delivery. The Chinese Ages and Stages Questionnaires was used to assess developmental behavior. The chi-square test and multivariate unconditional logistic regression model were used to analyze the differences in the behavioral development of early and full term infants.Results:The birth rate of early term infants was 24.74% (500/2 021). The detection rates of communication, gross motor, fine motor, problem solving and individual-social areas in early term infants were 2.1%, 3.2%, 6.1%, 6.3% and 2.7%, respectively. The detection rate of problem-solving area in early term infants was significantly higher than that in the full-term infants (6.3% vs. 3.7%, χ 2=5.42, P<0.05). After controlling for confounding factors, compared with full-term infants, the risk of problem-solving area in early infants was significantly increased ( OR=1.65, 95%CI:1.01-2.70, P<0.05). Conclusion:The risk of behavioral retardation in Early term infants is significantly higher than that in full-term infants, and long-term follow-up and appropriate early development promotion interventions are needed to improve their quality of life.
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On January 1st 2018, a male 44 years old diabetic patient with subcutaneous soft tissue infection in right thigh was admitted to our hospital. The patient repeatedly used the same needle to inject insulin subcutaneously in the unsterilized right thigh, and his blood glucose was badly controlled in the long term. Severe subcutaneous soft tissue infection of the right thigh occurred after his fatigue, accompanied with ketoacidosis. Then he received conservative treatment in the local hospital for one month, but the infection persisted. After being transferred to our hospital, we highly suspected the diagnosis of necrotizing fasciitis according to previous test indicators and local B-ultrasound results, but suggestion of aggressive surgery was refused. So we treated him with conservative therapies using sensitive antibiotics and supportive remedies. The patient was basically healed after treatment of 1 month and he was recovered well during the follow-up 2 months after discharged from our hospital. This case emphasizes the importance of standard injection of insulin and early diagnosis of severe subcutaneous soft tissue infection.
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Objective@#To understand the epidemiological characteristics and relevant factors on the comorbidity of hyperactivity behavior and allergic disease among preschool children in urban areas of Ma'anshan city.@*Methods@#During April 2014 to April 2015, 91 kindergartens over 3 years old were investigated. In the investigation, 16 439 questionnaires were distributed to parents, and 15 291 valid questionnaires were collected. Conners abbreviated symptom questionnaire (brief symptom questionnaire) was filled out by parents to assess the children's hyperactive behaviors. Information of allergic disease history was reported by parents, including allergic dermatitis/eczema, food/drug allergy, allergic rhinitis and asthma. Multivariate unconditional logistic regression was used to analyze the relevant factors of comorbidity of hyperactivity behavior and allergy diseases.@*Results@#The average age of the 15 291 children were (4.5±1.0) years old, among which 53.7% (8 218/15 291) were boys. The prevalence of hyperactive behaviors was 8.6%(1 317/15 291), and the comorbidity rate of hyperactivity and allergic deseases was 1.7% (258/15 291). After confounding factors including gender, age, delivery mode, father's age and pregnancy complications adjusted, poor sleep quality (OR=4.45, 95%CI: 2.85-6.94), long duration of watching TV at weekend (OR=1.39, 95%CI: 1.00-1.94) and poor eating behavior (OR=1.78, 95%CI: 1.07-2.98) were relevant factors of the comorbidity of hyperactivity and allergic diseases.@*Conclusion@#The prevalence of comorbidity of hyperactivity behavior and allergic disease among preschool children in urban areas of Ma'anshan city was not high. Poor night sleep quality, long duration of watching TV and frequently picky eating were relevant factors of the comorbidity of hyperactive behaviors and allergic diseases.
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<p><b>OBJECTIVE</b>To describe the epidemiological characteristics on the supplement of folic acid in progestation and early pregnancy, and to probe the protective effects of supplement of folic acid in early pregnancy against pregnant depression, in Ma'anshan city, Anhui province.</p><p><b>METHODS</b>In this cohort study, 5 150 subjects who had their first antenatal examination at Ma'anshan Maternal and Child Care Centers were recruited under informed consent, from October 2008 to October 2010. All the information were collected through questionnaires in the first, second and third trimesters respectively. A "Center for Epidemiological Studies Depression Scale (CES-D)" was used to assess the mood of depression in the second questionnaire. Single factor analysis and the unconditional multivariate logistic regression were applied to analyze the association of supplement folic acid in peri-conceptional period and pregnancy depression.</p><p><b>RESULTS</b>In the study, the prevalence of those who had never taken the supplement folic acid but only the supplement folic acid in progestation and supplement in the first-trimester, or supplement in the peri-conceptional period were 27.3%,0.5%, 27.4% and 17.9%, respectively. The incidence of pregnancy depression was 4.8% (247/5 150). Data from logistic regression analysis showed that, supplement of folic acid only in the first-trimester or in the peri-conceptional period were negatively associated with pregnancy depression even after adjustment for potential confounders. The adjusted odds ratio were 0.63 (95%CI:0.44-0.90) and 0.61 (95%CI:0.39-0.95) respectively.</p><p><b>CONCLUSION</b>Supplement of folic acid in peri-conceptional period could be a preventive factor for pregnancy depression.</p>
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Adulto , Femenino , Humanos , Embarazo , Estudios de Cohortes , Depresión , Ácido Fólico , Usos Terapéuticos , Atención Prenatal , Estudios Prospectivos , Encuestas y CuestionariosRESUMEN
Objective To describe the epidemiological characteristics on the supplement of folic acid in progestation and early pregnancy,and to probe the protective effects of supplement of folic acid in early pregnancy against pregnant depression,in Ma’anshan city,Anhui province. Methods In this cohort study,5 150 subjects who had their first antenatal examination at Ma’anshan Maternal and Child Care Centers were recruited under informed consent,from October 2008 to October 2010. All the information were collected through questionnaires in the first,second and third trimesters respectively. A“Center for Epidemiological Studies Depression Scale(CES-D)”was used to assess the mood of depression in the second questionnaire. Single factor analysis and the unconditional multivariate logistic regression were applied to analyze the association of supplement folic acid in peri-conceptional period and pregnancy depression. Results In the study,the prevalence of those who had never taken the supplement folic acid but only the supplement folic acid in progestation and supplement in the first-trimester,or supplement in the peri-conceptional period were 27.3%,0.5%,27.4%and 17.9%,respectively. The incidence of pregnancy depression was 4.8%(247/5 150). Data from logistic regression analysis showed that,supplement of folic acid only in the first-trimester or in the peri-conceptional period were negatively associated with pregnancy depression even after adjustment for potential confounders. The adjusted odds ratio were 0.63(95%CI:0.44-0.90) and 0.61(95%CI:0.39-0.95)respectively. Conclusion Supplement of folic acid in peri-conceptional period could be a preventive factor for pregnancy depression.
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Objective To describe the epidemiological characteristics on the supplement of folic acid in progestation and early pregnancy,and to probe the protective effects of supplement of folic acid in early pregnancy against pregnant depression,in Ma’anshan city,Anhui province. Methods In this cohort study,5 150 subjects who had their first antenatal examination at Ma’anshan Maternal and Child Care Centers were recruited under informed consent,from October 2008 to October 2010. All the information were collected through questionnaires in the first,second and third trimesters respectively. A“Center for Epidemiological Studies Depression Scale(CES-D)”was used to assess the mood of depression in the second questionnaire. Single factor analysis and the unconditional multivariate logistic regression were applied to analyze the association of supplement folic acid in peri-conceptional period and pregnancy depression. Results In the study,the prevalence of those who had never taken the supplement folic acid but only the supplement folic acid in progestation and supplement in the first-trimester,or supplement in the peri-conceptional period were 27.3%,0.5%,27.4%and 17.9%,respectively. The incidence of pregnancy depression was 4.8%(247/5 150). Data from logistic regression analysis showed that,supplement of folic acid only in the first-trimester or in the peri-conceptional period were negatively associated with pregnancy depression even after adjustment for potential confounders. The adjusted odds ratio were 0.63(95%CI:0.44-0.90) and 0.61(95%CI:0.39-0.95)respectively. Conclusion Supplement of folic acid in peri-conceptional period could be a preventive factor for pregnancy depression.