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Objective:To assess the clinical effectiveness and safety of Omalizumab for treating pediatric allergic asthma in real world in China.Methods:The clinical data of children aged 6 to 11 years with allergic asthma who received Omalizumab treatment in 17 hospitals in China between July 6, 2018 and September 30, 2020 were retrospectively analyzed.Such information as the demographic characteristics, allergic history, family history, total immunoglobulin E (IgE) levels, specific IgE levels, skin prick test, exhaled nitric oxide (FeNO) levels, eosinophil (EOS) counts, and comorbidities at baseline were collected.Descriptive analysis of the Omalizumab treatment mode was made, and the difference in the first dose, injection frequency and course of treatment between the Omalizumab treatment mode and the mode recommended in the instruction was investigated.Global Evaluation of Treatment Effectiveness (GETE) analysis was made after Omalizumab treatment.The moderate-to-severe asthma exacerbation rate, inhaled corticosteroid (ICS) dose, lung functions were compared before and after Omalizumab treatment.Changes in the Childhood Asthma Control Test (C-ACT) and Pediatric Asthma Quality of Life Questionnaire (PAQLQ) results from baseline to 4, 8, 12, 16, 24, and 52 weeks after Omalizumab treatment were studied.The commodity improvement was assessed.The adverse event (AE) and serious adverse event (SAE) were analyzed for the evaluation of Omalizumab treatment safety.The difference in the annual rate of moderate-to-severe asthma exacerbation and ICS reduction was investigated by using t test.The significance level was set to 0.05.Other parameters were all subject to descriptive analysis.A total of 200 allergic asthma patients were enrolled, including 75.5% ( n=151) males and 24.5% ( n=49) females.The patients aged (8.20±1.81) years. Results:The median total IgE level of the 200 patients was 513.5 (24.4-11 600.0) IU/mL.Their median treatment time with Omalizumab was 112 (1-666) days.Their first dose of Omalizumab was 300 (150-600) mg.Of the 200 cases, 114 cases (57.0%) followed the first Omalizumab dosage recommended in the instruction.After 4-6 months of Omalizumab treatment, 88.5% of the patients enrolled ( n=117) responded to Omalizumab.After 4 weeks of treatment with Omalizumab, asthma was well-controlled, with an increased C-ACT score [from (22.70±3.70) points to (18.90±3.74) points at baseline]. Four-six months after Omalizumab administration, the annual rate of moderate-to-severe asthma exacerbation had a reduction of (2.00±5.68) per patient year( t=4.702 5, P<0.001), the median ICS daily dose was lowered [0 (0-240) μg vs. 160 (50-4 000) μg at baseline] ( P<0.001), the PAQLQ score was improved [(154.90±8.57) points vs. (122.80±27.15) points at baseline], and the forced expiratory volume in one second % predicted (FEV 1%pred) was increased [(92.80±10.50)% vs. (89.70±18.17)% at baseline]. In patients with available evaluations for comorbidities, including allergic rhinitis, atopic dermatitis or eczema, urticaria, allergic conjunctivitis and sinusitis, 92.8%-100.0% showed improved symptoms.A total of 124 AE were reported in 58 (29.0%) of the 200 patients, and the annual incidence was 0(0-15.1) per patient year.In 53 patients who suffered AE, 44 patients (83.0%) and 9 patients (17.0%) reported mild and moderate AE, respectively.No severe AE were observed in patients.The annual incidence of SAE was 0(0-1.9) per patient year.Most common drug-related AE were abdominal pain (2 patients, 1.0%) and fever (2 patients, 1.0%). No patient withdrew Omalizumab due to AE. Conclusions:Omalizumab shows good effectiveness and safety for the treatment of asthma in children.It can reduce the moderate-to-severe asthma exacerbation rate, reduce the ICS dose, improve asthma control levels, and improve lung functions and quality of life of patients.
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Objective To investigate the incidence and risk factors of peripartum mood disorder (PPMD) in order to improve clinical prevention and intervention of this condition.Methods This was a prospective cohort study recruiting first-trimester pregnant women (＜13 gestational weeks) from Beijing Daxing Maternal and Child Care Hospital from October 1,2016 to December 31,2017.Zung Self-rating Anxiety Scale (SAS) and Zung Self-rating Depression Scale (SDS) were used to evaluate the anxiety and depression status in the second and third trimesters,respectively.Their life styles,social and environmental factors exposure during pregnancy were also collected.Statistical analysis was conducted using Chi-square test,student's t test,MannWhitney U test and multivariate logistic regression.Results (1) A total of 478 subjects were enrolled in early pregnancy and 460 (96.2％) and 431 (90.2％) of them completed SAS and SDS assessment in the second and third trimesters,respectively,and 413 (86.4％) of the subjects finished both assessments on two occasions.(2) The prevalence of anxiety and depression was 7.1％ (30/425) and 13.9％ (59/425) in the second trimester,and 11.2％ (44/392) and 21.5％ (84/390) in the third.The incidence of anxiety and depression in the third trimester was 7.7％ (26/336) and 9.6％ (30/313).(3) Cross-sectional data analysis showed that prolonged television watching was a risk factor of anxiety in the second (OR=1.216,95％CI:1.055-1.402) and third (OR=1.166,95％CI:1.044-1.303) trimester,while exercise was a protect factor (OR=0.238,95％CI:0.105-0.541;OR=0.432,95％CI:0.212-0.879).Pregnant women with longer sleeping time had lower risks of depression in the second trimester (OR=0.725,95％CI:0.554-0.950);those who did exercise had lower risks of depression in the third trimester (OR=0.450,95％CI:0.252-0.803).(4) Longitudinal-data analysis revealed that longer television watching time in the second trimester was a risk factor for anxiety (OR=1.264,95％CI:1.117-1.432) and depression (OR=1.119,95％CI:1.005-1.246) in the third trimester.Conclusions The prevalence of anxiety and depression in the third trimester is higher than that in the second trimester.The incidence of depression is higher than that of anxiety in the third trimester.Prolonged television viewing time in the second trimester is a risk factor for both anxiety and depression in the third trimester.
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Objective@#To investigate the incidence and risk factors of peripartum mood disorder (PPMD) in order to improve clinical prevention and intervention of this condition.@*Methods@#This was a prospective cohort study recruiting first-trimester pregnant women (<13 gestational weeks) from Beijing Daxing Maternal and Child Care Hospital from October 1, 2016 to December 31, 2017. Zung Self-rating Anxiety Scale (SAS) and Zung Self-rating Depression Scale (SDS) were used to evaluate the anxiety and depression status in the second and third trimesters, respectively. Their life styles, social and environmental factors exposure during pregnancy were also collected. Statistical analysis was conducted using Chi-square test, student's t test, Mann-Whitney U test and multivariate logistic regression.@*Results@#(1) A total of 478 subjects were enrolled in early pregnancy and 460 (96.2%) and 431 (90.2%) of them completed SAS and SDS assessment in the second and third trimesters, respectively, and 413 (86.4%) of the subjects finished both assessments on two occasions. (2) The prevalence of anxiety and depression was 7.1% (30/425) and 13.9% (59/425) in the second trimester, and 11.2% (44/392) and 21.5% (84/390) in the third. The incidence of anxiety and depression in the third trimester was 7.7% (26/336) and 9.6% (30/313). (3) Cross-sectional data analysis showed that prolonged television watching was a risk factor of anxiety in the second (OR=1.216, 95%CI: 1.055-1.402) and third (OR=1.166, 95%CI: 1.044-1.303) trimester, while exercise was a protect factor (OR=0.238, 95%CI: 0.105-0.541; OR=0.432, 95%CI: 0.212-0.879). Pregnant women with longer sleeping time had lower risks of depression in the second trimester (OR=0.725, 95%CI: 0.554-0.950); those who did exercise had lower risks of depression in the third trimester (OR=0.450, 95%CI: 0.252-0.803). (4) Longitudinal-data analysis revealed that longer television watching time in the second trimester was a risk factor for anxiety (OR=1.264, 95%CI: 1.117-1.432) and depression (OR=1.119, 95%CI: 1.005-1.246) in the third trimester.@*Conclusions@#The prevalence of anxiety and depression in the third trimester is higher than that in the second trimester. The incidence of depression is higher than that of anxiety in the third trimester. Prolonged television viewing time in the second trimester is a risk factor for both anxiety and depression in the third trimester.
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Objective Based on the objective test (A type) results of the 2014 comprehensive clinical course graduation test of 3+2 assistant general practitioners training,this article analyzed the differences between different teaching units,so as to provide objective basis for improving the teaching level of each unit.Method We established a database with EXCEL 2000,and put each question's ID and points,and the score of each student into the computer,so we could get the difficulty coefficient,distinction degree and reliability of the test paper,and calculate the difficulty coefficient and difference of each question.Then we analyzed the difficulty coefficient,the difference and the reliability of the 122 students' testing results,and compared the accuracy to the same question of the 6 teaching units.Result The objective test's (A type) difficulty coefficient is 0.77,distinction degree is 0.19,and reliability is 0.99.The highest score of the 122 students is 47 points,and the lowest score is 28 points,the average score is (38.5 ± 3.9) points.In the 50 questions,3 questions' difficulty coefficient is less than 0.4,14 questions' difficulty coefficient is between 0.4-0.7,33 questions' difficulty coefficient is above 0.7,so the difficulty degree of the paper is relatively low.In the 50 questions,23 questions' distinction degree is less than 0.15,17 questions' distinction degree is between 0.15-0.30,10 questions' distinction degree is above 0.30,so the distinction degree of the paper is relatively high.In the 50 questions,20 questions' accuracy appears larger differences between each unit:9 questions' accuracy has decreased significantly among 1-2 units,4 questions' accuracy decreased significantly among 3 units,3 questions' accuracy decreased significantly among 4 units,only 1 unit has high accuracy among 2 questions,and 2 questions' accuracy decreased significantly among all units.These problems are related to the teachers' teaching ability,the difficulty in mastering the key points of the curriculum,the lack of the concept of the general practitioners training.Conclusion The design of the examination paper is basically in line with the study purpose and the objectives of the training course.This examination paper was highly reliable,and suitable for the professional theory and ability test.There are site differences between each unit,which can provide an objective basis for improving the teaching level of different teaching unit,and we will solve the problems in the form of collective preparation next step.
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Objective To evaluate the clinical efficacy of standardized house dust mite allergen specific immunotherapy (SIT) for rhinitis and asthma in children. Methods Forty-two children with allergic rhinitis and asthma who received a standardized house dust mite allergen SIT in our hospital were enrolled in our study. The result of allergen skin prick test, serum specific IgE levels (sIgE) of house dust mite and dust mite,pulmonary function and symptom scores were analysed before and at one year after treatment in all children. Results Skin indexes of house dust mite and dust mite, symptom score were significantly decreased at one year after treatment,but the levels of house dust mite and dust mite sIgE,lung function test (FVC,FEVt,MEF25-75) showed no significant differences. Conclusion Children with allergic rhinitis and asthma have significant improvements in their skin sensitivity and clinical symptoms by given SIT for one year,but the impact of SIT on airway inflammation needs further observation.
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Objective To study the clinical significance of C-reactive protein(CRP),neutrophil granulocyte ratio(N% ) in acute exacerbations of hospitalized patients with chronic obstructive pulmonary disease ( COPD ). Methods The serum CRP levels,the gross of N% were detected of the same 71 patients with acute exacerbations of COPD before treatment and after getting better. And the correlations among above-mentioned indexes,the days counter before getting better and the days counter during hospitalization were observed. Results (1) The levels of CRP and N% of patients after getting better were significantly lower than those before treatment(P ＜0. 01). (2) There was a significant correlation between N% and the days counter before getting better(r =0.240,P ＜0.05) and also a significant correlation between the days counter before getting better and the days counter during hospitalization (r = 0. 567, P ＜0.01). Conclusion The serum CRP level and N% were objective markers in estimating pulmonary infection in COPD patients with acute exacerbations. And N% was a reliable indicator of judging the days counter before getting better and better than CRP.
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Objective To investigate the influences of pain on early neonatal neurobehavioral development Methods 65 newborn infants admitted to the Neonatal Intensive Care Unit( NICU )of our hospital from October,2009 to March,2010 were randomly chosen as the objects of this study.In light of Neonatal Behavioral Neurological Assessment( NBNA) revised by Professor Bao Xiulan,examinations were carried out before and after pain stimulation,and a statistical analysis of the results of the examinations was conducted.Results The total scores of NBNA before and after the pain stimulation were (36.49±1.73) vs.(34.80±1.79) respectively,demonstrating a significant difference.Specifically,after the pain stimulation,the scores of behavioral ability and active muscle tension decreased,with a very significant difference.However,there was no significant difference in terms of the scores of passive muscle tone,primitive reflexes and common reactions.Conclusions Neonatal pain exerts influences on early neurobehavioral development,particularly on behavioral ability and active muscle tension.The training of neonatal health care professionals in the management of and the intervention in neonatal pain should be strengthened in order to decrease the adverse effects of pain on neonates.
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Objective To understand the level of neonatal pain knowledge and attitudes of neonatal and obstetric department nurses, in order to supply the clinical basis for neonatal pain management. Methods Self-designed questionnaires to fill out on-site were distributed to 107 neonatal and obstetric department nurses (of which 40 were from neonatal department, 67 from obstetric department) for neonatal pain knowledge and attitudes. Results About question of neonatal pain, the average percentage of correct answers in the neonatal group was 75.5%, higher than 66.3% of the obstetric group, in the neonatal group, correct rate of seven questions was more than 80%,while in the obstetric group the correct rate of only one question was more than 80%, and 5 questions correct response rate was significantly lower than that of the neonatal group, the difference was significant. All nursing staff considered it essential or necessary to carry out the nursing knowledge of pain-related training. 95.0%(38/40) of neonatal nurses believed that they could properly assess the extent of neonatal pain, but only 83.6% (56/67) for the obstetric group, the difference between the two groups was significant. 97.5% (39/40) of neonatal nurses believed that they could make the right judgments on neonatal crying, and only 85.1%( 57/67) in the obstetric nurses, the difference between the two groups was significant.Conclusions Neonatal pain has gradually been recognized and paid attention to by the clinical front-line medical staff, they believe that it is necessary to receive training on neonatal pain, knowledge of neonatal pain of neonatal nurses is better than obstetric nurses.
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Objective To investigate the influencing factors of pain and the changes of vital signs in newborn infants. Methods Forty two newborn infants were rated by the behavioral scale of acute pain in newborn infants. The scores of pain were compared among infants with different gender,gestational age,birth weight,birth age,type of puncture and whether by vaginal birth or not. At the same time,the respiration rate,heart rate,blood pressure and oxygen saturation (SO2)were dynami-cally recorded by the multi-function monitor in the process of puncture. Results The average score of pain was 7.6. There was no significant difference among newborn infants with different gender,gestational age,birth weight and type of puncture(P> 0.05),while significant differences among infants with different birth age and whether by vaginal birth or not (P=0.015 and 0.043 respectively). In the process of puncture,the SO2 was significantly decreased,while the respiration rate,heart rate,sys-tolic and diastolic blood pressure were significantly increased. Conclusions Pain is prevalent in newborn infants and accom-panied by obvious changes of vital signs. The means of childbirth and birth age have significant influence on the neonatal pain. It is suggested to pay close attention to the neonatal pain and take effective interventions.
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Objective To study the changes of blood gastrointestinal hormones concentration and effect of early feeding in premature infants on it. Methods Seventy-two premature infants were divided into 4 groups: self-sucking (group Ⅰ),tube feeding (group Ⅱ),minimal enteral nutrition (MEN, group Ⅲ), non-nutritive sucking (NNS, group Ⅳ). The plasma motilin and serum gastrin were measured within 12 hour before enteral feeding, on day 3 and day 7 of life by radioimmunoassay. 16 full-term neonates were studied as control. Results (1)The serum concentration of gastrin in premature infants before enteral feeding, on day 3 and day 7 were (61?24)ng/L,(93?37)ng/L,(126?45) ng/L respectively, which were significantly lower than that of control(126?30) ng/L,(135?34)ng/L,and (178?46)ng/L,(P