Efficacy and safety of Omalizumab for the treatment of pediatric allergic asthma: a retrospective multicenter real-world study in China / 中华实用儿科临床杂志

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.

Effects of cyclamic acid on dynamic monitoring D-Dimer and thromboembolic prophylaxis during total hip arthroplasty / 中国综合临床

Objective To study the effects of use of cyclamic acid on monitoring D-Dimer and predicting deep venous thrombosis on lower limbs during total hip arthroplasty.Methods Ninety-three cases patients who received total hip arthroplasty operations at Joint Surgery Department of the Central Hospital of Zhuzhou city and Zhuzhou Hospital Affiliated to Xiangya Medical College of Central South University from December 2015 to May 2016 were selected as subjects and randomly assigned into study group with 50 cases and control group with 43 cases.During the operations,cyclamic acid was used intravenously and locally as a routine in the study group while saline was utilized instead in the control group.The D-Dimer was dynamically monitored before operation and 1,3,5,7,9 d after the operation,and venous color ultrasonography of both lower limbs were taken 3,6,9 d after the operation to check the conformation of thrombosis.Results The total blood loss after treatment in the study group was (350.5 ± 65.2) ml,intraoperative blood loss of (129.3 ± 43.1) ml,postoperative drainage volume of (80.9± 12.6) ml,occult blood loss of (141.9± 20.6) ml,corresponding to the control group were (560.8±60.6) ml,(208.9± 57.8) ml,(150.8 ± 18.9) ml,(202.9±23.9) ml.The above indicators were lower in the study group than in the control group,the differences between the two groups were statistically significant(t =16.02,7.59,21.24,13.22,P＜0.05).There were significant differences in terms of D2-dimer level of 1,3,5 d after the operation between the study group and the control group (P＜0.05),but at 7,9 d after the operation,the difference between the two groups were not statistically significant(P＞0.05).The study group and the control group at 9 d after operation with color Doppler ultrasound examination showed that there were 1 cases of patients with calf vein thrombosis both in two groups,there was no significant difference between the two groups(2.00％ vs.2.32％,x2 =0.012,P＞ 0.05).Conclusion The proper use of cyclamic acid can reduce blood loss and will not increase the risk of thrombosis.Monitoring dynamically on D-Dimer and deep venous color ultrasonography on lower limbs is helpful for early detection of thrombosis after total hip arthroplasty.However,the use of cyclamic acid during total hip arthroplasty will affect the monitoring on D-Dimer and therefore needs to be taken seriously.

The design of the static magnetic field testing coil for pacemaker / 中国医疗器械杂志

Based on the international standards about implantable pacemakers, designing the static magnetic field testing coil in accordance with the requirements of the standards. The testing result demonstrates that the designed coil could be used for the static magnetic field strength test of implantable pacemakers.

Agrobacterium-mediated genetic transformation of secondary somatic embryos in alfalfa / 生物工程学报

We describe a genetic transformation method of secondary somatic embryogenesis in alfalfa through cotyledon-stage somatic embryos of alfalfa infected by Agrobacterium strain GV3101. The Agrobacterium strain GV3101 contained binary vector pCAMBIA2301 that had gus gene as reporter and npt II gene as selectable marker. The infected primary embryos were induced through series of medium under 75 mg/L kanamycin selection. We obtained the transgenic alfalfa plants. Then, GUS expression in different tissue of transgenic alfalfa was tested by GUS histochemical analysis. Further, the stable integration and transformation efficiency were tested by polymerase chain reaction and Southern blotting hybridization. The result showed that GUS expression was different in different organs of transgenic alfalfa; the copy number of integrated npt II gene was from 1 to 4; the transformation efficiency via primary somatic embryogenesis was 65.82%.

Meet the challenge of the implementation of the EMC standard for medical electrical equipment / 中国医疗器械杂志

This paper reveals the EMC quality situation of China's medical electrical equipment and the existing security risks in order to arouse the concerns of the government supervision departments, technical inspection units, the production enterprises and the users. It also serves as a reference when formulating related policies and measures.