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1.
Chinese Journal of Radiological Health ; (6): 393-397, 2023.
Article in Chinese | WPRIM | ID: wpr-988210

ABSTRACT

Objective To improve the analysis of 134Cs, 137Cs, and 60Co in aerosol samples by the national key radiation environment laboratories. Methods Intercomparison of analysis results of 134Cs, 137Cs, and 60Co in standard aerosol samples was performed among the national key radiation environment laboratories according to Gamma spectrometry method of analyzing radionuclides in biological samples (GB/T 16145-1995 ), and the intercomparison results were evaluated by the standard deviation. Results Six laboratories were involved in the intercomparison. For 134Cs, 50% of the laboratories showed a relative deviation less than 10%, and 50% showed a relative deviation of 10%-20%. For 137Cs, 33.3% of the laboratories showed a relative deviation less than 10%, and 76.7% showed a relative deviation of 10%-20%. For 60Cs, all laboratories showed a relative deviation less than 10%. The overall intercomparison results were acceptable. Conclusion The laboratories in this intercomparison show generally good results.

2.
Chinese Journal of Medical Instrumentation ; (6): 433-436, 2023.
Article in Chinese | WPRIM | ID: wpr-982259

ABSTRACT

Standard drafting is an important part in the process of standard formulation and revision. By analyzing the status of the medical device industry standards drafting, thoughts and suggestions were proposed to further promote all relevant parties to actively participate in the standard drafting, effectively improve the quality of the standards, strengthen the technical support and promote the high-quality development of the industry. The statistical data of the participation of social organizations in the drafting and as the first unit drafting medical devices standards from 2017 to 2021 was researched, and the problems in the drafting of standards at this stage were analyzed. Based on the research and analyses, some thoughts and suggestions were proposed to strengthen the management of standard drafting units and promote the participation of all relevant parties in standard drafting. It is necessary to expand and enhance social participation in standard drafting further by innovating incentives, refining and strengthening normative requirements, and creating a positive social atmosphere.


Subject(s)
Reference Standards , China , Industry
3.
Chinese Medical Sciences Journal ; (4): 97-108, 2023.
Article in English | WPRIM | ID: wpr-981588

ABSTRACT

Objective To investigate the effects of propofol and sevoflurane on neurological recovery of traumatic brain injury (TBI) patients in the early postoperative stage.Methods We retrospectively analyzed the clinical data of TBI patients who underwent craniotomy or decompressive craniectomy. Generalized additive mixed model (GAMM) was used to analyze effects of propofol and sevoflurane on Glasgow Coma Scale (GCS) on postoperative days 1, 3, and 7. Multivariate regression analysis was used to analyze effects of the two anesthetics on Glasgow Outcome Scale (GOS) at discharge.Results A total of 340 TBI patients were enrolled in this study. There were 110 TBI patients who underwent craniotomy including 75 in the propofol group and 35 in the sevoflurane group, and 134 patients who underwent decompressive craniectomy including 63 in the propofol group and 71 in the sevoflurane group. It showed no significant difference in GCS at admission between the propofol and the sevoflurane groups among craniotomy patients (β = 0.75, 95%CI: -0.55 to 2.05, P = 0.260). However, elevation in GCS from baseline was 1.73 points (95%CI: -2.81 to -0.66, P = 0.002) less in the sevoflurane group than that in the propofol group on postoperative day 1, 2.03 points (95%CI: -3.14 to -0.91, P < 0.001) less on day 3, and 1.31 points (95%CI: -2.43 to -0.19, P = 0.022) less on day 7. The risk of unfavorable GOS (GOS 1, 2, and 3) at discharge was higher in the sevoflurane group (OR = 4.93, 95%CI: 1.05 to 23.03, P = 0.043). No significant difference was observed among two-group decompressive craniectomy patients in GCS and GOS.Conclusions Compared to propofol, sevoflurane was associated with worse neurological recovery during the hospital stay in TBI patients undergoing craniotomy. This difference was not detected in TBI patients undergoing decompressive craniectomy.

4.
Journal of Xi'an Jiaotong University(Medical Sciences) ; (6): 608-613, 2023.
Article in Chinese | WPRIM | ID: wpr-1005830

ABSTRACT

【Objective】 To revise the Highly Sensitive Child (HSC) Scale for Chinese Adolescents and investigate the role of adolescents’ sensitivity to environmental influences. 【Methods】 The HSC Scale was translated into Chinese. A total of 2166 adolescents in Xi’an were selected for exploratory factor, confirmatory factor analyses and reliability analysis. The participants were 609 healthy adolescents and 105 depressive adolescents aged 14-17 years, who were evaluated with the HSC scale and PHQ-9 scale as well as sleep duration and academic achievement questions. 【Results】 First, the factor structure (CFI=0.989, GFI=0.977, AGFI=0.958, TLI=0.983, RMSEA=0.042, RMR=0.050) indicated that HSC scale was a reliable measure of environmental sensitivity. The results supported a bifactor model with a general sensitivity factor and three group factors. Second, the Cronbach α was 0.892, and the test-retest reliability coefficient was 0.743. Third, depressive adolescents had a significantly higher HSC score, compared with the healthy ones (F=15.1, P<0.01). Fourth, the relationship between BMI and adolescent adjustment was moderated by environmental sensitivity. Simple slope analysis showed that when the level of environmental sensitivity was higher, weight gain could predict adolescents’ emotional, sleep and academic problems. 【Conclusion】 The Chinese version of HSC has good psychometric characteristics and may be applied in Chinese adolescents. Environmental sensitivity may be a personality factor that influences depressive symptoms in adolescents.

5.
Chinese Journal of Digestive Surgery ; (12): 816-821, 2022.
Article in Chinese | WPRIM | ID: wpr-955198

ABSTRACT

Objective:To investigate the application value of Hisense computer-assisted surgery system (CAS) three-dimensional reconstruction in the precision treatment of pediatric liver tumors.Methods:The retrospective and descriptive study was conducted. The clinicopathological data of 82 children with liver tumors who were admitted to Affiliated Hospital of Qingdao University from January 2013 to September 2021 were collected. There were 39 males and 43 females, aged 13(19)months. Children underwent upper abdominal dynamic enhanced computed tomography (CT) examination, and three-dimensional reconstruction was performed on CT images of arterial, equili-brium and venous phases with Hisense CAS. Surgical feasibility and scheme were evaluated and conducted based on the results of upper abdominal dynamic enhanced CT examination, and then revised according to three-dimensional reconstruction results of Hisense CAS. Observation indicators: (1) comparison of surgical scheme between two-dimensional enhanced CT images and three-dimensional reconstruction results of Hisense CAS; (2) intraoperative and postoperative situations; (3) follow-up. Follow-up was conducted by outpatient examination to detect postoperative compli-cations and residual liver compensation up to November 2021. Measurement data with normal distribution were represented as Mean± SD. Measurement data with skewed distribution were represented as M(IQR) or M(range). Count data were described as absolute numbers or percentages. Results:(1) Comparison of surgical scheme between two-dimensional CT images and three-dimensional reconstruction results of Hisense CAS. ① Based on the two-dimensional CT images, 42 cases of 82 children could undergo one-stage resection and 40 children could not. However, based on the three-dimensional reconstruction results of Hisense CAS, 48 cases of 82 children could undergo one-stage resection and 34 children could not. There were 6 children with one-stage resection feasibility based on the three-dimensional reconstruction results of Hisense CAS rather than the two-dimensional CT images. For the 34 children undergoing chemotherapy firstly, 31 cases had surgical feasibility after chemotherapy based on the two-dimensional CT images and 3 cases could not undergo surgery because of unapparent tumor regression or tumor surrounding impor-tant vessels. However, the 34 children had surgical feasibility after chemotherapy based on the three-dimensional reconstruction results of Hisense CAS. The revision rate of surgical feasibility was 11.0%(9/82) for the 82 children. ② Based on the two-dimensional CT images, 15 cases of 82 children underwent liver left lobectomy, 21 cases underwent liver right lobectomy, 7 cases underwent mesohepatectomy, 13 cases underwent extended left hemihepatectomy, 23 cases underwent extended right hemihepatectomy, 3 cases underwent segmental hepatectomy. However, based on the three-dimensional reconstruction results of Hisense CAS, 20 cases of 82 children underwent liver left lobectomy, 29 cases underwent liver right lobectomy, 7 cases underwent mesohepatectomy, 7 cases underwent extended left hemihepatectomy, 14 cases underwent extended right hemihepatectomy, 5 cases underwent segmental hepatectomy. The revision rate of surgical scheme was 36.6%(30/82) for the 82 children. (2) Intraoperative and postoperative situations. The operation time, volume of intraoperative blood loss, duration of postoperative hospital stay of the 82 children were (182±18)minutes, 20(10)mL, (10.2±1.9)days, respectively. (3) Follow-up. All the 82 children were followed up for 10 (range, 2?18)months. There was no obvious complication occurred to the 82 children after surgery, and the residual liver can satisfy the liver compensation of body. All the children survived well.Conclusion:Three-dimensional reconstruction of Hisense CAS is conducive to judging the surgical feasibility and formulation of accurate surgical plan of children with liver tumors.

6.
Chinese Journal of Applied Clinical Pediatrics ; (24): 1750-1755, 2022.
Article in Chinese | WPRIM | ID: wpr-954828

ABSTRACT

Objective:To analyze and summarize the application and significance of the computer-assisted surgery system in precision surgery of mediastinal tumors in children.Methods:The clinical data of 54 children that underwent mediastinal tumor resection surgery in the Affiliated Hospital of Qingdao University from August 2008 to November 2021 were collected.According to whether the Hisense CAS computer-assisted surgery system was used before the operation, the patients were divided into three-dimensional (3D) reconstruction group (29 cases, 53.70%) and two-dimensional (2D) CT group (25 cases, 46.30%). The surgical indicators, postoperative hospital stay, and the incidence of surgical complications were compared between the two groups.The t-test, Mann- Whitney U test, χ2 test or Fisher′ s exact test were carried out for statistical analysis.Simulated surgery and actual surgery were compared for both 3D reconstruction and 2D CT groups. Results:There were no significant differences in gender, age, height, weight, maximum tumor diameter and tumor location between the 3D reconstruction group and 2D CT group (all P>0.05). The operation time of the 3D reconstruction group was [(125.14±41.37) min] was shorter than that of the 2D CT group [(149.24±44.53) min] ( P=0.044). The intraoperative blood loss in the 3D reconstruction group [15.00(13.50, 25.00) mL] was less than that in the 2D CT group [36.00(30.00, 75.00) mL] ( P<0.001). In addition, the indwelling time the closed thoracic drainage tube [4.00 (3.00, 5.50) d] and postoperative hospitalization days [(8.83±3.39) d] in the 3D reconstruction group were shorter than those in the 2D CT group [7.00(5.00, 11.50) d, (11.00±4.10) d] ( P=0.001, 0.038). No significant difference in postoperative complication rates was found between the 3D reconstruction group and 2D CT group ( P>0.05). The simulated operation was consistent with the actual operation in the 3D reconstruction group. Conclusions:3D reconstruction by the computer-assisted surgery system can truly reveal the anatomical relationship between tumors and surrounding organs and blood vessels, and improve the accuracy and safety of surgical resection of mediastinal tumors in children.

7.
Chinese Journal of Radiological Health ; (6): 568-572, 2022.
Article in Chinese | WPRIM | ID: wpr-965680

ABSTRACT

@#<b>Objective</b> To ensure the effectiveness and improve the capacity of laboratories in the measurement of γ spectra of radionuclides. <b>Methods</b> A statistical analysis was performed using relative deviation, accuracy, precision, and relative combined uncertainty for the nationwide assessment of radionuclide γ spectrum measurement. <b>Results</b> In the assessment from 2018 to 2020, our laboratory showed qualified or above results, and the performance in 2019 was excellent. The maximum relative deviation of 11 measurements from 2018 to 2020 was 18.01%. The assessment showed |Z<sub>test</sub>|≤1 and U<sub>test</sub>≤2.58 in 2018, |Z<sub>test</sub>|≤1 and U<sub>test</sub>≤1 in 2019, and U<sub>test</sub>≤1 and U<sub>rel</sub>≤20% in 2020. <b>Conclusion</b> Our laboratory employs the correct method for radionuclide γ spectrum measurement, and the analysis data are accurate and reliable.

8.
Chinese Journal of Radiology ; (12): 196-200, 2022.
Article in Chinese | WPRIM | ID: wpr-932499

ABSTRACT

Objective:To explore the value of monoenergetic imaging on dual-layer spectral detector CT combined with individual injection protocol of contrast medium in brain CT angiography (CTA).Methods:Seventy-six patients who underwent brain CTA on the Philips IQon dual-layer spectral detector CT and individual injection protocol of contrast medium in Union Hospital of Tongji Medical College, Huazhong University of Science and Technology from August to November 2020 were retrospectively analyzed. Objective and subjective evaluation of image quality was performed in conventional energetic images (conventional group) which derived from 120 kVp hybrid iterative reconstruction algorithm and 50 keV virtual monoenergetic images (test group) which derived from spectral reconstruction algorithm. The objective evaluation content included CT values, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of internal carotid artery and middle cerebral artery, CT values and standard deviation (SD) of brain parenchyma. The subjective evaluation was completed by two senior radiologists according to the 5-point scale, and the inter-agreement between two radiologists was evaluated by Kappa test. Paired t test or Wilcoxon rank test was used for analysis between two groups. Results:The SNR and CNR of both internal carotid artery and middle cerebral artery, as well as CT values of internal carotid artery, middle cerebral artery and brain parenchyma, were significantly higher in test group than that in conventional group (all P<0.001). The subjective scores of two radiologists for test group were both 5 (5, 5) points, and the subjective scores for conventional group were both 4 (4, 4) points. The subjective scores of the radiologists were in good agreement, and the Kappa values were 0.74 and 0.84 respectively. The subjective scores of test group were significantly higher than that of conventional group ( Z=-11.15, P<0.001). Conclusion:Monoenergetic imaging on dual-layer spectral detector CT combined with individual injection protocol of contrast medium can improve SNR, CNR and the image quality of brain CTA.

9.
Chinese Journal of Cardiology ; (12): 585-590, 2022.
Article in Chinese | WPRIM | ID: wpr-940892

ABSTRACT

Objective: We evaluated the safety and efficacy of lipoprotein apheresis (LA) in patients with familial hypercholesterolemia (FH) who can't reach low-density lipoprotein cholesterol(LDL-C) target goals with the maximal tolerated dose of lipid-lowering agents. Methods: This was a retrospective cross-sectional study. Between February 2015 and November 2019, patients with FH who were admitted in Fuwai hospital and treated with LA were consecutively enrolled. Based on intensive lipid-lowering agents, these patients received LA by double filtration plasma pheresis (DFPP) method. The changes of lipid levels such as LDL-C and lipoprotein(a)[Lp(a)] were compared before and after LA treatment, and the changes of immunoglobulin (Ig) concentration and LA-related adverse effects were also discussed. Results: A total of 115 patients with FH were enrolled in this study, of which 8 cases were homozygous FH and 107 cases were heterozygous FH. The age was (43.9±12.2) years and there were 75 (65.2%) males, and 108 (93.8%) with coronary artery disease. For pre-and immediately after LA treatment, the LDL-C was (5.20±2.94) mmol/L vs. (1.83±1.08) mmol/L, Lp(a) concentration was 428.70(177.00, 829.50)mg/L vs. 148.90(75.90, 317.00) mg/L (P<0.001), with a decrease of 64.2% and 59.8% respectively. The levels of IgG and IgA measured 1 day after LA treatment were both in the normal range and IgM concentration was below the reference value, the reductions of which were 15.1%, 25.0% and 58.7% respectively (P<0.001). Six patients had mild symptoms of nausea, hypotension dyspnea and palpitation, the symptoms were relieved by symptomatic treatment. Conclusion: For patients with FH who do not achieve LDL-C target goal with the maximal tolerated lipid-lowering agents, especially those with elevated Lp(a) levels, LA, which can significantly further reduce LDL-C and Lp(a) levels, is an effective and safe option.


Subject(s)
Adult , Female , Humans , Male , Middle Aged , Blood Component Removal/methods , Cholesterol, LDL , Cross-Sectional Studies , Hyperlipoproteinemia Type II/therapy , Lipoprotein(a)/chemistry , Lipoproteins/chemistry , Retrospective Studies
10.
Acta Pharmaceutica Sinica B ; (6): 2417-2428, 2022.
Article in English | WPRIM | ID: wpr-929405

ABSTRACT

Glycosite-specific antibody‒drug conjugatess (gsADCs), harnessing Asn297 N-glycan of IgG Fc as the conjugation site for drug payloads, usually require multi-step glycoengineering with two or more enzymes, which limits the substrate diversification and complicates the preparation process. Herein, we report a series of novel disaccharide-based substrates, which reprogram the IgG glycoengineering to one-step synthesis of gsADCs, catalyzed by an endo-N-acetylglucosaminidase (ENGase) of Endo-S2. IgG glycoengineering via ENGases usually has two steps: deglycosylation by wild-type (WT) ENGases and transglycosylation by mutated ENGases. But in the current method, we have found that disaccharide LacNAc oxazoline can be efficiently assembled onto IgG by WT Endo-S2 without hydrolysis of the product, which enables the one-step glycoengineering directly from native antibodies. Further studies on substrate specificity revealed that this approach has excellent tolerance on various modification of 6-Gal motif of LacNAc. Within 1 h, one-step synthesis of gsADC was achieved using the LacNAc-toxin substrates including structures free of bioorthogonal groups. These gsADCs demonstrated good homogeneity, buffer stability, in vitro and in vivo anti-tumor activity. This work presents a novel strategy using LacNAc-based substrates to reprogram the multi-step IgG glycoengineering to a one-step manner for highly efficient synthesis of gsADCs.

11.
Chinese Journal of General Practitioners ; (6): 885-888, 2021.
Article in Chinese | WPRIM | ID: wpr-911722

ABSTRACT

The clinical data of a child with Van Wyk-Grumbach syndrome (VWGS) who visited Capital Institute of Pediatrics in 2019 were retrospectively analyzed. The patient was a seven year old girl, her main clinical manifestations included short stature (well below -2 standard deviations), obesity and breast development. The results of laboratory testing indicated that the level of thyrotropin (TSH)>100 mIU/L and the level of free thyroxine (FT 4) was 5.15 pmmol/L; serum estradiol and prolactin levels were significantly elevated; the gonadotropin-releasing hormone(GnRH) stimulation test showed that the gonad axis was not activated. She had giant ovarian cyst, pituitary hyperplasia, anemia and pericardial effusion. Bone age was delayed; and her blood lipids had increased. Therefore, she was diagnosed as Van Wyk-Grumbach syndrome. The patient received the treatment of levothyroxine, the drug does was gradually increased from 25 μg per day to 75 μg per day, vaginal bleeding was followed by medication for 3 days. Three months later, her thyroid function was back to normal, and giant ovarian cyst regressed, but the ovaries were bulky,pericardial effusion was absorbed. The levothyroxine dose was adjusted to 50 μg per day according to the test result of thyroid function. And 1 year late the thyroid function was normal, pituitary magnetic resonance imaging(MRI) showed the hyperplastic adenohypophysis was back to normal, no more vaginal bleeding occurred, and the giant ovarian cyst was shrunk.

12.
Chinese Journal of Medical Education Research ; (12): 856-859, 2021.
Article in Chinese | WPRIM | ID: wpr-908902

ABSTRACT

Objective:To study the effect of micro-course teaching combined with teacher standardized patient combined with objective structured clinical examination (TSP/OSCE) on clinical practice teaching of pediatric nursing.Methods:Forty nurses who performed clinical practice in Pediatrics Department from February 2019 to July 2019 were selected as the control group, and traditional teaching was adopted in the group. In addition, 42 nurses who performed clinical practice in Pediatrics Department from August 2019 to January 2020 were selected as the research group, and the micro-course teaching combined with TSP/OSCE mode teaching was adopted in the group. Two groups of nurses' theoretical and practical skills assessment results were analyzed, and a questionnaire survey was conducted to assess nurses' satisfaction with the teaching of pediatric nursing clinical practice training mode. SPSS 22.0 was used for t test and chi-square test. Results:The research group nurses' theoretical and practical skills assessment scores were better than those of the control group, and the difference was statistically significant ( P=0.000).The nurses in the research group were more satisfied than those in the control group with such eight aspects as improving practical skills, emergency response capabilities, humanistic care and service capabilities, communication skills, and stimulating their interest in nursing learning. There were statistically significant differences ( P<0.05). Conclusion:The use of micro-teaching combined with TSP/OSCE mode in the clinical practice teaching of pediatric nursing can improve nurses' clinical practice ability and increase nurses' satisfaction in pediatric training.

13.
Chinese Journal of Digestive Surgery ; (12): 1272-1277, 2021.
Article in Chinese | WPRIM | ID: wpr-930871

ABSTRACT

The concept of precision medicine has brought revolutionary changes to human health and medical treatment. In a broad sense, precision medicine is the application of advanced technologies such as gene sequencing, digital medicine, artificial intelligence, navigation technology, and biomedical engineering to clinical, basic, and public health medical research and practice. The purpose is to promote the continuous development of medical standards. The concept of precision surgery was first proposed by academician Dong Jiahong, who has played an exemplary role in the field of liver surgery for the oncology and other professional fields of surgery. The development and application of computer-assisted surgery systems have promoted the development of precision liver surgery. The digital liver three-dimensional reconstruction provides a new basis for liver vascular anatomy and liver segmentation, assists in the realization of individualized surgical planning, and the measurement of residual liver volume guarantees the safety of operation. The great progress of adult precision liver surgery has provided important help and guidance for the development of pediatric liver surgery. Compared with adults, pediatric liver tumors have their particularities. Pediatric liver tumors are often huge, complex in location, fast growing, and highly malignant. Most children do not have liver cirrhosis and are sensitive to chemotherapy. The liver volume changes greatly with age and weight. These differences determine that the treatment of liver tumors in children needs to adopt different models, and the diagnosis and treatment standards need to be improved. The authors elaborate on the topic of "from adult to child-the development and prospect of precision liver surgery" to promote precision surgery and comprehensive treatment of liver tumors.

14.
Chinese Journal of Applied Clinical Pediatrics ; (24): 609-612, 2021.
Article in Chinese | WPRIM | ID: wpr-882879

ABSTRACT

Objective:To analyze the clinical features and CYP17A1 gene mutation of 17α-hydroxylase/17, 20-lyase deficiency (17OHD). Methods:The clinical data, laboratory examination and genetic results of 6 children with 17OHD in the Department of Endocrinology, Children′s Hospital Affiliated to Capital Institute of Pediatrics from March 2014 to December 2019 were enrolled and analyzed retrospectively.Meanwhile, the clinical types of all congenital adrenocortical hyperplasia (CAH) patients were calculated and then the incidence of 17OHD was calculated.Results:The 6 cases were from 5 families, and the age at diagnosis was ranged from 1 year and 6 months to 15 years old, in which 2 cases were 46, XX and 4 cases were 46, XY.Their gender were all female.Three cases presented with hypertension (50.0%), 4 cases with hypokalemia (66.7%), and 1 case with labia mass (16.7%). The gonad developed into a testis in patients with 46, XY, and patients with 46, XX had ovarian hypoplasia.The laboratory tests revealed an decrease in the cortisol at 8 AM in all cases, ranging from 0.62 to 5.93 mg/L.Five cases displayed an increase in adrenocorticotropic hormone (ACTH) in the range of 84-271 ng/L, and 1 patient with normal ACTH (58 ng/L) had a peak cortisol of 1.75 mg/L after the ACTH challenge test.Elevated progesterone was detected in 6 patients with a normal 17 hydroxyprogesterone level.Further results proved low levels of testosterone and estradiol, and high levels of luteinizing hormone (LH), and follicle stimulating hormone (FSH). CT scan showed mild adrenal hyperplasia in all cases.Among 114 CAH patients during the same period, the incidence of 17OHD came second at 5.3%.The CYP17A1 gene mutation results indicated that 2 unrelated patients were homozygous mutation for p. Y329fs (c.985_987delTACinsAA), 2 siblings were compound heterozygous mutations for p. Y329fs and exon 1-7 deletion, 1 patient was compound heterozygous mutations of p. Y329fs and p. R416C (c.1246C>T), and 1 patient was homozygous mutations for p. L465P (c.1394T> C), which was first reported in China. Conclusions:17OHD is not rare in CAH.Female children with hypokalemia, hypertension, and hypogonadism can lead to diagnostic suspicion of 17OHD.The p. Y329fs mutation in Chinese 17OHD children is a hotspot.The p. L465P (c.1394T>C) mutation is a new mutation in China and it could enrich the mutant spectrum of CYP17A1 gene in China.

15.
Chinese Journal of Medical Instrumentation ; (6): 670-673, 2021.
Article in Chinese | WPRIM | ID: wpr-922080

ABSTRACT

On the basis of introducing FDA's regulatory measure and relevant requirement for life-cycle management of combination product, this paper aims to discuss corresponding countermeasure for supervision system construction in consideration of domestic drug-device combination product's current situation, in order to promote innovative development of relevant industries.


Subject(s)
Device Approval , Drug Approval , United States , United States Food and Drug Administration
16.
Chinese Journal of Traumatology ; (6): 5-10, 2021.
Article in English | WPRIM | ID: wpr-879669

ABSTRACT

Traumatic brain injury (TBI), a growing public health problem, is a leading cause of death and disability worldwide, although its prevention measures and clinical cares are substantially improved. Increasing evidence shows that TBI may increase the risk of mood disorders and neurodegenerative diseases, including Alzheimer's disease (AD). However, the complex relationship between TBI and AD remains elusive. Metabolic dysfunction has been the common pathology in both TBI and AD. On the one hand, TBI perturbs the glucose metabolism of the brain, and causes energy crisis and subsequent hyperglycolysis. On the other hand, glucose deprivation promotes amyloidogenesis via β-site APP cleaving enzyme-1 dependent mechanism, and triggers tau pathology and synaptic function. Recent findings suggest that TBI might facilitate Alzheimer's pathogenesis by altering metabolism, which provides clues to metabolic link between TBI and AD. In this review, we will explore how TBI-induced metabolic changes contribute to the development of AD.

17.
Chinese Journal of Medical Genetics ; (6): 526-530, 2021.
Article in Chinese | WPRIM | ID: wpr-879618

ABSTRACT

OBJECTIVE@#To summarize clinical manifestations and results of genetic testing in 12 children with Gitelman syndrome (GS).@*METHODS@#Clinical data of the children was collected. Whole exome sequencing(WES) was carried out to screen potential variants of genomic DNA. Candidate variants were verified by Sanger sequencing.@*RESULTS@#The patients have included 10 boys and 2 girls, whom were diagnosed at between 2.8 to 15.0 year old. Six patients were due to infections, 5 were due to short stature, and 1 was due to lower limb weakness. All patients were found to carry variants of SLC12A3 gene, which included 11 with compound heterozygous variants and 1 with homozygous variant. All of the 19 alleles of the SLC12A3 gene carried by the patients were delineated, which included 15 missense variants, 2 frameshift variants and 2 splice region variants. These variants were unreported previously, which included c.578_582dupCCACC (p.Asn195Profs*109), c.251C>T (p.Pro84Leu) and c.2843G>A (p.Trp948X).@*CONCLUSION@#The clinical symptoms of GS in children are atypical and often seen in older children. For children with occasional hypokalemia associated with growth failure, GS should be suspected. The majority of GS children carry two pathogenic variants of the SLC12A3 gene, mainly compound heterozygotes, among which p.Thr60Met is the most common one. The discovery of new variants has enriched the spectrum of SLC12A3 gene variants.


Subject(s)
Adolescent , Child , Child, Preschool , Female , Humans , Male , DNA , Genetic Testing , Gitelman Syndrome/genetics , Hypokalemia/genetics , Solute Carrier Family 12, Member 3/genetics
18.
Chinese Journal of Radiation Oncology ; (6): 1124-1129, 2020.
Article in Chinese | WPRIM | ID: wpr-868734

ABSTRACT

Objective:To observe the presence or absence of necroptosis in PC12 cells after radiation injury, and to detect the expression of receptor-interacting protein 3(RIP3) and evaluate its regulatory effect on necroptosis.Methods:PC12 cells were treated with different doses of irradiation and their necroptosis was detected by lactate dehydrogenase (LDH) release at different time points. After pretreatment with necroptosis inhibitor Necrostatin-1(Nec-1), the changes of cell necroptosis were detected by LDH. The expression level of RIP3 after irradiation intervention was detected by Western blot (WB). After pretreatment with the RIP3-specific inhibitor GSK′872, the changes of cell necroptosis were detected by LDH. The best transfection sequence of RIP3 knockout was screened by WB. The cells were divided into the control group, irradiation group, solvent control group, no-load control group and pretreatment group. WB, immunofluorescence staining, MTT, LDH and Annex V-fluorescein Isothiocyanate/Propidium Iodide (AnnexV-FITC/PI) flow cytometry were used for detection and analysis.Results:After 4 Gy irradiation, the degree of cell necrosis was the highest after 3 hours of culture, and the expression level of RIP3 protein was up-regulated. The cell necrosis was decreased after Nec-1, GSK′872 and RIP3 gene knockdown pretreatment.Conclusions:The radiation injury of 4 Gy can induce the necroptosis of PC12 cells, and the most significant effect can be observed when cultured for 3 hours after irradiation. RIP3 is involved in the process of necroptosis of PC12 cells induced by radiation injury, and plays a pivotal positive regulatory role.

19.
Chinese Journal of Radiological Medicine and Protection ; (12): 783-788, 2020.
Article in Chinese | WPRIM | ID: wpr-868511

ABSTRACT

Objective:To investigate the application value of third-generation dual-source CT(3-G DSCT) low-dose scan mode combined with iterative reconstruction technology in the screening of COVID-19 and to evaluate the radiation dose.Methods:One hundred and twenty patients suspected of COVID-19 from December 2019 to February 2020 were retrospectively analysed and randomly divided into two groups (test group and conventional group, 60 patients in each). The parameters for test group included 3-G DSCT, Turbo Flash scan mode, CARE kV, with reference 90 kV, pitch 2.0, and ADMIRE algorithm, while those parameters for conventional group included the 128-slice CT, conventional spiral scan mode, 120 kV, pitch 1.2, and FBP algorithm. The CT values of aorta, spinal posterior muscle, and subcutaneous fat, the aortic noise, signal-to-noise ratio (SNR), and contrast noise ratio (CNR) were compared to evaluate the image quality between two groups. Two experienced doctors scored the image quality using a double-blind method, and compared the CT dose index volume (CTDI vol), dose-length product (DLP), and effective dose ( E) of the two groups. Results:The CT value of the aorta and spinal posterior muscle and the aortic SNR in the test group were (45.38±4.77), (53.41±8.44) HU, and 2.82±0.59, and significantly higher than those in the conventional group [(39.68±6.26), (42.66±6.32) HU, 2.58±0.61, t=5.608, 7.897, 2.162, P<0.05]. The aortic noise, CNR and subjective scores between the two groups had no significant difference( P>0.05). The CTDI vol, DLP, and E in the test group were (3.09±1.02) mGy, (107.57±32.81) mGy·cm, (1.51±0.46) mSv, significantly lower than those in the conventional group [(7.00±1.80) mGy, (261.65±73.93) mGy·cm, (3.66±1.03) mSv; t=-14.680, -14.756, -14.756, P<0.05]. Conclusions:In the screening of COVID-19, using low-dose scanning mode of 3-G DSCT combined with iterative reconstruction technology would provide diagnostic quality images and meanwhile effectively reduce the radiation dose and improve the SNR of the image.

20.
Acta Pharmaceutica Sinica ; (12): 2934-2941, 2020.
Article in Chinese | WPRIM | ID: wpr-862288

ABSTRACT

To identify the composition of iridoids from Hedyotis diffusa Willd and explore the mechanism on its anti-renal fibrosis effect based on network pharmacology, LC-Q/TOF-MS (liquid chromatograpy-quadrupole/time of flight mass spectrometry) was used to analyze the iridoid ingredients and the related targets of renal fibrosis were obtained by DisGeNET database and MalaCards database. The potential targets were screened by SYBYL-X7.3 software. We then imported the identified ingredients and potential target genes into Cytoscape3.7.1 to construct the compound-target network and the protein-protein interaction (PPI) network. Finally, the gene ontology (GO) functional enrichment analysis and KEGG pathway enrichment analysis of the selected core genes were made to explore the mechanism of iridoids against renal fibrosis. There were 10 active iridoid compounds and 111 corresponding targets including dimethylarginine dimethylaminohydrolase 1 (DDAH1), heparanase (HPSE), human kirsten rat sarcoma viral oncogene (KRAS), moesin (MSN), etc. in compound-target network. The GO functional enrichment analysis obtained 211 GO entries. Twenty related signal pathways including Toll-like receptor signaling pathway, transforming growth factor-beta (TGF-β) signaling pathway, renal cell carcinoma signaling pathway, and the Janus kinase/signal transducer and activator of tran-ions (Jak-STAT) signaling pathway were selected by KEGG enrichment analysis. We preliminarily investigated the mechanism of the iridoid compounds on renal fibrosis to provide guide information for the subsequent experimental research and clinical application.

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