1.Data analysis of resolution discrepancies in minipool nucleic acid testing: A 2024 national study of Chinese blood stations
Ying YAN ; Qing HE ; Wei ZHENG ; Jie MA ; Le CHANG ; Huimin JI ; Huizhen SUN ; Lunan WANG
Chinese Journal of Blood Transfusion 2026;39(4):423-429
Objective: To investigate the incidence, characteristics, and influencing factors of resolution discrepancies within the minipool (MP) testing model across Chinese blood station laboratories in 2024. Methods: A nationwide, multicenter, cross-sectional study was conducted, including 334 blood station laboratories that reported nucleic acid reactive data among enzyme immunoassay non-reactive samples. Of these, 296 laboratories adopted the pool resolution model, with a total of 12 536 273 samples tested. Systematic analysis was performed on resolution data, focusing on the MP-NAT reactivity rate, the pool resolution concordance rate, and the resolution discrepancy rate. Subgroup analyses were conducted based on reagent types, viral targets, and Ct values. Potential causes were further explored through laboratory surveys and re-examination of raw amplification curves. Results: In 2024, the national average MP-NAT reactivity rate was 0.15%. The overall pool resolution concordance rate was 57.86%, which showed a gradual decline as Ct values increased across all reagents. The national average resolution discrepancy rate was 0.081‱(102/12 536 273), with 17.91%(53/296) of laboratories reporting at least one discrepancy. Nine reagent types were associated with these events, exhibiting reagent-specific patterns. For Reagent A2, the predominant discrepancy was HBV reactive pools resolving as HIV (36.36%); for Reagent D1, HBV pools frequently resolved as HCV (38.89%); and for Reagent E, the most common pattern was HIV pools resolving as HBV (48.00%). These resolution discrepancies were strongly associated with high Ct values: the median pool Ct for HBV exceeded 38, while those for HCV and HIV both exceeded 40. Investigations across 16 laboratories revealed that most discrepant samples exhibited “tailing” amplification curves, with some cases linked to cross-contamination or reagent batch-specific issues. Conclusion: While the incidence of resolution discrepancies in the MP-NAT model remains low in China, variations exist across different reagents and laboratories. These discrepancies are closely associated with low viral load, reagent performance, and laboratory operational practices.
2.Analysis of the adjustment of current eligibility criteria for alanine aminotransferase levels in blood screening in China
Le CHANG ; Ying YAN ; Huimin JI ; Huizhen SUN ; Lunan WANG
Chinese Journal of Blood Transfusion 2025;38(4):465-473
[Objective] To obtain accurate data on alanine aminotransferase (ALT) levels among blood donors in China and to explore the necessity of adjusting the qualification criteria for ALT. [Methods] A collaborative study was conducted involving 26 blood centers and 7 central blood stations with an annual testing volume exceeding 100 000 samples. Between December 1 and 15, 2024, pre-donation ALT testing was suspended for 1-2 days for all whole blood donations. ALT levels were measured only post-donation using standard laboratory equipment and reagents. All transfusion-transmitted infectious disease-related serological and nucleic acid testing, including hepatitis E virus (HEV) RNA testing, were performed. Within one week of testing completion, anonymized data on basic donor information, routine test results, and HEV RNA results were collected and statistically analyzed. [Results] A total of 21 345 blood donors were included in the study, with an ALT disqualification rate of 7.6% (1 623/21 345). The disqualification rate was 9.6% (1 453/15 205) for males and 2.8% (170/6 140) for females. There were significant regional variations in both the disqualification rates and levels of ALT, with Shaanxi Province exhibiting the highest disqualification rate (12.3%, 87/710) and Yunnan Province the lowest (2.9%, 19/652). Among the provinces (autonomous regions and municipalities), Beijing recorded the lowest ALT levels. ALT levels varied across different age groups and genders. Among all samples tested by HEV RNA, the HEV RNA positive rate was 0.29‰ (6/21 003). HCV infection was found to directly affect ALT levels, while HBV, HIV, syphilis, and HEV infections did not significantly impact ALT disqualification rates. It is recommended to adjust the ALT qualification criteria to twice the upper limit of the clinical reference range, which would increase the number of eligible blood donations by 6.61% (1 293/19 550). [Conclusion] In China, the ALT levels of blood donors are correlated with gender, age, geographical region, and HCV infection status. Appropriately raising the ALT eligibility criteria to ≤100 U/L for male donors and ≤80 U/L for female donors could expand the pool of eligible donors and reduce the blood discard rate while ensuring blood safety.
3.Cost-utility analysis of semaglutide versus canagliflozin in patients with type 2 diabetes poorly controlled with metformin
Yueru XU ; Yubo WANG ; Huimin PAN ; Huiting SHAN ; Ji CHEN ; Jianhua YANG
China Pharmacy 2025;36(9):1087-1092
OBJECTIVE To evaluate the long-term cost-effectiveness of canagliflozin or semaglutide in patients with type 2 diabetes mellitus(T2DM)poorly controlled with metformin. METHODS Based on the perspective of China’s health system, a Markov model was used to calculate the long-term costs and utilities of canagliflozin or semaglutide combined with metformin for T2DM patients in China for 30 years based on the data from SUSTAIN 8 study. The incremental cost-effectiveness ratio(ICER) and incremental net monetary benefit (INMB) were calculated using one time the 2024 per capita gross domestic product(GDP) as the willingness-to-pay(WTP) threshold. One-way sensitivity analysis, probability sensitivity analysis and scenario analysis were conducted to confirm the stability of the conclusions. RESULTS Compared with canagliflozin + metformin, ICER of semaglutide combined with metformin was 260 485.67 yuan/quality-adjusted life year (QALY),which was higher than the WTP threshold set in this study (95 749 yuan/QALY),and the corresponding INMB was -61 576.24 yuan,indicating that the canagliflozin + metformin regimen was more cost-effective. The cost of diabetes without complications treatment in the semaglutide + metformin group had the greatest influence on INMB,but changes in parameters within the selected range did not drive decision reversal. With the increasing of WTP threshold,the economic acceptability of semaglutide + metformin regimen increased. Under the current WTP threshold,the annual cost of semaglutide should be reduced by 42.95% to make the semaglutide + metformin regimen more cost- effective. CONCLUSIONS From the perspective of China’s health system, canagliflozin + metformin is more cost-effective than semaglutide + metformin for T2DM patients yueru. with poor glycemic control with metformin alone.
4.Rapid health technology assessment of SGLT-2 inhibitors in the treatment of type 2 diabetes mellitus
Huimin PAN ; Yubo WANG ; Huiting SHAN ; Ji CHEN ; Jianhua YANG
China Pharmacy 2025;36(23):2978-2984
OBJECTIVE To evaluate the safety, efficacy, and cost-effectiveness of sodium-glucose co-transporter 2 (SGLT-2) inhibitors for treating type 2 diabetes mellitus (T2DM). METHODS Retrieved databases such as PubMed, Cochrane Library, Embase, CNKI, as well as relevant health technology assessment (HTA) official websites, HTA reports, systematic review/meta- analysis and pharmacoeconomic studies about SGLT-2 inhibitors (including 12 types such as canagliflozin, dapagliflozin, and empagliflozin) in the treatment of T2DM were collected from the inception to January 28, 2025. After literature screening data extraction and quality assessment, a descriptive analysis was conducted on the results of the included studies. RESULTS A total of 38 articles were included, comprising 30 systematic reviews/meta-analyses, 4 pharmacoeconomic studies, and 4 HTA reports. In terms of effectiveness, most research results showed that canagliflozin was effective in controlling blood glucose, reducing body weight, and lowering blood pressure compared to other SGLT-2 inhibitors, while empagliflozin could effectively reduce all-cause mortality. In terms of safety, compared with other SGLT-2 inhibitors, empagliflozin has a lower overall adverse event rate and cardiovascular death risk, canagliflozin presented a higher risk of hypoglycemia, and dapagliflozin had a higher risk of urinary tract infections. In terms of economics, empagliflozin possessed greater economic advantages over both dapagliflozin and canagliflozin, while canagliflozin offered more benefits than dapagliflozin. CONCLUSIONS The selection of SGLT-2 inhibitors for the treatment of T2DM should be individualized. Canagliflozin is recommended for patients with high cardiovascular risk. Empagliflozin boasts the best overall safety profile. Dapagliflozin should be used with caution in patients at high risk of urinary tract infections. Based on foreign economic evidence, empagliflozin has economic advantages. In the future, drug economic studies under the Chinese health system need to be conducted.
5.The value of MR neuroimaging in image evaluation of facial neuritis.
Lihua LIU ; Huimin HUANG ; Xiaodong JI ; Wei WANG ; Ming HU
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(1):29-41
Objective:To exploring the value of MR neuroimaging for quantitative assessment of the facial nerve and peripheral lymph nodes in patients with acute peripheral facial paralysis. Methods:Based on a prospective experimental design, 32 patients with idiopathic peripheral facial palsy were enrolled in the experiment. Based on MR neuroimaging technology, MR high-resolution thin-layer images of bilateral facial nerves were acquired. The diameters of different segments of the bilateral facial nerve were measured, including the labyrinthine segment, the geniculate ganglion, the horizontal segment, the vertical segment, the stem-mammary foramen segment, the trunk of the parotid segment, the temporal trunk, and the cervical trunk, as well as the quantitative indicators of peri-auricular and parotid lymph nodes(number, length and diameter of the largest lymph nodes). Differences in quantitative indices of nerve diameter and peripheral lymph nodes between the paraplegic and healthy sides were compared using the paired t-test and Wilcoxon signed rank test. Results:The diameter of geniculate ganglion, mastoid foramen stem, parotid main trunk, temporal facial trunk, and cervical facial trunk were notably increased on the facial paralysis side compared to the contralateral side(P<0.05). However, no significant differences were observed in the diameter of labyrinthine segment, horizontal segment, or vertical segment compared to the contralateral side. There were significantly more periauricular lymph nodes on the facial paralysis side than the contralateral side(P=0.001). Conclusion:MR neuroimaging enables the quantitative assessment of structural changes in the facial nerve of patients with acute peripheral facial paralysis, demonstrating nerve enlargement in the geniculate ganglion, stylomastoid foramen segment, main trunk of the parotid segment, temporal facial trunk, and cervical facial trunk. Additionally, an increased number of periauricular lymph nodes is observed on the affected side. These findings may aid clinicians in assessing the efficacy of treatments and predict the prognosis of these patients.
Humans
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Facial Nerve/diagnostic imaging*
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Magnetic Resonance Imaging/methods*
;
Prospective Studies
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Female
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Male
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Neuroimaging/methods*
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Lymph Nodes/diagnostic imaging*
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Facial Paralysis/diagnostic imaging*
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Adult
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Middle Aged
6.Tianxiangdan (TXD) alleviates myocardial ischemia reperfusion-induced ferroptosis through the activation of estrogen receptor alpha (ERα).
Yuanjia YUE ; Yu LI ; Xing RONG ; Zhao JI ; Huimin WANG ; Liang CHEN ; Lin JIANG
Chinese Journal of Natural Medicines (English Ed.) 2025;23(1):102-110
Tianxiangdan (TXD), a traditional Chinese herbal remedy, demonstrates efficacy in mitigating myocardial ischemia-reperfusion (I/R)-induced damage. This study employed network pharmacology to evaluate the therapeutic targets and mechanisms of TXD in treating I/R. High-performance liquid chromatography-mass spectrometry (HPLC-MS) identified 86 compounds in TXD. Network pharmacological analysis predicted potential target genes and their modes of action. Cardiac function, ischaemic ST changes, lactate dehydrogenase (LDH), malondialdehyde (MDA), superoxide dismutase (SOD) activity, myocardial fiber, and infarct size were assessed using in vivo and in vitro I/R injury models. Estrogen receptor alpha (ERα) protein expression and estradiol (E2) levels were measured to confirm TXD's impact on estrogen levels and ERα expression. To examine if TXD reduces I/R injury through ERα, an AZD group (300 nmol·L-1 AZD9496 and 15% TXD serum) was compared to a TXD group (15% TXD serum). The study hypothesized that TXD upregulates the ERα-mediated iron metamorphosis pathway. I/R injury-induced ferroptosis was identified using a Fer-1 group (1.0 μmol·L-1 Fer-1 and 15% TXD serum) to elucidate the potential association between ferroptosis and ERα proteins. A DCFH-DA probe detected reactive oxygen species (ROS) and Fe2+, while Western blotting assessed target protein expression. Both in vitro and in vivo experiments demonstrated that TXD attenuated I/R injury by reducing elevated ST-segment levels, improving cardiac injury biomarkers (LDH, MDA, and SOD), alleviating pathological features, and preventing I/R-induced loss of cell viability in vitro. The effects and mechanisms of TXD on I/R injury-associated ferroptosis were investigated using I/R-induced H9c2 cells. The TXD group showed significantly decreased ROS and Fe2+ levels, while the AZ group (treated with AZD9496) exhibited increased levels. The TXD group demonstrated enhanced expression of ERα and glutathione peroxidase 4 (GPX4), with reduced levels of P53 protein and ferritin-heavy polypeptide 1 (FTH1). The AZ group exhibited contrasting effects on these expression levels. The literature indicated a novel connection between ERα and ferroptosis. TXD activates the ERα signaling pathway, promoting protection against I/R-induced myocardial cell ferroptosis. This study provides evidence supporting TXD use for myocardial ischemia treatment, particularly in older female patients who may benefit from its therapeutic outcomes.
Animals
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Ferroptosis/drug effects*
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Estrogen Receptor alpha/genetics*
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Myocardial Reperfusion Injury/genetics*
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Drugs, Chinese Herbal/pharmacology*
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Male
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Mice
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Humans
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Mice, Inbred C57BL
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Estradiol/metabolism*
7.Analysis of Dengue virus nucleic acid testing screening among blood donors in Xishuangbanna Dai Autonomous Prefecture, China
Xinru LIU ; Shaofang LU ; Ying YAN ; Jing DONG ; Ji WU ; Jie MA ; Le CHANG ; Huimin JI ; Huizhen SUN ; Mingwen DENG ; Xiaoqian GAO ; Lunan WANG
Chinese Journal of Blood Transfusion 2025;38(12):1662-1668
Objective: To investigate the prevalence of Dengue virus (DENV) infection among voluntary blood donors in Xishuangbanna Dai Autonomous Prefecture, and to evaluate the necessity of implementing nucleic acid testing (NAT) for blood donors during the rainy season (May-October). Methods: Prior to initiating donor screening, the Xishuangbanna Central Blood Center conducted in-house validation of reagent performance and participated in external quality assessment (EQA) organized by the National Center for Clinical Laboratories (NCCL). During the surveillance period (August-October 2024), a total of 2 919 donor samples were screened using a 6-sample mini-pool NAT strategy. Daily internal quality controls were recorded. Samples that tested positive in pooled screening were deconvoluted and retested in duplicate; only those reactive in both replicate wells were sent to the NCCL for confirmatory testing. At NCCL, samples underwent re-testing using five domestic NAT reagents, as well as serological assays for NS1 antigen and DENV-specific IgG/IgM. Confirmed positive samples were further characterized by serotyping, envelope (E) gene sequencing, and phylogenetic analysis using the maximum likelihood method. Results: The DENV NAT reagent demonstrated consistent detection of 40 copies/mL controls in individual donor (ID)-NAT test (mean CT: 35.61±0.40). During the 63-day quality control monitoring, DENV detection remained stable (mean CT: 22.53±0.72). The center achieved full marks in EQA assessments for 2023 and 2024. Three reactive pools were identified in initial screening, and subsequent individual testing confirmed three DENV RNA-positive donors (sample numbers: 2401, 2402, and 2403). The confirmatory test results from NCCL were: all five NAT platforms consistently detected DENV RNA in the three samples; for serological tests, 2 samples (2402, 2403) were positive for NS1 antigen, while all three samples were negative for both IgG and IgM antibodies. DENV serotyping reagents identified DENV-2 in all cases, which were further confirmed as DENV-2 Genotype Ⅱ-Cosmopolitan by E gene sequencing. Phylogenetic analysis indicated that samples 2401 and 2402 clustered with Southeast Asian strains (Thailand/MZ636802.1, Laos/PQ775621.1), while sample 2403 closely matched a previously reported local Yunnan strain (PV544686.1). Conclusion: DENV-2 infection was detected among blood donors in Xishuangbanna during the rainy season, indicating concurrent risks of imported and local transmission. We recommend implementing pooled NAT screening for blood donors in high-risk areas during dengue epidemic seasons, along with strengthened laboratory quality control, to enhance blood safety.
8.Effect of antidepressant treatment on longitudinal depressive burden in patients with bipolar depression
Yue ZHU ; Zhiying LI ; Huimin GAO ; Jun JI ; Shuzhe ZHOU ; Xin YU ; Yantao MA
Chinese Journal of Psychiatry 2025;58(2):134-140
Objective:To examine the effect of antidepressant treatment on the longitudinal depressive burden in patients with bipolar depression.Methods:Subjects were recruited from a national multicenter, naturalistic observational project: Comprehensive Assessment and Follow-up Descriptive Study on Bipolar Disorder study (CAFE-BD). A total of 110 patients with bipolar depression (51 males, 59 females; aged 18-64 years, mean age 34.4±11.1 years) were consecutively enrolled between January 2012 and December 2013 from outpatients and inpatients of nine medical institutions, including six psychiatric hospitals and three general hospitals. Based on the use of antidepressants as defined in this study, patients were classified into a medicated group (Ads, n=74) and a non-medicated group (nAds, n=36). Diagnosis of bipolar depression was confirmed using the MINI (Chinese version), and baseline and follow-up assessments were conducted using the Assessment of Mood Disorders Evaluation (ADE) and the Clinical Monitoring Form (CMF). Depression burden indicators, including aggregate depression scores (SUM-D), number of depressive symptoms (NUM-D), and total depression burden, were compared between the Ads group and nAds group at mid-term (the 6 th month) and endpoint (the 12 nd month). Longitudinal changes in these indicators were also analyzed. Results:The proportion of bipolar depressive patients on antidepressants was 67% (74/110). Among them, 85% (63/74) were taking antidepressants at baseline; this dropped to 76% (56/74) at mid-term, and 64% (47/74) at the endpoint. SUM-D were higher in the Ads group than in the nAds group at baseline (9 (6.5, 11) vs 7.38 (5.5, 9.0); W=1 712.00, P=0.015), and there was no statistically significant difference in NUM-D and total depressive burden between two groups at any time points ( P>0.05). Compared to baseline, the Ads group had significantly lower SUM-D (0.5 (0, 1), 1.33 (0.5, 2.5) vs. 9 (6.5, 11); W=2 770.00, 2 743.00), NUM-D (0 (0, 0), 0 (0, 1) vs. 7 (5, 8); W=2 621.00, 2 601.50) and total depressive burden (c 2=64.36, 59.00) at both mid-term and endpoint (all P<0.001); While SUM-D (0.59 (0.4, 0.7), 1 (0.8, 2.5) vs. 7.38 (5.5, 9.0); W=664.50, W=666.00), NUM-D (0 (0, 0), 0 (0, 1) vs. 6 (4, 7); W=527.00, 528.00) and total depression burden ( χ 2=31.00, 31.00) in the nAds group were also significantly decreased at both mid-term and endpoint (all P<0.001). There were no statistically significant differences in the changes in depression burden indicators between the two groups from baseline to mid-follow-up or endpoint, nor from mid-follow-up to endpoint ( P>0.05). Conclusion:In a 12-month real-world naturalistic follow-up study, both medicated and non-medicated bipolar depression groups experienced significant and similar reductions in depression burden.
9.ACD/AutoChrom-assisted method development for detection of related substances in buprenorphine API
Yaqin ZHANG ; Fengqin CHEN ; Bo JI ; Guihua LU ; Haoli SUN ; Chunyan SUN ; Huimin LYU ; Ruwei WANG
Drug Standards of China 2025;26(3):278-284
Objective:To establish a high-performance liquid chromatography(HPLC)method for the determina-tion of related substances in buprenorphine active pharmaceutical ingredient(API)using advanced ACD/Auto-Chrom method development software for comprehensive parameter simulation and design.Methods:An Agilent ZORBAX Eclipse Plus C18 column(4.6 mm × 150 mm,3.5 μm)was used with a mobile phase consisting of 40 mmol·L-1 potassium dihydrogen phosphate solution and acetonitrile in a gradient elution mode.The flow rate was set at 1.3 mL·min-1,the column temperature was maintained at 35 ℃,the detection wavelength was 240 nm,and the injection volume was 5 μL.Results:The impurities A,B,D,E,F,G,H,I,and J in buprenorphine were effectively separated from the main component.The linear ranges were 0.33-83.73,0.20-78.74,0.20-40.28,0.22-43.31,0.32-78.98,0.13-63.74,0.51-101.54,0.22-43.72,and 0.40-80.37 μg·mL-1,respectively.The limits of detection(LOD)were 0.10,0.06,0.06,0.06,0.09,0.04,0.15,0.07,and 0.12 μg·mL-1,respectively,while the limits of quantification(LOQ)were 0.33,0.20,0.20,0.22,0.32,0.13,0.51,0.22,and 0.40 μg·mL-1,respectively.The accuracy,precision,and robustness of the method met the required standards.Conclusion:This method is suitable for the determi-nation and quality control of related substances such as impurities A,B,D,E,F,G,H,I,and J in buprenorphine API.
10.Summary of single-center treatment experience for 51 cases of traumatic subdural effusion in infants and Young children
Guangchun JI ; Jin ZHANG ; Dehai QU ; Dongpo LV ; Fei JIANG ; Huimin JIA
Journal of Clinical Surgery 2025;33(5):457-460
Objective To explore the clinical features,treatment and prognosis of traumatic subdural effusion(TSE)in infants.Methods Data of 51 cases of traumatic subdural effusion in infants admitted to the single center of Dalian Women and Children Medical Center(Group)from February 2013 to February 2020 were retrospectively analyzed,and their clinical manifestations,imaging features,treatment methods and prognosis were summarized and analyzed.Results Fifty-one cases(26 males and 25 females),ranging in age from 1 month to 3 years old of traumatic subdural effusion in infants were reviewed in our hospital,all cases were confirmed by Computed Tomography(CT)examination.31 cases were treated conservatively,29 cases were cured,and 2 cases were treated surgically due to poor conservative treatment.Surgical treatment was performed in 22 cases(including 2 cases who received surgical treatment due to poor conservative treatment).One patient underwent puncture and continuous drainage at the lateral Angle of the anterior fontanelle and was cured.Twenty-one cases underwent cranial drilling,subdural space catheterization for external drainage,and 17 cases(80.95%,17/21)were cured at one time.There were 4 cases(19.05%,4/21)of recurrence after external drainage with catheterization.Two cases were cured by external drainage with Ommaya capsule insertion and intermittent aspiration and fluid drainage.It was changed to subdural peritoneal shunt surgery,and 2 cases were cured after the operation.There was no surgical infection or death in all the children in the group.The median follow-up time ranged from 3 months to 60 months,and the conditions were all stable.Conclusion Traumatic subdural effusion is a common complication after craniocerebral injury in infants and young children.Due to its lack of self-expression,the hidden condition is often ignored.Moreover,the brain tissue of infants and young children is in the growth and development stage,which will affect the development of brain tissue after its onset.

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