1.Effect of cryopreservation on the stability of ELISA and NAT results of donor plasma
Xiaoyan ZHANG ; Feifan WANG ; Ziyue ZHAO ; Fei GUO ; Yan ZANG ; Haihui GU ; Zhanshan ZHA
Chinese Journal of Blood Transfusion 2026;39(9):1218-1222
Objective: To investigate the stability of plasma from blood donors cryopreserved at-80℃for two months in ELISA and NAT detection (HBV, HCV, and HIV), and to provide a reference for the preservation, transportation, and retrospective testing of samples collected in remote areas or during emergency blood collection. Methods: Three sets of experimental designs were adopted, each including ELISA (HBsAg, anti-HCV, HIV Ag-Ab) and NAT (HBV DNA, HCV RNA, HIV-1 RNA) testing. Stability validation test: 136 positive and 150 negative donor samples were selected, retested with the original reagents after cryopreservation at-80℃for two months, and the ELISA S/CO values, NAT Ct values, and result concordance rates before and after freezing were compared. Limit of detection validation test: Standard substances with known concentrations were diluted into three gradients of weakly reactive samples (ELISA S/CO values of 0.8-5, NAT Ct values of 35-42). Each was tested six times before and after freezing, the mean values were calculated, and the ELISA S/CO values and NAT Ct values were compared. Real-world validation test: 300 randomly selected donor samples were subjected to plasma separation after initial testing and cryopreserved for two months. The reactive detection rates of ELISA and NAT before and after freezing were compared. Results: Stability validation test: In ELISA testing, 3 samples converted from weak-positive to negative, and 3 samples converted from weak-positive to gray zone, yielding a concordance rate of 97.9%. In NAT testing, 2 samples converted from weak-positive to gray zone, yielding a concordance rate of 99.30%. Significant differences were observed in both ELISA S/CO values and NAT Ct values after freezing (P<0.05). Limit of detection validation test: No significant differences were found in ELISA S/CO values or NAT Ct values for the three concentrations of weakly reactive samples before and after freezing (P>0.05); only the anti-HCV ELISA result for the 0.5 NCU/mL sample converted from positive to the gray zone. Real-world validation test: The ELISA reactive detection rates before and after freezing were 1.67% vs 1.00%, and the NAT reactive detection rates were 0.33% vs 0.33%, with no significant differences (P≥0.05). Conclusion: After cryopreservation of donor plasma at-80℃for two months, the overall concordance rates for ELISA and NAT testing are extremely high. Although weak-positive samples are susceptible to freezing effects, the overall qualitative results remain stable, demonstrating that deep-low temperature cryopreservation can effectively maintain the stability of viral marker detection.
2.Evaluation of the efficacy of corticosteroids in male children with Duchenne muscular dystrophy
Jialu XU ; Qinrong HUANG ; Hongliang HUO ; Yuting ZHANG ; Xiaoyan SHEN ; Liang TAO ; Xujun CAO ; Qin GU ; Nong XIAO ; Haifeng LI
Chinese Journal of Pediatrics 2025;63(8):885-890
Objective:To evaluate the efficacy of corticosteroids in male children with Duchenne muscular dystrophy (DMD), and provide evidence for the rational clinical use of medication.Methods:This was a multicenter medical record series study which conducted from January 15 th to March 14 th, 2025. A total of 53 male children with DMD admitted to the Department of Rehabilitation of Children′s Hospital, Zhejiang University School of Medicine, Children′s Hospital of Chongqing Medical University and Affiliated Children′s Hospital of Soochow University from 2020 to 2024 were enrolled. Clinical data, corticosteroid usage, and the follow-up data were collected. The North star ambulatory assessment (NSAA) was used as the primary efficacy indicator. Generalized estimating equations (GEE) exchangeable working matrices were used for longitudinal analysis, and the least squares mean were used to compare the change trend of the efficacy evaluation index across different medication durations. Results:The age at the initiation of corticosteroid treatment was (6.3±1.9) years. The follow-up duration was 1.2 (0.9, 2.2) years. After treatment, the raw scores and linear scores of NSAA were both significantly higher than those before treatment ((22±7) vs. (19±5) points, (60±16) vs. (53±8) points; t=3.98, 3.69; both P<0.001). The 10 meter running time and time rising from floor were both shorter than those before treatment (6 (4, 8) vs. 7 (6, 9) s, 5 (3, 6) vs. 6 (5, 9) s; Z=2.62, 3.47; both P<0.01). GEE model analysis revealed all nonlinear correlation between motor function (NSAA linear score, 10-meter running velocity, and rising from floor velocity) and the duration of corticosteroid treatment (all P<0.05). Least squares mean comparison all showed that the medication effect first increased and then decreased with duration, reaching the peak at 1.1-2.0 years after treatment (all P<0.05). Conclusions:Corticosteroids can improve the motor function in male children with DMD, with the maximum treatment effect occurring 1 to 2 years after the initiation of treatment. It is necessary to comprehensively leverage time-varying efficacy of corticosteroids to optimize individualized treatment regimens for maximal motor function benefits in children with DMD.
3.Clinical characteristics and efficacy of glyceryl phenylbutyrate treatment in 20 pediatric patients with urea cycle disorder
Wenjuan QIU ; Chengkai SUN ; Yuan XIAO ; Xiaoyan HUANG ; Cui SONG ; Jin WU ; Haiyan WEI ; Liwen WU ; Dan YU ; Hongwei DU ; Chen LIU ; Xuefan GU
Chinese Journal of Pediatrics 2025;63(9):1005-1010
Objective:To investigate the clinical characteristics of urea cycle disorder (UCD), the efficacy and safety of glyceryl phenylbutyrate (GPB) therapy in pediatric patients with UCD.Methods:This study was a retrospective, single-arm, multicenter clinical study. The clinical data of 20 pediatric patients with UCD who received GPB treatment at 9 hospitals nationwide between December 2021 and August 2024 were collected. The clinical manifestations, laboratory results, and molecular genetic characteristics were analyzed, ammonia levels and other laboratory results were evaluated pre-post GPB therapy by paired t-tests or Wilcoxon tests. Results:Among the 20 pediatric patients with UCD, there were 8 males and 12 females, and the onset age was 2.8 (1.4, 5.7) years. The ammonia levels were 174 (125, 342) μmol/L at first onset. The symptoms included vomiting in 6 cases, drowsiness in 5 cases, epilepsy in 5 cases, developmental delay in 5 cases, psychiatric and behavioral abnormalities in 3 cases, and lethargy in 1 case, and 18 cases exhibited abnormal liver function. Twenty cases included 6 UCD subtypes, with 11 cases being ornithine transcarbamylase deficiency. A total of 27 variants were identified, 11 (41%) of which were novel. The age of patients who began GPB therapy was 4.0 (1.5, 6.6) years. Ten cases stopped GPB after 4.2 (3.4, 5.3) months, with 4 patients undergoing liver transplantation and 6 discontinuing for financial reasons. The remaining ten patients continued GPB therapy for 11.6 (8.6, 14.0) months. The duration of GPB treatment was 6.0 (4.2, 12.3) months, at the final visit, the levels of ammonia, platelets and aspartate aminotransferase were lower compared to those of pre-treatment (all P<0.05). The serum albumin level was higher than that of pre-treatment ( P=0.016). Two patients suffered only one episode of acute hyperammonaemia, with ammonia levels of 232 and 141 μmol/L, respectively. Nine cases experienced adverse effects potentially related to GPB, decreased appetite in 6 cases, vomiting in 3 cases, abnormal skin oil odor in 2 cases, somnolence, fatigue and diarrhea each in 1 case, with symptoms improved within 6 (3, 10) days. Conclusions:UCD primarily manifests with neurological and gastrointestinal symptoms, and early diagnosis of UCD could be achieved through the analysis of ammonia. GPB may effectively reduce ammonia levels in UCD pediatric patients, with favorable safety and tolerability.
4.Clinical characteristics and outcomes of elderly patients with stage Ⅰ diffuse large B-cell lymphoma: a study by the Jiangsu Cooperative Lymphoma Group (JCLG)
Yi XIA ; Jing HE ; Weiying GU ; Tao JIA ; Tingxun LU ; Yongle LI ; Jiahao ZHOU ; Bingzong LI ; Haiying HUA ; Ping LIU ; Yuqing MIAO ; Yuexin CHENG ; Xiaoyan XIE ; Yunping ZHANG ; Wenzhong WU ; Zhuxia JIA ; Xuzhang LU ; Chunling WANG ; Liang YU ; Min XU ; Jinning SHI ; Weifeng CHEN ; Wanchuan ZHUANG ; Zhen QIAN ; Jun QIAN ; Haiwen NI ; Yifei CHEN ; Qiudan SHEN ; Jianyong LI ; Wenyu SHI
Chinese Journal of Internal Medicine 2025;64(6):504-513
Objective:To summarize the clinical characteristics of elderly patients with stage Ⅰ diffuse large B-cell lymphoma (DLBCL) and analyze the factors associated with prognosis.Methods:A case series study was conducted by retrospectively collecting clinical data from patients aged over 60 years with newly diagnosed stage Ⅰ DLBCL across 20 medical centers in Jiangsu Province, China, between June 2010 and April 2023. The involved site, classification and treatment plan were summarized. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Statistical analyses were performed using the Kaplan-Meier method, and Cox regression model.Results:The study included 255 patients with a median age of 69 years, of whom 130 (51.0%) were male, 66 (25.9%) were aged ≥75 years and 26 (10.1%) had a high Charlson Comorbidity Index (CCI) score of ≥2. Extranodal involvement was observed in 163 (63.9%) patients, with the stomach (37.4%, 61/163), intestine (19.0%, 31/163), testes (11.0%, 18/163), and breast (7.4%, 12/163) being the most frequently affected sites. The non-germinal center B-cell (non-GCB) subtype was prevalent in 63.7% of patients (142/223), with no significant difference between the nodal and extranodal groups ( P=0.681). Furthermore, 73.9% (184/249) and 11.7% (29/249) of patients received the R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) and R-miniCHOP regimen, respectively. The overall 3-year PFS rate was 81.5%, and the 3-year OS rate was 85.6%. Patients aged ≥75 years ( HR=2.910, 95% CI 1.565-5.408, P=0.001) and/or with a CCI score ≥2 ( HR=2.324, 95% CI 1.141-4.732, P=0.020) had a significantly poorer PFS. Incorporating age ≥75 years and CCI score ≥2 into the stage-modified international prognostic index (sm-IPI) can better stratify the prognosis of elderly patients with stage Ⅰ DLBCL. The 3-year PFS rate was 48.7% in the high-risk group versus 85.7% in the low-risk group ( P<0.001). Conclusions:Our findings show that the elderly patients with stage Ⅰ DLBCL were predominantly characterized by extranodal involvement (particularly in the stomach and intestinal tract) and non-GCB subtype. Age ≥75 years and CCI ≥2 were identified as independent prognostic factors. The newly established sm-IPI-75-CCI incorporating these factors demonstrated superior prognostic discrimination compared to conventional risk assessment systems.
5.Progress in diagnosis and treatment of aortic endovascular stent infection after endovascular aortic repair
Xiaoyan YANG ; Jina GU ; Lin CHEN
Chinese Journal of Nosocomiology 2025;35(20):3194-3200
Aortic endovascular stent infection(AEI)is a rare and potentially fatal complication following endovas-cular aortic repair(EVER).Its occurrence involves multiple factors.Actively preventing the colonization and ad-hesion of pathogenic microorganisms on the stent can significantly reduce the incidence rate of AEI.The clini-cal manifestations of AEI are nonspecific.Patients who develop unexplained fever,fatigue,pain or elevated in-flammatory markers after EVER should be alerted to the possibility of AEI and require laboratory and imaging ex-aminations to be improved actively for further clarification.For patients diagnosed with AEI who can tolerate sur-gery,the preferred treatment is to thoroughly remove infected materials and tissues,and to reconstruct blood sup-ply and administer antibacterial therapy according to the patient's condition.For those who cannot tolerate surger-y,long-term or lifelong antibacterial drug therapy is required,which can be supplemented by percutaneous punc-ture drainage.Strict screening of EVER patients,active prevention of pathogen colonization,early diagnosis and multidisciplinary combination treatment can significantly reduce the incidence and fatality rate of AEI,there-by improving patient prognosis.
6.Application of ASSR with different stimuli in hearing impaired children's hearing threshold assessment
Jialei ZHOU ; Fang CHEN ; Sihang GU ; Wenqing HUANG ; Xiaoyan LI
Chinese Archives of Otolaryngology-Head and Neck Surgery 2025;32(6):358-361
OBJECTIVE To investigate the application value of narrow-band CE-Chirp ASSR(NB CE-Chirp ASSR)and modulated acoustic ASSR in the assessment of hearing threshold in children with hearing impairment.METHODS Forty-eight children with sensorineural hearing loss were tested by pure tone audiometry(PTA),NB CE-Chirp ASSR and modulated acoustic ASSR.According to the results of pure tone audiometry,they were divided into mild to moderate group(48 ears)and severe to profound group(48 ears).The difference and correlation between pure tone hearing threshold and ASSR response threshold of different stimuli were compared between 500-4 000 Hz.RESULTS The absolute differences between the NB CE-Chirp ASSR response threshold and the PTA threshold in 48 children were all smaller than the differences between the modulated acoustic ASSR response threshold and the PTA threshold,and the differences were statistically significant(P<0.001).Under the same stimulus sound,the absolute difference between ASSR response threshold and pure tone hearing threshold in the mild to moderate group was higher than that in the severe to very severe group.The correlation coefficients between NB CE-Chirp ASSR threshold and pure tone hearing threshold are higher than those between modulated sound ASSR threshold and pure tone hearing threshold at 500-4 000 Hz.The test time of NB CE-Chirp ASSR[(20.92±9.33)min]was significantly shorter than that of modulated acoustic ASSR[(33.68±10.97)min](P=0.004).CONCLUSION NB CE-Chirp ASSR can more accurately assess the hearing threshold of children with different degrees of hearing loss than modulated acoustic ASSR.
7.Radiofrequency ablation of inferior turbinate in the treatment of allergic rhinitis in children.
Shilei PU ; Meizhen GU ; Hongming XU ; Xiaoyan LI
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(2):114-119
Objective:To investigate the safety and efficacy of submucous radiofrequency ablation of the inferior turbinate, and to provide a clinical basis for the surgical treatment of allergic rhinitis in children. Methods:Patients with obstructive sleep apnea syndrome and allergic rhinitis who were admitted to the Department of Otolaryngology Head and Neck Surgery of Shanghai Children's Hospital from January 2021 to December 2023 and underwent bilateral submucous radiofrequency ablation of the inferior turbinate and radiofrequency ablation of the adenoid tonsil were included in the study. Observational and statistical indexes were used to evaluate the curative effect. Results:A total of 51 cases were included in this study, and 43 cases were followed up for half a year. Submucous radiofrequency ablation of the inferior turbinate plus radiofrequency ablation of the adenoid tonsil achieved a good effect (total effective rate 93%), and there was a statistically significant difference in the preoperative and postoperative symptoms of the children(P<0.05). There were no complications such as bleeding, Eustachian tube injury, nasal adhesion, or nasal dryness. Conclusion:Under the premise of strict control of surgical indications, children with allergic rhinitis can be treated surgically. Inferior turbinate submucous radiofrequency ablation is more minimally invasive, effective, and safe, and can be used in clinical practice.
Humans
;
Turbinates/surgery*
;
Rhinitis, Allergic/surgery*
;
Radiofrequency Ablation/methods*
;
Child
;
Male
;
Female
;
Sleep Apnea, Obstructive/surgery*
;
Treatment Outcome
;
Catheter Ablation
;
Adolescent
8.Observation and analysis of Vitamin D levels in 147 children undergoing adenoidectomy and/or tonsillectomy.
Jun DU ; Qinglong GU ; Yingxia LU ; Guimin HUANG ; Xiaojun ZHAN ; Lin WANG ; Xiaoyan WANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(6):515-522
Objective:To observe and analyze the levels of vitamin D(VD) and their influencing factors in children undergoing adenoidectomy and/or tonsillectomy. Methods:A total of 147 children who received adenoidectomy and/or tonsillectomy in our hospital from November 2018 to March 2019 were selected as the experimental groups, gender and age matched 147 healthy children of the same period were selected as the control group. The differences of VD levels between the two groups were compared, the factors affecting VD levels were investigated, and patients with VD deficiency/insufficiency in the experimental groups were followed up postoperatively. Results:The VD levels of the experimental groups were(19.6±6.6) ng/mL and those of the control groups were (22.5±6.5)ng/mL, which was significantly different (P<0.01). The experimental groups were divided into inflammation groups and Sleeping disorder breathing(SDB)groups. The VD levels of the two groups were (19.1±6.7)ng/mL and (21.9±6.4)ng/mL, which was significantly different (P<0.05). Regression analysis showed that VD levels were negatively correlated with age, body mass index (BMI), adenoid hypertrophy, tonsil hypertrophy and Anti-streptolysin O(ASO)levels (P<0.05). VD values were remeasured one year postoperatively in 23 of 72 children in the VD deficiency/deficiency groups, and there was a statistically significant difference between preoperative and postoperative VD values[(14.3±3.9)ng/mL and (17.1±5.5) ng/mL, respectively, P<0.05]. There was a significant difference in postoperative VD value between the inflammation groups and the SDB groups[ (15.6±5.9) ng/mL and (20.5±2.1) ng/mL, respectively, P<0.05]. Conclusion:Children who underwent adenoidectomy and/or tonsillectomy had lower VD levels than healthy children.VD levels decreased with increasing age,BMI and ASO values,and associated with the size of adenoid and tonsil. Preoperative VD levels were lower in the inflammation groups, adenoidectomy and/or tonsillectomy improved VD deficiency/insufficiency status, and postoperative elevation of VD levels was more pronounced in the SDB groups.
Humans
;
Tonsillectomy
;
Adenoidectomy
;
Vitamin D/blood*
;
Vitamin D Deficiency
;
Male
;
Female
;
Postoperative Period
;
Child
;
Case-Control Studies
;
Child, Preschool
9.Characteristics of cardiopulmonary exercise testing and analysis of risk factors for decreased aerobic capacity in children with non-acute bronchial asthma exacerbations
Pengli WANG ; Lizhen HUANG ; Wujun JIANG ; Wenjing GU ; Lina XU ; Pengyun LI ; Xuena XU ; Qianying YU ; Xiaoyan SHI ; Chuangli HAO
Chinese Journal of Applied Clinical Pediatrics 2025;40(8):595-602
Objective:To investigate the characteristics of cardiopulmonary exercise testing and risk factors for decreased aerobic capacity in children with non-acute asthma exacerbations, to assess their cardiopulmonary health and to provide a basis for improvement.Methods:A case-control study.Sixty-one children with non-acute asthma exacerbations treated at the Outpatient Department of Children′s Hospital of Soochow University from October 2022 to December 2023 and 22 control children during the same period were included.Binary Logistic regression was employed to assess risk factors for decreased aerobic capacity in children with asthma.Results:Among the included 61 children with non-acute asthma exacerbations, there were 33 cases in the chronic persistent phase (chronic persistent phase group) and 28 in the clinical remission phase(clinical remission group).There were 22 children in the control group.During the peak exercise phase of the cardiopulmonary exercise testing, the mean kilogram body weight oxygen uptake (VO 2/kg), the percentage of predicted kilogram body weight oxygen uptake, and metabolic equivalents (Met) in the chronic persistent phase group were lower than those in the control and clinical remission phase groups.The mean VO 2/kg recovery from the cardiopulmonary exercise testing in the first minute in the chronic persistent phase group was lower than that in the control and clinical remission phase groups.The median Met and ventilation per minute recovery in the chronic persistent phase group were lower than those in the control group.The median heart rate recovery in asthma children was lower than that in control children.The percentage of cardiopulmonary exercise testing abnormalities was higher in asthma children with symptoms after excise than that in asthma children without symptoms after excise.The percentage of decreased ventilation efficiency in asthma children with symptoms after excise was higher than that in asthma children without symptoms after excise.Multivariate regression analysis showed that a higher body mass index (BMI) ( OR=1.577, 95% CI: 1.113-2.235, P=0.010) and a higher peak respiratory reserve ( OR=1.103, 95% CI: 1.018-1.195, P=0.017) were risk factors of decreased aerobic capacity.The risk of decreased aerobic capacity in the chronic persistent phase was 7.949 times higher than that in the clinical remission phase ( OR=7.949, 95% CI: 1.290-48.996, P=0.025). Conclusions:The aerobic capacity is decreased and ventilatory recovery is slower in children with chronic persistent asthma than those in healthy children.The heart rate recovery in asthma children is slower than that in healthy children.A high BMI, a high peak respiratory reserve, and chronic persistence of asthma are independent risk factors for decreased aerobic capacity in children with non-acute asthma exacerbations.asthma.
10.Construction and practice of smart health and elderly care standard system in Shanghai
Jian WANG ; Mianzhi CHENG ; Xiaohua YE ; Weihua GU ; Chun FAN ; Yuyao JIANG ; Min XU ; Yihan XU ; Yang WANG ; Xiaoyan GU ; Yihua JIANG ; Liying YAO ; Shusheng OUYANG ; Xin LIU ; Xijie YUAN ; Jian CHEN ; Ni YANG ; Qi CHEN ; Jingjing FANG
Journal of Navy Medicine 2025;46(1):83-90
With the rapid development of population aging in various countries around the world,the health and elderly care industry has been paid high attention.The standardization of smart health and elderly care technology and services is particularly important.This paper firstly reviewed the policies related to healthy elderly care in China.By analyzing the industrial standards and provincial standards issued,this paper focused on the policies proposed by the Shanghai Municipal Government for the standardization of smart health and elderly care,as well as the researches on the standard system and the construction of standard families.Shanghai group standards in the field of smart health and elderly care were summarized,including the guidelines for the construction of standard systems,elderly care service platforms,community elderly cafeterias,portable health monitoring terminals,indoor sports services,and home-based elderly care safety monitoring.A series of case analyses of the standardized implementation of the above aspects were also provided.Through standardization research and practice in recent years,it has been fully demonstrated that the standard research plays an important leading role in the field of smart health and elderly care.

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