1.Optimization of Processing Technology of Calcined Pyritum Based on QbD Concept and Its XRD Fingerprint Analysis
Xin CHEN ; Jingwei ZHOU ; Haiying GOU ; Lei ZHONG ; Tianxing HE ; Wenbo FEI ; Jialiang ZOU ; Yue YANG ; Dewen ZENG ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):197-205
ObjectiveBased on the concept of quality by design(QbD), the processing process of calcined Pyritum was optimized, and its X-ray diffraction(XRD) fingerprint was established. MethodsThe safety, effectiveness and quality controllability of calcined Pyritum were taken as the quality profile(QTPP), the color, hardness, metallic luster, phase composition, the contents of heavy metals and hazardous elements were taken as the critical quality attributes(CQAs), and the calcination temperature, calcination time, paving thickness and particle size were determined as the critical process parameters(CPPs). Differential thermal analysis, X-ray diffraction(XRD) and inductively coupled plasma mass spectrometry(ICP-MS) were used to analyze the correlation between the calcination temperature and CQAs of calcined Pyritum. Then, based on the criteria importance through intercriteria correlation(CRITIC)-entropy weight method, the optimal processing process of calcined Pyritum was optimized by orthogonal test. Powder XRD was used to analyze the phase of calcined Pyritum samples processed according to the best process, and the mean and median maps of calcined Pyritum were established by the superposition of geometric topological figures, and similarity evaluation and cluster analysis were carried out. ResultsThe results of single factor experiments showed that the physical phase of Pyritum changed from FeS2 to Fe7S8 during the process of temperature increase, the color gradually deepened from dark yellow, and the contents of heavy metals and harmful elements decreased. The optimized processing process of calcined Pyritum was as follows:calcination temperature at 750 ℃, calcination time of 2.5 h, paving thickness of 3 cm, particle size of 0.8-1.2 cm, vinegar quenching 1 time[Pyritum-vinegar(10∶3)]. After calcination, the internal structure of Pyritum was honeycomb-shaped, which was conducive to the dissolution of active ingredients. XRD fingerprints of 13 batches of calcined Pyritum characterized by 10 common peaks were established. The similarities of the relative peak intensities of the XRD fingerprints of the analyzed samples were>0.96, and it could effectively distinguish the raw products and unqualified products. ConclusionTemperature is the main factor affecting the quality of calcined Pyritum. After processing, the dissolution of the effective components in Pyritum increases, and the contents of heavy metals and harmful substances decrease, reflecting the function of processing to increase efficiency and reduce toxicity. The optimized processing process is stable and feasible, and the established XRD fingerprint can be used as one of the quality control standards of calcined Pyritum.
2.Optimization of Processing Technology of Calcined Pyritum Based on QbD Concept and Its XRD Fingerprint Analysis
Xin CHEN ; Jingwei ZHOU ; Haiying GOU ; Lei ZHONG ; Tianxing HE ; Wenbo FEI ; Jialiang ZOU ; Yue YANG ; Dewen ZENG ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):197-205
ObjectiveBased on the concept of quality by design(QbD), the processing process of calcined Pyritum was optimized, and its X-ray diffraction(XRD) fingerprint was established. MethodsThe safety, effectiveness and quality controllability of calcined Pyritum were taken as the quality profile(QTPP), the color, hardness, metallic luster, phase composition, the contents of heavy metals and hazardous elements were taken as the critical quality attributes(CQAs), and the calcination temperature, calcination time, paving thickness and particle size were determined as the critical process parameters(CPPs). Differential thermal analysis, X-ray diffraction(XRD) and inductively coupled plasma mass spectrometry(ICP-MS) were used to analyze the correlation between the calcination temperature and CQAs of calcined Pyritum. Then, based on the criteria importance through intercriteria correlation(CRITIC)-entropy weight method, the optimal processing process of calcined Pyritum was optimized by orthogonal test. Powder XRD was used to analyze the phase of calcined Pyritum samples processed according to the best process, and the mean and median maps of calcined Pyritum were established by the superposition of geometric topological figures, and similarity evaluation and cluster analysis were carried out. ResultsThe results of single factor experiments showed that the physical phase of Pyritum changed from FeS2 to Fe7S8 during the process of temperature increase, the color gradually deepened from dark yellow, and the contents of heavy metals and harmful elements decreased. The optimized processing process of calcined Pyritum was as follows:calcination temperature at 750 ℃, calcination time of 2.5 h, paving thickness of 3 cm, particle size of 0.8-1.2 cm, vinegar quenching 1 time[Pyritum-vinegar(10∶3)]. After calcination, the internal structure of Pyritum was honeycomb-shaped, which was conducive to the dissolution of active ingredients. XRD fingerprints of 13 batches of calcined Pyritum characterized by 10 common peaks were established. The similarities of the relative peak intensities of the XRD fingerprints of the analyzed samples were>0.96, and it could effectively distinguish the raw products and unqualified products. ConclusionTemperature is the main factor affecting the quality of calcined Pyritum. After processing, the dissolution of the effective components in Pyritum increases, and the contents of heavy metals and harmful substances decrease, reflecting the function of processing to increase efficiency and reduce toxicity. The optimized processing process is stable and feasible, and the established XRD fingerprint can be used as one of the quality control standards of calcined Pyritum.
3.Clinical efficacy of acupuncture combined with computer speech disorder correction training in the treatment of autistic children
Journal of Xinxiang Medical College 2024;41(1):26-31
Objective To explore the clinical efficacy of acupuncture combined with computer speech disorder correction training in the treatment of children with autism.Methods A total of 108 children with autism admitted to the Department of Pediatrics,Puyang Oilfield General Hospital Affiliated to Xinxiang Medical University from December 2019 to December 2021 were selected as the research subjects.According to the treatment methods,the children were divided into the control group and the observation group,with 54 children in each group.The children in the control group received computer speech disorder correction training,while the children in the.observation group received acupuncture treatment on the basis of the control group,and all children were treated for 4 months.Before and after treatment,the severity of symptoms of children was evaluated by the childhood autism rating scale(CARS),the treatment effectiveness of language function of children was evaluated by the language delayed development test(S-S method),the abnormal behavior of children was evaluated by the autism behavior checklist(ABC),and the central nervous system function of children was evaluated by the Gesell development scale(GDS).The satisfaction of the children's family members was evaluated by the Chinese version of critical care family satisfaction survey(C-CCFSS).Results There was no significant difference in the CARS score of children between the two groups before treatment(P>0.05);after treatment,the CARS score of children in the observation group was significantly lower than that in the control group(P<0.05);there was no significant difference in the CARS score before and after treatment in the control group(P>0.05);the CARS score of children in the observation group after treatment was significantly lower than that before treatment(P<0.05).The total effective rates of language function therapy of children in the control group and observation group were 83.33%(45/54)and 96.30%(52/54),respectively;the total effective rate of language function therapy of children in the observation group was significantly higher than that in the control group(x2=4.960,P<0.05).Before treatment,there was no significant difference in the each item scores and scores total scores of ABC of children between the two groups(P>0.05);the each item scores and total scores of ABC of children in the two groups after treatment were significantly lower than those before treatment(P<0.05);after treatment,the each item scores and total scores of ABC of children in the observation group were significantly lower than those in the control group(P<0.05).Before treatment,there was no signifi-cant difference in GDS score of children between the two groups(P>0.05);after treatment,the GDS score of children in the observation group was significantly higher than that in the control group(P<0.05);there was no significant difference in GDS score of children before and after treatment in the control group(P>0.05);the GDS score of children in the observation group after treatment was significantly higher than that before treatment(P<0.05).The satisfaction of family member of children in the control group and the observation group was 81.48%(44/54)and 94.44%(51/54),respectively.The satisfaction of family member of children in the observation group was significantly higher than that in the control group(x2=4.285,P<0.05).Conclusion Acupuncture combined with computer speech disorder correction training can effectively improve the severity of the clinical symptoms and abnormal behavior of children with autism,promote language function and intellectual recovery,and has high family satisfaction,which is worthy of clinical promotion and application.
4.Short- and long-term effects of R4 versus R3+R4 endoscopic thoracic sympathicotomy for acrohyperhidrosis: A retrospective cohort study in a single center
Ziqiang HONG ; Wenxi GOU ; Yannan SHENG ; Xiangdou BAI ; Baiqiang CUI ; Dacheng JIN ; Yunjiu GOU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(05):733-738
Objective To compare the short- and long-term effects of R4 versus R3+R4 endoscopic thoracic sympathicotomy (ETS) for acrohyperhidrosis. Methods We retrospectively analyzed the clinical data of patients with acrohyperhidrosis admitted to the Department of Thoracic Surgery of Gansu Provincial Hospital for surgical treatment from April 2014 to April 2021. The patients were divided into two groups according to the methods of ETS, including a R4 group and a R3+R4 group. Perioperative clinical data and postoperative follow-up data were collected to compare the short- and long-term outcomes of the two groups. Results A total of 155 eligible patients were included. There were 60 patients in the R4 group, including 23 males and 37 females, with a mean age of 22.55±2.74 years. There were 95 patients in the R3+R4 group, including 40 males and 55 females, with a mean age of 23.14±3.65 years. There were no statistical differences between the two groups in terms of baseline indicators such as gender, age and positive family history (P>0.05). Total operative time was 38.67±5.20 min in the R4 group and 40.05±5.18 min in the R3+R4 group; intraoperative bleeding was 7.25±3.25 mL in the R4 group and 7.95±3.90 mL in the R3+R4 group; postoperative hospital stay was 1.28±0.52 d in the R4 group and 1.38±0.57 d in the R3+R4 group, the differences between the two groups in the above indicators were not statistically significant (P>0.05). Postoperative hand hyperhidrosis symptoms were significantly relieved in both groups, and the complete remission rate was better in the R3+R4 group than that in the R4 group (98.0% vs. 93.3%), but the difference was not statistically significant (P=0.358). The R3+R4 group was superior to the R4 group in terms of the relief of plantar hyperhidrosis symptoms, patient satisfaction and quality of life index at 6 months postoperatively (P<0.05). There was no statistical difference in the overall incidence of compensatory hyperhidrosis at 12 months postoperatively between the two groups (P=0.867), but the incidence of compensatory hyperhidrosis was higher in the R3+R4 group than that in the R4 group (72.6% vs. 70.0%). Conclusion The perioperative outcomes of R4 and R3+R4 ETS are similar, but R3+R4 ETS has a higher rate of symptomatic relief of acrohyperhidrosis, and patients have a better postoperative quality of life. R3+R4 ETS is a reliable option for the treatment of acrohyperhidrosis. However, patients need to be informed that this procedure may increase the risk of compensatory hyperhidrosis.
5.Analysis of non-targeted variants by invasive prenatal diagnosis for pregnant women undergoing preimplantation genetic testing
Si LI ; Ziyi XIAO ; Chenyu GOU ; Xiaolan LI ; Yijuan HUANG ; Yuanqiu CHEN ; Shujing HE ; Zhiqiang ZHANG ; Zi REN ; Song GUO ; Weiying JIANG ; Yu GAO
Chinese Journal of Medical Genetics 2024;41(11):1283-1289
Objective:To compare the results of invasive prenatal diagnosis and preimplantation genetic testing (PGT) and explore the underlying mechanism.Methods:Clinical data of pregnant women undergoing PGT and invasive prenatal diagnosis at the Sixth Affiliated Hospital of Sun Yat-sen University from January 2019 to December 2022 were collected. The results of PGT and invasive prenatal diagnosis were compared, and the outcomes of pregnancies were followed up. This study has been approved by the Medical Ethics Committee of the the Sixth Affiliated Hospital of Sun Yat-sen University (No. 2022SLYEC-491).Results:A total of 172 couples were included in this study, and 26 non-targeted variants were discovered upon prenatal diagnosis, including 10 cases (38.5%) by chromosomal karyotyping, 15 (57.7%) by chromosomal microarray analysis (CMA), and 1 (3.8%) by whole exome sequencing. The 10 karyotypic anomalies had included 6 chromosomal polymorphisms, 2 chromosomal mosaicisms, 1 paternally derived translocation, and 1 missed maternal chromosomal inversion. CMA has identified 15 copy number variations (CNVs), which included 11 microdeletions and microduplications, 3 loss of heterozygosity, and 1 low-level mosaicism of paternal uniparental disomy. One CNV was classified as pathogenic, and another one was likely pathogenic, whilst the remaining 13 were classified as variants of uncertain significance. Therefore, 8.7% of CNVs was detected by invasive prenatal diagnosis after PGT. 92.3% (24/26) of the non-targeted variants have been due to technological limitations of next-generation sequencing (NGS).Conclusion:Invasive prenatal diagnosis after PGT can detect non-targeted variants, which may further reduce the incidence of birth defects.
6.Analysis of nutritional status of nasopharyngeal carcinoma patients and its impact on quality of life
Kai ZHOU ; Xiao-Xia GOU ; Hu MA ; Guo-Ping HE ; Xin TIAN ; Hui XU ; Bi FENG
Parenteral & Enteral Nutrition 2024;31(5):280-287
Objective:To investigate the correlation between nutritional status and quality of life in inpatients with nasopharyngeal carcinoma and to analyze the factors affecting nutritional status,so as to provide evidence for clinical nutritional support treatment.Methods:In this study,we retrospectively collected data from patients with nasopharyngeal carcinoma who met the inclusion and exclusion criteria in the Head and Neck Oncology Department of Zunyi Medical University Affiliated Hospital from 2014 to 2019.The NRS 2002 scale was used for nutritional risk screening,the PG-SGA scale for nutritional status assessment and the EORTCQLQ-C30 V3.0 scale for quality of life assessment.To further explore the correlation between nutritional status and quality of life,as well as the factors affecting nutritional status.Results:A total of 216 patients were collected,including 168 male(77.78%);average age(50.5±10.58)years;26.85%were at nutritional risk(NRS 2002 score≥3);28.70%were moderate malnutrition(PG-SGA score 4-8),and 23.15%were severe malnutrition(PG-SGA score≥9).There were significant differences in several physical examinations(such as body weight,body mass index,muscle circumference at the midpoint of the upper arm,etc.)and blood biochemical indexes(such as prealbumin,neutrophils,urea nitrogen,etc.)of patients with different nutritional status were differed between groups(P<0.05).Univariate analysis showed that age≥65 years was a risk factor for the development of severe malnutrition(OR:3.429,95%CI:1.467 to 8.014,P=0.004),whereas a high level of education(senior high school and above)was a protective factor(OR:0.027,95%CI:0.011 to 0.064,P=0.000).The poorer the nutritional status of nasopharyngeal carcinoma patients,the lower the quality of life.Conclusion:Nasopharyngeal carcinoma patients have a high incidence of malnutrition;the poorer the nutritional status of the patient,the lower the quality of life;routine nutritional diagnosis and treatment of nasopharyngeal carcinoma patients after admission to the hospital is recommended to improve clinical outcomes.
7.Discussion on key points for technical evaluation of bone guided hearing aids
Jiajun HE ; Qingjie YU ; Deshuang GOU
International Journal of Biomedical Engineering 2024;47(3):300-304
Bone-guided hearing aids are an important means of compensating for hearing loss. In recent years, with the advancement and iteration of new technologies and functions, the development of bone-guided hearing aids has been progressing rapidly, resulting in the constant emergence of various new products. However, the current lack of corresponding evaluation standards for this product has led to difficulties in registration, marketing, quality control, and evaluation standards. This study focuses on the technical evaluation perspective and elaborates on the main points of focus in technical evaluation work, such as product structure composition, main risks, performance requirements, and clinical evaluation. The aim is to provide a basis for the design and development, production, registration, use, and post-market supervision of the product.
8.Construction and biological characterization of lmo2363 gene deletion strain of Listeria monocytogenes
Ji ZHI ; Qing CAO ; Xuehui ZHAO ; Haohao ZHANG ; Ziqiu FAN ; Yonghui MA ; Jing DENG ; Zengwen HE ; Jinrui MA ; Kunzhong ZHANG ; Qian CHONG ; Caixia WANG ; Huiwen XUE ; Huitian GOU
Chinese Journal of Veterinary Science 2024;44(9):1923-1929,1956
This study aims to investigate the function of lmo2363 gene in stress resistance of Liste-ria monocytogenes strain LM83-1.In this study,the lmo2363 gene deletion strain and complement-ation strain of Listeria monocytogenes were constructed using overlapping extended PCR and ho-mologous recombination techniques,and the growth ability,stress survival rate and biofilm forma-tion ability of wild,deletion strain and complementation strain were compared under different stress environments.lmo2363 gene deletion strain and complementation strain of Listeria monocy-togenes were successfully constructed in this experiment.The growth curves showed that the growth capacity of the deletion strain was weaker than the wild strain LM83-1 under 4 ℃,7%NaCl,10%NaCl,3.5%ethanol,4.0%ethanol and pH5 stress(P<0.001).The results of stress survival test showed that the survival rate of the deletion strain was significantly lower than the wild strain after 1 h treatment with pH3 and 10 mmol/L H2 O2 stress(P<0.010).The biofilm forming ability of the deletion strain was decreased compared with that of the wild strain(P<0.050).This study confirmed that lmo2363 gene mediated the adaptation of LM to low temperature,high osmotic pressure,ethanol and acid stress environment and affected the formation of LM bio-film.This study laid a foundation for further exploring the function of lmo2363 gene in the stress resistance process of Listeria monocytogenes.
9.Changes of serum inflammatory factors and peripheral blood T cell subsets in patients with narcolepsy and their correlations with onset
Xuelian CHEN ; Wenqiang ZHONG ; Jia HE ; Haiyan GOU ; Yan CHEN ; Yanmei ZHU
Chinese Journal of Neuromedicine 2024;23(7):711-715
Objective:To observe the changes of peripheral blood T cell subsets and serum tumor necrosis factor (TNF)-α and interleukin (IL)-6 contents in narcolepsy type 1 (NT1) patients and their correlations with narcolepsy, and provide basis for finding the biological markers of narcolepsy.Methods:A retrospective analysis was performed. From March 2022 to December 2023, 23 patients with NT1 admitted to Epilepsy and Sleep Disorder Center, Second Affiliated Hospital of Harbin Medical University and 23 healthy controls underwent physical examination of nervous system in our center were enrolled. T lymphocyte subsets CD4 + and CD8 + in peripheral blood were calculated by flow cytometry. Serum TNF-α and IL-6 contents were detected by enzyme-linked immunosorbent assay. Multivariate Logistic regression was used to determine the correlations of NT1 with CD4 + T lymphocyte count and IL-6 and TNF-α contents, and diagnostic values of CD4 + T lymphocyte and TNF-α in NT1 were evaluated via area under receiver operating characteristics (ROC) curve. Results:Compared with the healthy controls, the NT1 patients had significantly increased peripheral blood CD4 + T lymphocyte count ([820.61±316.87] /μL vs. [1121.04±387.47] /μL), and significantly higher serum TNF-α and IL-6 contents ([39.97±10.64] pg/mL vs. [57.01±19.92] pg/mL; [22.50±6.09] pg/mL vs. [33.66±17.28] pg/mL, P<0.05). No significant difference in peripheral blood CD8 + T lymphocyte count was noted between the 2 groups ([668.65±276.45] pg/mL vs. [592.52±217.78] pg/mL, P>0.05). Multivariate Logistic regression showed that CD4 + T lymphocyte count and serum TNF-α content were independent risk factors for NT1 ( OR=1.004, 95% CI: 1.001-1.006, P=0.007; OR=1.133, 95% CI: 1.032-1.243, P=0.009). Area under ROC curve of the two combined indexes was 0.881(95% CI: 0.784-0.977, P=0.001), enjoying sensitivity of 0.783 and specificity of 0.870. Conclusion:Combination of peripheral blood CD4 + T lymphocyte count and serum TNF-α content has high diagnostic performance in predicting NT1.
10.A 3D-printed ankle-foot orthosis aids stroke survivors′ recovery of walking function
Ge GAO ; Huaping GUO ; Man HE ; Xiaojun FANG ; Lijie GOU
Chinese Journal of Physical Medicine and Rehabilitation 2024;46(6):524-528
Objective:To compare the effect of a 3D-printed ankle and foot orthosis (AFO) with that of a traditional AFO on the recovery of walking function after a stroke.Methods:Thirty-four hemiplegic stroke survivors were randomly divided into an observation group and a control group, each of 17. Both groups were taught good limb placement and given joint mobility, standing and walking training for 4 weeks wearing either a 3D-printed or a conventional AFO. Walking speed, walking endurance, and dynamic balance were evaluated before and after the experiment using the 10-metre walk test (10MWT), the 6-minute walk test (6MWT), and the timed up and go test (TUGT). Integrated electromyography (iEMG) was also performed on each subject′s bilateral rectus femoris, anterior tibialis, and gastrocnemius muscles during walking, and their healthy and affected side iEMG results were compared to assess the activation of the affected lower limb muscles.Results:After treatment, the 10MWT, 6MWT, and TUGT results of both groups had improved significantly, but the observation group′s average results were then significantly better than those in the control group. The iEMG disparities between the healthy and affected sides had also decreased significantly, but on average the disparities in the observation group were significantly smaller than in the control group.Conclusion:Both types of AFO can effectively improve the walking speed, walking endurance, and dynamic balance of hemiplegic stroke survivors and promote muscle activation in the affected lower limb. A 3D-printed AFO is relatively more effective.

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