1.Study on the effect of different administration regimens of iprrazole enteric-coated tablets on inhibiting gastric acid secretion
Ting-Yuan PANG ; Zhi WANG ; Zi-Shu HU ; Zi-Han SHEN ; Yue-Qi WANG ; Ya-Qian CHEN ; Xue-Bing QIAN ; Jin-Ying LIANG ; Liang-Ying YI ; Jun-Long LI ; Zhi-Hui HAN ; Guo-Ping ZHONG ; Guo-Hua CHENG ; Hai-Tang HU
The Chinese Journal of Clinical Pharmacology 2024;40(1):92-96
Objective To compare the effects of 20 mg qd and 10 mg bidadministration of iprrazole enteric-coated tablets on the control of gastric acid in healthy subjects.Methods A randomized,single-center,parallel controlled trial was designed to include 8 healthy subjects.Randomly divided into 2 groups,20 mg qd administration group:20 mg enteric-coated tablets of iprrazole in the morning;10 mg bid administration group:10 mg enteric-coated tablets of iprrazole in the morning and 10 mg in the evening.The pH values in the stomach of the subjects before and 24 h after administration were monitored by pH meter.The plasma concentration of iprazole after administration was determined by HPLC-MS/MS.The main pharmacokinetic parameters were calculated by Phoenix WinNonlin(V8.0)software.Results The PK parameters of iprrazole enteric-coated tablets and reference preparations in fasting group were as follows:The Cmax of 20 mg qd group and 10 mg bid group were(595.75±131.15)and(283.50±96.98)ng·mL-1;AUC0-t were(5 531.94±784.35)and(4 686.67±898.23)h·ng·mL-1;AUC0-∞ were(6 003.19±538.59)and(7 361.48±1 816.77)h·ng·mL-1,respectively.The mean time percentage of gastric pH>3 after 20 mg qd and 10 mg bid were 82.64%and 61.92%,and the median gastric pH within 24 h were 6.25±1.49 and 3.53±2.05,respectively.The mean gastric pH values within 24 h were 5.71±1.36 and 4.23±1.45,respectively.The correlation analysis of pharmacokinetic/pharmacodynamics showed that there was no significant correlation between the peak concentration of drug in plasma and the inhibitory effect of acid.Conclusion Compared with the 20 mg qd group and the 10 mg bid group,the acid inhibition effect is better,the administration times are less,and the safety of the two administration regimes is good.
2.Biomarkers Screening and Mechanisms Analysis of the Restraint Stress-Induced Myocardial Injury in Hyperlipidemia ApoE-/-Mice
Shang-Heng CHEN ; Sheng-Zhong DONG ; Zhi-Min WANG ; Guang-Hui HONG ; Xing YE ; Zi-Jie LIN ; Jun-Yi LIN ; Jie-Qing JIANG ; Shou-Yu WANG ; Han-Cheng LIN ; Yi-Wen SHEN
Journal of Forensic Medicine 2024;40(2):172-178
Objective To explore the biomarkers and potential mechanisms of chronic restraint stress-induced myocardial injury in hyperlipidemia ApoE-/-mice.Methods The hyperlipidemia combined with the chronic stress model was established by restraining the ApoE-/-mice.Proteomics and bioinformatics techniques were used to describe the characteristic molecular changes and related regulatory mechanisms of chronic stress-induced myocardial injury in hyperlipidemia mice and to explore potential diagnostic biomarkers.Results Proteomic analysis showed that there were 43 significantly up-regulated and 58 sig-nificantly down-regulated differentially expressed proteins in hyperlipidemia combined with the restraint stress group compared with the hyperlipidemia group.Among them,GBP2,TAOK3,TFR1 and UCP1 were biomarkers with great diagnostic potential.KEGG pathway enrichment analysis indicated that fer-roptosis was a significant pathway that accelerated the myocardial injury in hyperlipidemia combined with restraint stress-induced model.The mmu_circ_0001567/miR-7a/Tfr-1 and mmu_circ_0001042/miR-7a/Tfr-1 might be important circRNA-miRNA-mRNA regulatory networks related to ferroptosis in this model.Conclusion Chronic restraint stress may aggravate myocardial injury in hyperlipidemia mice via ferrop-tosis.Four potential biomarkers are selected for myocardial injury diagnosis,providing a new direction for sudden cardiac death(SCD)caused by hyperlipidemia combined with the restraint stress.
3.Temporal trend of the global prevalence rate of tension-type headache in children and adolescents in 1990-2021
Ling-Zi YAO ; De-Nan JIANG ; Jing WU ; Guang-Dian SHEN ; Jin CAO ; Si-Qing CHENG ; Shi-Yi SHAN ; Ze-Yu LUO ; Jia-Li ZHOU ; Pei-Ge SONG
Chinese Journal of Contemporary Pediatrics 2024;26(10):1058-1065
Objective To investigate the prevalence of tension-type headache(TTH)in children and adolescents aged 0-19 years globally in 1990-2021,and to provide a basis for the prevention and treatment of TTH.Methods Based on the Global Burden of Disease Study data,the age-standardized prevalence distribution of TTH and its changing trend were analyzed among the children and adolescents aged 0-19 years,with different sexes,age groups,sociodemographic index(SDI)regions and countries/territories.Results The age-standardized prevalence rate(ASPR)of TTH in children and adolescents aged 0-19 globally in 2021 was 17 339.89/100 000,which was increased by 1.73%since 1990.The ASPR in females was slightly higher than that in males(1990:17 707.65/100 000 vs 16 403.78/100 000;2021:17 946.29/100 000 vs 16 763.09/100 000).The ASPR in adolescence was significantly higher than that in school-aged and preschool periods(1990:27 672.04/100 000 vs 10 134.16/100 000;2021:28 239.04/100 000 vs 10 059.39/100 000).Regions with high SDI exhibited a higher ASPR than the other regions,with significant differences in prevalence rates across different countries.From 1990 to 2021,there was a slight increase in global ASPR,with an average annual percentage change(AAPC)of 0.06%.Females experienced a smaller increase than males based on AAPC(0.04%vs 0.07%).There was reduction in ASPR in preschool and school-aged groups,with an AAPC of-0.02%,while there was a significant increase in ASPR in adolescence,with an AAPC of 0.07%.ASPR decreased in regions with low-middle and low levels of SDI,with an AAPC of-0.02%and-0.04%,respectively,while it increased in regions with middle SDI,with an AAPC of 0.24%.Conclusions There is a consistent increase in the ASPR of TTH in children and adolescents aged 0-19 years globally,with significant differences across sexes,age groups,SDI regions and countries/territories.
4.Analysis of prognostic factors of extranodal NK/T-cell lymphoma treated with pegaspargase/L-asparaginase: a multicenter retrospective study.
Zi Yuan SHEN ; Xi Cheng CHEN ; Hui Rong SHAN ; Tao JIA ; Wei Ying GU ; Fei WANG ; Qing Ling TENG ; Ling WANG ; Chun Ling WANG ; Yu Ye SHI ; Hao ZHANG ; Yu Qing MIAO ; Tai Gang ZHU ; Chun Yan JI ; Jing Jing YE ; Ming Zhi ZHANG ; Xu Dong ZHANG ; Liang WANG ; Kai Lin XU ; Wei SANG
Chinese Journal of Hematology 2023;44(8):642-648
Objective: To explore the prognostic factors of extracellular NK/T cell lymphoma (ENKTL) treated with pegaspargase/L-asparaginase. Methods: The clinical data of 656 ENKTL patients diagnosed at 11 medical centers in the Huaihai Lymphoma Working Group from March 2014 to April 2021 were retrospectively analyzed. The patients were randomly divided into two groups: a training set (460 cases) and a validation set (196 cases) at 7∶3, and the prognostic factors of the patients were analyzed. A prognostic scoring system was established, and the predictive performance of different models was compared. Results: Patients' median age was 46 (34, 57) years, with 456 males (69.5% ) and 561 nasal involvement (85.5% ). 203 patients (30.9% ) received a chemotherapy regimen based on L-asparaginase combined with anthracyclines, and the 5-year overall survival rate of patients treated with P-GEMOX regimen (pegaspargase+gemcitabine+oxaliplatin) was better than those treated with SMILE regimen (methotrexate+dexamethasone+cyclophosphamide+L-asparaginase+etoposide) (85.9% vs 63.8% ; P=0.004). The results of multivariate analysis showed that gender, CA stage, the Eastern Cooperative Oncology Group performance status (ECOG PS) score, HGB, and EB virus DNA were independent influencing factors for the prognosis of ENKTL patients (P<0.05). In this study, the predictive performance of the prognostic factors is superior to the international prognostic index, Korean prognostic index, and prognostic index of natural killer lymphoma. Conclusion: Gender, CA stage, ECOG PS score, HGB, and EB virus DNA are prognostic factors for ENKTL patients treated with pegaspargase/L-asparaginase.
Male
;
Humans
;
Middle Aged
;
Asparaginase/therapeutic use*
;
Prognosis
;
Retrospective Studies
;
Lymphoma, Extranodal NK-T-Cell/drug therapy*
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Etoposide
;
Cyclophosphamide
;
Methotrexate/therapeutic use*
;
DNA/therapeutic use*
;
Treatment Outcome
5.Safety of butylphthalide and edaravone in patients with ischemic stroke: a multicenter real-world study.
Shu-Xian LYU ; Dong-Fang QIAN ; Yu-Fei FENG ; Cheng-Wu SHEN ; Lu-Bo GUO ; Jian-Tao LYU ; Peng-Fei JIN ; Ting LI ; Si-Yuan TAN ; Zi-Xuan ZHANG ; Lin HUANG ; Xue ZHONG ; Le-Qun SU ; Xin HU ; Xin HUANG ; Xue-Yan CUI
Journal of Geriatric Cardiology 2023;20(4):293-308
BACKGROUND:
Butylphthalide (NBP) and edaravone (EDV) injection are common acute ischemic stroke medications in China, but there is a lack of large real-world safety studies on them. This study aimed to determine the incidence of adverse events, detect relevant safety signals, and assess the risk factors associated with these medications in real-world populations.
METHODS:
In this study, data of acute ischemic stroke patients were extracted from the electronic medical record database of six tertiary hospitals between January 2019 and August 2021. Baseline confounders were eliminated using propensity score matching. The drugs' safety was estimated by comparing the results of 24 laboratory tests standards on liver function, kidney function, lipid level, and coagulation function. The drugs' relative risk was estimated by logistic regression. A third group with patients who did not receive NBP or EDV was constructed as a reference. Prescription sequence symmetry analysis was used to evaluate the associations between adverse events and NBP and EDV, respectively.
RESULTS:
81,292 patients were included in this study. After propensity score matching, the NBP, EDV, and third groups with 727 patients in each group. Among the 15 test items, the incidence of adverse events was lower in the NBP group than in the EDV group, and the differences were statistically significant. The multivariate logistic regression equation revealed that NBP injection was not a promoting factor for abnormal laboratory test results, whereas EDV had statistically significant effects on aspartate transaminase, low-density lipoprotein cholesterol and total cholesterol. Prescription sequence symmetry analysis showed that NBP had a weak correlation with abnormal platelet count. EDV had a positive signal associated with abnormal results in gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, prothrombin time, and platelet count.
CONCLUSIONS
In a large real-world population, NBP has a lower incidence of adverse events and a better safety profile than EDV or other usual medications.
6.Clinicopathologic characteristics and prognostic analysis of testicular diffuse large B-cell lymphoma.
Yue WANG ; Zi Yang SHI ; Qing SHI ; Shuo WANG ; Mu Chen ZHANG ; Rong SHEN ; Yang HE ; Hui Ling QIU ; Hong Mei YI ; Lei DONG ; Li WANG ; Shu CHENG ; Peng Peng XU ; Wei Li ZHAO
Chinese Journal of Hematology 2023;44(4):321-327
Objective: To analyze the clinicopathologic characteristics and prognosis of testicular diffuse large B-cell lymphoma (DLBCL) . Methods: A retrospective analysis was performed on 68 patients with testicular DLBCL admitted to Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine from October 2001 to April 2020. The gene mutation profile was evaluated by targeted sequencing (55 lymphoma-related genes) , and prognostic factors were analyzed. Results: A total of 68 patients were included, of whom 45 (66.2% ) had primary testicular DLBCL and 23 (33.8% ) had secondary testicular DLBCL. The proportion of secondary testicular DLBCL patients with Ann Arbor stage Ⅲ-Ⅳ (P<0.001) , elevated LDH (P<0.001) , ECOG score ≥ 2 points (P=0.005) , and IPI score 3-5 points (P<0.001) is higher than that of primary testicular DLBCL patients. Sixty-two (91% ) patients received rituximab in combination with cyclophosphamide, adriamycin, vincristine, and prednisone (R-CHOP) -based first-line regimen, whereas 54 cases (79% ) underwent orchiectomy prior to chemotherapy. Patients with secondary testicular DLBCL had a lower estimated 5-year progression-free survival (PFS) rate (16.5% vs 68.1% , P<0.001) and 5-year overall survival (OS) rate (63.4% vs 74.9% , P=0.008) than those with primary testicular DLBCL, and their complete remission rate (57% vs 91% , P=0.003) was also lower than that of primary testicular DLBCL. The ECOG scores of ≥2 (PFS: P=0.018; OS: P<0.001) , Ann Arbor stages Ⅲ-Ⅳ (PFS: P<0.001; OS: P=0.018) , increased LDH levels (PFS: P=0.015; OS: P=0.006) , and multiple extra-nodal involvements (PFS: P<0.001; OS: P=0.013) were poor prognostic factors in testicular DLBCL. Targeted sequencing data in 20 patients with testicular DLBCL showed that the mutation frequencies of ≥20% were PIM1 (12 cases, 60% ) , MYD88 (11 cases, 55% ) , CD79B (9 cases, 45% ) , CREBBP (5 cases, 25% ) , KMT2D (5 cases, 25% ) , ATM (4 cases, 20% ) , and BTG2 (4 cases, 20% ) . The frequency of mutations in KMT2D in patients with secondary testicular DLBCL was higher than that in patients with primary testicular DLBCL (66.7% vs 7.1% , P=0.014) and was associated with a lower 5-year PFS rate in patients with testicular DLBCL (P=0.019) . Conclusion: Patients with secondary testicular DLBCL had worse PFS and OS than those with primary testicular DLBCL. The ECOG scores of ≥2, Ann Arbor stages Ⅲ-Ⅳ, increased LDH levels, and multiple extra-nodal involvements were poor prognostic factors in testicular DLBCL. PIM1, MYD88, CD79B, CREBBP, KMT2D, ATM, and BTG2 were commonly mutated genes in testicular DLBCL, and the prognosis of patients with KMT2D mutations was poor.
Male
;
Adult
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Humans
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Prognosis
;
Retrospective Studies
;
Myeloid Differentiation Factor 88
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China/epidemiology*
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Testicular Neoplasms/drug therapy*
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Cyclophosphamide
;
Rituximab/therapeutic use*
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Lymphoma, Large B-Cell, Diffuse/drug therapy*
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Prednisone/therapeutic use*
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Doxorubicin/therapeutic use*
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Vincristine/therapeutic use*
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Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
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Immediate-Early Proteins/therapeutic use*
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Tumor Suppressor Proteins
7.Skin diseases in the Da Qing Diabetes Study: a cross-sectional study.
Chang-Bing SHEN ; Xin QIAN ; Rui-Xing YU ; Xue-Lei JI ; Yin-Juan SHI ; Jing GAO ; Cheng-Xu LI ; Ke-Ke LI ; Wen-Min FEI ; Xue SHEN ; Zi-Yi WANG ; Yang HAN ; Xiao-Li NING ; Randy KO ; Yi-Hsiang HSU ; Xian-Yong YIN ; Guang-Wei LI ; Yong CUI
Chinese Medical Journal 2021;134(10):1191-1198
BACKGROUND:
The prevalence of skin diseases and diabetes mellitus (DM) are prominent around the world. The current scope of knowledge regarding the prevalence of skin diseases and comorbidities with type 2 DM (T2DM) is limited, leading to limited recognition of the correlations between skin diseases and T2DM.
METHODS:
We collected 383 subjects from the Da Qing Diabetes Study during the period from July 9th to September 1st, 2016. The subjects were categorized into three groups: Normal glucose tolerance (NGT), impaired glucose tolerance (IGT), and T2DM. The prevalence and clinical characteristics of skin diseases were recorded and investigated.
RESULTS:
In this cross-sectional study, 383 individuals with ages ranging from 53 to 89-year-old were recruited. The overall prevalence of skin diseases was 93.5%, and 75.7% of individuals had two or more kinds of skin diseases. Additionally, there were 47 kinds of comorbid skin diseases in patients with T2DM, of which eight kinds of skin diseases had a prevalence >10%. The prevalence of skin diseases in NGT, IGT, and T2DM groups were 93.3%, 91.5%, and 96.6%, respectively; stratified analysis by categories showed a statistically significant difference in "disturbances of pigmentation" and "neurological and psychogenic dermatoses". The duration of T2DM also significantly associated with the prevalence of "disturbances of pigmentation" and "neurological and psychogenic dermatoses". Subsequently, the prevalence of "disturbances of pigmentation" was higher in males than females in NGT (P < 0.01) and T2DM (P < 0.01) groups. In addition, the difference in the prevalence of "disturbances of pigmentation" was also significant in NGT and T2DM groups (P < 0.01).
CONCLUSIONS
There was a high prevalence of skin diseases in the Da Qing Diabetes Study. To address the skin diseases in the Da Qing Diabetes Study, increased awareness and intervention measures should be implemented.
Aged
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Aged, 80 and over
;
Blood Glucose
;
Cross-Sectional Studies
;
Diabetes Mellitus, Type 2/epidemiology*
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Female
;
Glucose Intolerance/epidemiology*
;
Glucose Tolerance Test
;
Humans
;
Male
;
Middle Aged
;
Skin Diseases/epidemiology*
9.Diagnostic capacity of skin tumor artificial intelligence-assisted decision-making software in real-world clinical settings.
Cheng-Xu LI ; Wen-Min FEI ; Chang-Bing SHEN ; Zi-Yi WANG ; Yan JING ; Ru-Song MENG ; Yong CUI
Chinese Medical Journal 2020;133(17):2020-2026
BACKGROUND:
Youzhi artificial intelligence (AI) software is the AI-assisted decision-making system for diagnosing skin tumors. The high diagnostic accuracy of Youzhi AI software was previously validated in specific datasets. The objective of this study was to compare the performance of diagnostic capacity between Youzhi AI software and dermatologists in real-world clinical settings.
METHODS:
A total of 106 patients who underwent skin tumor resection in the Dermatology Department of China-Japan Friendship Hospital from July 2017 to June 2019 and were confirmed as skin tumors by pathological biopsy were selected. Dermoscopy and clinical images of 106 patients were diagnosed by Youzhi AI software and dermatologists at different dermoscopy diagnostic levels. The primary outcome was to compare the diagnostic accuracy of the Youzhi AI software with that of dermatologists and that measured in the laboratory using specific data sets. The secondary results included the sensitivity, specificity, positive predictive value, negative predictive value, F-measure, and Matthews correlation coefficient of Youzhi AI software in the real-world.
RESULTS:
The diagnostic accuracy of Youzhi AI software in real-world clinical settings was lower than that of the laboratory data (P < 0.001). The output result of Youzhi AI software has good stability after several tests. Youzhi AI software diagnosed benign and malignant diseases by recognizing dermoscopic images and diagnosed disease types with higher diagnostic accuracy than by recognizing clinical images (P = 0.008, P = 0.016, respectively). Compared with dermatologists, Youzhi AI software was more accurate in the diagnosis of skin tumor types through the recognition of dermoscopic images (P = 0.01). By evaluating the diagnostic performance of dermatologists under different modes, the diagnostic accuracy of dermatologists in diagnosing disease types by matching dermoscopic and clinical images was significantly higher than that by identifying dermoscopic and clinical images in random sequence (P = 0.022). The diagnostic accuracy of dermatologists in the diagnosis of benign and malignant diseases by recognizing dermoscopic images was significantly higher than that by recognizing clinical images (P = 0.010).
CONCLUSION
The diagnostic accuracy of Youzhi AI software for skin tumors in real-world clinical settings was not as high as that of using special data sets in the laboratory. However, there was no significant difference between the diagnostic capacity of Youzhi AI software and the average diagnostic capacity of dermatologists. It can provide assistant diagnostic decisions for dermatologists in the current state.
10.Unmet Needs and Services of Rehabilitation for People with Visual Disability Using Logistic Regression Analysis
Xin-ling LU ; Xin LI ; Zhuo-ying QIU ; Di CHEN ; Zi-wei CHENG ; Jia-ni CHEN ; Zhao-hui SHEN ; Ai-min ZHANG ; Hui-wei ZHANG
Chinese Journal of Rehabilitation Theory and Practice 2020;26(5):513-517
Objective:To analyze the characteristics of needs and development of rehabilitation services for people with visual disability (PVD). Methods:A total of 241 865 PVDs administration data of unmet needs and services of rehabilitation at provincial level were sampled and analyzed the characteristics of needs and services of rehabilitation, and the related factors of needs and services. Results:There were 50 882 (21.0%) PVDs reported their needs of rehabilitation, from high to low were assistive devices (56.5%), medicine (29.0%), nursing care (24.6%), functional training (15.5%), and surgery (4.2%). There were 43 492 (18.0%) PVDs reported their received services of rehabilitation, from high to low were assistive devices (55.0%), medicine (21.6 %), nursing care (20.8%), functional training (20.7%) and surgery (2.3%). The logistic regression model showed that severities of disabilities related with the reported unmet needs and received services (

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