1.Viewing Psychiatric Disorders Through Viruses: Simple Architecture, Burgeoning Implications.
Lingzhuo KONG ; Boqing ZHU ; Yifan ZHUANG ; Jianbo LAI ; Shaohua HU
Neuroscience Bulletin 2025;41(9):1669-1688
A growing interest in the comprehensive pathogenic mechanisms of psychiatric disorders from the perspective of the microbiome has been witnessed in recent decades; the intrinsic link between microbiota and brain function through the microbiota-gut-brain axis or other pathways has gradually been realized. However, little research has focused on viruses-entities characterized by smaller dimensions, simpler structures, greater diversity, and more intricate interactions with their surrounding milieu compared to bacteria. To date, alterations in several populations of bacteriophages and viruses have been documented in both mouse models and patients with psychiatric disorders, including schizophrenia, major depressive disorder, autism spectrum disorder, and Alzheimer's disease, accompanied by metabolic disruptions that may directly or indirectly impact brain function. In addition, eukaryotic virus infection-mediated brain dysfunction provides insights into the psychiatric pathology involving viruses. Efforts towards virus-based diagnostic and therapeutic approaches have primarily been documented. However, limitations due to the lack of large-scale cohort studies, reliability, clinical applicability, and the unclear role of viruses in microbiota interactions pose a challenge for future studies. Nevertheless, it is conceivable that investigations into viruses herald a new era in the field of precise psychiatry.
Humans
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Mental Disorders/virology*
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Animals
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Brain/virology*
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Gastrointestinal Microbiome/physiology*
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Viruses
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Virus Diseases/complications*
2.Clinicopathological features of early gastric carcinoma with lymphoid stroma
Wang GENGFANG ; Li TING ; He CHONGFANG ; Zhuang SHAOHUA ; Chen YINGTING ; Cheng YUQING
Chinese Journal of Clinical Oncology 2025;52(11):557-564
Objective:To investigate the clinicopathological characteristics of patients with early gastric carcinoma with lymphoid stroma(EGCLS).Methods:A retrospective analysis was conducted on 27 consecutive patients with EGCLS who underwent radical surgery at The Second People's Hospital of Changzhou between January 2007 and December 2023.Sixty-nine cases of conventional early gastric carcinoma with matched T stages were randomly selected as controls.Immunohistochemical staining was performed to detect the expression of P53,mismatch repair(MMR)proteins,programmed death-ligand 1(PD-L1),E-cadherin,and human epidermal growth factor receptor 2(HER2)in the study cohort.FISH analysis was conducted on HER2 2+cases,and in situ hybridization was used to detect Epstein-Barr virus(EBV).Res-ults:No significant differences were observed between the two groups in terms of patient sex,age,tumor location,size,ulceration,lymph-ovascular or perineural invasion,tumor budding grade,P53 expression,or MMR protein deficiency.The EGCLS group showed significantly higher proportions of SM2 invasion(88.9%),poor tumor differentiation(70.4%),pushing tumor border(48.1%),PD-L1 positivity(59.3%),Epstein-Barr virus-encoded small RNA(EBER)positivity(55.6%),and abnormal E-cadherin expression(48.1%)compared to the control group(59.4%,46.4%,18.8%,24.6%,1.4%,and 23.2%,respectively;P<0.05).The frequency of lymph node metastasis(7.4%)and the pro-portion of elevated macroscopic type(14.8%)in the EGCLS group were significantly lower than in the control group(30.4%and 40.6%,re-spectively;P<0.05).Lymphovascular invasion,tumor budding grade,and non-EGCLS status were identified as risk factors for lymph node metastasis,with lymphovascular invasion being the only independent risk factor.Conclusions:EGCLS is a rare subtype of early gastric car-cinoma characterized by a low frequency of lymph node metastasis and a high proportion of EBER positivity or MMR protein deficiency.En-doscopic resection or immunotherapy may be preferred treatment options for patients who are not suitable candidates for surgery.
3.Analysis of common non-bacterial pathogens in hospitalized children with acute respiratory infections: a multicenter study in four regions of Fujian Province in 2023
Lin CAI ; Xiaoman GAO ; Fucun ZHU ; Xiuhua LIU ; Wenlong ZHOU ; Shaohua GE ; Lijuan ZHUANG ; Guanglin ZHANG ; Xiaoping LAI ; Ting LIU
Chinese Journal of Preventive Medicine 2025;59(10):1665-1675
Objective:To analyze the distribution and epidemiological characteristics of common non-bacterial pathogens in hospitalized children with acute respiratory tract infections(ARTI)from a multi-center study covering 4 regions in Fujian Province in 2023.Methods:A retrospective cohort study was conducted using medical record analysis.A total of 22 769 hospitalized children with ARTI were enrolled from January to December 2023 across seven regional pediatric medical centers in Fujian Province (covering four major geographical divisions of Fuzhou, Nanping, Sanming and Longyan; all selected hospitals were regional children′s medical centers).Using single-tube multiplex PCR with fragment analysis on a Sanger sequencing platform, the nucleic acids of 11 common non-bacterial respiratory pathogens were tested in nasopharyngeal swabs collected from 22 769 children. These pathogens included influenza A virus(FluA), influenza B virus(FluB), parainfluenza virus(PIV), respiratory syncytial virus (RSV), adenovirus (ADV), human rhinovirus (HRV), human bocavirus (HBoV), human coronavirus (HCoV), human metapneumovirus(HMPV), Mycoplasma pneumoniae(MP), and Chlamydia (Ch). Count data were described as [ n(%)], and the chi-square test/Fisher′s exact test was used to compare the differences in rates between groups. Epidemiological features, including positive detection rates, pathogen profiles, and correlations with region, sex, age and month, were analyzed. Results:Among 22 769 children with ARTI, pathogens were detected in 16 213 cases (71.21%), including 13 340 single infections (58.59%).The detection rates of single pathogens in descending order were human rhinovirus (HRV, 12.95%), Mycoplasma pneumoniae(MP, 12.27%), respiratory syncytial virus(RSV, 11.12%), influenza A virus (Flu-A, 7.98%), parainfluenza virus(PIV, 4.66%), human metapneumovirus(HMPV, 4.60%), adenovirus(ADV, 2.70%), human bocavirus(HBoV, 0.84%), human coronavirus(HCoV, 0.82%), influenza B virus(Flu-B, 0.47%) and Chlamydia(Ch, 0.18%).Mixed infections occurred in 2 873 cases(12.62%), primarily dual infections(2 679 cases).Regional analysis revealed significant disparities:Luoyuan County Hospital (Fuzhou) exhibited the highest total detection rate(86.59%, 1 414/1 633)and mixed infection rate(23.27%, 380/1 633)(both P<0.001), with notably elevated MP (26.39%, 431/1 633);Jian′ou City Hospital(Nanping) ranked second for Flu-A(14.21%, 409/2 879), RSV(13.20%, 380/2 879) and mixed infections(17.12%, 493/2 879);Lianjiang County Hospital(Fuzhou) showed distinct prevalence of Flu-A(10.68%, 130/1 217), PIV(6.00%, 73/1 217), and HBoV(1.73%, 21/1 217); Yong′an City Hospital (Sanming) reported high MP (26.07%, 238/913) and RSV(12.38%, 113/913);Shaowu City Hospital(Nanping) was dominated by MP (18.60%, 407/2 188) and HRV(13.39%, 293/2 188); Tingzhou Hospital(Longyan) had the highest HRV (17.88%, 407/2 276) and Flu-B (0.75%, 17/2 276); and Fuzhou Children′s Hospital showed elevated ADV(3.38%, 394/11 663) and HCoV(1.08%, 126/11 663). Except for Flu-B(0.47%, 108/22 769; P=0.054) and Ch(0.18%, 40/22769; P=0.900), all pathogens and mixed infections exhibited significant regional variations ( P<0.05).Gender analysis indicated higher detection rates of HRV, RSV, Flu-A, ADV, PIV, HBoV and mixed infections in males, while MP, HMPV, Flu-B, HCoV, and Ch were more prevalent in females, with statistically significant differences for HRV and MP (both P<0.001). Age stratification showed the highest overall detection rate in the 3-<6 years group (75.48%; P<0.001): RSV and Ch peaked in infants (<1 year), HRV, PIV, ADV and HBoV in toddlers (1-<3 years), HMPV, HCoV, and mixed infections in preschool children (3-<6 years), and MP, Flu-A and Flu-B in older children (6-<18 years).Analyzing the prevalent months, the monthly prevalence trends of pathogens in various regions are similar.Seasonal trends demonstrated year-round HRV activity (peaking in spring/autumn), MP prevalence in autumn/winter, RSV surges in spring-summer (April-June) and late summer-autumn (August-October), and Flu-A predominanced in winter-spring. Conclusion:Multiplex PCR with fragment analysis demonstrated high diagnostic efficacy. The top 4 non-bacterial pathogens in Fujian Province′s ARTI-hospitalized children in 2023 were HRV, MP, RSV and Flu-A. Pathogen distribution exhibited significant regional, age and seasonal variations, emphasizing the need for targeted prevention strategies.
4.Mitophagy in cardiovascular diseases
Shaohua LU ; Haixia ZHUANG ; Chen ZHU ; Du FENG
Chinese Journal of Pathophysiology 2025;41(1):142-156
Cardiovascular diseases(CVD)remain a leading cause of mortality worldwide,with complex pathogenic mechanisms.Mitochondrial dysfunction,a key hallmark in CVD pathology,disrupts cellular homeostasis through oxidative stress,calcium imbalance,and reduced ATP production,ultimately damaging cardiomyocytes.Mitopha-gy,a selective autophagy process,plays a crucial protective role by degrading dysfunctional mitochondria,thus maintain-ing mitochondrial quality and quantity balance in cells.Recent studies have highlighted the significant regulatory role of mitophagy in various CVD pathological processes,including heart failure,myocardial infarction,ischemia/reperfusion in-jury,hypertension,and atherosclerosis.Notably,a variety of drugs have been shown good potential in the targeted regula-tion of mitophagy activity,which provides a new idea for the treatment of CVD.This review systematically elucidates the latest advances in understanding the molecular mechanisms,pathophysiological functions,and potential therapeutic appli-cations of mitophagy in CVD.It provides a theoretical foundation for deepening our comprehension of CVD pathogenesis and developing innovative treatment strategies,offering new insights into cardiovascular disease management.
5.Analysis of common non-bacterial pathogens in hospitalized children with acute respiratory infections: a multicenter study in four regions of Fujian Province in 2023
Lin CAI ; Xiaoman GAO ; Fucun ZHU ; Xiuhua LIU ; Wenlong ZHOU ; Shaohua GE ; Lijuan ZHUANG ; Guanglin ZHANG ; Xiaoping LAI ; Ting LIU
Chinese Journal of Preventive Medicine 2025;59(10):1665-1675
Objective:To analyze the distribution and epidemiological characteristics of common non-bacterial pathogens in hospitalized children with acute respiratory tract infections(ARTI)from a multi-center study covering 4 regions in Fujian Province in 2023.Methods:A retrospective cohort study was conducted using medical record analysis.A total of 22 769 hospitalized children with ARTI were enrolled from January to December 2023 across seven regional pediatric medical centers in Fujian Province (covering four major geographical divisions of Fuzhou, Nanping, Sanming and Longyan; all selected hospitals were regional children′s medical centers).Using single-tube multiplex PCR with fragment analysis on a Sanger sequencing platform, the nucleic acids of 11 common non-bacterial respiratory pathogens were tested in nasopharyngeal swabs collected from 22 769 children. These pathogens included influenza A virus(FluA), influenza B virus(FluB), parainfluenza virus(PIV), respiratory syncytial virus (RSV), adenovirus (ADV), human rhinovirus (HRV), human bocavirus (HBoV), human coronavirus (HCoV), human metapneumovirus(HMPV), Mycoplasma pneumoniae(MP), and Chlamydia (Ch). Count data were described as [ n(%)], and the chi-square test/Fisher′s exact test was used to compare the differences in rates between groups. Epidemiological features, including positive detection rates, pathogen profiles, and correlations with region, sex, age and month, were analyzed. Results:Among 22 769 children with ARTI, pathogens were detected in 16 213 cases (71.21%), including 13 340 single infections (58.59%).The detection rates of single pathogens in descending order were human rhinovirus (HRV, 12.95%), Mycoplasma pneumoniae(MP, 12.27%), respiratory syncytial virus(RSV, 11.12%), influenza A virus (Flu-A, 7.98%), parainfluenza virus(PIV, 4.66%), human metapneumovirus(HMPV, 4.60%), adenovirus(ADV, 2.70%), human bocavirus(HBoV, 0.84%), human coronavirus(HCoV, 0.82%), influenza B virus(Flu-B, 0.47%) and Chlamydia(Ch, 0.18%).Mixed infections occurred in 2 873 cases(12.62%), primarily dual infections(2 679 cases).Regional analysis revealed significant disparities:Luoyuan County Hospital (Fuzhou) exhibited the highest total detection rate(86.59%, 1 414/1 633)and mixed infection rate(23.27%, 380/1 633)(both P<0.001), with notably elevated MP (26.39%, 431/1 633);Jian′ou City Hospital(Nanping) ranked second for Flu-A(14.21%, 409/2 879), RSV(13.20%, 380/2 879) and mixed infections(17.12%, 493/2 879);Lianjiang County Hospital(Fuzhou) showed distinct prevalence of Flu-A(10.68%, 130/1 217), PIV(6.00%, 73/1 217), and HBoV(1.73%, 21/1 217); Yong′an City Hospital (Sanming) reported high MP (26.07%, 238/913) and RSV(12.38%, 113/913);Shaowu City Hospital(Nanping) was dominated by MP (18.60%, 407/2 188) and HRV(13.39%, 293/2 188); Tingzhou Hospital(Longyan) had the highest HRV (17.88%, 407/2 276) and Flu-B (0.75%, 17/2 276); and Fuzhou Children′s Hospital showed elevated ADV(3.38%, 394/11 663) and HCoV(1.08%, 126/11 663). Except for Flu-B(0.47%, 108/22 769; P=0.054) and Ch(0.18%, 40/22769; P=0.900), all pathogens and mixed infections exhibited significant regional variations ( P<0.05).Gender analysis indicated higher detection rates of HRV, RSV, Flu-A, ADV, PIV, HBoV and mixed infections in males, while MP, HMPV, Flu-B, HCoV, and Ch were more prevalent in females, with statistically significant differences for HRV and MP (both P<0.001). Age stratification showed the highest overall detection rate in the 3-<6 years group (75.48%; P<0.001): RSV and Ch peaked in infants (<1 year), HRV, PIV, ADV and HBoV in toddlers (1-<3 years), HMPV, HCoV, and mixed infections in preschool children (3-<6 years), and MP, Flu-A and Flu-B in older children (6-<18 years).Analyzing the prevalent months, the monthly prevalence trends of pathogens in various regions are similar.Seasonal trends demonstrated year-round HRV activity (peaking in spring/autumn), MP prevalence in autumn/winter, RSV surges in spring-summer (April-June) and late summer-autumn (August-October), and Flu-A predominanced in winter-spring. Conclusion:Multiplex PCR with fragment analysis demonstrated high diagnostic efficacy. The top 4 non-bacterial pathogens in Fujian Province′s ARTI-hospitalized children in 2023 were HRV, MP, RSV and Flu-A. Pathogen distribution exhibited significant regional, age and seasonal variations, emphasizing the need for targeted prevention strategies.
6.Mitophagy in cardiovascular diseases
Shaohua LU ; Haixia ZHUANG ; Chen ZHU ; Du FENG
Chinese Journal of Pathophysiology 2025;41(1):142-156
Cardiovascular diseases(CVD)remain a leading cause of mortality worldwide,with complex pathogenic mechanisms.Mitochondrial dysfunction,a key hallmark in CVD pathology,disrupts cellular homeostasis through oxidative stress,calcium imbalance,and reduced ATP production,ultimately damaging cardiomyocytes.Mitopha-gy,a selective autophagy process,plays a crucial protective role by degrading dysfunctional mitochondria,thus maintain-ing mitochondrial quality and quantity balance in cells.Recent studies have highlighted the significant regulatory role of mitophagy in various CVD pathological processes,including heart failure,myocardial infarction,ischemia/reperfusion in-jury,hypertension,and atherosclerosis.Notably,a variety of drugs have been shown good potential in the targeted regula-tion of mitophagy activity,which provides a new idea for the treatment of CVD.This review systematically elucidates the latest advances in understanding the molecular mechanisms,pathophysiological functions,and potential therapeutic appli-cations of mitophagy in CVD.It provides a theoretical foundation for deepening our comprehension of CVD pathogenesis and developing innovative treatment strategies,offering new insights into cardiovascular disease management.
7.Clinicopathological features of early gastric carcinoma with lymphoid stroma
Wang GENGFANG ; Li TING ; He CHONGFANG ; Zhuang SHAOHUA ; Chen YINGTING ; Cheng YUQING
Chinese Journal of Clinical Oncology 2025;52(11):557-564
Objective:To investigate the clinicopathological characteristics of patients with early gastric carcinoma with lymphoid stroma(EGCLS).Methods:A retrospective analysis was conducted on 27 consecutive patients with EGCLS who underwent radical surgery at The Second People's Hospital of Changzhou between January 2007 and December 2023.Sixty-nine cases of conventional early gastric carcinoma with matched T stages were randomly selected as controls.Immunohistochemical staining was performed to detect the expression of P53,mismatch repair(MMR)proteins,programmed death-ligand 1(PD-L1),E-cadherin,and human epidermal growth factor receptor 2(HER2)in the study cohort.FISH analysis was conducted on HER2 2+cases,and in situ hybridization was used to detect Epstein-Barr virus(EBV).Res-ults:No significant differences were observed between the two groups in terms of patient sex,age,tumor location,size,ulceration,lymph-ovascular or perineural invasion,tumor budding grade,P53 expression,or MMR protein deficiency.The EGCLS group showed significantly higher proportions of SM2 invasion(88.9%),poor tumor differentiation(70.4%),pushing tumor border(48.1%),PD-L1 positivity(59.3%),Epstein-Barr virus-encoded small RNA(EBER)positivity(55.6%),and abnormal E-cadherin expression(48.1%)compared to the control group(59.4%,46.4%,18.8%,24.6%,1.4%,and 23.2%,respectively;P<0.05).The frequency of lymph node metastasis(7.4%)and the pro-portion of elevated macroscopic type(14.8%)in the EGCLS group were significantly lower than in the control group(30.4%and 40.6%,re-spectively;P<0.05).Lymphovascular invasion,tumor budding grade,and non-EGCLS status were identified as risk factors for lymph node metastasis,with lymphovascular invasion being the only independent risk factor.Conclusions:EGCLS is a rare subtype of early gastric car-cinoma characterized by a low frequency of lymph node metastasis and a high proportion of EBER positivity or MMR protein deficiency.En-doscopic resection or immunotherapy may be preferred treatment options for patients who are not suitable candidates for surgery.
8.Short-term efficacy of surgical treatment for multiple pulmonary nodules: A retrospective study in a single center
Qi ZHANG ; Ling GUO ; Xin GAO ; Shaohua XIE ; Qiang LI ; Xiang ZHUANG ; Run XIANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(02):255-262
Objective To summarize and analyze the clinical diagnosis, surgical treatment and prognosis of multiple pulmonary nodules (MPNs). Methods The clinical data of lung cancer patients who received surgical treatment in our hospital from 2018 to 2020 were collected. The short-term efficacy of surgical treatment for MPNs was analyzed. Results A total of 97 patients were enrolled, including 30 males and 67 females with an average age of 56.1±10.0 years at onset ill. There were 62 patients with double lesions, 22 patients with three lesions, 4 patients with four lesions, and 9 patients with more than four lesions. A total of 213 lesions were surgically treated, including 88 pure ground-glass nodules, 81 partially solid nodules, and 7 solid nodules. There were 87 simultaneous surgeries and 10 staged surgeries, with an average operation interval of 5.2 months. The pathological combination type included adenocarcinoma-adenocarcinoma in 96 (99.0%) patients, squamous cell carcinoma-squamous cell carcinoma in 1 (1.0%) patient, and no lymph node metastasis was found. The 2-year disease-free survival (DFS) rate was 92.1%, and the overall survival (OS) rate was 100.0%. Univariate analysis showed that high-risk lesion size>2 cm (P=0.316), residual lesions (P=0.782) and pathological combination type (P=0.913) had statistical effect on the 2-year DFS rate. Conclusion MPNs are mainly diagnosed with multiple primary lung cancers, and the pathological combination is mostly adenocarcinoma-adenocarcinoma combination. Imaging examination is of great help to the surgical approach selection, diagnosis and differential diagnosis of MPNs. During the operation, maximal preservation of lung function and complete resection of high-risk nodules should be taken as the principle, and the prognosis is satisfactory.
9.Clinical characteristics and prognosis analysis of TCF3-PBX1 fusion gene-positive childhood B-cell precursor acute lymphoblastic leukemia
Shuquan ZHUANG ; Yongzhi ZHENG ; Jian LI ; Shaohua LE ; Hong WEN ; Xingguo WU ; Xueling HUA ; Hao ZHENG ; Zaisheng CHEN ; Kaizhi WENG
Journal of Leukemia & Lymphoma 2023;32(1):38-44
Objective:To investigate the clinical characteristics and prognostic factors of TCF3-PBX1 fusion gene-positive childhood B-cell precursor acute lymphoblastic leukemia (B-ALL).Methods:The clinical data of 1 287 newly diagnosed children with B-ALL who were admitted to five hospital in Fujian province (Fujian Medical University Union Hospital, the First Affiliated Hospital of Xiamen University, Zhangzhou Affiliated Hospital of Fujian Medical University, Quanzhou First Hospital Affiliated to Fujian Medical University, Nanping First Hospital of Fujian Province) from April 2011 to December 2020 were retrospectively analyzed. According to the results of TCF3-PBX1 fusion gene testing, all the patients were divided into TCF3-PBX1-positive group and TCF3-PBX1-negative group. The clinical characteristics, early treatment response [minimal residual disease (MRD) at middle stage and end of induction chemotherapy] and long-term efficacy [overall survival (OS) and event-free survival (EFS)] of the patients in both groups were compared. Kaplan-Meier method was used for survival analysis. The prognostic factors of TCF3-PBX1-positive B-ALL were analyzed by using Cox proportional hazards model. Among 83 children with TCF3-PBX1-positive B-ALL, the treatment regimens, risk stratification and efficacy evaluation of 62 cases were performed by using Chinese Children's Leukemia Group (CCLG)-ALL 2008 regimen and 21 cases were performed by using Chinese Children's Cancer Group (CCCG)-ALL 2015 regimen, and the efficacy and incidence of serious adverse events (SAE) between the two groups compared.Results:Among 1 287 B-ALL patients, 83 patients (6.4%) were TCF3-PBX1-positive. The proportion of patients with initial white blood cell count (WBC)≥50×10 9/L in the TCF3-PBX1-positive group was higher than that in the TCF3-PBX1-negative group, while the proportions of patients with MRD ≥1% on induction chemotherapy day 15 or day 19, and MRD ≥0.01% on induction chemotherapy day 33 or day 46 in the TCF3-PBX1-positive group were lower than those in the TCF3-PBX1-negative group (all P < 0.05). Univariate Cox regression analysis showed that MRD ≥1% on induction chemotherapy day 15 or day 19 and TCF3-PBX1 ≥0.01% on induction chemotherapy day 33 or day 46 were risk factors for OS and EFS (all P < 0.05). Multivariate analysis showed that MRD ≥1% on induction chemotherapy day 15 or day 19 was an independent risk factor for OS ( HR = 10.589, 95% CI 1.903-58.933, P = 0.007) and EFS ( HR = 10.218, 95% CI 2.429-42.980, P = 0.002). TCF3-PBX1≥0.01% on induction chemotherapy day 33 or day 46 was an independent risk factor for EFS ( HR = 6.058, 95% CI 1.463-25.087, P = 0.013) but not for OS ( HR = 3.550, 95% CI 0.736-17.121, P = 0.115). The 10-year EFS and OS rates of the TCF3-PBX1-positive group were 84.6% (95% CI 76.9%-93.1%) and 89.1% (95% CI 82.1%-96.6%), and the differences between the two groups were not statistically significant (both P > 0.05). Among 80 children who received standardized treatment, compared with children who were treated with CCLG-ALL 2008 regimen, the incidence of infection-related SAE was lower in children who were treated with CCCG-ALL 2015 regimen [0 (0/21) vs. 20.3% (12/59), χ2 = 5.22, P = 0.022], but there were no statistical differences in treatment-related mortality, relapse rate, EFS and OS between the two groups (all P > 0.05). Conclusions:Children with TCF3-PBX1-positive B-ALL have a good prognosis, and MRD≥1% at middle stage of induction chemotherapy and TCF3-PBX1≥0.01% at the end of induction chemotherapy may be influencing factors for poor prognosis. CCCG-ALL 2015 regimen can reduce infection-related SAE while achieving good efficacy.
10.Discussion of the process of conducting an investigator-initiated research
Wei DAI ; Xing WEI ; Yaqin WANG ; Yangjun LIU ; Jia LIAO ; Shaohua XIE ; Bin HU ; Hongfan YU ; Yang PU ; Wei XU ; Yuqian ZHAO ; Fang LIU ; Xiaoqin LIU ; Xiang ZHUANG ; Biyu SHEN ; Shaoping WAN ; Qiang LI ; Qiuling SHI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(02):299-304
The number of investigator initiated research (IIR) is increasing. But the recognition and management of IIR in China is still in its infancy, and there is a lack of specific and operable guidance for the implementation process. Based on our practical experiences, previous literature reports, and current policy regulations, the authors took prospective IIR as an example to summarize the implementation process of IIR into 14 steps, which are as the following: study initiation, ethical review, study registration, study filing, case report form design, database establishment, standard operating procedure making, investigator training, informed consent, data collection, data entry, data verification, data locking and data archiving.

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