1.The Solomon Four-Group Design:Key Considerations in Design and Statistical Analysis and Their Significance in Clinical Trials of Traditional Chinese Medicine
Wenqian ZHANG ; Yufei LI ; Tong LIN ; Xintong WEI ; Yingjie WANG ; Jianping LIU ; Ying ZHANG
Journal of Traditional Chinese Medicine 2025;66(16):1649-1655
The Solomon four-group design, a critical method for improving internal validity in clinical research, can reduce bias and control the interference of Hawthorne effects and pretest sensitization on research results, which offers unique advantages in evaluating complex intervention outcomes. This paper systematically outlined the core framework and key points of statistical analysis of the Solomon four-group design, summarized its applications in clinical research at home and abroad, explored its advantages and limitations, and discussed the potential value in traditional Chinese medicine (TCM) clinical trials. It is believed that the Solomon four-group design can help distinguish between testing effects and intervention effects in TCM clinical studies, and reduce the bias in the evaluation of subjective indicators. Meanwhile, given the complexity of the Solomon four-group design and the particularity of TCM clinical research, it is proposed that future TCM clinical studies should focus on using psychological scales, know-ledge, attitude, and behavior measurements, and other similat evaluations as endpoints. It also advocates strengthening interdisciplinary collaboration to provide new methodological paths for TCM clinical research.
2.Incidence of pulmonary tuberculosis and its influencing factors in Hubei Province based on the geographically weighted regression model
Xingxing LU ; Xun LIU ; Fan WANG ; Jianjun YE ; Yu ZHANG ; Chengfeng YANG ; Liping ZHOU ; Hongxing WANG ; Wenqian ZHOU
Journal of Public Health and Preventive Medicine 2025;36(5):28-31
Objective To study the spatial distribution of the incidence of pulmonary tuberculosis in Hubei Province and its influencing factors, so as to improve the theoretical basis for scientific development of tuberculosis prevention and control measures in the future. Methods The data of reported incidence of tuberculosis and related influencing factors in various counties and districts of Hubei Province in 2020 were collected. Global Moran's I index, hotspot analysis and geographically weighted regression (GWR) model analysis were used to calculate the spatial autocorrelation of the incidence of tuberculosis, and to analyze the influencing factors affecting the incidence rate of tuberculosis. Results There were obvious regional differences in the space distribution of the incidence rate of tuberculosis. Hot spot analysis showed positive spatial correlation and obvious clustering. The GWR model (AICc=784.251) in this study had higher AICc value compared to the ordinary least squares regression (OLS) model (AICc=804.2585). The GWR model showed that the increase in the proportion of the population aged 65 and above and the proportion of the ethnic minority population had a significant promoting effect on the increase of the incidence rate of tuberculosis, and there was significant spatial heterogeneity. The effect of PM2.5 concentration on the incidence rate of pulmonary tuberculosis varied in different regions, and the degree of effect was also different. Conclusion The proportion of people aged 65 and above and the proportion of ethnic minorities may significantly influence the incidence of pulmonary tuberculosis. The effect of PM2.5 concentration varies in different regions, so targeted measures should be formulated according to the situation in different regions.
3.Incidence of pulmonary tuberculosis and its influencing factors in Hubei Province based on the geographically weighted regression model
Xingxing LU ; Xun LIU ; Fan WANG ; Jianjun YE ; Yu ZHANG ; Chengfeng YANG ; Liping ZHOU ; Hongxing WANG ; Wenqian ZHOU
Journal of Public Health and Preventive Medicine 2025;36(5):28-31
Objective To study the spatial distribution of the incidence of pulmonary tuberculosis in Hubei Province and its influencing factors, so as to improve the theoretical basis for scientific development of tuberculosis prevention and control measures in the future. Methods The data of reported incidence of tuberculosis and related influencing factors in various counties and districts of Hubei Province in 2020 were collected. Global Moran's I index, hotspot analysis and geographically weighted regression (GWR) model analysis were used to calculate the spatial autocorrelation of the incidence of tuberculosis, and to analyze the influencing factors affecting the incidence rate of tuberculosis. Results There were obvious regional differences in the space distribution of the incidence rate of tuberculosis. Hot spot analysis showed positive spatial correlation and obvious clustering. The GWR model (AICc=784.251) in this study had higher AICc value compared to the ordinary least squares regression (OLS) model (AICc=804.2585). The GWR model showed that the increase in the proportion of the population aged 65 and above and the proportion of the ethnic minority population had a significant promoting effect on the increase of the incidence rate of tuberculosis, and there was significant spatial heterogeneity. The effect of PM2.5 concentration on the incidence rate of pulmonary tuberculosis varied in different regions, and the degree of effect was also different. Conclusion The proportion of people aged 65 and above and the proportion of ethnic minorities may significantly influence the incidence of pulmonary tuberculosis. The effect of PM2.5 concentration varies in different regions, so targeted measures should be formulated according to the situation in different regions.
4.Comparison of the microbiota diversity between autogenous and anautogenous Culex pipiens pallens
Jingjing LEI ; Wenxiang LÜ ; Wenqian WANG ; Haifang WANG ; Xiuxia GUO ; Peng CHENG ; Maoqing GONG ; Lijuan LIU
Chinese Journal of Schistosomiasis Control 2024;36(1):52-58
Objective To investigate the microbiota composition and diversity between autogenous and anautogenous Culex pipiens pallens, so as to provide insights into unraveling the pathogenesis of autogeny in Cx. pipiens pallens. Methods Autogenous and anautogenous adult Cx. pipiens pallens samples were collected at 25 ℃, and the hypervariable regions of the microbial 16S ribosomal RNA (16S rRNA) gene was sequenced on the Illumina NovaSeq 6000 sequencing platform. The microbiota abundance and diversity were evaluated using the alpha diversity index, and the difference in the microbiota structure was examined using the beta diversity index. The microbiota with significant differences in the abundance between autogenous and anautogenous adult Cx. pipiens pallens samples was identified using the linear discriminant analysis effect size (LEfSe). Results The microbiota in autogenous and anautogenous Cx. pipiens pallens samples belonged to 18 phyla, 28 classes, 70 orders, 113 families, and 170 genera, and the dominant phyla included Proteobacteria, Bacteroidetes, and so on. At the genus level, Wolbachia was a common dominant genus, and the relative abundance was (77.6 ± 11.3)% in autogenous Cx. pipiens pallens samples and (47.5 ± 8.5)% in anautogenous mosquito samples, while Faecalibaculum (0.4% ± 0.1%), Dubosiella (0.5% ± 0.0%) and Massilia (0.5% ± 0.1%) were specific species in autogenous Cx. pipiens pallens samples. Alpha diversity analysis showed that higher Chao1 index and ACE index in autogenous Cx. pipiens pallens samples than in anautogenous samples (both P values > 0.05), and lower Shannon index (P > 0.05) and Simpson index (P < 0.05) in autogenous Cx. pipiens pallens samples than in anautogenous samples. LEfSe analysis showed a total of 48 significantly different taxa between autogenous and anautogenous Cx. pipiens pallens samples (all P values < 0.05). Conclusion There is a significant difference in the microbiota diversity between autogenous and anautogenous Cx. pipiens pallens.
5.Risk factors for pulmonary infection in patients after cardiac surgery: A systematic review and meta-analysis
Wenqian CAI ; Dequan WU ; Yue SUN ; Bo LIU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(11):1655-1662
Objective To systematically evaluate the risk factors for pulmonary infection after cardiac surgery. Methods A computer search was performed to collect researches on risk factors for pulmonary infection in patients after cardiac surgery from the databases, including CNKI, Wanfang, VIP, CBM, PubMed, The Cochrane Library, EBSCO, CINAHL, Web of Science, EMbase from the inception to August 2023. Two researchers independently extracted data and assessed the literature according to the inclusion and exclusion criteria, and the quality of the literature was evaluated using the Newcastle-Ottawa Scale (NOS). The meta-analysis was performed using RevMan 5.4 software. Results A total of 23 studies covering 24348 patients were selected, including 21 case-control studies and 2 cohort studies. The NOS scores were≥6 points. The results of meta-analysis showed that age (OR=2.16, 95%CI 1.80 to 2.59, P<0.001), smoking history (OR=1.91, 95%CI 1.67 to 2.18, P<0.001), pulmonary disease (OR=1.61, 95%CI 1.40 to 1.85, P<0.001), diabetes mellitus (OR=1.62, 95%CI 1.26 to 2.08, P<0.001), operation time (OR=2.54, 95%CI 1.86 to 3.46, P<0.001), cardiopulmonary bypass (CPB) (OR=3.78, 95%CI 2.11 to 6.77, P<0.001), CPB time (OR=2.30, 95%CI 1.94 to 2.71, P<0.001), blood transfusion (OR=2.55, 95%CI 2.04 to 3.20, P<0.001), postoperative mechanical ventilation time (OR=2.78, 95%CI 2.34 to 3.30, P<0.001), tracheal intubation time (OR=3.93, 95%CI 2.45 to 6.31, P<0.001) and repeated tracheal intubation (OR=8.74, 95%CI 4.17 to 18.30, P<0.001) were independent risk factors for pulmonary infection in patients after cardiac surgery. Conclusion Age, smoking history, pulmonary disease, diabetes mellitus, operation time, CPB, CPB time, blood transfusion, postoperative mechanical ventilation time, tracheal intubation time, and repeated tracheal intubation are risk factors for pulmonary infection in patients after cardiac surgery. It can be used as a reference to strengthen perioperative evaluation and nursing of high-risk patients and reduce the incidence of pulmonary infection.
6.Prospective Cohort Investigation on Physical Activity of Osteoporosis Outcomes (PAOPO) in Jidong:Objectives,Study Design,and Baseline Characteristics
Yang JINGZHI ; Shen HAO ; Wang SICHENG ; Bai LONG ; Geng ZHEN ; Jing YINGYING ; Xu KE ; Liu YUHE ; Wu WENQIAN ; Zhang HAO ; Zhang YUANWEI ; Li ZUHAO ; Wang CHUANDONG ; Wang GUANGCHAO ; Chen XIAO ; Su JIACAN
Biomedical and Environmental Sciences 2024;37(9):1067-1079
Objective The aim of this study was to investigate the prospective association between physical activity (PA),independently or in conjunction with other contributing factors,and osteoporosis (OP) outcomes. Methods The Physical Activity in Osteoporosis Outcomes (PAOPO) study was a community-based cohort investigation. A structured questionnaire was used to gather the participants' sociodemographic characteristics. Bone mineral density (BMD) measurements were performed to assess OP outcomes,and the relationship between BMD and OP was evaluated within this cohort. Results From 2013 to 2014,8,471 participants aged 18 years and older were recruited from Tangshan,China's Jidong community. Based on their PA level,participants were categorized as inactive,moderately active,or very active. Men showed higher physical exercise levels than women across the activity groups. BMD was significantly higher in the very active group than in the moderately active and inactive groups. Individuals aged>50 years are at a higher risk of developing OP and osteopenia. Conclusion The PAOPO study offers promising insights into the relationship between PA and OP outcomes,encouraging the implementation of PA in preventing and managing OP.
7.Relationship between the expression level of ABCC4 and miR-125b-5p in prostate cancer tissues and postoperative prognosis
Yuan JIA ; Hongfu WANG ; Nan LIU ; Kai YIN ; Wenqian QI
International Journal of Laboratory Medicine 2024;45(10):1159-1164,1170
Objective To explore the relationship between the expression levels of adenosine triphosphate binds to the box transporter C4(ABCC4)and microRNA-125b-5p(miR-125b-5p)and survival 3 years after surgery in prostate cancer(PCa)tissue.Methods A total of 60 patients with PCa diagnosed in Huanghua People's Hospital from November 2017 to February 2020 were selected,and PCa tissues(PCa group)and pa-racancer tissues(control group)were collected intraoperatively.The expression levels of ABCC4 mRNA,miR-125b-5p and ABCC4 in the samples were detected;the patients were followed up for 3 years.The correlation between the expression levels of ABCC4 mRNA and miR-125b-5p in PCa tissues,their relationship with clini-copathological features and prognosis,and the factors affecting the prognosis of PCa patients,the predictive value of both for 3-year survival of patients were analyzed.Results The expression level and positive rate of ABCC4 mRNA in PCa group were higher than those in control group,and the expression level of miR-125b-5p was lower than that in control group,and the differences were statistically significant(P<0.05).The expres-sion level of ABCC4 mRNA and miR-125b-5p in PCa tissue was negatively correlated(P<0.05).The expres-sion level of ABCC4 mRNA and miR-125b-5p in PCa tissue was related to tumor stage,serum prostate specific antigen,Gleason score and tumor metastasis(P<0.05).The 3-year cumulative survival rate of patients in the ABCC4 mRNA high expression group and the miR-125b-5p low expression group was lower than that in the ABCC4 mRNA low expression group and the miR-125b-5p high expression group,respectively,and the differ-ences were statistically significant(P<0.05).The expression level of ABCC4 mRNA in the PCa tissue in death group was higher than that in survival group,and the expression level of miR-125b-5p was lower than that in survival group,and the differences were statistically significant(P<0.05).High expression of ABCC4 mRNA and low expression of miR-125b-5p were independent risk factors for poor prognosis in PCa patients(P<0.05).Compared to the area under the curve(AUC)predicted by ABCC4 mRNA and miR-125b-5p alone for 3-year survival in PCa patients,the combined prediction of the two had a higher AUC(P<0.05).Conclu-sion ABCC4 is highly expressed and miR-125b-5p is low expressed in PCa patients'cancer tissues,and the combination of the two has a high predictive power for 3-year survival in PCa patients.
8.A retrospective cohort study exploring clinical characteristics and treatment of hyperthyroid cardiopathy
Xiaoyun FENG ; Ninger ZHENG ; Huijing WU ; Yuwen ZHOU ; Wenqian REN ; Li ZHAO ; Fang LIU ; Yufan WANG
Chinese Journal of Endocrinology and Metabolism 2024;40(9):746-751
Objective:To retrospectively summarize the clinical characteristics and treatment of 49 patients with hyperthyroid cardiopath and to explore the diagnosis and treatment methods of hyperthyroid cardiopathy.Methods:A total of 49 patients with hyperthyroid cardiopath(HC group) who were successfully treated and followed up in the Department of Endocrinology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, from January 2016 to December 2021 were collected, and 85 cases of Graves′ disease without heart disease were collected as the control group(GD group). The medical history, laboratory tests, and echocardiographic parameters of the two groups were compared. Differences in thyroid and cardiac indicators before and after treatment in the HC group were summarized, along with the dosage of β-receptor blockers used in treating different types of conditions(atrial fibrillation and heart failure.Results:Patients in the HC group were older and had a longer duration of hyperthyroidism than those in the GD group( P<0.001, P=0.002). There were no significant differences in thyroid hormone levels between the two groups except for reverse triiodothyronine(rT 3). Age and rT 3 were independent risk factors of hyperthyroid cardiopathy. rT 3 level was linearly positively correlated with brain natriuretic peptide, systolic pulmonary artery pressure, left artrium diamete (LAD) and left ventricular end-systolic diameter(LVDs; r=0.352, P<0.001; r=0.392, P=0.019; r=0.202, P=0.029; r=0.242, P=0.028). In patients of HC group, free triiodothyronine(FT 3) level returned to normal range after 2.87(1.63, 5.53) months of treatment with radioiodine(41/49) or antithyroid drugs(8/49), while brain natriuretic peptide, LAD, LVDs, and systolic pulmonary artery pressure declined after 5.00(1.25, 8.00) months of treatment. Non-selective β-receptor blockers were used for both hyperthyroid heart failure and atrial fibrillation, and there was no statistically significant difference in dosage[(86.52±47.83)mg vs(88.67±47.19)mg, P>0.05]. Conclusions:rT 3 may be a biomarker of hyperthyroid cardiopath and indicate the severity of hyperthyroidism. β-receptor blockers are crucial in treating patients with hyperthyroidism who develop atrial fibrillation and heart failure.
9.Clinical and genetic analysis of patients of PCDH19 gene related epilepsy
Jun ZHANG ; Zhigang YANG ; Miao LIU ; Ying WANG ; Yuan WANG ; Guohong CHEN ; Yanli MA ; Wenqian ZHANG ; Wenjing BI ; Jie DENG ; Fang WANG
Chinese Journal of Neurology 2024;57(10):1120-1126
Objective:To investigate the clinical and gene variant characteristics of PCDH19 gene related epilepsy, and improve the ability of clinicians in early disease identification. Methods:The clinical data of 3 PCDH19 gene related epilepsy patients admitted to Children′s Hospital Affiliated to Zhengzhou University from October 2018 to August 2023 diagnosed by gene detection were reviewed and analyzed. Results:All the patients are female, and the onset age of seizure ranged in their infancy. Seizures in clusters and fever sensitivity were observed in all patients, and were very hard to control by single-drug treatment. Proband 1 was seizure-free after 2 kinds of anti-epileptic drug treatment, but with mild degree of intellectual disability. Proband 2 had refractory epilepsy with severe degree of intellectual disability. Proband 3 was seizure-free after 2 kinds of anti-epileptic drug treatment and without intellectual disability. In the first family, the proband carried heterozygous c.369C>G variant in the PCDH19 gene which was identified as de novo after parental validation. In the second family, the proband carried c.1652T>A variant inherited from her mother. In the third family, the proband carried c.278G>A variant inherited from her father. The 3 mutations had not been reported in the Human Gene Mutation Database. Conclusions:PCDH19 gene related epilepsy is one special kind of X-linked inherited epilepsy syndrome characterized by seizures in clusters and sensitivity to fever. And gene detection can help with early diagnosis and make rational clinical strategies in time. The variants c.369C>G, c.1652T>A and c.278G>A have enriched the gene variant spectrum of PCDH19.
10.Stereotactic electroencephalography in epileptogenic foci excision in pediatric patients with drug-resistant epilepsy: an analysis of 126 cases
Yaoling LIU ; Yue HU ; Zhaozhao ZHANG ; Jianwei CHEN ; Jianfei HU ; Yongcui LANG ; Wenqian LI ; Ning ZHANG ; Qiang LIU ; Guangming ZHANG
Chinese Journal of Neuromedicine 2024;23(7):684-691
Objective:To discuss the efficacy and safety of stereotactic electroencephalography (SEEG) in epileptogenic foci excision in pediatric patients with drug-resistant epilepsy.Methods:A total of 126 pediatric patients (<18 years old) with drug-refractory epilepsy who received SEEG-guided epileptogenic foci excision in Epilepsy Center, Aviation General Hospital from January 2015 to March 2022 were selected. The clinical data and efficacy were retrospectively analyzed, and prognoses of these pediatric patients were evaluated by Engel grading 1 year after resection.Results:(1) A total of 1289 electrodes were implanted, with a mean of (10.09±2.92) electrodes per pediatric patient; 55 pediatric patients had unilateral implant and 71 had bilateral implant. Mean EEG monitoring time was (8.69±5.71) d, ranged 3-28 d. Epileptogenic focus could be located in 114 pediatric patients (90.5%) after initial implantation under SEEG monitoring, and secondary implantation for accurate positioning was given in 12 pediatric patients (9.5%). (2) Lobectomy was performed in 27 pediatric patients (21.4%), multi-lobectomy or tailored cortical resection in 36 (28.6%), tailored cortical resection on single lobe in 60 (47.6%), and tailored cortical resections on single lobe or hippocampal amygdala resection combined with corpus callosotomy in 3 (2.4%). Minimally invasive exploring hemostasis under SEEG was performed in 13 pediatric patients (17 electrodes) and postoperative CT was normal. A little asymptomatic epidural, subdural or cerebral parenchymal hematoma spontaneously absorbed was noted in 4 pediatric patients after implantation under SEEG monitoring. No perioperative infection, CSF leakage, death or severe disability was noted. (3) Mean follow-up was performed for (26.1±7.26) months; 66 (52.3%) pediatric patients reached Engel grading I, 33 (26.2%) reached Engel grading II, 21 reached Engel grading III (16.7%), and 6 (4.8%) reached Engel grading IV. Thirteen pediatric patients with failed resection received SEEG-guided epileptogenic foci excision for the second time: 8 (76.9%) had Engel grading I and 2 had Engel grading II 1 year after follow-up, accounting for 76.9% totally.Conclusion:SEEG-guided epileptogenic foci excision is safe and effective in drug-refractory epilepsy; for pediatric patients with poor initial results, SEEG can be used to relocate the epileptogenic focus, and a second resection of epileptogenic focus can also obtain good results.


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