1.Research Status and Design Ideas of Placebo Manipulation in Clinical Trial Design of Tuina
Jingui WANG ; Haining ZHANG ; Shun FAN ; Yusheng LI ; Hongyi WANG ; An BAO ; Wei ZHANG ; Huanan LI
Journal of Traditional Chinese Medicine 2025;66(11):1128-1132
The rationale for the design of control groups in tuina clinical trial is the foundation for rigorously validating the effectiveness and safety of this therapy. This article reviewed the current state of the design of tuina placebo in control groups of clinical trials, pointed out the necessity of setting up tuina placebo in clinical trials of tuina, analyzed the challenges in implementing blinding of tuina manipulation, and concluded that tuina placebo is still challenged by the placebo effect, the diversification of tuina manipulation but the lack of standardization, and the difficulty of implementing blinding due to the high level of public awareness of tuina. This article also summarized the design of placebo manipulation in three types of clinical trials, including spinal manipulation, acupressure, and paediatric tuina, and proposed four strategies for designing placebo tuina manipulation-controlling placebo effects, developing operational standards for placebo tuina manipulation, ensuring the rigor of blinding implementation, and applying new technologies to enhance the standardization and blinding capacity of placebo tuina methods. So the article is aimed at improving the methodological quality of tuina clinical trial designs, and promoting the standardization and scientificity of tuina clinical trial design.
2.Factors influencing influenza vaccination coverage among kindergarten and primary school children in Zhejiang Province, 2023
Minchao LI ; Jing TAO ; Rui ZHANG ; Yumeng WU ; Zhaokai HE ; Chen WU
Shanghai Journal of Preventive Medicine 2025;37(1):23-28
ObjectiveTo investigate the influenza vaccination coverage among kindergarten and primary school children in Zhejiang Province in 2023 and analyze the influencing factors, and to provide the basis for improving the effect of influenza vaccination in children. MethodsA multi-stage random cluster sampling method was used to select 3 681 parents of children from 10 primary schools and kindergartens based on economic level and geographical distribution in Zhejiang Province, who participated in an online questionnaire survey, including basic information about the children and their parents, parents’ knowledge about influenza, and their willingness to vaccination. ResultsAmong the 3 681 parents surveyed, 33.82% (1 245/3 681) reported that their children received influenza vaccination in 2023. Multivariate logistic regression analysis showed that factors contributing to children’s influenza vaccination included both parents [adjusted OR (95%CI): 1.56 (1.32‒1.84)] and children [6.04 (5.04‒7.27)] having a history of influenza vaccination, parents’ conviction the influenza vaccine could protect children from severe diseases [1.43 (1.19‒1.74)], and the willingness of most parents would let their children get vaccinated [1.40 (1.13‒1.74)]. In contrast, vaccine hesitancy among parents [0.55 (0.43‒0.69)] and the belief that influenza is just a common cold [0.80 (0.65‒1.00)] were hindering factors. ConclusionThe influenza vaccination coverage among children is insufficient. Both the vaccination history of parents and children, as well as parents’ correct understanding of influenza and the effectiveness of influenza vaccine, significantly influence the influenza vaccination status in children. Efforts to address vaccine hesitancy and misconceptions about influenza are essential to improve vaccination rates.
3.Spatiotemporal clustering analysis and ARIMA-SVM model prediction of hand-foot-mouth disease in Zibo City in 2018- 2023
Ming FENG ; Ling ZHANG ; Tao SUN ; Haixia CAO ; Haining ZHU ; Ling WANG
Journal of Public Health and Preventive Medicine 2025;36(6):76-80
Objective To analyze the spatial and temporal distribution characteristics of hand-foot-mouth disease (HFMD) in Zibo City, to explore the key incidence areas, and to find a suitable prediction model, so as to provide reference for the prevention and control of HFMD. Methods The spatiotemporal clustering characteristics of HFMD in Zibo City from 2018 to 2023 were analyzed by using SaTScan 10.0.2 software and ArcGIS 10.7 software. A combination model of ARIMA and SVM was established, and the prediction results were verified and compared. Results Spatial clustering analysis showed that there was spatial clustering of the incidence of HFMD in various townships of Zibo City from 2020 to 2022. The high-high clustering areas and Getis-Ord hot spot areas were mainly concentrated in some main urban areas of Zhangdian District, Zichuan District, and Huantai County. A total of 2-5 aggregation areas were detected by spatiotemporal scanning analysis. The first-type aggregation areas were mainly concentrated in the towns of Zhangdian District, Huantai County, Linzi District, Zhoucun District and Gaoxin District. The aggregation months were July, August, September and November. The model prediction results showed that the ARIMA-SVM combined model was more accurate than the traditional ARIMA model. Conclusion There is a spatiotemporal clustering of hand-foot-mouth disease in Zibo City. The ARIMA-SVM combined model can be used to predict the incidence of hand-foot-mouth disease in Zibo City, and to strengthen health education and disease monitoring in high-risk areas and populations during the epidemic months.
4.Medium- and long-term efficacy of percutaneous mechanical thrombectomy with stent implantation in patients with iliac vein stenosis and thrombosis.
Chunlun CHEN ; Chenyang QIU ; Lan SHEN ; Renda ZHU ; Huaji ZHOU ; Hongkun ZHANG
Journal of Zhejiang University. Medical sciences 2025;54(1):108-114
OBJECTIVES:
To investigate the medium- and long-term efficacy of percutaneous mechanical thrombectomy (PMT) combined with stent implantation for treatment of iliac vein stenosis with lower extremity deep venous thrombosis (LEDVT).
METHODS:
Clinical and follow-up data of 125 patients with iliac vein stenosis and LEDVT who underwent PMT and stent implantation at five hospitals in northern Zhejiang province from January 2017 to June 2021 were collected. The thrombus clearance rate, thrombus recurrence rate, patency rate of iliac vein stents and post-thrombotic syndrome (PTS) occurrence rate were documented, and safety indicators such as bleeding, death, pulmonary embolism, stent fracture and displacement were assessed.
RESULTS:
Among 125 patients, for clearance of limb thrombosis, there were 8 cases of grade I (6.4%), 10 cases of grade II (8.0%), and 107 cases of grade III (85.6%). Patients were followed up for a median period of 74 months. According to the Villalta score, the recurrence rates of limb thrombosis at 12, 24 and 36 months were 8.48%, 8.93% and 10.91%; the iliac vein patency rates were 91.52%, 91.07%, and 89.09%; and the incidences of PTS were 5.08%, 5.36% and 6.36%, respectively. There were no major adverse events such as death, massive pulmonary embolism or severe hepatic and renal insufficiency, and no readmission intervention events due to stent fracture or other incidence were found.
CONCLUSIONS
PMT combined with iliac vein stent implantation is effective for patients with iliac vein stenosis complicated by LEDVT with good medium- and long-term efficacy and safety, which is worthy of clinical application.
Humans
;
Stents
;
Iliac Vein/pathology*
;
Venous Thrombosis/surgery*
;
Thrombectomy/methods*
;
Female
;
Male
;
Middle Aged
;
Aged
;
Adult
;
Constriction, Pathologic/surgery*
;
Treatment Outcome
;
Follow-Up Studies
5.Clinical features and prognostic analysis of colorectal extranodal NK/T cell lymphoma
Xiangyu LI ; Jianning YAO ; Xuyang DONG ; Liangxing CHENG ; Xuexiu ZHANG ; Mengge SU ; Haining ZHOU ; Jinlin XIE ; Zhaoxiang SONG ; Fei HAN
Chinese Journal of Oncology 2024;46(8):782-793
Objective:To investigate the clinical manifestations, endoscopic characteristics, and prognostic factors of patients with colorectal extranodal NK/T cell lymphoma.Methods:The clinical data of 52 patients with colorectal extranodal NK/T cell lymphoma admitted to the First Affiliated Hospital of Zhengzhou University from January 2013 to January 2023 were retrospectively analyzed. Their clinical manifestations and endoscopic characteristics were summarized, and the prognostic factors were analyzed by Cox regression model.Results:Among the 52 patients with colorectal extranodal NK/T cell lymphoma, there were 35 males and 17 females, with a male-to-female ratio of 2.06∶1. Among the general symptoms, abdominal pain was the most common (39 cases), and B symptoms occurred in 47 patients, among which fever was the most common lymphoma B symptom (42 cases), and gastrointestinal perforation was the most common complication (18 cases). Forty-three patients underwent colonoscopy, and the main manifestations under endoscopy were the ulceration type (24 cases). The ulcers were irregular at the edges and often covered with moss at the bottom. The median survival time was 4.3 months. Multivariate Cox regression analysis showed that hemocytic syndrome ( HR=8.50,95% CI: 1.679-8.328, P=0.001), serum albumin ( HR=3.59,95% CI: 1.017-6.551, P=0.048), and with or without chemotherapy ( HR=0.31, 95% CI: 0.246-1.061, P=0.025) were independent factors influencing the overall survival of patients with colorectal extranodal NK/T cell lymphoma. Conclusions:Colorectal extranodal NK/T cell lymphoma is a rare disease with a very poor prognosis. When patients present with abdominal pain and lymphoma B symptoms, and when ulcers with irregular edges and moss covering the bottom are found under endoscopy, the disease should be considered, and endoscopic biopsy should be taken in time for pathological diagnosis. The prognosis of patients with hemophagocytic syndrome and hypoproteinemia is poor. This disease should be treated with chemotherapy and surgery, and on this basis, hemophagocytic syndrome and hypoproteinemia should be treated to improve the prognosis of patients.
6.A cortical thickness study of insomnia disorder patients based on MRI
Wei CHEN ; Hui WANG ; Ziyi LIU ; Yu SHANG ; Haining LI ; Wenxuan HAN ; Qiange ZHU ; Ming ZHANG
Journal of Practical Radiology 2024;40(11):1766-1769
Objective To investigate the changes of cortical thickness in patients with insomnia disorder(ID).Methods High-resolution MRI data were collected from 32 ID patients(ID group)and 30 healthy controls(HC)(HC group).The cortical thickness of both groups were analyzed using statistical parametric mapping 12(SPM12)software,while considering age,gender,and educational level as covariates.The cortical thickness in brain regions showed statistically significant differences was extracted for Pearson's correla-tion analyses with sleep and mood-related scales.Results Compared with the HC group,the ID group exhibited significantly decreased cortical thickness in brain regions such as the left insula,fusiform gyrus,orbitofrontal lobe,superior temporal gyrus,middle temporal gyrus,lateral occipital lobe and right caudal anterior cingulate gyrus[P<0.05,family-wise error(FWE)correction].Furthermore,reduced cortical thickness of the cingulate gyrus was negatively correlated with the Pittsburgh sleep quality index(PSQI)score(r=-0.437,P=0.012).Conclusion The cortical thickness of several brain regions associated with sleep and mood are significantly reduced in patients with ID,providing potential neuroimaging evidence for understanding the pathophysiological mechanism of ID.
7.Clinical features and prognostic analysis of colorectal extranodal NK/T cell lymphoma
Xiangyu LI ; Jianning YAO ; Xuyang DONG ; Liangxing CHENG ; Xuexiu ZHANG ; Mengge SU ; Haining ZHOU ; Jinlin XIE ; Zhaoxiang SONG ; Fei HAN
Chinese Journal of Oncology 2024;46(8):782-793
Objective:To investigate the clinical manifestations, endoscopic characteristics, and prognostic factors of patients with colorectal extranodal NK/T cell lymphoma.Methods:The clinical data of 52 patients with colorectal extranodal NK/T cell lymphoma admitted to the First Affiliated Hospital of Zhengzhou University from January 2013 to January 2023 were retrospectively analyzed. Their clinical manifestations and endoscopic characteristics were summarized, and the prognostic factors were analyzed by Cox regression model.Results:Among the 52 patients with colorectal extranodal NK/T cell lymphoma, there were 35 males and 17 females, with a male-to-female ratio of 2.06∶1. Among the general symptoms, abdominal pain was the most common (39 cases), and B symptoms occurred in 47 patients, among which fever was the most common lymphoma B symptom (42 cases), and gastrointestinal perforation was the most common complication (18 cases). Forty-three patients underwent colonoscopy, and the main manifestations under endoscopy were the ulceration type (24 cases). The ulcers were irregular at the edges and often covered with moss at the bottom. The median survival time was 4.3 months. Multivariate Cox regression analysis showed that hemocytic syndrome ( HR=8.50,95% CI: 1.679-8.328, P=0.001), serum albumin ( HR=3.59,95% CI: 1.017-6.551, P=0.048), and with or without chemotherapy ( HR=0.31, 95% CI: 0.246-1.061, P=0.025) were independent factors influencing the overall survival of patients with colorectal extranodal NK/T cell lymphoma. Conclusions:Colorectal extranodal NK/T cell lymphoma is a rare disease with a very poor prognosis. When patients present with abdominal pain and lymphoma B symptoms, and when ulcers with irregular edges and moss covering the bottom are found under endoscopy, the disease should be considered, and endoscopic biopsy should be taken in time for pathological diagnosis. The prognosis of patients with hemophagocytic syndrome and hypoproteinemia is poor. This disease should be treated with chemotherapy and surgery, and on this basis, hemophagocytic syndrome and hypoproteinemia should be treated to improve the prognosis of patients.
8.Analysis of foodborne diseases pathogen infection characteristics in Haining City, Zhejiang Province from 2014 to 2023
Minchao LI ; Lijun SONG ; Guofei LU ; Yunheng ZHANG ; Tianwang ZHAO
Shanghai Journal of Preventive Medicine 2024;36(7):638-643
ObjectiveTo analyze the epidemiological characteristics of pathogens in foodborne disease cases in Haining City, Zhejiang Province, and to provide a basis for the prevention and investigation of foodborne diseases and outbreak events. MethodsInformation on foodborne disease patients from 2014 to 2023 was collected, and stool or anal swab samples were tested for relevant pathogens. The χ2 test was used to compare the differences in pathogen detection rates among different groups, and multivariate logistic regression analysis was used to analyze the risk factors for pathogen detection. ResultsA total of 5 814 samples were tested, with a positive detection rate of 15.36%. The detection rates were 4.95% for norovirus, 4.49% for Escherichia coli, 3.59% for Salmonella, 2.22% for Vibrio parahaemolyticus, and 0.11% for Shigella. The positive detection rates showed seasonal characteristics, with a minor peak in March-April dominated by norovirus and a major peak in July-September dominated by bacteria. The three groups with the highest detection rates were workers, white-collar workers and other groups. Multivariate logistic regression analysis showed that age, season, and antibiotic use before consultation were significant influencing factors for pathogen detection (P<0.05). Total pathogen detection risk was lower in the group that took antibiotics before visiting the clinic compared to those who did not (OR=0.29, 95%CI: 0.15‒0.49). The detection risk for norovirus was lower in the preschool age group (OR=0.19, 95%CI: 0.04‒1.00), in summer and autumn (OR range 0.23‒0.41), and in the group taking antibiotics (OR=0.42, 95%CI: 0.15‒0.92), but higher in the adolescent group (OR=1.40, 95%CI: 1.05‒1.88). The detection risk for enteropathogenic Escherichia coli was higher in summer (OR=1.82, 95%CI: 1.30‒2.60). The detection risk for Salmonella increased in the elderly group and in summer (OR range 1.44‒2.21), but decreased in the adolescent group, in winter, and in the group taking antibiotics (OR range 0.22‒0.65). The detection risk for Vibrio parahaemolyticus increased in summer and autumn (OR range 1.80‒1.90), but decreased in the primary and secondary school student group and in winter (OR range 0.10‒0.32). ConclusionThe prevalence of foodborne disease pathogens in Haining City is relatively high. Age, season, and antibiotic use before consultation are independent influencing factors for pathogen detection. These findings suggest that specific hypotheses regarding pathogenic factors can be proposed based on the time of occurrence and the age distribution of cases during field investigations of foodborne outbreaks.
9.Current status of ex vivo liver resection and autotransplantation in treatment of benign liver lesions
Shuai ZHANG ; Fazhu FEI ; Zhixin WANG ; Haining FAN ; Haijiu WANG ; Lizhao HOU
Journal of Clinical Hepatology 2024;40(12):2543-2547
Benign liver lesions mainly include hepatic hemangioma, focal nodular hyperplasia of the liver, hepatocellular adenoma, and hepatic angiomyolipoma. Hepatic alveolar echinococcosis is a type of parasitic disease, and since it mainly occurs in the liver, it is also a benign lesion of the liver. The clinical treatment of benign liver lesions is mainly based on follow-up observation, supplemented by surgical resection. For patients with end-stage diseases, liver transplantation can be performed due to the large volume of the lesion, the invasion of a number of surrounding large vessels, unclear anatomic location, and the possibility of intraoperative rupture and massive hemorrhage. Since patients with poor liver function based on the liver allocation score for organ donation are more likely to get donor liver, it is difficult for patients with benign liver lesions to obtain the corresponding donor liver resources due to the growth pattern of benign liver lesions, thereby leading to the limited application of allogeneic liver transplantation. Since its emergence in the 1980s, ex vivo liver resection and autotransplantation (ELRA) has brought a new way for the treatment of such patients. This article summarizes the current application of ELRA in benign liver lesions, in order to provide a reference for diagnosis and treatment by clinical medical staff.
10.Expression of neutrophil extracellular traps and phagocytic functions among patients with hepatic alveolar echinococcosis
Zhuoga RENZENG ; Haining FAN ; Kangjie YANG ; Zhixin WANG ; Yaogang ZHANG ; Yongliang LU ; Haijiu WANG
Chinese Journal of Schistosomiasis Control 2024;36(1):25-33
Objective To investigate the expression of neutrophil extracellular traps (NETs) and phagocytic function in the peripheral blood of patients with hepatic alveolar echinococcosis (HAE), and to examine their correlations with clinical inflamma tory indicators and liver functions. Methods A total of 50 patients with HAE admitted to Department of Hepatobiliary and Pancreatic Surgery, The Affiliated Hospital of Qinghai University from August 2022 to June 2023 were enrolled, while 50 age- and gender-matched healthy individuals from the Centre for Healthy Examinations of the hospital during the same period served as controls. The levels of NETs markers neutrophil myeloperoxidase (MPO) and neutrophil elastase (NE) were measured using enzyme-linked immunosorbent assay (ELISA). Peripheral blood neutrophils were isolated using density gradient centrifugation, stimulated in vitro using phorbol 12-myristate 13 acetate (PMA), and the levels of MPO and citrullination histone H3 (CitH3) released by neutrophils were quantified using flow cytometry. The phagocytic functions of neutrophils were examined using flow cytometry. In addition, the correlations of MPO and NE levels with clinical inflammatory indicators and liver biochemical indicators were examined using Spearman correlation analysis among HAE patients. Results The peripheral blood plasma MPO[(417.15 ± 76.08) ng/mL vs. (255.70 ± 80.84) ng/mL; t = 10.28, P < 0.05], NE[(23.16 ± 6.75) ng/mL vs. (11.92 ± 3.17) ng/mL; t = 10.65, P < 0.05]and CitH3 levels[(33.93 ± 18.93) ng/mL vs. (19.52 ± 13.89) ng/mL; t = 4.34, P < 0.05]were all significantly higher among HAE patients than among healthy controls, and a lower phagocytosis rate of neutrophils was detected among HAE patients than among healthy controls[(70.85 ± 7.32)% vs. (94.04 ± 3.90)%; t = 20.18, P < 0.05], and the ability to produce NETs by neutrophils was higher among HAE patients than among healthy controls following in vitro PMA stimulation. Pearson correlation analysis showed that the phagocytosis rate of neutrophils correlated negatively with platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), interleukin-6 (IL-6) level and C-reactive protein (CRP) level (rs = −0.515 to −0.392, all P values < 0.05), and the MPO and NE levels positively correlated with inflammatory markers NLR, PLR, CRP and IL-6 (rs = 0.333 to 0.445, all P values < 0.05) and clinical liver biochemical indicators aspartic transaminase, alanine aminotransferase, direct bilirubin and total bilirubin among HAE patients (rs = 0.290 to 0.628, all P values < 0.001). Conclusions Excessive formation of NETs is found among HAE patients, which affects the phagocytic ability of neutrophils and results in elevated levels of inflammatory indicators. NETs markers may be promising novel biomarkers for early diagnosis, monitoring, and severity assessment of liver disease.


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