1.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
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Child
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Child, Preschool
;
Female
;
Humans
;
Male
;
Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
;
Tic Disorders/drug therapy*
;
Treatment Outcome
2.Spatio-Temporal Pattern and Socio-economic Influencing Factors of Tuberculosis Incidence in Guangdong Province: A Bayesian Spatiotemporal Analysis.
Hui Zhong WU ; Xing LI ; Jia Wen WANG ; Rong Hua JIAN ; Jian Xiong HU ; Yi Jun HU ; Yi Ting XU ; Jianpeng XIAO ; Ai Qiong JIN ; Liang CHEN
Biomedical and Environmental Sciences 2025;38(7):819-828
OBJECTIVE:
To investigate the spatiotemporal patterns and socioeconomic factors influencing the incidence of tuberculosis (TB) in the Guangdong Province between 2010 and 2019.
METHOD:
Spatial and temporal variations in TB incidence were mapped using heat maps and hierarchical clustering. Socioenvironmental influencing factors were evaluated using a Bayesian spatiotemporal conditional autoregressive (ST-CAR) model.
RESULTS:
Annual incidence of TB in Guangdong decreased from 91.85/100,000 in 2010 to 53.06/100,000 in 2019. Spatial hotspots were found in northeastern Guangdong, particularly in Heyuan, Shanwei, and Shantou, while Shenzhen, Dongguan, and Foshan had the lowest rates in the Pearl River Delta. The ST-CAR model showed that the TB risk was lower with higher per capita Gross Domestic Product (GDP) [Relative Risk ( RR), 0.91; 95% Confidence Interval ( CI): 0.86-0.98], more the ratio of licensed physicians and physician ( RR, 0.94; 95% CI: 0.90-0.98), and higher per capita public expenditure ( RR, 0.94; 95% CI: 0.90-0.97), with a marginal effect of population density ( RR, 0.86; 95% CI: 0.86-1.00).
CONCLUSION
The incidence of TB in Guangdong varies spatially and temporally. Areas with poor economic conditions and insufficient healthcare resources are at an increased risk of TB infection. Strategies focusing on equitable health resource distribution and economic development are the key to TB control.
Humans
;
China/epidemiology*
;
Incidence
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Bayes Theorem
;
Spatio-Temporal Analysis
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Tuberculosis/epidemiology*
;
Socioeconomic Factors
3.The preliminary therapeutic effect of endoscopic ultrasound-guided tissue adhesive injection with the assistance of metal clips in treatment of cirrhotic patients with gastric varices and gastric-renal shunt
Jiali MA ; Zhenglin AI ; Julong HU ; Yu JIANG ; Yuling ZHOU ; Xiuxia LIANG ; Hongshan WEI ; Ping LI
Journal of Clinical Hepatology 2024;40(4):734-738
ObjectiveTo investigate the safety and efficacy of endoscopic ultrasound-guided tissue adhesive injection with the assistance of metal clips in the treatment of cirrhotic patients with gastric varices and gastric-renal shunt (GRS). MethodsThe patients who attended Beijing Ditan Hospital, Capital Medical University, due to liver cirrhosis and gastric varices from February to June 2023 were enrolled, and all patients were confirmed to have GRS and received endoscopic ultrasound-guided tissue adhesive injection with the assistance of metal clips. The primary evaluation index was alleviation or disappearance of varicose veins after surgery, and the secondary evaluation indices were surgical completion and complications. ResultsA total of 11 patients were enrolled in this study, among whom there were 7 male patients and 4 female patients, with a median age of 55 years. Of all patients, 1 had Child class A liver function, 7 had Child class B liver function, and 3 had Child class C liver function. The maximum (median) diameter of the shunt was 8 mm, and the minimum (median) diameter of the shunt was 4 mm. The median blood flow velocity of the target vessel was 11 cm/s before treatment and 5 cm/s after occlusion with metal clips. The median amount of tissue adhesive injected was 2 mL, and the amount of lauromacrogol used was 1 mL. Disappearance of blood flow signals was observed in all patients after surgery (100%), and the success rate of surgery was 100%. No patient experienced rebleeding after follow-up for 6 weeks. Gastroscopy at 1 month after surgery showed that gastric varices were eradicated or almost disappeared in 9 patients and were alleviated in 2 patients. ConclusionEndoscopic ultrasound-guided tissue adhesive injection with the assistance of metal clips is a feasible, safe, and effective treatment method for cirrhotic patients with gastric varices and GRS.
4.Feasibility of Two-Screw Anterior Fixation for Odontoid Fractures in a Chinese Population:A Morphometric Study Based on Computed Tomography
Yixiang AI ; Dereje Gobena ALEMAYEHU ; Genwen MAO ; Yaping LIANG ; Ran CAO ; Jiale HU ; Yimin YANG ; Zhiwei REN
Clinics in Orthopedic Surgery 2023;15(6):983-988
Background:
To evaluate the feasibility of treating odontoid fractures in the Chinese population with two cortical screws based on computed tomography (CT) scans and describe a new measurement strategy to guide screw insertion in treating these fractures.
Methods:
A retrospective review of cervical computed tomographic scans of 128 patients (aged 18–76 years; men, 55 [43.0%]) was performed. The minimum external transverse diameter (METD), minimum external anteroposterior diameter (MEAD), maximum screw length (MSL), and screw projection back angle (SPBA) of the odontoid process were measured on coronal and sagittal CT images.
Results:
The mean values of METD and MEAD were 10.0 ± 1.1 mm and 12.0 ± 1.0 mm, respectively, in men and 9.2 ± 1.0 mm and 11.0 ± 1.0 mm, respectively, in women. Both measurements were significantly higher in men (p < 0.001). In total, 87 individuals (68%) had METD > 9.0 mm that could accommodate two 3.5-mm cortical screws. The mean MSL value and SPBA range were 34.4 ± 2.9 mm and 13.5°–24.2°, respectively, with no statistically significant difference between men and women.
Conclusions
The insertion of two 3.5-mm cortical screws was possible for anterior fixation of odontoid fractures in 87 patients (68%) in our study, and there was a statistically significant difference between men and women.
5.Course of disease and related epidemiological parameters of COVID-19: a prospective study based on contact tracing cohort.
Yan ZHOU ; Wen Jia LIANG ; Zi Hui CHEN ; Tao LIU ; Tie SONG ; Shao Wei CHEN ; Ping WANG ; Jia Ling LI ; Yun Hua LAN ; Ming Ji CHENG ; Jin Xu HUANG ; Ji Wei NIU ; Jian Peng XIAO ; Jian Xiong HU ; Li Feng LIN ; Qiong HUANG ; Ai Ping DENG ; Xiao Hua TAN ; Min KANG ; Gui Min CHEN ; Mo Ran DONG ; Hao Jie ZHONG ; Wen Jun MA
Chinese Journal of Preventive Medicine 2022;56(4):474-478
Objective: To analyze the course of disease and epidemiological parameters of COVID-19 and provide evidence for making prevention and control strategies. Methods: To display the distribution of course of disease of the infectors who had close contacts with COVID-19 cases from January 1 to March 15, 2020 in Guangdong Provincial, the models of Lognormal, Weibull and gamma distribution were applied. A descriptive analysis was conducted on the basic characteristics and epidemiological parameters of course of disease. Results: In total, 515 of 11 580 close contacts were infected, with an attack rate about 4.4%, including 449 confirmed cases and 66 asymptomatic cases. Lognormal distribution was fitting best for latent period, incubation period, pre-symptomatic infection period of confirmed cases and infection period of asymptomatic cases; Gamma distribution was fitting best for infectious period and clinical symptom period of confirmed cases; Weibull distribution was fitting best for latent period of asymptomatic cases. The latent period, incubation period, pre-symptomatic infection period, infectious period and clinical symptoms period of confirmed cases were 4.50 (95%CI:3.86-5.13) days, 5.12 (95%CI:4.63-5.62) days, 0.87 (95%CI:0.67-1.07) days, 11.89 (95%CI:9.81-13.98) days and 22.00 (95%CI:21.24-22.77) days, respectively. The latent period and infectious period of asymptomatic cases were 8.88 (95%CI:6.89-10.86) days and 6.18 (95%CI:1.89-10.47) days, respectively. Conclusion: The estimated course of COVID-19 and related epidemiological parameters are similar to the existing data.
COVID-19
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Cohort Studies
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Contact Tracing
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Humans
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Incidence
;
Prospective Studies
6.Analysis of intestinal microbial diversity in Leopoldamys edwardsi based on illumina sequencing technique.
Duan Duan XUAN ; Yuan Li LI ; Guan Nan ZHANG ; Lin Wei DING ; Pei Pei CAO ; Rui Jie JIA ; Yu Ai ZHENG ; Xiao Jun ZHOU ; Liang Yuan PAN ; Shou Kui HU ; Li Na NIU
Chinese Journal of Preventive Medicine 2022;56(4):512-518
To explore the composition and diversity of the intestinal microflora of Leopoldamys edwardsi in Hainan Island. In November 2019, DNA was extracted from fecal samples of 25 adult Leopoldamys edwardsi (14 males and 11 females) in Hainan Island at the Joint Laboratory of tropical infectious diseases of Hainan Medical College and Hong Kong University. Based on the IonS5TMXL sequencing platform, single-end sequencing (Single-End) was used to construct a small fragment library for single-end sequencing. Based on Reads shear filtration and OTUs clustering. The species annotation and abundance analysis of OTUs were carried out by using mothur method and SSUrRNA database, and further conducted α diversity and β diversity analysis. A total of 1481842 high quality sequences, belonging to 14 Phyla, 85 families and 186 Genera, were obtained from 25 intestinal excrement samples of Leopoldamys edwardsi. At the level of phyla classification, the main core biota of the Leopoldamys edwardsi contained Firmicutes (46.04%),Bacteroidetes (25.34%), Proteobacteria (17.09%), Tenericutes (7.38%) and Actinobacteria (1.67%), these five phyla account for 97.52% of all phyla. The ratio of Helicobacter which occupied the largest proportion at the genus level was 12.44%, followed by Lactobacillus (11.39%), Clostridium (6.19%),Mycoplasma (4.23%) and Flavonifractor (3.52%). High throughput sequencing analysis showed that the intestinal flora of Leopoldamys edwardsi in Hainan Island was complex and diverse, which had the significance of further research.
Adult
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Animals
;
Bacteria/genetics*
;
Feces/microbiology*
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Female
;
Gastrointestinal Microbiome/genetics*
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High-Throughput Nucleotide Sequencing
;
Humans
;
Intestines
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Male
;
Murinae/genetics*
7.Analysis of epidemiological characteristics of pulmonary tuberculosis patients in Fengtai District, Beijing City from 2011 to 2021.
Yuan Lian HU ; Ping AI ; Xue Jiao JIA ; Dong Yan ZHANG ; Xiao XUE ; Ling DENG ; Wei CHEN ; Guo Liang YANG ; Li Jie CHANG ; Zhen Jie XIN
Chinese Journal of Preventive Medicine 2022;56(9):1302-1306
Objective: To analyze the epidemiological characteristics of pulmonary tuberculosis (PTB) in Fengtai District from 2011 to 2021. Methods: A retrospective study was conducted, the data of PTB patients in Fengtai District from 2011 to 2021 were collected in Chinese disease prevention and Control Information System, which included etiological classification, gender, age, occupation, onset time, demographic information etc. the epidemiological characteristics of reported PTB patients was analysis. Results: A total of 10 342 cases of PTB were reported from 2011 to 2021 in Fengtai District, with an average annual reported incidence rate of 42.87/ 100 000. The incidence rate was the highest in 2012(75.89/100 000), and significantly declined from 2013, which declined to 29.70/100 000 in 2017. It showed a slow rise from 2018 to 2021. The difference was statistically significant (χ2=1 471.77,P<0.001).There were 2 975 cases of etiologic positive PTB from 2011 to 2021, and 76 cases of Rifampicin-resistant PTB from 2017 to 2021. The ratio of male cases to female was 1.75, the average annual incidence rate of male (53.94/100 000) was higher, than female(31.57/100 000).(χ2=704.01,P<0.001). Among all age groups, 25-29 years group, 20-24 years group and 30-34 years group had the highest proportion, which were 1 506 cases (14.56%) , 1 292 cases (12.49%) and 1 024 cases (9.90%) respectively. The average annual incidence rate was the lowest in the group less than 10 years old (1.43/100 000), and the highest in the group 85 years old and over (195.20/100 000), the difference was statistically significant(χ2=3164.24, P<0.001). The top occupations from high to low were housework and unemployment (2 917 cases, 28.21%), retirees (2 308 cases, 22.32%), workers (1 047 cases, 10.12%), cadres and staff (950 cases, 9.19%), farmers (860 cases, 8.32%), business services (698 cases, 6.75%), teachers and students (455 cases, 4.40%). Conclusion: From 2011 to 2021, the incidence rate of PTB was decreased from 2012 to 2017, and slowly increased lately in Fengtai District. The epidemiological characteristics of PTB vary in different age and gender.
Adult
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Aged, 80 and over
;
Beijing
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Child
;
China/epidemiology*
;
Female
;
Humans
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Incidence
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Male
;
Retrospective Studies
;
Rifampin
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Tuberculosis, Pulmonary/prevention & control*
8.Evaluation of effect based on different typing methods in Escherichia coli.
Wen Juan LIANG ; Ai Ling HU ; Jin Zhao LONG ; Jin Qin ZHU ; Guangcai DUAN
Chinese Journal of Epidemiology 2022;43(8):1321-1325
Objective: To evaluate the typing and clinical application effect based on clustered regularly interspaced short palindromic repeats (CRISPRs), serotype, and Multilocus Sequence Typing (MLST). Methods: The spacers, serotype and sequence type (ST) were obtained with CRISPRsFinder, SeroTypeFinder and MLST. PCR was used to amplify the CRISPRs, and the spacers were used to predict serotype and ST, then comparing with the serotype and ST. Results: We defined the I-E CRISPR/Cas as CT-Ⅰ, I-F CRISPR/Cas as CT-Ⅱ, and only CRISPR3-4 as CT-Ⅲ. We designated each unique arrangement spacer profile as a unique CRISPRs type. A total of 79 CT types, 76 serotypes, and 66 STs were identified. The CRISPRs typing was the most discriminating, with the Simpson index of 0.936, having the highest correlation with serology with the adjusted Rand index of 0.908. The CRISPRs type could divide the same serotype (ST) into two subtypes [O157∶H7(ST11), O104∶H4(ST678), and O26∶H11(ST21)]. The detection rates of CRISPR1, CRISPR2, CRISPR3, CRISPR4, and CRISPR3-4 were 81.1%, 94.5%, 1.4%, 1.4%, and 4.6%, with the accuracy rate of 95.0% and 100.0% according to the spacers to forecast O157∶H7 (ST11) and ST131. Conclusion: Based on the CRISPRs spacer, this method can be used as an essential molecular typing for E.coli, as it presents a good typing and clinical application effect.
Escherichia coli/genetics*
;
Escherichia coli Infections
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Humans
;
Multilocus Sequence Typing
9.Effect of Mobile Health for Standardized Management on Women with Gestational Diabetes Mellitus.
Fei-Ling HUANG ; Hui-Ying HU ; Su-Han ZHANG ; Li LI ; Li ZHANG ; Xiao-Xia CHEN ; Chu-Ci ZHANG ; Hong-Xiu ZHONG ; Ai-Min YAO ; Cui-Ying LIU ; Ning-Zhi ZHANG ; Xiao-Wen XUE ; Liang-Kun MA
Acta Academiae Medicinae Sinicae 2021;43(4):551-557
Objective To explore the performance of mobile health platform for standardized management of pregnant women with gestational diabetes mellitus(GDM). Methods A randomized controlled trial was conducted,in which 295 women with GDM were randomized into two groups(traditional management group and mobile health management group)by a computer-generated sequence.The traditional management group accepted standardized GDM management,and the mobile health management group was supplemented by mobile health management based on the standardized management.The glycemic control rate and the incidences of low birth weight,macrosomia,preterm birth,premature rupture of membranes,postpartum hemorrhage after cesarean section,neonatal asphyxia,malformation,and admission to the neonatal intensive care unit were compared between the two groups. Results The glycemic control rate in mobile health management group was significantly higher than that in the traditional management group [(67.22±22.76)%
Cesarean Section
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Diabetes, Gestational/therapy*
;
Female
;
Fetal Macrosomia
;
Humans
;
Infant, Newborn
;
Pregnancy
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Pregnancy Outcome
;
Premature Birth
;
Telemedicine
10.Risk factors for rebleeding after endoscopic selective variceal devascularization in patients with hepatitis B cirrhosis and acute variceal bleeding
Jiali MA ; Yu JIANG ; Julong HU ; Zhenglin AI ; Lingling HE ; Yuling ZHOU ; Xiuxia LIANG ; Yijun LIN ; Hongshan WEI ; Ping LI
Journal of Clinical Hepatology 2021;37(11):2569-2574
Objective To investigate the rebleeding rate after endoscopic selective variceal devascularization (ESVD) and the predictive factors for rebleeding in patients with hepatitis B cirrhosis and esophageal variceal bleeding (EVB). Methods The patients with hepatitis B cirrhosis and EVB who attended Beijing Ditan Hospital, Capital Medical University, from October 2010 to December 2019 and underwent ESVD for the first time were enrolled, and a total of 442 patients were screened out based on inclusion and exclusion criteria. Routine clinical indices, laboratory markers, imaging findings, and endoscopic findings were compared between patients, and the patients were followed up to observe rebleeding. The t -test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups; the chi-square test was used for comparison of categorical data between two groups. The Kaplan-Meier method was used to describe rebleeding and survival status, and a Cox regression analysis was used to determine the independent risk factors for variceal rebleeding. Results The 1-, 2-, 3-, 4-, and 5-year cumulative rebleeding rates after first ESVD treatment were 25.11%, 33.94%, 39.82%, 42.08%, and 45.02%, respectively. The univariate analysis showed that age, systolic pressure, duration of antiviral therapy ≥1 year, ascites, white blood cell count, neutrophil, and direct bilirubin were associated with rebleeding (all P < 0.05), and the multivariate analysis showed that duration of antiviral therapy ≥1 year (hazard ratio [ HR ]=0.504, 95% confidence interval [ CI ]: 0.357-0.711, P < 0.001) and ascites ( HR =1.424, 95% CI : 1.184-1.714, P < 0.001) were independent influencing factors for variceal rebleeding. Conclusion ESVD has a low rebleeding rate in the treatment of hepatitis B cirrhosis with EVB, and presence of ascites and a short duration of antiviral therapy are independent risk factors for rebleeding after treatment.

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