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
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Female
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Humans
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Male
;
Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
;
Treatment Outcome
2.Genetic profiling and intervention strategies for phenylketonuria in Gansu, China: an analysis of 1 159 cases.
Chuan ZHANG ; Pei ZHANG ; Bing-Bo ZHOU ; Xing WANG ; Lei ZHENG ; Xiu-Jing LI ; Jin-Xian GUO ; Pi-Liang CHEN ; Ling HUI ; Zhen-Qiang DA ; You-Sheng YAN
Chinese Journal of Contemporary Pediatrics 2025;27(7):808-814
OBJECTIVES:
To investigate the molecular epidemiology of children with phenylketonuria (PKU) in Gansu, China, providing foundational data for intervention strategies.
METHODS:
A retrospective analysis was conducted on 1 159 PKU families who attended Gansu Provincial Maternity and Child Care Hospital from January 2012 to December 2024. Sanger sequencing, multiplex ligation-dependent probe amplification, whole exome sequencing, and deep intronic variant analysis were used to analyze the PAH gene.
RESULTS:
For the 1 159 children with PKU, 2 295 variants were identified in 2 318 alleles, resulting in a detection rate of 99.01%. The detection rates were 100% (914/914) in 457 classic PKU families, 99.45% (907/912) in 456 mild PKU families, and 96.34% (474/492) in 246 mild hyperphenylalaninemia families. The 2 295 variants detected comprised 208 distinct mutation types, among which c.728G>A (14.95%, 343/2 295) had the highest frequency, followed by c.611A>G (4.88%, 112/2 295) and c.721C>T (4.79%, 110/2 295). The cumulative frequency of the top 23 hotspot variants reached 70.28% (1 613/2 295), and most variant alleles were detected in exon 7 (29.19%, 670/2 295).
CONCLUSIONS
Deep intronic variant analysis of the PAH gene can improve the genetic diagnostic rate of PKU. The development of targeted detection kits for PAH hotspot variants may enable precision screening programs and enhance preventive strategies for PKU.
Humans
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Phenylketonurias/epidemiology*
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Female
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Male
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Retrospective Studies
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Phenylalanine Hydroxylase/genetics*
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Mutation
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Child, Preschool
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China/epidemiology*
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Child
;
Infant
3.Impacts of Sulforaphane on Cell Proliferation and Apoptosis in Acute Promyelogenous Leukemia by Regulating the PI3K/Akt/mTOR Signaling Pathway.
Cui-Cui WANG ; Zhen-Jing LI ; Xiu-Hong JIA ; Jian-Chang LI
Journal of Experimental Hematology 2025;33(3):633-639
OBJECTIVE:
To investigate the impacts of sulforaphane (SPN) on cell proliferation and apoptosis in acute promyelogenous leukemia by regulating the PI3K/Akt/mTOR signaling pathway.
METHODS:
NB4 cells were divided into 5 μmol/L SPN group, 10 μmol/L SPN group, 20 μmol/L SPN group, 740 Y-P (10 μmol/L) group and 20 μmol/L SPN+740 Y-P group, and the untreated NB4 cells were used as the control group. CCK-8, Hoechst 33342 staining, flow cytometry and monodansulfonylpentanediamine (MDC) were used to detect cell proliferation, apoptosis and autophagy, respectively. The expression levels of Bcl-2, Bax, cyclin D1 and LC3B mRNA were detected by qRT-PCR. Western blot was used to detect the expression levels of PI3K/Akt/mTOR pathway-related proteins in NB4 cells.
RESULTS:
Compared with the control group, the proliferation rate, Bcl-2, cyclin D1 mRNA expressions, p-PI3K/PI3K, p-Akt/Akt, and p-mTOR/mTOR ratio were greatly increased in the 740 Y-P group (P < 0.05), the apoptosis rate, percentage of MDC positive, Bax and LC3B mRNA expression levels were greatly decreased (P < 0.05). The proliferation rate, Bcl-2, cyclin D1 mRNA expression levels, p-PI3K/PI3K, p-Akt/Akt, and p-mTOR/mTOR ratio were greatly decreased in the 5 μmol/L SPN group, 10 μmol/L SPN group, and 20 μmol/L SPN group (P < 0.05), the apoptosis rate, percentage of MDC positive,Bax and LC3B mRNA expression levels were greatly increased, there were differences among different SPN treatment groups (P < 0.05). Compared with the 20 μmol/L SPN group, the proliferation rate, Bcl-2, cyclin D1 mRNA expression levels, p-PI3K/PI3K, p-Akt/Akt, and p-mTOR/mTOR ratio were greatly increased in the 20 μmol/L SPN+740 Y-P group(P < 0.05), the apoptosis rate, percentage of MDC positive, Bax and LC3B mRNA expression levels were greatly decreased (P < 0.05). Compared with the 740 Y-P group, the proliferation rate, Bcl-2, cyclin D1 mRNA expression levels, p-PI3K/PI3K, p-Akt/Akt, and p-mTOR/mTOR ratio in the 20 μmol/L SPN+740 Y-P group were greatly reduced (P < 0.05), the apoptosis rate, percentage of MDC positive, Bax and LC3B mRNA expression levels were greatly increased (P < 0.05).
CONCLUSION
SPN reduces the proliferation of acute promyelocytic leukemia cells and promotes cells apoptosis by inhibiting the PI3K/Akt/mTOR signaling pathway.
Cell Proliferation/drug effects*
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Apoptosis/drug effects*
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Humans
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TOR Serine-Threonine Kinases/metabolism*
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Signal Transduction/drug effects*
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Proto-Oncogene Proteins c-akt/metabolism*
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Isothiocyanates/pharmacology*
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Phosphatidylinositol 3-Kinases/metabolism*
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Sulfoxides
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Cell Line, Tumor
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Cyclin D1/metabolism*
4.Evidence gap between the systematic reviews and clinical concerns in acupuncture and moxibustion for frozen shoulder.
Zhen LUO ; Weijuan GANG ; Xiaoyi HU ; Huan CHEN ; Lu WANG ; Wencui XIU ; Tianyu MING ; Xianghong JING
Chinese Acupuncture & Moxibustion 2025;45(11):1673-1680
OBJECTIVE:
To reveal the gap between the evidence of systematic reviews (SRs) and clinical concerns by systematically summarizing the evidence on acupuncture and moxibustion for frozen shoulder and investigating the concerns and needs of clinicians in treatment with acupuncture and moxibustion for this disease.
METHODS:
The articles of SR and Meta-analysis on acupuncture and moxibustion for frozen shoulder were searched from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase and Cochrane Library, starting from the inception of each database up to December 31st, 2022. Two researchers screened the articles and extracted data independently. Using AMSTAR-2, the methodological quality of the included studies was evaluated. Based on systematic reviews and expert discussion, a questionnaire on clinical concerns of acupuncture and moxibustion for frozen shoulder was developed and distributed to clinicians. The discrepancies between the evidence and clinical concerns were compared from 5 dimensions, including population, interventions, control measures, outcome indicators and review time points.
RESULTS:
The evidence gaps existed between SRs and clinical concerns. In the existing studies, the needs of personalized treatment were not fully considered in terms of different syndromes/patterns of frozen shoulder and stages of illness, the outcome indicators were not employed properly, the time for outcome measurement was vague, the control groups were set up outside of standardization, and the methodological quality was lower.
CONCLUSION
It is suggested that future studies should improve the quality of methodology, lay more consideration to different patient groups, optimize outcome indicators and standardize the setting of control groups, so as to better meet the needs of patients and achieve the best match between evidence and clinicians' needs.
Humans
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Acupuncture Therapy
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Bursitis/therapy*
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Evidence Gaps
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Moxibustion
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Systematic Reviews as Topic
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Meta-Analysis as Topic
5.Effectiveness of Pentavalent Rotavirus Vaccine - a Propensity Score Matched Test Negative Design Case-Control Study Using Medical Big Data in Three Provinces of China.
Yue Xin XIU ; Lin TANG ; Fu Zhen WANG ; Lei WANG ; Zhen LI ; Jun LIU ; Dan LI ; Xue Yan LI ; Yao YI ; Fan ZHANG ; Lei YU ; Jing Feng WU ; Zun Dong YIN
Biomedical and Environmental Sciences 2025;38(9):1032-1043
OBJECTIVE:
The objective of our study was to evaluate the vaccine effectiveness (VE) of the pentavalent rotavirus vaccine (RV5) among < 5-year-old children in three provinces of China during 2020-2024 via a propensity score-matched test-negative case-control study.
METHODS:
Electronic health records and immunization information systems were used to obtain data on acute gastroenteritis (AGE) cases tested for rotavirus (RV) infection. RV-positive cases were propensity score matched with RV-negative controls for age, visit month, and province.
RESULTS:
The study included 27,472 children with AGE aged 8 weeks to 4 years at the time of AGE diagnosis; 7.98% (2,192) were RV-positive. The VE (95% confidence interval, CI) of 1-2 and 3 doses of RV5 against any medically attended RV infection (inpatient or outpatient) was 57.6% (39.8%, 70.2%) and 67.2% (60.3%, 72.9%), respectively. Among children who received the 3rd dose before turning 5 months of age, 3-dose VE decreased from 70.4% (53.9%, 81.1%) (< 5 months since the 3rd dose) to 63.0% (49.1%, 73.0%) (≥ 1 year since the 3rd dose). The three-dose VE rate was 69.4% (41.3%, 84.0%) for RVGE hospitalization and 57.5% (38.9%, 70.5%) for outpatient-only medically attended RVGE.
CONCLUSION
Three-dose RV5 VE against rotavirus gastroenteritis (RVGE) in children aged < 5 years was higher than 1-2-dose VE. Three-dose VE decreased with time since the 3rd dose in children who received the 3rd dose before turning five months of age, but remained above 60% for at least one year. VE was higher for RVGE hospitalizations than for medically attended outpatient visits.
Humans
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Rotavirus Vaccines/immunology*
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China/epidemiology*
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Case-Control Studies
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Child, Preschool
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Infant
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Rotavirus Infections/epidemiology*
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Male
;
Propensity Score
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Female
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Vaccine Efficacy
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Gastroenteritis/virology*
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Vaccines, Attenuated
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Rotavirus
6.Key technology and equipment development status of first-aid robotics
Zhen-bao WANG ; Zi-jian WANG ; Xin-xi XU ; Xin LIU ; Tao CHENG ; Pei-peng LIU ; Xiu-guo ZHAO ; Chen SU
Chinese Medical Equipment Journal 2025;46(3):96-114
The development status of the key technologies of first-aid robotics was introduced in autonomous system,embo-died intelligence,digital twins,large artificial intelligence model and autonomous unmanned medical treatment.The present situation in first-aid robotics equipment was reviewed for first-aid diagnosis,treatment,assistance and transportation.The development trends of the key technology and equipment of first-aid robotics were analyzed.It was pointed out the involve-ment of big model-based embodied intelligence technology and digital twins technology in first aid might provide new pers-pectives for the application and advancement of specialized first-aid robotics.[Chinese Medical Equipment Journal,2025,46(3):96-114]
7.Key technology and equipment development status of first-aid robotics
Zhen-bao WANG ; Zi-jian WANG ; Xin-xi XU ; Xin LIU ; Tao CHENG ; Pei-peng LIU ; Xiu-guo ZHAO ; Chen SU
Chinese Medical Equipment Journal 2025;46(3):96-114
The development status of the key technologies of first-aid robotics was introduced in autonomous system,embo-died intelligence,digital twins,large artificial intelligence model and autonomous unmanned medical treatment.The present situation in first-aid robotics equipment was reviewed for first-aid diagnosis,treatment,assistance and transportation.The development trends of the key technology and equipment of first-aid robotics were analyzed.It was pointed out the involve-ment of big model-based embodied intelligence technology and digital twins technology in first aid might provide new pers-pectives for the application and advancement of specialized first-aid robotics.[Chinese Medical Equipment Journal,2025,46(3):96-114]
8.Pathogenicity analysis of a tyrosine kinase Cps2C mutant strain of Streptococcus suis serotype 2
Miao LIN ; Hua NI ; Yu-he WANG ; Feng ZHENG ; Cheng-liang TANG ; Xiu-zhen PAN
Chinese Journal of Zoonoses 2024;40(11):1009-1017
This study was aimed at predicting the biological function of Streptococcus suis serotype 2(S.suis 2)tyrosine kinase Cps2C through bioinformatics and analyzing its effects on S.suis 2 pathogenicity.Online bioinformatics tools were used to analyze and predict the localization,conserved domains,transmembrane domains,protein similarity,and protein three-di-mensional structure of Cps2C.A BALB/c mouse infection model was used to compare and analyze clinical characteristics,mor-tality rates,and blood bacterial loads in mice infected with the wild-type strain 05ZYH33 and the cps2C gene knockout strainΔcps2C.Additionally,heart,brain,and joint tissue sections from infected mice were stained with hematoxylin and eosin(HE)for comparative pathological analysis.The Cps2C protein-coding gene is located upstream of the capsule biosynthesis locus cps,lacks transmembrane domains,is a homologous protein to Streptococcus pneumoniae tyrosine kinase CpsD with a 64%amino acid sequence similarity,and is potentially involved in bacterial capsule synthesis regulation.Cps2C deficiency significantly de-creased the pathogenicity of S.suis 2 in mice(P<0.05).Compared with the wild-type strain,the Δcps2C strain showed a sig-nificantly lower blood bacterial load(P<0.000 1).Heart,brain,and joint tissues of mice infected intraperitoneally with strains 05ZYH33 and Δcps2C remained structurally intact without e-dema,hemorrhage,or inflammatory cell infiltration;moreo-ver,characteristic lesion features of endocarditis,meningitis,or arthritis were absent.Streptococcus suis serotype 2 tyrosine kinase Cps2C may be an important regulatory factor in capsule biosynthesis,and its deficiency decreases bacterial blood survival capability and pathogenicity in mice.
9.Information system-based continuous improvement of healthcare-associated infection underreporting of a tertiary hospital during its initial establish-ment
Qin JI ; Mei-zhen QIAO ; Xiu-zhen WANG
Chinese Journal of Infection Control 2024;23(12):1567-1572
Objective To monitor healthcare-associated infection(HAI)through a systematic intelligent informa-tion-based surveillance system,and gradually reduce the underreporting rate of HAI in the newly built tertiary hos-pital through continuous improvement measures.Methods Underreporting rate of HAI in a tertiary hospital at the baseline period of the initial establishment stage(from March to December 2021)was analyzed.Under the monitor of a systematic intelligent information system,intervention measures in the first period(from January to October 2022)focusing on informing the usage path of the system and urging timely reporting;in the second period(from November 2022 to June 2023),intervention measures focusing on improving warning strategies and increasing on-site monitoring frequency were implemented.Differences in HAI underreporting rate before and after taking inter-vention measures were compared.Results The underreporting rate of HAI during the baseline period was as high as 29.14%,which decreased to 5.48%at the first intervention period,and 1.84%at the second intervention peri-od.The diffe-rence in underreporting rates of HAI among three periods was statistically significant(x-=125.659,P<0.001).The achievement rate and progress rate of continuous improvement at the first,second period were 123.62%and 81.19%,142.63%and 93.69%,respectively.Conclusion Based on a systematic intelligent infor-mation system,HAI underreporting rate at the early stage of the construction of a newly built tertiary hospital can be effectively reduced by adopting a series of continuous improvement measures.
10.A survey on the management status and indicators of pathogen detection rate before antimicrobial treatment of inpatients in 265 medical institu-tions in Guangdong Province
Jia-jin CHEN ; Zhen-feng ZHONG ; Shi-yun WANG ; Ting HUANG ; Shu-xian CHEN ; Chen ZHU ; Yi-nan LI ; Li-li PENG ; Yuan-chun MO ; Min-shan CHEN ; Wei-qing LIN ; Xiu-juan QU ; Fang YU ; Zhi-xing LI ; Shu-mei SUN
Chinese Journal of Infection Control 2024;23(12):1499-1507
Objective To evaluate the management and indicators of pathogen detection before antimicrobial treat-ment for inpatients in second level and above medical institutions(MIs)in Guangdong Province,and provide direc-tion and decision-making basis for the improvement of pathogen detection quality in the region.Methods The ma-nagement status,information system functions,and pathogen detection rate indicators of secondary and above MIs in 21 cities in Guangdong Province was surveyed through online questionnaire surveys and system submission.A baseline survey on sentinel monitoring MIs was conducted from July 15th to August 8th,2023.From November 7th to 30th,a baseline survey on non-sentinel monitoring MIs was launched.Surveys on indicator information of all MIs were completed from January 15th to 30th,2024.Results A total of 265 MIs were surveyed,and the proportions of establishing special working groups(83.98%),developing special action improvement plans(79.01%),estab-lishing pathogen detection rate management systems(91.71%),and developing management assessment plans(76.80%)of tertiary MIs were all higher than that of secondary MIs,differences were all statistically significant(all P<0.05).The proportion of tertiary MIs with various information system functions was higher than that of secondary MIs(all P<0.05).The pathogen detection rate(61.07%)before antimicrobial treatment and health-care-associated infection(HAI)diagnosis-related pathogen detection rate(88.00%)of inpatients in tertiary MIs were both higher than those in secondary MIs(both P<0.05).Among different types of MIs,pathogen detection rate before antimicrobial treatment of inpatients in maternal and child health MIs was higher than that in other types of MIs.HAI diagnosis-related pathogen detection rate in other specialized hospitals was the highest,and pathogen detection rate before combined use of key antimicrobial treatment in traditional Chinese medicine hospitals was the lowest,differences were all statistically significant(all P<0.05).Conclusion Tertiary MIs have more advantages in management strategies and information technology construction than secondary MIs,secondary MIs need more guidance and support.Monitoring and analysis of pathogen detection rate indicators in MIs of different levels and types should be strengthened through special actions.

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