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
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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.Progress in cohort study of children and adolescents health
Yunqi GUAN ; Weiming ZENG ; Jun JIANG ; Yinshu PAN ; Wei JIANG ; Zhu YU ; Ke HUANG ; Wei WU ; Meng WANG ; Jieming ZHONG ; Min YU
Chinese Journal of Epidemiology 2024;45(9):1308-1314
Cohort study of children and adolescents health is an ideal method to explore health-related problems from childhood to adulthood, to which more attention has been paid. This paper summarizes the progress in cohort study of children and adolescents health conducted both at home and abroad by introducing the study design, main contents. Emphasizing the international exchange and cohort integration, continuously expanding cohort research field, and using multi-source data for high-quality follow-up have become the trend of cohort study of children and adolescents health.
3.Practice of enhanced recovery after surgery reduces postoperative inflammation in patients undergoing laparoscopic gastric cancer surgery
Jingyi WANG ; Jun ZHONG ; Chaogang YANG ; Xiaojiao WANG ; Meng WEI ; Xiaoyan CHEN ; Bilong FENG ; Chunwei PENG
Chinese Journal of General Surgery 2024;39(11):833-838
Objective:To evaluate the application of enhanced recovery after surgery in patients undergoing laparoscopic gastric cancer surgery and its impact on the systemic inflammatory response (SIR).Methods:The clinical data of patients undergoing laparoscopic gastric cancer surgery at the Department of Gastrointestinal Surgery, Zhongnan Hospital, Wuhan University from Mar 2021 to Mar 2023 was retrospectively analyzed.Results:A total of 234 patients with gastric cancer were enrolled (120 cases in ERAS group and 114 cases in routine group). There were no significant differences in preoperative indexes between the two groups (all P>0.05). After laparoscopic surgery, the postoperative ventilation time and hospital stay of patients in ERAS group were significantly shorter than those in the conventional group (all P<0.05). Neutrophil to lymphocyte ratio (NLR) , platelet to lymphocyte ratio (PLR) and systemic immune-inflammatory (SII) index of patients in ERAS group were significantly lower on day 1 and day 3 after surgery than in conventional group (all P<0.05). The ratio of lymphocyte to monocyte (LMR) in ERAS group was significantly higher than that in conventional group on day 1 and day 7 after surgery (all P<0.05). Conclusions:ERAS can improve postoperative SIR indexes in patients undergoing laparoscopic gastric cancer surgery, shorten postoperative recovery time, and enhance the efficacy of laparoscopic gastric cancer surgery by reducing perioperative systemic inflammation.
4.Melatonin Ameliorates Abnormal Sleep-Wake Behavior via Facilitating Lipid Metabolism in a Zebrafish Model of Parkinson's Disease.
Meng-Zhu PANG ; Han-Xing LI ; Xue-Qin DAI ; Xiao-Bo WANG ; Jun-Yi LIU ; Yun SHEN ; Xing XU ; Zhao-Min ZHONG ; Han WANG ; Chun-Feng LIU ; Fen WANG
Neuroscience Bulletin 2024;40(12):1901-1914
Sleep-wake disorder is one of the most common nonmotor symptoms of Parkinson's disease (PD). Melatonin has the potential to improve sleep-wake disorder, but its mechanism of action is still unclear. Our data showed that melatonin only improved the motor and sleep-wake behavior of a zebrafish PD model when melatonin receptor 1 was present. Thus, we explored the underlying mechanisms by applying a rotenone model. After the PD zebrafish model was induced by 10 nmol/L rotenone, the motor and sleep-wake behavior were assessed. In situ hybridization and real-time quantitative PCR were used to detect the expression of melatonin receptors and lipid-metabolism-related genes. In the PD model, we found abnormal lipid metabolism, which was reversed by melatonin. This may be one of the main pathways for improving PD sleep-wake disorder.
Animals
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Zebrafish
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Melatonin/pharmacology*
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Lipid Metabolism/drug effects*
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Disease Models, Animal
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Rotenone/pharmacology*
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Sleep Wake Disorders/metabolism*
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Parkinson Disease/metabolism*
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Motor Activity/drug effects*
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Sleep/drug effects*
5.MRI-based radiomics machine learning model for differentiating small renal cell carcinoma from fat-poor renal angiomyolipoma
Rui-Ting WANG ; Lian-Ting ZHONG ; Xian-Pan PAN ; Lei CHEN ; Meng-Su ZENG ; Yu-Qin DING ; Jian-Jun ZHOU
Chinese Journal of Clinical Medicine 2023;30(6):940-945
Objective To investigate the value of multi-phase MRI-based radiomics machine learning models in differentiating small renal cell carcinoma(sRCC)from fat-poor renal angiomyolipoma(fp-AML).Methods 79 cases of sRCCs and 35 cases of fp-AMLs(diameter≤4 cm)which were confirmed by pathology were retrospectively analyzed.The volume of interest(VOI)of the total tumor was manually delineated on the images of T2WI(T2),unenhanced phase(UP),corticomedullary phase(CMP)and nephrographic phase(NP)and then the radiomics of the VOIs were extracted respectively.The training set and the test set were set according to the ratio of 7∶3.The t-test,maximal relevance and minimal redundancy(mRMR)and the least absolute shrinkage and selection operator(LASSO)were used to select the radiomics features.The selected features were used to build classification models with logistic regression(LR)and support vector machine(SVM).The receiver operating characteristic(ROC)curve was used to evaluate the classification performances of the models.Results There were 4,12,3,11 and 15 optimal features obtained from T2、UP、CMP、NP and the combined four phases,respectively.The radiomics features based on NP or the combined four phases with LR model performed best,AUCs were respectively 0.956,0.986 in the training set and both were 0.881 in the test set.Conclusion The multi-phase MRI-based radiomics machine learning model has favorable diagnostic performance in differentiating sRCC from fp-AML.
6.Establishment of evaluation method for disinfection efficacy of positive pressure bio-protective hood
Ke-Yin MENG ; Shan-Shan ZHANG ; Wan-Bo LUO ; Zhao-Yang BU ; Teng YAO ; Zhong-Hai WAN ; Peng DU ; Jun LIU
Chinese Medical Equipment Journal 2023;44(9):33-37
Objective To establish a method for evaluating the disinfecting effect of positive-pressure protective hoods by testing the disinfecting effect of canine influenza virus(CIV)on the positive-pressure protective hood with 1%Virkon S disinfectant.Methods The neutralizer was selected considering the characteristics of 1%Virkon S disinfectant in accordance with"Disinfection technical specifications"(2002 edition),and the effectiveness of the neutralizer was verified by determining median tissue culture infectious dose(TTCID50)of different samples inoculated with canine renal cells;in the same environment the effects of viral vectors and environment on viral activity were detected by measuring the TCID50 at different time points when CIV acted on the positive pressure protective hood;the optimal disinfection time was determined by establishing a viral vector model and a viral infiltration and sampling method,combining the results of viral recovery rates by real-time quantitative polymerase chain reaction and enzyme-linked immunosorbent assay and viral titer measurements by TCID50 and 50%egg infectious dose(EID50).Results The phosphate buffer solution of 0.1%lecithin,2%Tween 80 and 0.5%sodium thiosulfate could be used as a neutralizer for 1%Virkon S disinfectant;the viral vectors and environment had no effects on CIV activity at different time points;the average recover rate was 96.12%for the samples inoculated with canine renal cells and 95.98%for the chicken eggs,and 1%Virkon S disinfectant behaved the best 4 min after its action on CIV on the positive-pressure protective hood.Conclusion The method proposed for evaluating the disinfection effect of the positive-pressure protective hood is effective in establishing optimal disinfection conditions for the positive-pressure protective hood.[Chinese Medical Equipment Journal,2023,44(9):33-37]
7.Prediction of superantigen active sites and clonal expression of staphylococcal enterotoxin-like W.
Yu Hua YANG ; Xin KU ; Ya Nan GONG ; Fan Liang MENG ; Dong bo BU ; Ya Hui GUO ; Xiao Yue WEI ; Li Jin LONG ; Jia Ming FAN ; Mao Jun ZHANG ; Jian Zhong ZHANG ; Xiao Mei YAN
Chinese Journal of Epidemiology 2023;44(4):629-635
Objective: The docking and superantigen activity sites of staphylococcal enterotoxin-like W (SElW) and T cell receptor (TCR) were predicted, and its SElW was cloned, expressed and purified. Methods: AlphaFold was used to predict the 3D structure of SElW protein monomers, and the protein models were evaluated with the help of the SAVES online server from ERRAT, Ramachandran plot, and Verify_3D. The ZDOCK server simulates the docking conformation of SElW and TCR, and the amino acid sequences of SElW and other serotype enterotoxins were aligned. The primers were designed to amplify selw, and the fragment was recombined into the pMD18-T vector and sequenced. Then recombinant plasmid pMD18-T was digested with BamHⅠand Hind Ⅲ. The target fragment was recombined into the expression plasmid pET-28a(+). After identification of the recombinant plasmid, the protein expression was induced by isopropyl-beta-D- thiogalactopyranoside. The SElW expressed in the supernatant was purified by affinity chromatography and quantified by the BCA method. Results: The predicted three-dimensional structure showed that the SElW protein was composed of two domains, the amino-terminal and the carboxy-terminal. The amino-terminal domain was composed of 3 α-helices and 6 β-sheets, and the carboxy-terminal domain included 2 α-helices and 7 antiparallel β-sheets composition. The overall quality factor score of the SElW protein model was 98.08, with 93.24% of the amino acids having a Verify_3D score ≥0.2 and no amino acids located in disallowed regions. The docking conformation with the highest score (1 521.328) was selected as the analysis object, and the 19 hydrogen bonds between the corresponding amino acid residues of SElW and TCR were analyzed by PyMOL. Combined with sequence alignment and the published data, this study predicted and found five important superantigen active sites, namely Y18, N19, W55, C88, and C98. The highly purified soluble recombinant protein SElW was obtained with cloning, expression, and protein purification. Conclusions: The study found five superantigen active sites in SElW protein that need special attention and successfully constructed and expressed the SElW protein, which laid the foundation for further exploration of the immune recognition mechanism of SElW.
Humans
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Enterotoxins/genetics*
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Superantigens/genetics*
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Catalytic Domain
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Selenoprotein W/metabolism*
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Receptors, Antigen, T-Cell
8.Performance of screening of contacts of COVID-19 cases in same flight.
Dan LI ; Ying QIN ; Si Meng FAN ; Zhi Bin PENG ; Hui GE ; Zhao Rui CHANG ; Rui ZHANG ; Xiao Kun YANG ; Hong Ting ZHAO ; Jian Dong ZHENG ; Shi Cheng YU ; Hui WANG ; Jun YAN ; Zhong Jie LI
Chinese Journal of Epidemiology 2023;44(5):713-719
Objective: To understand the performance of 2019-nCoV nucleic acid detection in screening of contacts of COVID-19 cases in same flights and provide evidence for the effective screening of persons at high risk for the infection in domestic flights. Methods: The information of passengers who took same domestic flights with COVID-19 cases in China from April 1, 2020 to April 30, 2022 were retrospectively collected,and χ2 test was used to analyze positive nucleic acid detection rates in the passengers in different times before the onsets of the index cases, in different seat rows and in epidemic periods of different 2019-nCoV variants. Results: During the study period, a total of 433 index cases were identified among 23 548 passengers in 370 flights. Subsequently, 72 positive cases of 2019-nCoV nucleic acid were detected in the passengers, in whom 57 were accompanying persons of the index cases. Further analysis of the another 15 passengers who tested positive for the nucleic acid showed that 86.67% of them had onsets or positive detections within 3 days after the diagnosis of the index cases, and the boarding times were all within 4 days before the onsets of the index cases. The positive detection rate in the passengers who seated in first three rows before and after the index cases was 0.15% (95%CI: 0.08%-0.27%), significantly higher than in the passengers in other rows (0.04%, 95%CI: 0.02%-0.10%, P=0.007),and there was no significant difference in the positive detection rate among the passengers in each of the 3 rows before and after the index cases (P=0.577). No significant differences were found in the positive detection rate in the passengers, except the accompanying persons, among the epidemics caused by different 2019-nCoV variants (P=0.565). During the Omicron epidemic period, all the positive detections in the passengers, except the accompanying persons, were within 3 days before the onset of the index cases. Conclusions: The screening test of 2019-nCoV nucleic acid can be conducted in the passengers took the same flights within 4 days before the onsets of the index cases on board. Passengers who seated within 3 rows from the index cases can considered as the close contacts at high risk for 2019-nCoV, for whom screening should be conducted first and special managements are needed. The passengers in other rows can be classified as general risk persons for screening and management.
Humans
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COVID-19
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Retrospective Studies
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SARS-CoV-2
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China
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Nucleic Acids
9.Population structure of food-borne Staphylococcus aureus in China.
Ya Hui GUO ; Zi Long HE ; Qing Long JI ; Hai Jian ZHOU ; Fan Liang MENG ; Xiao Feng HU ; Xiao Yue WEI ; Jun Cai MA ; Yu Hua YANG ; Wei ZHAO ; Li Jin LONG ; Xin WANG ; Jia Ming FAN ; Xiao Jie YU ; Jian Zhong ZHANG ; De HUA ; Xiao Mei YAN ; Hai Bin WANG
Chinese Journal of Epidemiology 2023;44(6):982-989
Objective: To understand the population structure of food-borne Staphylococcus (S.) aureus in China. Methods: Whole genome sequencing was used to analyze 763 food-borne S. aureus strains from 16 provinces in China from 2006 to 2020. Multilocus sequence typing (MLST), staphylococcal protein A gene (spa) typing, and staphylococcal chromosome cassettemec (SCCmec) typing were conducted, and minimum spanning tree based on ST types (STs) was constructed by BioNumerics 7.5 software. Thirty-one S. aureus strains isolated from imported food products were also included in constructing the genome phylogenetic tree. Results: A total of 90 STs (20 novel types) and 160 spa types were detected in the 763 S. aureus isolates. The 72 STs (72/90, 80.0%) were related to 22 clone complexes. The predominant clone complexes were CC7, CC1, CC5, CC398, CC188, CC59, CC6, CC88, CC15, and CC25, accounting for 82.44% (629/763) of the total. The STs and spa types in the predominant clone complexes changed over the years. The methicillin-resistant S. aureus (MRSA) detection rate was 7.60%, and 7 SCCmec types were identified. The ST59-t437-Ⅳa (17.24%, 10/58), ST239-t030-Ⅲ (12.07%, 7/58), ST59-t437-Ⅴb (8.62%, 5/58), ST338-t437-Ⅴb (6.90%, 4/58) and ST338-t441-Ⅴb (6.90%, 4/58) were the main types in MRSA strains. The genome phylogenetic tree had two clades, and the strains with the same CC, ST, and spa types clustered together. All CC7 methicillin sensitive S. aureus strains were included in Clade1, while 21 clone complexes and all MRSA strains were in Clade2. The MRSA strains clustered according to the SCCmec and STs. The strains from imported food products in CC398, CC7, CC30, CC12, and CC188 had far distances from Chinese strains in the tree. Conclusions: In this study, the predominant clone complexes of food-borne strains were CC7, CC1, CC5, CC398, CC188, CC59, CC6, CC88, CC15, and CC25, which overlapped with the previously reported clone complexes of hospital and community-associated strains in China, suggesting that close attention needs to be paid to food, a vehicle of pathogen transmission in community and food poisoning.
Humans
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Staphylococcus aureus/genetics*
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Methicillin-Resistant Staphylococcus aureus/genetics*
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Multilocus Sequence Typing
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Phylogeny
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Staphylococcal Infections/epidemiology*
;
China/epidemiology*
10.Progress on the researches of acupuncture preconditioning before surgery.
Meng-Yue GU ; Huo-Lin ZENG ; Feng-Cheng DENG ; Yong-Jun ZHANG ; Hui ZHONG
Chinese Acupuncture & Moxibustion 2023;43(6):727-732
This paper reviews the researches on acupuncture preconditioning before surgery in recent years and explores its application value from three aspects, i.e. relieving preoperative anxiety, preventing from postoperative cognitive dysfunction, and preventing from postoperative gastrointestinal dysfunction. As a relatively safe non-drug treatment, acupuncture has the underlying advantages in participating into multidisciplinary coordination in the enhanced recovery after surgery (ERAS). By building up higher-quality medical evidences and revealing the effect mechanism of acupuncture from multi-dimenisonal aspects, it is expected that acupuncture technology can be coordinated with ERAS to optimize the clinical path in the perioperative period, and boost the development of the perioperative medicine ultimately.
Humans
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Acupuncture Therapy
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Anxiety
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Anxiety Disorders
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Enhanced Recovery After Surgery
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Perioperative Period

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