1.Application of Quality Evaluation of Blind Method in Clinical Trials of Traditional Chinese Medicine
Zeyang SHI ; Yuan SUN ; Wenxin MA ; Yuyi WANG ; Zhijun BU ; Xuehui WANG ; Youyou ZHENG ; Jianping LIU ; Zhaolan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(3):75-80
The quality evaluation of the blind method is to evaluate the clinical blind data obtained from clinical trials adopting the blind method and judge the effectiveness of the blind method by investigating the blind effect of different blind objects. A successful blind method can avoid the influence of subjective factors on the test results of subjects and researchers to a certain extent. The quality evaluation of the blind method can reflect not only the effectiveness of the blind method but also the accuracy and credibility of clinical trial results. In recent years, randomized controlled trials have been widely used in the evaluation of the clinical efficacy of traditional Chinese medicine (TCM), but the quality of the implementation of blind methods is uneven, and the evaluation criteria have not yet been formed. In this paper, the data collection methods, calculation principles, advantages, and disadvantages of two quantitative quality evaluation methods of blind methods, namely James Blinding Index (JBI) and Bang Blinding Index (BBI), were introduced. The two indexes were analyzed in a randomized controlled trial of acupuncture and moxibustion to relieve postoperative oral pain. The calculation process of the results was demonstrated by R software and visualized by forest map. At the same time, a tool table was designed to facilitate the collection of evaluation data of blind methods in TCM clinical trials at different stages. Finally, the necessity and feasibility of quality evaluation of blind method in TCM research were discussed to provide a basis for evaluating and improving the quality of blind method implementation in TCM clinical trials.
2.Safety and Effectiveness of Chloral Hydrate for Auditory Brainstem Response Tests in Children
Xiangling ZHANG ; Xinyi YAO ; Min LIU ; Youyou JIN ; Zhaoli MENG ; Haotian LIU ; Yun ZHENG
Journal of Audiology and Speech Pathology 2024;32(6):524-527
Objective To study the safety and effectiveness of chloral hydrate in children undergoing ABR tests.Methods From December 2015 to March 2022,5 513 children under the age of 12 were selected for ABR ex-amination in West China Hospital of Sichuan University,who received chloral hydrate sedation(dose of 30 mg/kg).Data on administration method(mixed or direct),sleep deprivation(yes or no),failure performance(such asfailure to sleep,insufficient sedation,superficial sleep),adverse events(vomiting,irritability,etc.)were retrospectively analyzed.Total sedation failure rate,sedation failure rates in different age groups(≤0.5 years,0.5~3 years,3~12 years)and adverse event rate were calculated.Results Among the 5 513 ABR tests,199(3.61%)failed seda-tion.The sedation failure rates in different age groups(≤0.5 years,0.5~3 years,3~12 years)were 3.03%,4.31%and 3.11%,respectively.In the sedation failure tests,insufficient sedation was found in 81.91%of the tests.The incidence of adverse events was 10.55%,with most commonly vomiting.Conclusion The sedation fail-ure rate and the incidence of adverse events of chloral hydrate at 30 mg/kg were relatively low,thus chloral hydrate can be considered safe and effective at this dose.
3.A practical study on creating service-oriented party branches in functional departments through"branch co-construction"by the party branch of the affiliated hospital
Qing LIU ; Youyou MAO ; Liuyan FENG ; Chengyuan FANG
Modern Hospital 2024;24(9):1347-1349
Promoting the integration of party building with business work is a strong political guarantee for the high-quali-ty development of public hospitals in the new era."Party Branch Co-construction at Primary Level"is a vehicle for integrating Party building efforts with the main service tasks and supporting central work activities.This project focuses on the hospital's high-quality development with a goal-oriented and problem-oriented approach,aiming to create"service-oriented"Party branches within functional departments.Through the"Branch Co-construction"activities,it explores:1.Joint organization of activities;2.Business coordination;3.Joint team development.The project aims to integrate the regular organization activities of functional department Party branches with clinical business work,enhancing the awareness of proactive and front-line service in functional departments.It continuously explores ways and methods for"co-construction and joint work"with clinical medical and technical department Party branches,leveraging the exemplary role of Party members and the fighting bastion role of Party branches.
4.Relationship between serum indoxyl sulfate,Clusterin and coronary artery lesions in patients with acute coronary syndrome and its predictive value for short-term prognosis
Guanghui LIU ; Youyou DU ; Tao KONG
Journal of Xinxiang Medical College 2024;41(8):737-743
Objective To investigate the relationship between serum indoxyl sulfate(IS),Clusterin and coronary artery lesions in patients with acute coronary syndrome(ACS)and its predictive value for short-term prognosis.Methods A total of 120 ACS patients who were admitted to the First Affiliated Hospital of Zhengzhou University from June 2021 to October 2022 were selected as the research subjects(ACS group),and another 80 healthy volunteers who underwent physical examinations in our hospital during the same period were selected as the control group.Serum IS and Clusterin levels of patients in the ACS group and control group were detected by enzyme-linked immunosorbent assay.ACS patients were divided into a single-vessel disease group(n=43),a double-vessel disease group(n=49)and a multi-vessel disease group(n=28)according to the number of coronary artery lesions,divided into a mild lesion group(n=37),moderate lesion group(n=48)and severe lesion group(n=35)according to the Gensini score,and divided into a good prognosis group(n=85)and a poor prognosis group(n=35)according to the short-term prognosis.The influencing factors for poor short-term prognosis in ACS patients were analyzed by univariate and multivariate logistic regression,and the predictive value of serum IS and Clusterin levels for poor short-term prognosis in ACS patients was evaluated by receiver operating characteristic(ROC)curve.Results The serum IS and Clusterin levels of patients in the ACS group were significantly higher than those in the control group(P<0.05).The serum IS and Clusterin levels of patients in the single-vessel disease group,double-vessel disease group and multi-vessel disease group increased in turn(P<0.05).The serum IS and Clusterin levels of patients in the mild lesion group,moderate lesion group and severe lesion group increased in turn(P<0.05).The incidence of poor short-term prognosis in 120 ACS patients was 29.17%(35/120).Univariate analysis showed that,ACS type,Gensini score,KILLIP grade,number of coronary artery lesions,IS,and Clusterin were related to the short-term prognosis in ACS patients(P<0.05).Multivariate logistic regression analysis showed that,increased Gensini score,increased IS,increased Clusterin,KILLIP grade≥Ⅲ,and multi-vessel coronary artery disease were independent risk factors for poor short-term prognosis in ACS patients(P<0.05).The area under the ROC curve(AUC)for predicting poor short-term prognosis in ACS patients based on serum IS level was 0.747(95%confidence interval:0.529-0.946),with sensitivity of 71.43%,specificity of 74.12%,accuracy of 73.33%,and Youden index of 0.455.The AUC for predicting poor short-term prognosis in ACS patients based on serum Clusterin level was 0.693(95%confidence interval:0.439-0.951),with sensitivity of 68.57%,specificity of 70.59%,accuracy of 7.00%,and Youden index of 0.392.The AUC for predicting poor short-term prognosis in ACS patients based on both serum IS and Clusterin levels was 0.825(95%confidence interval:0.687-0.968),with sensitivity of 82.86%,specificity of 83.53%,accuracy of 83.33%,and Youden index of 0.664.Conclusion Increased serum IS and Clusterin levels are associated with aggravation of coronary artery disease and poor short-term prognosis in ACS patients,and a combination of the two has a high predictive value for poor short-term prognosis in ACS patients.
5.Explanation of health standard for operators of nuclear power plants
Youyou WANG ; Huahui BIAN ; Weibo CHEN ; Yuhan HOU ; Chang LIU ; Mengyue QIU ; Yi ZHOU ; Huaxian WANG ; Lizhen YE ; Yulong LIU
Chinese Journal of Radiological Medicine and Protection 2024;44(10):862-865
In order to facilitate the accurate comprehension and correct implemention of the national occupational health standard Health standard for operators of nuclear power plants (GBZ/T 164-2022), this article presents an in-depth elucidation encompassing the significance of the standard promulgation, the background of its revision, the current status of the relevant domestic and international standards, the basis for revision of the principal technical inclusion and the application scope of the standard. The aim is to provide a guidance the selection, appropriate evaluation, and occupational health monitoring of nuclear power plant operators, ultimately ensuring the safe operation of nuclear facilities.
6.Attention Situation of Chinese Patent Medicine for Constipation in Traditional Chinese Medicine Diagnosis and Treatment Guidelines/Consensus and National Reimbursement Drug List
Youyou ZHENG ; Xuehui WANG ; Yunru CHEN ; Mei HAN ; Hongguo RONG ; Jianping LIU ; Xing LIAO ; Zhaolan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(20):135-143
ObjectiveTo evaluate the methodological quality of traditional Chinese medicine (TCM) diagnosis and treatment guidelines/consensus of constipation with Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ)tool, and to study the attention situation of the included Chinese patent medicines in China's National Reimbursement Drug List in the guidelines/consensus. MethodThe data of CNKI,VIP,Wanfang Data,SinoMed,PubMed and Cochrane from the inception of the databases to October 2021 were searched to collect the TCM diagnosis and treatment guidelines/consensus of constipation. Then,the diagnosis and treatment standards and recommended Chinese patent medicines were extracted. Two researchers assessed the methodological quality of the guidelines/consensus with AGREE Ⅱ tool independently. The quality of reports was evaluated by Reporting Items for practice Guidelines in HealThcare (RIGHT) Statement. The recommended Chinese patent medicines in the guidelines/consensus were compared with those in the National Reimbursement Drug List. ResultEleven consensus and 2 guidelines were included,involving 794 experts. The scores of AGREE II were clarity of presentation(59.0%),scope and purpose(44.0%),stakeholder involvement(23.1%),rigor of development (12.1%),applicability (11.1%),and editorial independence (8.3%) from high to low. Five articles were recommended at B level(recommended after revision) and 8 articles were at C level (not recommended). The average scores of RIGHT Statement were as follows:basic information (93.59%),background (57.69%),evidence (18.46%),recommendations (20.88%),review and quality assurance (19.23%),funding,declaration and management of interests (0.00%), and other information (0.00%). The included guidelines/consensus recommended a total of 27 Chinese patent medicines,among which 20 were included in the National Reimbursement Drug List,with 4 species of Class A and 16 species of Class B, accounting for 74.1% of all recommended Chinese patent medicines. Ten purgative Chinese patent medicines in the National Reimbursement Drug List were recommended by the guidelines/consensus,accounting for 50% of all purgative drugs, and 8 were not recommended. There were prescriptions for purgation, for promoting digestion and removing food stagnation, for clearing heat and purging fire,and for warming the middle and dissipating cold,Tibetan medicine and Mongolian medicine. ConclusionBy the AGREE Ⅱ assessment,the methodological quality of the TCM diagnosis and treatment guidelines/consensus of constipation included in this study needed to be improved in the future. The report quality evaluated with RIGHT Statement was low. Most drugs included in the National Reimbursement Drug List were paid attention in the TCM diagnosis and treatment guidelines/consensus of constipation. Moreover,the drugs included in the National Reimbursement Drug List could basically fulfill the clinical needs reflexed from the guidelines/consensus recommendations. However, the reasons of some drugs failing to be included in the National Reimbursement Drug List needed to be studied in the future.
7.Whole-genome sequencing analysis of the victim exposed to a super high dose of iridium-192 during the Nanjing radiological accident in 2014
Daojiang YU ; Wenling TU ; Zhiqiang JIANG ; Min WANG ; Yuhong SHI ; Yulong LIU ; Youyou WANG ; Shuyu ZHANG
Chinese Journal of Radiological Medicine and Protection 2021;41(4):247-252
Objective:To investigate radiation-induced somatic mutations and variations and provide theoretical basis for clarifying radiation-induced genetic changes and long-term effects by whole-genome sequencing analysis of the genetic variations of the victim of the " 5.7" 192Ir radiation accident in Nanjing. Methods:Normal back skin tissue, irradiated bone and soft tissues, and peripheral blood were collected from the victim 2 047 days post-irradiation. DNA of these samples was extracted and sequenced with high-throughput genomics and analyzed by bioinformatics method. The genetic variations of between irradiated and normal tissues were compared.Results:Compared with normal back skin tissue, there are large amounts of genetic variations in the irradiated bone and soft tissues and peripheral blood, including base substitution (transition, transversion), small insertion, small deletion, copy number variation (gain, loss) and structure variation (large deletion, large duplication, inversion, intra-chromosomal translocation, inter-chromosomal translocation). There were 10 666 genetic variations in the irradiated bone and soft tissues and 11 233 genetic variations in peripheral blood, where thousands of genes were involved in. These variations occurred in the exons, introns, UTR′3, UTR′5, splicing sites, within 5 kb upstream of transcription initiation site, within 5 kb downstream of transcription termination site, ncRNA and intergenic region. All chromosomes had genetic variations.Conclusions:There were a large number of genetic variations in the irradiated tissues and blood of the victim at 2 047 days after irradiation, which may affect the body function and cause the long-term effects.
8.Impact of the number of chemotherapy cycle of concurrent chemotherapy during radiotherapy on clinical prognosis of limited-stage small cell lung cancer
Xingping GE ; Hao YU ; Jiaqi ZHANG ; Zhen ZHANG ; Youyou WANG ; Peng WANG ; Liming XU ; Ningbo LIU ; Lujun ZHAO
Chinese Journal of Radiation Oncology 2021;30(7):671-675
Objective:To investigate the role of concurrent chemoradiotherapy in the treatment of limited-stage small cell lung cancer (LS-SCLC) and the impact of the number of chemotherapy cycle during radiotherapy (RT) on clinical prognosis.Methods:Patients with LS-SCLC treated with definitive radiotherapy from May, 2008 to September, 2016 were included in the study. The primary endpoint was overall survival (OS), which was calculated from the start of treatment to the date of death or last follow-up. The effect of the number of concurrent chemotherapy cycle and other clinical factors on clinical efficacy was analyzed. Survival analysis was performed with Kaplan- Meier method, and multivariate analysis was performed with Cox regression model. Results:Three hundred and seventeen patients were eligible for the analysis. Among them, 129 patients received sequential chemoradiotherapy and 188 patients received concurrent chemoradiotherapy. Among patients receiving concurrent chemoradiotherapy, 86 patients received 1 cycle of concurrent chemotherapy and 102 cases of 2 cycles of concurrent chemotherapy. The median follow-up time was 22.47 months. Multivariate survival analysis showed that only clinical stage, timing of RT administration and prophylactic cranial irradiation (PCI) were the independent prognostic factor for OS. The median OS in patients who received 1 cycle and 2 cycles of concurrent chemotherapy during RT were 33.8 months and 30.4 months ( P=0.400). No matter in elder patients or in younger patients, in early RT group or in late RT group and application of PCI or not, the number of concurrent chemotherapy cycle exerted no significant impact on OS. The incidence of grade 3 or above adverse events was 20% in the 1-cycle concurrent chemotherapy group, and 13.7% in the 2-cycle concurrent chemotherapy group. Conclusions:Concurrent chemoradiotherapy is the standard treatment of LS-SCLC. Two cycles of concurrent chemotherapy during RT is not necessarily superior to 1 cycle of concurrent chemotherapy. The optimal number of concurrent chemotherapy cycle during RT need to be studied in a large prospective randomized clinical trial.
9.Randomized controlled trial of the clinical effectiveness and safety of Jiuwei-Zhuhuang San plus amoxilcillin sodium and sulbactam sodium for the children with bacterial pneumonia
Zhen DA ; Wenbin HOU ; Siyi WANG ; Youyou ZHENG ; Yuanxi LI ; Huilan LIU ; Yuxin SUN ; Zhaolan LIU
International Journal of Traditional Chinese Medicine 2021;43(12):1174-1178
Objective:To evaluate the clinical effectiveness and safety of Jiuwei-Zhuhuang San plus amoxilcillin sodium and sulbactam sodium in the treatment of bacterial pneumonia in children. Methods:A total of 120 patients with bacterial pneumonia in children from 1 year to 14 years old were randomly divided into the study group ( n=90) and the control group ( n=30) with ratio 3 to 1, the random sequence created by SAS software. Both groups were treated with amoxilcillin sodium for basic treatment, the observation group was treated with Jiuwei-Zhuhuang San. Both groups were treated for 1 week and followed up for 1 week. The cough frequency, clinical effective rate, symptoms and signs score, Traditonal Chinese medicine (TCM) pattern scores and adverse event rate were observed. Results:Eighteen cases were dropped and eliminated in the observation group, and 4 cases were dropped and eliminated in the control group, so 72 of observation group and 26 of control group were analyzed. After treatment, the clinical effective rate of the observation group was 27.8% (20/72), and the control group was 0% (0/26), where the difference was significant ( χ2=7.445, P=0.006). The difference of TCM syndrome score before and after treatment in the observation group (-16.8 ± 8.2 vs. -11.0 ± 5.8, t=-3.858) was lower than that of the control group ( P<0.01). There was significant difference between the two groups ( Z=-2.347, P= 0.019) in the TCM syndrome. The cough frequency of the observation group was 41.7% (30/72), and the control group was 26.9% (7/26). There wasn’t any significant differences in the cough frequency between two groups ( P>0.05). There was no statistical difference in symptoms and signs score or adverse event rate between two groups ( P>0.05). Conclusion:On the basis of amoxicillin sodium and sulbactam sodium, combined use of Jiuwei-Zhuhuang San can improve the clinical effectiveness of children with bacterial pneumonia.
10. The application of the concept of parabiotic tissue protection in the repair of acute radiation-induced skin injury
Daojiang YU ; Tianlan ZHAO ; Yulong LIU ; Youyou WANG ; Shuai WANG ; Shuyu ZHANG ; Jianping CAO
Chinese Journal of Plastic Surgery 2019;35(5):465-471
Objective:
To evaluate the parabiotic tissue protection concept in the repairment of acute radiation-induced skin injury.
Methods:
Seven patients(3 males and 4 females) with acute radiation injury treated in the Department of Plastic Surgery of the Second Affiliated Hospital of Soochow University from February 2014 to January 2018. The ages of patients ranged from 45 to 76 years. The wound areas include perineum and buttock (

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