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.Research progress of tralokinumab for the treatment of moderate and severe atopic dermatitis
Chinese Journal of Primary Medicine and Pharmacy 2024;31(3):474-476
Tralokinumab is a selective interleukin-13 inhibitor developed by LEO Pharma in Denmark. It was granted approval by the US Food and Drug Administration on December 27, 2021, for the treatment of patients aged 18 years or older with moderate to severe atopic dermatitis whose disease is refractory to or cannot be fully controlled by local prescription therapy. This article presents a comprehensive review of the recent research progress in the treatment of moderate to severe atopic dermatitis with tralokinumab.
3.Study on the application value of combined spinal-epidural anesthesia under the assistant of ultrasound localization on patients with lower limb fracture
Tao LIU ; Xu LI ; Hongliang QI ; Cheng WANG ; Gang LUO ; Jingui LI
China Medical Equipment 2024;21(2):94-97
Objective:To explore application value of combined spinal-epidural anesthesia under the assistant of ultrasound location on lower limb fractures.Methods:A total of 80 patients with lower limb fractures who underwent surgical treatment at the 901th Hospital of the PLA Joint Service Support Force from July 2020 to July 2022 were selected,and they were divided into a control group and an observation group according to the random number table method,with 40 cases in each group.The control group received epidural anesthesia under ultrasound,and the observation group received the combined lumbar-epidural anesthesia under ultrasound.The lidocaine dosage,anesthetic block time,anesthesia onset time and dosage of additional analgesic,as well as the changes in vital signs such as diastolic blood pressure(DBP),systolic blood pressure(SBP)and heart rate(HR),between the two groups of patients were compared.In addition,the thrombelastogram,anesthetic effects and occurrence of adverse reactions also were compared between two groups.Results:The lidocaine dosage,anesthetic block time,anesthesia onset time and dosage of additional analgesic of the observation group were significantly higher than those in the control group,and the differences were statistically significant(t=8.657,23.483,12.785,16.600,P<0.05),respectively.There were no statistically significant differences in DBP,SBP,HR,comprehensive coagulation index(CI),reaction time(R),formation time of blood cell agglutination(K)and incidence of adverse reactions between two groups before anesthesia,at the 30th minute after anesthesia and after the end of anesthesia(P>0.05).Compared with α angle before anesthesia and at the 30th minute after anesthesia,the α angles of the two groups increased significantly after anesthesia(t=6.564,5.783,P<0.05),respectively.The mechanical strength(G)of the blood clot and the maximum amplitude(MA)of chromatogram of the observation group were significantly reduced after completed anesthesia,and the differences of them were statistically significant(t=8.480,4.236,P<0.05),respectively.There were no significant differences between G and MA in the control group(P>0.05).The total effective rate of the observation group was 97.50%,which was significantly higher than 80.00% of the control group,and the difference was statistically significant(x2=4.507,P<0.05).Conclusion:The combined spinal-epidural anesthesia under the assistant of ultrasound location can effectively reduce the amount of anesthetics in patients with lower limb fracture,which has fast block and effect.In addition,it has little influence on circulatory function,and it is less likely to form a hypercoagulable state.It has better clinical anesthesia effect.
4.Distribution of Traditional Chinese Medicine Patterns in Patients with Spasmodic Torticollis Based on Factor Analysis and Cluster Analysis:A Cross-sectional Study
Jinyang LI ; Huanan LI ; Xinming LIU ; Junshi WANG ; Haiteng WANG ; Jianwu WANG ; Jingui WANG
Journal of Traditional Chinese Medicine 2024;65(15):1586-1592
ObjectiveTo analyze the traditional Chinese medicine (TCM) patterns in patients with spasmodic torticollis and provide reference for standardized differentiation and clinical treatment. MethodsA cross-sectional study was conducted in the spasmodic torticollis outpatient clinic and dystonia ward of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine from June 2022 to December 2023. The general information including gender, age, duration of disease and type, and the TCM four examinations data such as symptoms, tongue manifestation and pulse manifestation of 198 patients with spasmodic torticollis were obtained by means of on-site questionnaires. Descriptive frequency analysis, factor analysis, and cluster analysis were performed, and the distribution of major TCM patterns were summarized based on the clinical information. ResultsA total of 198 patients with spasmodic torticollis were included, of which 89 (44.95%) were male and 109 (55.05%) were female, with an average age of 40.70±0.96 years and an average course of disease of 24.78±2.32 months. A total of 296 symptoms/signs were obtained, with a cumulative frequency of 6756 times, of which 58 symptoms/signs had a frequency ≥20%, and the top three were neck and back stiffness (83.84%), condition related to emotions (74.75%) and irritability (72.73%). Factor analysis of 58 symptoms/signs showed that factor rotation converged after 51 iterations, resulting in 20 common factors with a cumulative contribution of 64.03%. The top three syndrome elements related to the location of the disease were liver, channels, tendons and bones, and those related nature of the disease were dominated by qi stagnation, blood stasis and yin deficiency. The cluster analysis of the 20 common factors showed that the main TCM patterns were internal stirring of liver wind syndrome, liver-kidney yin deficiency syndrome, turbid phlegm obstruction syndrome, and pathogen congested in the channels syndrome. Among the 198 patients, 81 were diagnosed with internal stirring of liver wind syndrome, 60 with liver-kidney yin deficiency syndrome, 37 with turbid phlegm obstruction syndrome, and 20 with pathogen congested in the channels syndrome.There was no statistically significant difference in the distribution of TCM patterns among patients of different genders, age groups, and duration of disease (P>0.05). ConclusionSpasmodic torticollis is mainly located in the liver, mostly with internal stirring of liver wind syndrome, liver-kidney yin deficiency syndrome, turbid phlegm obstruction syndrome, and pathogen congested in the channels syndrome.
5.Investigation on Preventive Effect of Total Saponins of Notoginseng Radix et Rhizoma on Aspirin-induced Small Intestine Injury Based on Serum Metabolomics
Wenhui LIU ; Guodong HUA ; Baochen ZHU ; Ruoyu GAO ; Xin HUANG ; Meng WANG ; Zheng LIU ; Jiaojiao CHENG ; Zhibin SONG ; Jingui WANG ; Chunmiao XUE
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):196-203
ObjectiveMetabolomics was utilized to investigate the preventive effect of notoginseng total saponins(NTS) on aspirin(acetyl salicylic acid, ASA)-induced small bowel injury in rats. MethodFifty male SD rats were randomly divided into normal and model groups, NTS high-dose and low-dose groups(62.5, 31.25 mg·kg-1), and positive drug group(omeprazole 2.08 mg·kg-1+rebamipide 31.25 mg·kg-1), with 10 rats in each group. Except for the normal group, rats in other groups were given ASA enteric-coated pellets 10.41 mg·kg-1 daily to establish a small intestine injury model. On this basis, each medication group was gavaged daily with the corresponding dose of drug, and the normal group and the model group were gavaged with an equal amount of drinking water. Changes in body mass and fecal characteristics of rats were recorded and scored during the period. After 14 weeks of administration, small intestinal tissues of each group were taken for hematoxylin-eosin(HE) staining, scanning electron microscopy to observe the damage, and the apparent damage of small intestine was scored. Serum from rats in the normal group, the model group, and the NTS high-dose group was taken and analyzed for metabolomics by ultra-performance liquid chromatography-quadrupole-electrostatic field orbitrap high-resolution mass spectrometry(UPLC-Q-Exactive Orbitrap MS), and the data were processed by multivariate statistical analysis, the potential biomarkers were screened by variable importance in the projection(VIP) value≥1.0, fold change(FC)≥1.5 or ≤0.6 and t-test P<0.05, and pathway enrichment analysis of differential metabolites was performed in conjunction with Human Metabolome Database(HMDB) and Kyoto Encyclopedia of Genes and Genomes(KEGG). ResultAfter 14 weeks of administration, the average body mass gain of the model group was lower than that of the normal group, and the NTS high-dose group was close to that of the normal group. Compared with the normal group, the fecal character score of rats in the model group was significantly increased(P<0.05), and compared with the model group, the scores of the positive drug group and the NTS high-dose group were reduced, but the difference was not statistically significant. HE staining and scanning electron microscopy results showed that NTS could significantly improve ASA-induced small intestinal injury, compared with the normal group, the small bowel injury score of the model group was significantly increased(P<0.01), compared with the model group, the small bowel injury scores of the NTS low and high dose groups were significantly reduced(P<0.05, P<0.01). Serum metabolomics screened a total of 75 differential metabolites between the normal group and the model group, of which 55 were up-regulated and 20 were down-regulated, 76 differential metabolites between the model group and the NTS groups, of which 14 were up-regulated and 62 were down-regulated. NTS could modulate three differential metabolites(salicylic acid, 3-hydroxybenzoic acid and 4-hydroxybenzoic acid), which were involved in 3 metabolic pathways, namely, the bile secretion, the biosynthesis of folic acid, and the biosynthesis of phenylalanine, tyrosine and tryptophan. ConclusionNTS can prevent ASA-induced small bowel injury, and the underlying mechanism may be related to the regulation of bile secretion and amino acid metabolic pathways in rats.
6.Survey of the cognition of interventional radiology and employment intention in the students majoring in imaging technology in medical school
Yongming ZHANG ; Hanfeng YANG ; Jiayu SUN ; Yan FU ; Jingui LI ; Yuxi LIU ; Ruosu WANG ; Xiao LI
Journal of Interventional Radiology 2024;33(8):910-914
Objective To discuss the cognition of interventional radiology(IR)and employment intention in the students majoring in imaging technology in medical school.Methods From June 7 to July 31 of 2023,a voluntary and anonymous online questionnaire survey concerning the cognition of IR and employment intention was conducted in the students majoring in medical imaging technology in Sichuan University,North Sichuan Medical College,Harbin Medical University,Hebei Medical University,Changzhi Medical College and Sichuan Vocational College of Health and Rehabilitation.The data obtained from the survey were analyzed by descriptive analysis and chi-square test using SPSS 24.0 statistical software.Results A total of 126 valid questionnaires were received.Eighty-seven students(69.05%),94 students(74.61%)and 81(64.28%)students had no knowledge or just had a little bit knowledge about the medical position and current status of IR in the fields of cardiovascular diseases,neurological diseases,and tumor diagnosis and treatment respectively.The IR course was obligatory course for the medical imaging technology specialty in all the schools participating in this survey,and 112 students(91.8%)stated that the school curriculum is the main way to acquire knowledge of IR,and the internet platforms,television science popularization and academic conferences were the other ways to acquire knowledge of IR.Four students(3.17%),17 students(13.49%),57 students(45.24%),39 students(30.95%)and 9 students(7.14%)participating in this survey expressed that they had no intention,no willingness,neutral attitude,high willingness and high intention respectively to engage in IR work in future.The difference in the degree of willingness to engage in IR specialty in future between students of different gender as well as between students with different schooling level was not statistically significant,and the exposure to radiation,work-related high stress,and long working time were the main influencing factors for students to consider IR as their professional career.Conclusion At present,both the cognition of IR and the employment intention are not high in the students majoring in imaging technology in medical school.Therefore,it is very important to improve their cognition of IR and willingness to engage in IR profession.
7.Effect of exogenous IL-18 binding protein on sepsis-associated lung injury in rats and role of NLRP3 inflammasomes
Yan LI ; Yanan WANG ; Xuhua HUO ; Yulin CHANG ; Jingui GAO
Chinese Journal of Anesthesiology 2024;44(11):1391-1396
Objective:To evaluate the effect of exogenous interleukin-18 (IL-18) binding protein (IL-18BP) on sepsis-associated lung injury and the role of NOD-like receptor family pyrin domain-containing 3 (NLRP3) inflammasomes in rats.Methods:This study was performed in two parts. Experiment Ⅰ Thirty-six SPF-grade healthy male Sprague-Dawley rats, aged 6-8 weeks, weighing 200 g, were allocated into 3 groups ( n=12 each) using a random number table method: sham operation group (S group), sepsis-associated lung injury group (SLI group), and sepsis-associated lung injury+ IL-18BP group (SI group). The rat model of sepsis-associated lung injury was developed using cecal ligation and puncture. The rats in group S underwent laparotomy without the subsequent ligation and puncture procedures. IL-18BP 1.5 mg/kg was intraperitoneally injected immediately after surgery in group SI. Experiment Ⅱ The aforementioned 36 rats were allocated into 3 groups ( n=12 each) using a random number table method: sepsis-associated lung injury + IL-18BP + vehicle group (SIV group), sepsis-associated lung injury + IL-18BP + MCC950 group (SIM group), and sepsis-associated lung injury + IL-18BP + nigericin group (SIN group). In SIV group, SIM group and SIN group, solvent, MCC950 (NLRP3 inhibitor, 5 mg/kg) and nigerin (NLRP3 agonist, 2 mg/kg) were intraperitoneally injected at 30 min before surgery respectively, and IL-18BP 1.5 mg/kg was intraperitoneally injected after operation. HE staining was used to observe the lung injury at 24 h after operation. The left lung tissues were obtained for calculation of the wet/dry weight (W/D) ratio. The concentrations of IL-18 and IL-18BP in broncho-alveolar lavage fluid (BALF) were determined by enzyme-linked immunosorbent assay. The percentage of NLRP3 positive cells in lung tissues was detected by immunofluorescence. The expression of IL-18, IL-18BP, cl-caspase-1 and gasdermin D (GSDMD) in lung tissues was detected by Western blot. Results:Experiment Ⅰ Compared with group S, the injury score of lung tissues, W/D ratio, concentrations of IL-18 and IL-18BP in BALF, and percentage of NLRP3 positive cells were significantly increased, and the expression of IL-18, IL-18BP, cl-caspase-1 and N-GSDMD was up-regulated in group SLI ( P<0.05). Compared with group SLI, the injury score of lung tissues, W/D ratio, concentrations of IL-18 and IL-18BP in BALF, and percentage of NLRP3 positive cells were significantly decreased, the expression of IL-18, cl-caspase-1 and N-GSDMD was down-regulated, and the expression of IL-18BP was up-regulated in group SI ( P<0.05). Experiment Ⅱ Compared with group SIV, the injury score of lung tissues, W/D ratio, concentrations of IL-18 in BALF, and percentage of NLRP3 positive cells were significantly decreased, and the expression of IL-18, cl-caspase-1 and N-GSDMD was down-regulated in group SIM, and the injury score of lung tissues, W/D ratio, concentrations of IL-18 in BALF, and percentage of NLRP3 positive cells were significantly increased, and the expression of IL-18, cl-caspase-1 and N-GSDMD was up-regulated in group SIN ( P<0.05). Conclusions:Exogenous IL-18BP can reduce sepsis-associated lung injury, and the mechanism is related to inhibition of activation of NLRP3 inflammasomes in rats.
8.Analysis of acupoint selection rules of Tuina in the treatment of infantile autumn diarrhea based on Traditional Chinese Medicine Inheritance Support Platform
Haining ZHANG ; Zhiyang LIU ; Yixin WANG ; Xiaofan ZHANG ; Huanan LI ; Jingui WANG
International Journal of Traditional Chinese Medicine 2022;44(3):325-329
Objective:To analyze the rules and distribution of acupuncture points used in pediatric tuina treatment for autumn diarrhea, and to provide a theoretical basis for the promotion and application of Tuina treatment techniques for pediatric diarrhea.Methods:We searched the literature on Tuina treatment of pediatric autumn diarrhea in the Chinese academic journals full-text database (CNKI), Chinese science and technology journals full-text database (VIP), Wanfang database and Chinese biomedical database (SinoMed), and collected the Tuina prescriptions on children's autumn diarrhea disease from the database to March 2021,with the help of the Traditional Chinese Medicine Inheritance Support Platform (V 2.0) software,and Data mining technology was applied to analyze the common acupoints and acupoint distribution of pediatric Tuina treatment of autumn diarrhea to form the core acupoints used in pediatric Tuina treatment of autumn diarrhea.Results:A total of 101 pediatric autumn diarrhea Tuina prescriptions were screened, involving 61 acupoints, among them 18 acupoints used more frequently, and 35 acupoint combinations were obtained, including 15 two-acupoint combinations, 11 three-acupoint combinations, and 2 four-acupoint combinations, and 7 new acupoint combinations were obtained.Conclusion:The core points mainly belong to the spleen meridian, large intestine meridian, abdomen, seven knotted bones, turtle tail, spine, and umbilicus, which can be used as a basic Tuina prescription for clinical reference.
9.Temporal trend of antibiotic use among primary school children in Shanghai, 2017-2020
Yuanping WANG ; Chuanxi TANG ; Minghui HAN ; Hongji FANG ; Jingui WU ; Chaowei FU ; Hexing WANG ; Qingwu JIANG
Chinese Journal of Preventive Medicine 2022;56(6):843-846
To investigate the temporal trend of antibiotic use among children in Shanghai from 2017 to 2020. The stratified cluster sampling method was used to establish a dynamic cohort of healthy children based on primary schools in Changning District, Shanghai. In the cohort, there were 282 children from 2017, 287 children from 2018, 294 from 2019 and 301 from 2020. A total of 700 children aged 7-11 years were included in the study. The basic information and antibiotic use of children were investigated by questionnaire every year, and their height and weight were measured at the same time. Chi-square test was used to analyze the difference of antibiotic use rate in each year and generalized estimation equation was used to analyze the temporal trend of antibiotic use. The results showed that the use rates of all antibiotics, cephalosporins, azithromycin and other antibiotics (including penicillin, lincomycin, quinolones, etc.) of children between 2017 and 2020 were 15.6%, 10.5%, 2.7%, and 2.4%, respectively. In 2017, 2018, 2019, and 2020, there were significant differences for the use rates of total antibiotics and other antibiotics in children ( P=0.033, P=0.040), and there were no significant differences for the use rates of cephalosporins and azithromycin ( P=0.274, P=0.455). After adjusting for children′s basic characteristics, the generalized estimation equation showed that the annual use rate of all antibiotics, cephalosporins, and other antibiotics decreased over time.
10.Temporal trend of antibiotic use among primary school children in Shanghai, 2017-2020
Yuanping WANG ; Chuanxi TANG ; Minghui HAN ; Hongji FANG ; Jingui WU ; Chaowei FU ; Hexing WANG ; Qingwu JIANG
Chinese Journal of Preventive Medicine 2022;56(6):843-846
To investigate the temporal trend of antibiotic use among children in Shanghai from 2017 to 2020. The stratified cluster sampling method was used to establish a dynamic cohort of healthy children based on primary schools in Changning District, Shanghai. In the cohort, there were 282 children from 2017, 287 children from 2018, 294 from 2019 and 301 from 2020. A total of 700 children aged 7-11 years were included in the study. The basic information and antibiotic use of children were investigated by questionnaire every year, and their height and weight were measured at the same time. Chi-square test was used to analyze the difference of antibiotic use rate in each year and generalized estimation equation was used to analyze the temporal trend of antibiotic use. The results showed that the use rates of all antibiotics, cephalosporins, azithromycin and other antibiotics (including penicillin, lincomycin, quinolones, etc.) of children between 2017 and 2020 were 15.6%, 10.5%, 2.7%, and 2.4%, respectively. In 2017, 2018, 2019, and 2020, there were significant differences for the use rates of total antibiotics and other antibiotics in children ( P=0.033, P=0.040), and there were no significant differences for the use rates of cephalosporins and azithromycin ( P=0.274, P=0.455). After adjusting for children′s basic characteristics, the generalized estimation equation showed that the annual use rate of all antibiotics, cephalosporins, and other antibiotics decreased over time.

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