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.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.
4.Alternative Biological Material for Tissue Engineering of the Vagina: Porcine-Derived Acellular Vaginal Matrix
Yanpeng TIAN ; Yibin LIU ; Yanlai XIAO ; Zhongkang LI ; Mingle ZHANG ; Liang CHEN ; Zhen LI ; Wangchao ZHANG ; Zhiqiang ZHANG ; Desheng KONG ; Li MENG ; Yanfang DU ; Jingkun ZHANG ; Jingui GAO ; Xianghua HUANG
Tissue Engineering and Regenerative Medicine 2024;21(2):277-290
BACKGROUND:
Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome is a severe congenital disorder characterized by vaginal hypoplasia caused by dysplasia of the Müllerian duct. Patients with MRKH syndrome often require nonsurgical or surgical treatment to achieve satisfactory vaginal length and sexual outcomes. The extracellular matrix has been successfully used for vaginal reconstruction.
METHODS:
In this study, we developed a new biological material derived from porcine vagina (acellular vaginal matrix, AVM) to reconstruct the vagina in Bama miniature pigs. The histological characteristics and efficacy of acellularization of AVM were evaluated, and AVM was subsequently transplanted into Bama miniature pigs to reconstruct the vaginas.
RESULTS:
Macroscopic analysis showed that the neovaginas functioned well in all Bama miniature pigs with AVM implants. Histological analysis and electrophysiological evidence indicated that morphological and functional recovery was restored in normal vaginal tissues. Scanning electron microscopy showed that the neovaginas had mucosal folds characteristics of normal vagina. No significant differences were observed in the expression of CK14, HSP47, and a-actin between the neovaginas and normal vaginal tissues. However, the expression of estrogen receptor (ER) was significantly lower in the neovaginas than in normal vaginal tissues. In addition, AVM promoted the expression of b-catenin, c-Myc, and cyclin D1. These results suggest that AVM might promotes vaginal regeneration by activating the b-catenin/cMyc/cyclin D1 pathway.
CONCLUSION
This study reveals that porcine-derived AVM has potential application for vaginal regeneration.
5.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.
6.Pirfenidone suppressing esophageal stent-related restenosis after stent placement: an animal experimental study
Yan FU ; Xiaowu ZHANG ; Yawei LI ; Jiawei CAO ; He ZHAO ; Tao GONG ; Jingui LI ; Xiao LI
Chinese Journal of Radiology 2021;55(5):534-539
Objective:To investigate the preventive efficacy of pirfenidone in esophageal stent-related restenosis and the related underlying mechanisms.Methods:Twenty-four rats underwent esophageal stent placement were included in this study. The rats were randomly assigned to three groups, with 8 rats in each group. The three groups were set to receive placebo, 150 mg/kg pirfenidone and 300 mg/kg pirfenidone daily by oral administration for 28 days, respectively. Twenty-eight days after stent placement, the stented esophagi were harvested for histological examinations. The number of epithelial layers, the thickness of submucosal fibrosis, the percentage of granulation tissue area, the degree of inflammatory cell infiltration, the degree of collagen deposition, and the α-SMA staining scores were evaluated. One-way ANOVA was performed for the statistical comparison of the number of epithelial layers, the degree of inflammatory cell infiltration, the degree of collagen deposition and the α-SMA staining scores among these three groups. The Kruskal-Wallis H test was used for comparison of the thickness of submucosal fibrosis and the percentage of granulation tissue area among the three groups. Results:Gross pathological findings showed that both pirfenidone groups had significantly less luminal fibrotic tissue formation and restenosis than placebo group. The percentage of granulation tissue areas in placebo group, 150 mg/kg and 300 mg/kg pirfenidone groups were 57.23%±25.68%, 21.80%±6.65% and 12.18%±6.37%, respectively. Both pirfenidone groups showed significantly less granulation tissue areas than placebo group ( P<0.01). The degree of inflammatory cell infiltration, the degree of collagen deposition and the α-SMA staining scores were 3.28±0.55, 3.38±0.63 and 2.75±0.38 in placebo group, 2.30±0.46, 2.36±0.58 and 2.00±0.42 in 150 mg/kg pirfenidone group, and 1.86±0.38, 1.91±0.41 and 1.57±0.28 in 300 mg/kg pirfenidone group, respectively. Both pirfenidone groups showed significantly less inflammatory cell infiltration, collagen deposition and α-SMA staining scores than placebo group ( P<0.01). Conclusion:Pirfenidone can suppress esophageal stent-related restenosis in rats by significantly inhibiting inflammation, myofibroblast activation and proliferation, and fibrotic tissue formation.
7.Analysis on drug transporters-mediated interaction between drugs and metformin
Jingui ZHANG ; Mengwen HE ; Chao WANG
Chinese Journal of Primary Medicine and Pharmacy 2021;28(12):1775-1779
Objective:To investigate the potential drug interactions of outpatient prescriptions containing metformin combined with other drugs from the perspective of drug transporters.Methods:The prescriptions containing metformin that were used in the Outpatient Department of Hainan General Hospital, China between July and December 2019 were collected. The potential interaction between drugs and metformin used in the prescriptions was analyzed according to drug instructions, Drugbank, PubMed databases.Results:A total of 15 568 outpatient prescriptions containing metformin were collected, including 9 146 prescriptions for male patients and 6 422 prescriptions for female patients. A total of 14 902 prescriptions contained combined medication. The drugs used in combination included other hypoglycemic drugs, antiplatelet drugs, antihypertensive drugs, lipid-lowering drugs, and neuroprotective drugs. The drug transporters including aspirin, atorvastatin calcium, repaglinide, bisoprolol, metoprolol and clopidogrel had a potential interaction with metformin. There were 11 614 prescriptions containing drug transporters and metformin, including 5 938 prescriptions inhibiting organic cation transporter 1 and 5676 prescriptions inhibiting organic cation transporter 2.Conclusion:There is no incompatibility between the outpatient prescriptions containing metformin and the commonly used drugs for chronic diseases, but the outpatient doctors do not have enough knowledge about dose adjustment caused by potential interaction.
8.Clinical study of peripheral vascular intervention via radial artery
Yawei LI ; Jiawei CAO ; Xiaowu ZHANG ; He ZHAO ; Tao GONG ; Jingui LI ; Xiao LI
Chinese Journal of Oncology 2021;43(1):143-146
Objective:To discuss the safety and feasibility of transradial access (TRA) in performing peripheral arterial intervention.Methods:The clinical data of the patients underwent peripheral vascular intervention via TRA in our hospital from September 2017 to March 2019 were reviewed. The success rate of radial artery puncture and subsequent operation after puncture, and related postoperative complications within 30 days were analyzed.Results:The clinical data of 112 peripheral arterial intervention procedures via TRA performed on 106 patients were reviewed, including transcatheter arterial chemoembolization in 83 cases, bronchial arterial infusion in 4 cases, pelvic tumor embolization in 11 cases and 14 other cases. The success rate of all interventional punctures was 97.3% (109/112), the operative success rate of interventional procedures was 98.2% (107/109). The TRA operation was failed in 5 patients, who were then converted to receive the femoral artery puncture and complete successfully. The severe complication of the operation was aortic dissection (2 cases). Minor complications included 2 cases of radial artery occlusion, radial artery spasm, arm pain and puncture point hematoma for each case. The severe complication and the minor complication rates were 1.8% (2/112) and 4.5% (5/112), respectively. Sixteen emergency operations were performed successfully, and no complication occurred.Conclusion:The TRA is a clinically safe and feasible approach for peripheral arterial interventional procedure.
9.Clinical study of peripheral vascular intervention via radial artery
Yawei LI ; Jiawei CAO ; Xiaowu ZHANG ; He ZHAO ; Tao GONG ; Jingui LI ; Xiao LI
Chinese Journal of Oncology 2021;43(1):143-146
Objective:To discuss the safety and feasibility of transradial access (TRA) in performing peripheral arterial intervention.Methods:The clinical data of the patients underwent peripheral vascular intervention via TRA in our hospital from September 2017 to March 2019 were reviewed. The success rate of radial artery puncture and subsequent operation after puncture, and related postoperative complications within 30 days were analyzed.Results:The clinical data of 112 peripheral arterial intervention procedures via TRA performed on 106 patients were reviewed, including transcatheter arterial chemoembolization in 83 cases, bronchial arterial infusion in 4 cases, pelvic tumor embolization in 11 cases and 14 other cases. The success rate of all interventional punctures was 97.3% (109/112), the operative success rate of interventional procedures was 98.2% (107/109). The TRA operation was failed in 5 patients, who were then converted to receive the femoral artery puncture and complete successfully. The severe complication of the operation was aortic dissection (2 cases). Minor complications included 2 cases of radial artery occlusion, radial artery spasm, arm pain and puncture point hematoma for each case. The severe complication and the minor complication rates were 1.8% (2/112) and 4.5% (5/112), respectively. Sixteen emergency operations were performed successfully, and no complication occurred.Conclusion:The TRA is a clinically safe and feasible approach for peripheral arterial interventional procedure.
10.Effect of abdominal mechanical stimulation on nervous system in irritable bowel syndrome-Diarrehea
Xiongfei LUO ; Siwen LIU ; Huanan LI ; Wei ZHANG ; Jingui WANG ; Bo LI ; Qiangsong WANG
International Journal of Biomedical Engineering 2020;43(2):94-99
Objective:To observe the effect of abdominal mechanical stimulation on rats with irritable bowel syndrome-Diarrehea (IBS-D), and to explore the possible mechanism of abdominal massage mechanical stimulation to improve IBS-D.Method:60 newborn Wistar rats were randomly divided into blank group, model group and abdominal massage group, 20 rats for each group. The IBS-D rat model was established by separating the mother rats and newborn rats. In the abdominal massage group, the IBS-D rats were treated with abdominal rubbing once a day for 14 days. In the model group, the IBS-D rats were only bound to the experimental platform once a day for 5 min for 14 days. The rats in blank group were not made model and with no intervention. The intestinal motility and visceral sensitivity of rats were measured by the time of glass bulb expulsion and the abdominal lift volume threshold. The pathological changes of rat colon tissue were observed by hematoxylin-eosin staining. The changes of mast cells in colon tissue were observed by toluidine blue staining. The ultramicrostructure of intestinal glial cells was observed by transmission electron microscope. The content of proinflammatory factors IL-6 and IL-1β in rat plasma was determined by ELISA.Results:Compared with the model group, mechanical stimulation of the abdominal massage can significantly prolong the discharge time of the glass beads [(2.5±0.2) min vs (1.6±0.2) min], increase the abdominal lift volume threshold of rats [(0.5±0.1) ml vs (0.4±0.1) ml], improve the pathological state of the colon tissue, and reduce the number of mast cells [(2.64±0.22) per field vs (5.61±0.12) per field], reduce the number of mitochondria in the intestinal glial cells and increase the density of heterochromatin, and can also reduce the secretion of proinflammatory factors IL-6 [(189.4±4.7) pg/ml vs (224.8±8.6) pg/ml] and IL-1β [(178.4±7.1) pg/ml vs (191.4±8.4) pg/ml], and the differences were statistically significant (all P<0.05). Conclusions:Mechanical stimulation of abdominal massage can increase the visceral sensitivity of IBS-D rats, regulate intestinal glial cells and reduce the secretion of proinflammatory factors. The mechanism may be related to the intestinal-brain axis.

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