1.Bibliometric analysis of registration of thyroid-associated ophthalmopathy clinical trials based on ICTRP
Shuyi LIU ; Jiacheng YAN ; Hang LI ; Wei LU
Chinese Journal of Experimental Ophthalmology 2025;43(9):833-838
Objective:To study the characteristics of thyroid-associated ophthalmopathy (TAO) clinical trials based on WHO International Clinical Trials Registry Platform (ICTRP).Methods:The WHO ICTRP database was searched from their inception to October 25, 2024.Data including the basic registration information, study type, study design, study stage, intervention measures and outcomes were extracted, and a descriptive analysis of the included trials was performed using bibliometric method.Results:A total of 288 trials were identified, the number of registrations for TAO interventional clinical trials was on the rise.Among them, 13 trials without key registration information, 93 without intervention, 2 with non-TAO subjects, 28 without control group, and 4 with duplicate study registration numbers or extension studies were excluded.Finally, 142 intervention trials were included in this study.The top three in registration numbers were China (44 trials), the United States (40 trials), and Europe (31 trials), and most of them were single-center studies (99 trials, accounting for 69.7%). For study design, 131 trials were randomized controlled trials, and 122 trials reported its masking method.Main stage of the trials was phase Ⅲ (31 trials, accounting for 21.8%). Drug treatments (121 trials, accounting for 85.2%) were the main intervention measures, and most of them were monoclonal antibody drugs (55 trials). Clinical activity score (81 trials) and exophthalmia (80 trials) were the commonly used outcome measures.Conclusions:The number of registrations for TAO interventional clinical trials is on the rise, with monoclonal antibody drugs as the main intervention measures.However, issues such as the limited registration number, uneven distribution of countries/regions, incomplete information, and low quality of study design remain to be addressed.Researchers should raise the awareness of registration and design of clinical trials, deepen international and interregional cooperation, improve the review and tracking mechanism of clinical trial registration platforms, and promote the high-quality development of TAO clinical trials.
2.Bibliometric analysis of registration of thyroid-associated ophthalmopathy clinical trials based on ICTRP
Shuyi LIU ; Jiacheng YAN ; Hang LI ; Wei LU
Chinese Journal of Experimental Ophthalmology 2025;43(9):833-838
Objective:To study the characteristics of thyroid-associated ophthalmopathy (TAO) clinical trials based on WHO International Clinical Trials Registry Platform (ICTRP).Methods:The WHO ICTRP database was searched from their inception to October 25, 2024.Data including the basic registration information, study type, study design, study stage, intervention measures and outcomes were extracted, and a descriptive analysis of the included trials was performed using bibliometric method.Results:A total of 288 trials were identified, the number of registrations for TAO interventional clinical trials was on the rise.Among them, 13 trials without key registration information, 93 without intervention, 2 with non-TAO subjects, 28 without control group, and 4 with duplicate study registration numbers or extension studies were excluded.Finally, 142 intervention trials were included in this study.The top three in registration numbers were China (44 trials), the United States (40 trials), and Europe (31 trials), and most of them were single-center studies (99 trials, accounting for 69.7%). For study design, 131 trials were randomized controlled trials, and 122 trials reported its masking method.Main stage of the trials was phase Ⅲ (31 trials, accounting for 21.8%). Drug treatments (121 trials, accounting for 85.2%) were the main intervention measures, and most of them were monoclonal antibody drugs (55 trials). Clinical activity score (81 trials) and exophthalmia (80 trials) were the commonly used outcome measures.Conclusions:The number of registrations for TAO interventional clinical trials is on the rise, with monoclonal antibody drugs as the main intervention measures.However, issues such as the limited registration number, uneven distribution of countries/regions, incomplete information, and low quality of study design remain to be addressed.Researchers should raise the awareness of registration and design of clinical trials, deepen international and interregional cooperation, improve the review and tracking mechanism of clinical trial registration platforms, and promote the high-quality development of TAO clinical trials.
3.Heterozygous CARD9 mutation favors the development of allergic bronchopulmonary aspergillosis.
Xia XU ; Haiwen LU ; Jianxiong LI ; Jielin DUAN ; Zhongwei WANG ; Jiawei YANG ; Shuyi GU ; Rongguang LUO ; Shuo LIANG ; Wei TANG ; Fengying ZHANG ; Jingqing HANG ; Juan GE ; Xin LIN ; Jieming QU ; Xinming JIA ; Jinfu XU
Chinese Medical Journal 2023;136(16):1949-1958
BACKGROUND:
Previous research demonstrated that a homozygous mutation of g.136372044G>A (S12N) in caspase recruitment domain family member 9 ( CARD9 ) is critical for producing Aspergillus fumigatus -induced ( Af -induced) T helper 2 (T H 2)-mediated responses in allergic bronchopulmonary aspergillosis (ABPA). However, it remains unclear whether the CARD9S12N mutation, especially the heterozygous occurrence, predisposes the host to ABPA.
METHODS:
A total of 61 ABPA patients and 264 controls (including 156 healthy controls and 108 asthma patients) were recruited for sequencing the CARD9 locus to clarify whether patients with this heterozygous single-nucleotide polymorphisms are predisposed to the development of ABPA. A series of in vivo and in vitro experiments, such as quantitative real-time polymerase chain reaction, flow cytometry, and RNA isolation and quantification, were used to illuminate the involved mechanism of the disease.
RESULTS:
The presence of the p.S12N mutation was associated with a significant risk of ABPA in ABPA patients when compared with healthy controls and asthma patients, regardless of Aspergillus sensitivity. Relative to healthy controls without relevant allergies, the mutation of p.S12N was associated with a significant risk of ABPA (OR: 2.69 and 4.17 for GA and AA genotypes, P = 0.003 and 0.029, respectively). Compared with patients with asthma, ABPA patients had a significantly higher heterozygous mutation (GA genotype), indicating that p.S12N might be a significant ABPA-susceptibility locus ( aspergillus sensitized asthma: OR: 3.02, P = 0.009; aspergillus unsensitized asthma: OR: 2.94, P = 0.005). The mutant allele was preferentially expressed in ABPA patients with heterozygous CARD9S12N , which contributes to its functional alterations to facilitate Af -induced T H 2-mediated ABPA development. In terms of mechanism, Card9 wild-type ( Card9WT ) expression levels decreased significantly due to Af -induced decay of its messenger RNA compared to the heterozygous Card9S12N . In addition, ABPA patients with heterozygous CARD9S12N had increased Af -induced interleukin-5 production.
CONCLUSION
Our study provides the genetic evidence showing that the heterozygous mutation of CARD9S12N , followed by allele expression imbalance of CARD9S12N , facilitates the development of ABPA.
Humans
;
Aspergillosis, Allergic Bronchopulmonary/complications*
;
Aspergillus fumigatus/genetics*
;
Asthma/genetics*
;
Aspergillus
;
Mutation/genetics*
;
CARD Signaling Adaptor Proteins/genetics*
4.Clinical features and diagnosis analysis of the patients after recreational diving
Hang LI ; Haidong WANG ; Xiaojing ZHANG ; Shuyi PAN
Chinese journal of nautical medicine and hyperbaric medicine 2020;27(3):300-304,308
Objective:To provide a reference for diving medical doctors on the diagnosis and differentiation of the patients with discomfort symptoms after recreational diving, by analyzing those patients′ clinical data and summarizing the features of clinical symptoms, the first diagnosis and consultation at the clinical visit.Methods:The clinical data of 102 outpatients and inpatients with discomfort after recreational diving admitted in and visited the Department of Hyperbaric Oxygen of the Sixth Medical Center of PLA General Hospital from October 2011 to October 2018 were retrospectively analyzed. The age, gender and other demographical data of the patients, as well as the diving history, the first diagnosis, the first consulted department, the department that made confirmed diagnosis, and the number of departments that the patients were transferred, were analyzed.Results:Among the 102 patients included in the study, the age of 30-44 years old accounted for the highest proportion (49.0%), dizziness and headache were the most common symptoms (34.3%) among all discomfort symptoms, and the clinical symptoms mainly involved head, heart, lung, and digestive system. The symptoms of digestive system and the vegetative nervous system were more commonly seen in women than those in men. The diving depths which was less than 10 meters accounted for 84.3%. The majority of patients experienced multiple dives within 24 hours (42.2%). The patients who had the discomfort symptoms after arriving at surface accounted for 69.6%. The proportion of decompression sickness in the diagnosis only accounted for 16.7%. The emergency department was the most-visited department (51.9%) within all the first consulted departments. The average number of departments in which the patients were transferred between the first consulted department and the department that made confirmed diagnosis was 2.2±1.7. Multiple dives, diving depth, suspected history of improper decompression, and the time of symptoms appearing were all significantly correlated with the diagnosis of decompression sickness ( P<0.05). Age, sex, the frequency of previous exercise, stress or panic during the diving were significantly correlated with the diagnosis of non-decompression sickness ( P<0.05). Conclusion:Regarding the diagnosis of the patients with discomfort symptoms after recreational diving, diagnosis other than decompression sickness should be considered.
5.Analysis on research hotpots of hyperbaric oxygen nursing in China based on word frequency and co-word cluster analysis
Jianqiu CAO ; Minglong WEI ; Li PENG ; Hang LI ; Shuyi PAN
Chinese journal of nautical medicine and hyperbaric medicine 2020;27(6):669-672
Objective:To analyze the research hotspots of hyperbaric oxygen nursing in China.Methods:We retrieved the research literature on hyperbaric oxygen nursing in China from China National Knowledge Infrastructure (CNKI) and Wanfang Data, used the Statistical Analysis Toolkit for Informetrics (STAI 3.2) to make statistical and word frequency analysis on the key words of those literature, and constructed a co-word matrix. Then we carried out cluster analysis by using SPSS 23.0 and analyzed the research hotspots according to the tree diagram.Results:A total of 704 papers were retrieved, and 30 high-frequency key words were gained. Based on that, five hotspots were obtained by cluster analysis as follows: hyperbaric oxygen nursing solutions and measures, the role of psychiatric and mental health nursing in hyperbaric oxygen therapy, the effect and value of risk management in hyperbaric oxygen therapy, nursing measures in hyperbaric oxygen therapy for patients received tracheostomy, and the application of different nursing methods or models on patients in hyperbaric oxygen therapy.Conclusion:Based on word frequency analysis and co-word cluster analysis, this study objectively reveals the current research hotspots of hyperbaric oxygen nursing in China, which can be compared with overseas research hotspots in the same field to direct future research.
6.Clinical features and diagnosis analysis of the patients after recreational diving
Hang LI ; Haidong WANG ; Xiaojing ZHANG ; Shuyi PAN
Chinese journal of nautical medicine and hyperbaric medicine 2020;27(3):300-304,308
Objective:To provide a reference for diving medical doctors on the diagnosis and differentiation of the patients with discomfort symptoms after recreational diving, by analyzing those patients′ clinical data and summarizing the features of clinical symptoms, the first diagnosis and consultation at the clinical visit.Methods:The clinical data of 102 outpatients and inpatients with discomfort after recreational diving admitted in and visited the Department of Hyperbaric Oxygen of the Sixth Medical Center of PLA General Hospital from October 2011 to October 2018 were retrospectively analyzed. The age, gender and other demographical data of the patients, as well as the diving history, the first diagnosis, the first consulted department, the department that made confirmed diagnosis, and the number of departments that the patients were transferred, were analyzed.Results:Among the 102 patients included in the study, the age of 30-44 years old accounted for the highest proportion (49.0%), dizziness and headache were the most common symptoms (34.3%) among all discomfort symptoms, and the clinical symptoms mainly involved head, heart, lung, and digestive system. The symptoms of digestive system and the vegetative nervous system were more commonly seen in women than those in men. The diving depths which was less than 10 meters accounted for 84.3%. The majority of patients experienced multiple dives within 24 hours (42.2%). The patients who had the discomfort symptoms after arriving at surface accounted for 69.6%. The proportion of decompression sickness in the diagnosis only accounted for 16.7%. The emergency department was the most-visited department (51.9%) within all the first consulted departments. The average number of departments in which the patients were transferred between the first consulted department and the department that made confirmed diagnosis was 2.2±1.7. Multiple dives, diving depth, suspected history of improper decompression, and the time of symptoms appearing were all significantly correlated with the diagnosis of decompression sickness ( P<0.05). Age, sex, the frequency of previous exercise, stress or panic during the diving were significantly correlated with the diagnosis of non-decompression sickness ( P<0.05). Conclusion:Regarding the diagnosis of the patients with discomfort symptoms after recreational diving, diagnosis other than decompression sickness should be considered.
7.Analysis on research hotpots of hyperbaric oxygen nursing in China based on word frequency and co-word cluster analysis
Jianqiu CAO ; Minglong WEI ; Li PENG ; Hang LI ; Shuyi PAN
Chinese journal of nautical medicine and hyperbaric medicine 2020;27(6):669-672
Objective:To analyze the research hotspots of hyperbaric oxygen nursing in China.Methods:We retrieved the research literature on hyperbaric oxygen nursing in China from China National Knowledge Infrastructure (CNKI) and Wanfang Data, used the Statistical Analysis Toolkit for Informetrics (STAI 3.2) to make statistical and word frequency analysis on the key words of those literature, and constructed a co-word matrix. Then we carried out cluster analysis by using SPSS 23.0 and analyzed the research hotspots according to the tree diagram.Results:A total of 704 papers were retrieved, and 30 high-frequency key words were gained. Based on that, five hotspots were obtained by cluster analysis as follows: hyperbaric oxygen nursing solutions and measures, the role of psychiatric and mental health nursing in hyperbaric oxygen therapy, the effect and value of risk management in hyperbaric oxygen therapy, nursing measures in hyperbaric oxygen therapy for patients received tracheostomy, and the application of different nursing methods or models on patients in hyperbaric oxygen therapy.Conclusion:Based on word frequency analysis and co-word cluster analysis, this study objectively reveals the current research hotspots of hyperbaric oxygen nursing in China, which can be compared with overseas research hotspots in the same field to direct future research.
8.Clinical efficacy of hyperbaric oxygen treatment on the middle stage steroid-induced necrosis of the femoral head
Hang LI ; Xuedong BAI ; Yu ZHANG ; Chen YANG ; Haidong WANG ; Shuyi PAN
Chinese journal of nautical medicine and hyperbaric medicine 2018;25(2):94-98,102
Objective To investigate the clinical efficacy of hyperbaric oxygen (HBO) therapy on steroid-induced necrosis of the femoral head (SNFH) at the stages of ARCO Ⅱ a and Ⅲ a.Methods A prospective,randomized,controlled trial was performed in 53 patients (20 were excluded),who were conformed to have SNFH at the stages of ARCOⅡa and Ⅲa through clinical medical care and or hospitalization.Before enrollment,the Harris and MRI scores (the indexes of femoral head necrosis,the areas of necrosis and bone marrow edema) were evaluated in all the subjects.After enrollment,the patients were randomly assigned to the experimental group or the cross group.Before enrollment and after 60 sessions of HBO therapy,the patients in the experimental group were evaluated the second time,which included Harris/MRI scores and relief rate of coxalgia.After 3-month intervention and 6-month HBO therapy,the patients in the cross group had evaluations the second and third times,which also included Harris/MRI scores and relief rate of coxalgia.Results Following HBO therapy,the Harris scores of either the experimental group or the cross group all increased,and the bone marrow edema scores decreased [Before HBO therapy in the experimental group:(68.4 ± 8.2) scores,after HBO thercopy:(76.2 ± 3.6) scores;Before HBO therapy in the cross group:(67.5 ± 4.1) scores;after HBO therapy:(76.1 ± 3.9)scores] (P < 0.05),while the Harris scores,the area of femoral head necrosis and the bone marrow edema scores all failed to improve in the patients of the cross group (P < 0.05).Following HBO therapy,statistical significance could be noted in the relief rate of coxalgia in both groups (P < 0.05).Conclusions HBO therapy could improve Harris and MRI scores of the patients at middle stage of steroid-induced necrosis of the femoral head,and could also alleviate coxalgia symptoms of the patients with SNFH.
9.Clinical efficacy of hyperbaric oxygen treatment on the middle stage steroid-induced necrosis of the femoral head
Hang LI ; Xuedong BAI ; Yu ZHANG ; Chen YANG ; Haidong WANG ; Shuyi PAN
Chinese journal of nautical medicine and hyperbaric medicine 2018;25(2):94-98,102
Objective To investigate the clinical efficacy of hyperbaric oxygen (HBO) therapy on steroid-induced necrosis of the femoral head (SNFH) at the stages of ARCO Ⅱ a and Ⅲ a.Methods A prospective,randomized,controlled trial was performed in 53 patients (20 were excluded),who were conformed to have SNFH at the stages of ARCOⅡa and Ⅲa through clinical medical care and or hospitalization.Before enrollment,the Harris and MRI scores (the indexes of femoral head necrosis,the areas of necrosis and bone marrow edema) were evaluated in all the subjects.After enrollment,the patients were randomly assigned to the experimental group or the cross group.Before enrollment and after 60 sessions of HBO therapy,the patients in the experimental group were evaluated the second time,which included Harris/MRI scores and relief rate of coxalgia.After 3-month intervention and 6-month HBO therapy,the patients in the cross group had evaluations the second and third times,which also included Harris/MRI scores and relief rate of coxalgia.Results Following HBO therapy,the Harris scores of either the experimental group or the cross group all increased,and the bone marrow edema scores decreased [Before HBO therapy in the experimental group:(68.4 ± 8.2) scores,after HBO thercopy:(76.2 ± 3.6) scores;Before HBO therapy in the cross group:(67.5 ± 4.1) scores;after HBO therapy:(76.1 ± 3.9)scores] (P < 0.05),while the Harris scores,the area of femoral head necrosis and the bone marrow edema scores all failed to improve in the patients of the cross group (P < 0.05).Following HBO therapy,statistical significance could be noted in the relief rate of coxalgia in both groups (P < 0.05).Conclusions HBO therapy could improve Harris and MRI scores of the patients at middle stage of steroid-induced necrosis of the femoral head,and could also alleviate coxalgia symptoms of the patients with SNFH.
10.Therapeutic effects of hyperbaric oxygen combined with glucocorticoid on refractory idiopathic sudden deafness
Chen YANG ; Yu ZHANG ; Hang LI ; Xiang'en MENG ; Shuyi PAN
Chinese journal of nautical medicine and hyperbaric medicine 2014;21(4):219-221
Objective Observe the therapeutic effects of hyperbaric oxygen (HB0) combined with glucocorticoid (GC) on refractory idiopathic sudden deafness.Methods Forty-two patients with sudden deafness (refractory idiopathic sudden deafness),who failed to recover after over one month of onset,were admitted into our Center from 2010 to 2013 for treatment with HBO combined with GC (referred to as the combined treatment group).Another 2 groups of patients with refractory idiopathic sudden deafness (each consisting of 32 patients),who were admitted into either our Center or the Department of Otorhinolaryngology of the Navy General Hospital and treated with simple HBO or GC,were used as controls.Through analyses of effective rates,cure rates and improvement rates in hearing,differences in therapeutic effects were compared between the patient group treated with HB0 combined with GC and the 2 control groups.Results The effective rate (59.52%) and improvement rate [(61.3 ± 4.7)%] for the combined treatment group were obviously higher than those of the simple HBO group[28.13%,(43.6 ± 5.5)%] and the simple hormone group [31.25%,(56.4 ± 4.1%].Conclusions The therapeutic effect of combined treatment with HBO + GC could produce good effects on refractory sudden deafness,however,adverse effects of hormones should be closely monitored in the process of the combined treatment.

Result Analysis
Print
Save
E-mail