1.Analysis of the management status and project undertaking of drug clinical trial institutions in Jiangxi Province after the implementation of the filing system
Min JIANG ; Li LIN ; Chenxi GAN ; Wenxiong SUN ; Qingsong XU ; Xiuli ZHAO
China Pharmacy 2025;36(3):275-279
OBJECTIVE To investigate and analyze the current management of drug clinical trial institutions in Jiangxi Province and the situation of undertaking drug clinical trials after the implementation of the filing system. METHODS A survey was conducted on 38 new institutions (obtained qualifications during the implementation of the filing system) and old institutions (obtained qualifications during the implementation of the recognition system) that had completed drug clinical trial institution qualification filing for more than one year in Jiangxi Province. The survey focused on the basic information of the institutions, the number of registered principal investigator (PI), institutional hardware and information construction, personnel allocation and training, and drug registration clinical trials undertaken by the institutions. RESULTS Of 38 institutions surveyed, there were 22 general hospitals and 16 specialized hospitals; there were 24 old institutions and 14 new institutions. Whether in general hospitals or specialized hospitals, the old institutions were better than the new institutions in the number of approved beds, the number of outpatients, the number of inpatients, the number of specialties, and the number of PI; both old and new institutions had separate offices; all new institutions were set up with GCP pharmacy. The adoption of clinical trial management system in new institutions is significantly less than in old institutions. In the general hospital, both the number of full-time managers and the number of quality controllers in old institutions were significantly more than in the new institutions, while the opposite was true at the level of specialized hospitals. In terms of centralized training on GCP, new institutions were all better than the old ones. Whether in general hospitals or specialized hospitals, the number of drug registration clinical trial projects undertaken by new institutions was significantly less than that of old ones. CONCLUSIONS The new institutions are worse than the old institutions in comprehensive strength and information construction of hospitals, and the number of clinical trials undertaken by new institutions is also less than old institutions.
2.Listeria Brainstem Encephalitis With Myelitis Misdiagnosed as Acute Disseminated Encephalomyelitis:Report of One Case.
Dan-Ying WU ; Qin-Xue WANG ; Dong-Mei ZHU ; Yu-Jing GAN ; Min HUANG ; Su-Ming ZHOU
Acta Academiae Medicinae Sinicae 2025;47(4):673-678
Listeria brainstem encephalitis with myelitis is extremely rare in clinical practice.Since the clinical manifestations are non-specific,MRI is helpful for diagnosis.Positive cerebrospinal fluid culture is considered the gold standard for diagnosis.This article reports a case of an immunocompetent individual with listeria brainstem encephalitis with myelitis,aiming to enhance the awareness of this condition.
Humans
;
Brain Stem/pathology*
;
Diagnostic Errors
;
Encephalitis/complications*
;
Encephalomyelitis, Acute Disseminated/diagnosis*
;
Listeriosis/complications*
;
Myelitis/complications*
3.Digital repair for a patient with limited mouth opening: a case report and literature review
YANG Zhenghao ; ZHU Xiting ; LI Chen ; ZHOU Min ; GAN Xueqi
Journal of Prevention and Treatment for Stomatological Diseases 2024;32(3):216-222
Objective:
To explore an accurate method to obtain an intraoral model of patients with specific limited mouth opening (microstomia) due to systemic scleroderma.
Methods:
This study followed medical ethics, and informed consent has been obtained from patients. A case of Ken's Type I mandibular dentition defect scleroderma with limited mouth opening was addressed with digital technology as the leading method combined with the traditional impression method of segmental impression. Individual trays were made based on the patient's left and right mandibular dentition, and segmented molds were obtained. Simultaneously, intraoral scanning was performed to obtain the morphological data of both the soft and hard tissues of the upper and lower mandibles. After each part of the model was obtained, the mandibular model was scanned and digitally aligned to form the final denture model, and the final removable partial denture was designed and made by computer aided design/computer aided manufacturing (CAD/CAM) technology. At the same time, combined with the literature, the diagnosis and treatment of removable partial denture in patients with limited mouth opening were retrospectively analyzed.
Results:
The denture was well retained and achieved a good repair effect. The patients expressed satisfaction with the mastication efficiency and other functions of the denture. The findings of the literature review show that the integration of digital technology with the traditional impression method, along with computer fitting, can accurately obtain the patient's oral model and facilitate successful follow-up repairs. However, when the anterior mandibular dentition of the patient is absent, the margin of error is increased in this procedure, which deserves further exploration.
Conclusion
Utilizing digital technology as the leading method, combined with the traditional impression method of segmental impression, for the repair of dental defects in patients with limited mouth opening, has proven to be effective. Thus, patients report a positive medical experience with high satisfaction, indicating that this approach is worthy of clinical promotion.
4.Application of socket-shield technique for immediate implant placement and provisionalization in esthetic zone:a case report and literature review
Xiting ZHU ; Hao WANG ; Zhuoli ZHU ; Min ZHOU ; Chen LI ; Xueqi GAN
Journal of Prevention and Treatment for Stomatological Diseases 2024;32(1):57-63
Objective To investigate the effect of the socket-shield technique(SST)concurrent with immediate im-plant placement and provisionalization(IIPP)in the aesthetic restoration of anterior teeth.Methods A case of maxil-lary anterior tooth stumps with a thin labial bone wall was treated with SST for preservation of labial soft and hard tissue fullness,combined with an immediate implant placement and immediate provisional crown for restoring the shape of the tooth and gingival molding.Results Immediate implant placement and provisionalization restored the morphology and function of the affected tooth in the shortest possible time.The patient's labial soft and hard tissue contours in the affected tooth area were well preserved in the 18-month follow-up after the application of the SST,which presented a better aesthetic result.The literature review indicates that the indications for SST are unrestorable maxillary anterior teeth,whose dental,periodontal and periapical tissues are healthy and intact.In the esthetic zone,root shielding is effec-tive in maintaining the soft and hard tissue contour on the labial side of the implant.However,there is no consensus on the technical details of SST,such as the ideal coronal height and thickness of the shield,and the management of the gap between the shield and the implant.Thus,more clinical studies and histologic evidence are needed to provide a refer-ence for clinical decision-making.In addition,digital technology can improve the accuracy of implant placement and shield preparation.Conclusion The correct application of SST combined with IIPP in the esthetic zone can ensure es-thetic results.However,more high-quality evidence-based medical evidence is needed for its long-term efficacy,and in-dications should be strictly controlled during clinical application.
5.Effect of night-shift work and anxiety on work-related musculoskeletal disorders in electronic manufacturing employees
Xiaoyi LI ; Yushuo LIANG ; Wenzhen GAN ; Ruizhen LIN ; Xinyang YU ; Huiqing CHEN ; Min YANG ; Jiabin CHEN
China Occupational Medicine 2024;51(5):505-510
Objective To analyze the effect of night-shift work, anxiety and their interaction on work-related musculoskeletal disorders (WMSDs) among electronics manufacturing employees. Methods A total of 2 676 employees from 58 electronic manufacturing enterprises in the Pearl River Delta region of Guangdong Province were selected as the research subjects using the judgment sampling method. The Basic Situation Survey Scale, Generalized Anxiety Disorder 7-item Scale and Questionnaire of Musculoskeletal Disorders were used to assess night-shift work, anxiety and the prevalence of WMSDs in employees. The multivariate logistic regression model was used to analyze the effects of night-shift work, anxiety and their combined effects on the risk of WMSDs. Results The proportion of night-shift work was 30.3%, and the detection rates of anxiety and WMSDs were 26.8% and 41.3%, respectively. The results of multivariate logistic regression analysis showed that night-shift work and anxiety were independent risk factors of WMSDs in the research subjects, after excluding the influence of confounding factors such as age, marital status, enterprise size and length of service [odds ratio (OR) and 95% confidence interval (CI) were 1.307 (1.092-1.564) and 3.282 (2.739-3.934), respectively, both P<0.01]. Compared with those without night-shift work or anxiety, the risk of WMSDs was higher in individuals with only night-shift work, only anxiety, or both night-shift work and anxiety [OR and 95%CI were 1.347 (1.091-1.663), 3.395 (2.727-4.227) and 4.117 (3.072-5.519), respectively, all P<0.01]. Conclusion Both night-shift work and anxiety can increase the risk of WMSDs among electronic manufacturing employees, and these two factors exhibit a synergistic effect in increasing the risk of WMSDs.
6.Survival analysis of patients with diffuse large B-cell lymphoma after chemotherapy using Fuzheng Jiedu Formula and its mechanism of action on lymphocyte subsets
Xi LI ; Wenyi ZHOU ; Shiya ZHUANSUN ; Xinbei YUAN ; Yijie YANG ; Hua FU ; Wei SHEN ; Min XU ; Xinjin GAN ; Jiahui LU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1603-1611
Objective To evaluate the survival of patients with diffuse large B-cell lymphoma(DLBCL)after chemotherapy using Fuzheng Jiedu Formula and to explore the intrinsic correlation between the lymphocyte subset level and the survival of patients with DLBCL.Methods A total of 234 patients with DLBCL who had completed chemotherapy and achieved complete or partial response in the Department of Hematology,Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital,Tongji University from January 1,2013,to December 31,2023,were recruited.A cohort study design was adopted,with"whether to receive continuous Fuzheng Jiedu Formula treatment for≥6 months after chemotherapy"as the exposed factor.Patients meeting this exposed factor were divided into the traditional Chinese medicine(TCM)cohort,whereas those who did not meet this exposed factor were divided into the observation cohort.The 1-and 2-year progression-free survival(PFS)rate,overall survival(OS)rate,and duration of response(DOR)of the two cohorts were compared.The survival curves of PFS and OS of the two cohorts were drawn,and subgroup survival analysis was performed to determine factors affecting disease progression.The effect of Fuzheng Jiedu Formula on lymphocyte subset count level was observed.Results The study included 126 and 108 patients in the TCM and observation cohorts,respectively.Compared with the observation cohort,the 2-year PFS rate,2-year OS rate,and DOR were increased in the TCM cohort(P<0.05).The PFS in the TCM cohort was higher than that in the observation cohort[HR=0.542,95%CI(0.345-0.853),P<0.01].The result of subgroup analysis showed that PFS in the TCM cohort was higher than that in the observation cohort in the age≥60 years,AA stage Ⅲ-Ⅳ,CD4+
7.Digital repair for a patient with limited mouth opening:a case report and literature review
Zhenghao YANG ; Xiting ZHU ; Chen LI ; Min ZHOU ; Xueqi GAN
Journal of Prevention and Treatment for Stomatological Diseases 2024;(3):216-222
Objective To explore an accurate method to obtain an intraoral model of patients with specific limited mouth opening(microstomia)due to systemic scleroderma.Methods This study followed medical ethics,and informed consent has been obtained from patients.A case of Ken's Type Ⅰ mandibular dentition defect scleroderma with limited mouth opening was addressed with digital technology as the leading method combined with the traditional impression method of segmental impression.Individual trays were made based on the patient's left and right mandibular dentition,and segmented molds were obtained.Simultaneously,intraoral scanning was performed to obtain the morphological data of both the soft and hard tissues of the upper and lower mandibles.After each part of the model was obtained,the man-dibular model was scanned and digitally aligned to form the final denture model,and the final removable partial denture was designed and made by computer aided design/computer aided manufacturing(CAD/CAM)technology.At the same time,combined with the literature,the diagnosis and treatment of removable partial denture in patients with limited mouth opening were retrospectively analyzed.Results The denture was well retained and achieved a good repair ef-fect.The patients expressed satisfaction with the mastication efficiency and other functions of the denture.The findings of the literature review show that the integration of digital technology with the traditional impression method,along with computer fitting,can accurately obtain the patient's oral model and facilitate successful follow-up repairs.However,when the anterior mandibular dentition of the patient is absent,the margin of error is increased in this procedure,which deserves further exploration.Conclusion Utilizing digital technology as the leading method,combined with the tradi-tional impression method of segmental impression,for the repair of dental defects in patients with limited mouth open-ing,has proven to be effective.Thus,patients report a positive medical experience with high satisfaction,indicating that this approach is worthy of clinical promotion.
8.Survival analysis of patients with diffuse large B-cell lymphoma after chemotherapy using Fuzheng Jiedu Formula and its mechanism of action on lymphocyte subsets
Xi LI ; Wenyi ZHOU ; Shiya ZHUANSUN ; Xinbei YUAN ; Yijie YANG ; Hua FU ; Wei SHEN ; Min XU ; Xinjin GAN ; Jiahui LU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1603-1611
Objective To evaluate the survival of patients with diffuse large B-cell lymphoma(DLBCL)after chemotherapy using Fuzheng Jiedu Formula and to explore the intrinsic correlation between the lymphocyte subset level and the survival of patients with DLBCL.Methods A total of 234 patients with DLBCL who had completed chemotherapy and achieved complete or partial response in the Department of Hematology,Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital,Tongji University from January 1,2013,to December 31,2023,were recruited.A cohort study design was adopted,with"whether to receive continuous Fuzheng Jiedu Formula treatment for≥6 months after chemotherapy"as the exposed factor.Patients meeting this exposed factor were divided into the traditional Chinese medicine(TCM)cohort,whereas those who did not meet this exposed factor were divided into the observation cohort.The 1-and 2-year progression-free survival(PFS)rate,overall survival(OS)rate,and duration of response(DOR)of the two cohorts were compared.The survival curves of PFS and OS of the two cohorts were drawn,and subgroup survival analysis was performed to determine factors affecting disease progression.The effect of Fuzheng Jiedu Formula on lymphocyte subset count level was observed.Results The study included 126 and 108 patients in the TCM and observation cohorts,respectively.Compared with the observation cohort,the 2-year PFS rate,2-year OS rate,and DOR were increased in the TCM cohort(P<0.05).The PFS in the TCM cohort was higher than that in the observation cohort[HR=0.542,95%CI(0.345-0.853),P<0.01].The result of subgroup analysis showed that PFS in the TCM cohort was higher than that in the observation cohort in the age≥60 years,AA stage Ⅲ-Ⅳ,CD4+
9.Digital repair for a patient with limited mouth opening:a case report and literature review
Zhenghao YANG ; Xiting ZHU ; Chen LI ; Min ZHOU ; Xueqi GAN
Journal of Prevention and Treatment for Stomatological Diseases 2024;(3):216-222
Objective To explore an accurate method to obtain an intraoral model of patients with specific limited mouth opening(microstomia)due to systemic scleroderma.Methods This study followed medical ethics,and informed consent has been obtained from patients.A case of Ken's Type Ⅰ mandibular dentition defect scleroderma with limited mouth opening was addressed with digital technology as the leading method combined with the traditional impression method of segmental impression.Individual trays were made based on the patient's left and right mandibular dentition,and segmented molds were obtained.Simultaneously,intraoral scanning was performed to obtain the morphological data of both the soft and hard tissues of the upper and lower mandibles.After each part of the model was obtained,the man-dibular model was scanned and digitally aligned to form the final denture model,and the final removable partial denture was designed and made by computer aided design/computer aided manufacturing(CAD/CAM)technology.At the same time,combined with the literature,the diagnosis and treatment of removable partial denture in patients with limited mouth opening were retrospectively analyzed.Results The denture was well retained and achieved a good repair ef-fect.The patients expressed satisfaction with the mastication efficiency and other functions of the denture.The findings of the literature review show that the integration of digital technology with the traditional impression method,along with computer fitting,can accurately obtain the patient's oral model and facilitate successful follow-up repairs.However,when the anterior mandibular dentition of the patient is absent,the margin of error is increased in this procedure,which deserves further exploration.Conclusion Utilizing digital technology as the leading method,combined with the tradi-tional impression method of segmental impression,for the repair of dental defects in patients with limited mouth open-ing,has proven to be effective.Thus,patients report a positive medical experience with high satisfaction,indicating that this approach is worthy of clinical promotion.
10.Survival analysis of patients with diffuse large B-cell lymphoma after chemotherapy using Fuzheng Jiedu Formula and its mechanism of action on lymphocyte subsets
Xi LI ; Wenyi ZHOU ; Shiya ZHUANSUN ; Xinbei YUAN ; Yijie YANG ; Hua FU ; Wei SHEN ; Min XU ; Xinjin GAN ; Jiahui LU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(11):1603-1611
Objective To evaluate the survival of patients with diffuse large B-cell lymphoma(DLBCL)after chemotherapy using Fuzheng Jiedu Formula and to explore the intrinsic correlation between the lymphocyte subset level and the survival of patients with DLBCL.Methods A total of 234 patients with DLBCL who had completed chemotherapy and achieved complete or partial response in the Department of Hematology,Longhua Hospital Shanghai University of Traditional Chinese Medicine and Shanghai East Hospital,Tongji University from January 1,2013,to December 31,2023,were recruited.A cohort study design was adopted,with"whether to receive continuous Fuzheng Jiedu Formula treatment for≥6 months after chemotherapy"as the exposed factor.Patients meeting this exposed factor were divided into the traditional Chinese medicine(TCM)cohort,whereas those who did not meet this exposed factor were divided into the observation cohort.The 1-and 2-year progression-free survival(PFS)rate,overall survival(OS)rate,and duration of response(DOR)of the two cohorts were compared.The survival curves of PFS and OS of the two cohorts were drawn,and subgroup survival analysis was performed to determine factors affecting disease progression.The effect of Fuzheng Jiedu Formula on lymphocyte subset count level was observed.Results The study included 126 and 108 patients in the TCM and observation cohorts,respectively.Compared with the observation cohort,the 2-year PFS rate,2-year OS rate,and DOR were increased in the TCM cohort(P<0.05).The PFS in the TCM cohort was higher than that in the observation cohort[HR=0.542,95%CI(0.345-0.853),P<0.01].The result of subgroup analysis showed that PFS in the TCM cohort was higher than that in the observation cohort in the age≥60 years,AA stage Ⅲ-Ⅳ,CD4+


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