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.

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*

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+

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.

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.

Objective To investigate the clinical application of skin bridge preopening window drainage in enhanced recovery of mixed hemorrhoids surgically treated with external dissection and internal ligation.Methods A total of 620 patients with mixed hemorrhoids surgically treated with external dissection and internal ligation were retrospectively analyzed from March 1,2021-February 28,2022.Patients were divided into the observation group(n=304)and the control group(n=316)according to the single and even numbers randomly generated at the time of admission.In the observation group,on the basis of conventional operation and drug treatment in the control group,most of them chose to implement preopening window drainage of the skin bridge according to the intraoperative evaluation of the anal skin bridge according to the unified evaluation criteria.Symptom-sign scoring scale used to evaluate the anal edema and pain after the operation.To compare and analyze differences in anal edema,anal pain and the postoperative hospital stay between the observation group and the control.Results The average daily edema scores of the observation group and the control group were 0.56 and 1.2 points,respectively.The average daily edema score of the observation group was lower than that of the control group,with the statistically significant differences(P＜0.05).The average daily pain scores of the observation group and the control group were 0.6 and 1.201+0.289 points,respectively.The average daily pain score of the observation group was lower than that of the control group,with the statistically significant differences(P＜0.05).The average hospitalization days of the observation group and the control group were 8 days and 10 days,respectively.The average length of stay in the observation group was less than that in the control group,with the statistically significant differences(P＜0.05).Conclusion Skin bridge preopening window drainage can effectively relieve the degree of anal edema and pain in patients with mixed hemorrhoids surgically treated with external dissection and internal ligation,improve clinical efficacy,shorten the postoperative hospital stay.It has practical value and clinical significance for enhanced recovery.

Objective This study assesses the effect of 6S standard operation procedure(SOP)on the centralized man-agement of flexible endoscopes within a disinfection supply center.Methods A retrospective analysis was conducted on the cen-tralized management of 38 flexible endoscopes in the Disinfection and Supply Center of Foshan Maternal and Child Health Hospi-tal.From January to June 2022,the endoscopes were managed conventionally without the 6S SOP,as the routine group.From Ju-ly to December 2022,the endoscopes were managed with the 6S SOP,as the research group.The two groups were compared in terms of the adherence to cleaning and disinfection standards,pass rate of cleaning and disinfection,incidence of adverse events,and satisfaction degrees of healthcare providers.Results The research group under the 6S SOP management showed an signifi-cant improvement in the disinfection pass rate compared to the routine group,although the difference was not statistically signifi-cant.However,it presented a significant reduction in the incidence of adverse endoscopic events(P＜0.05)and a significant in-crease in healthcare provider satisfaction(P＜0.05).Conclusion The 6S SOP in the centralized management of flexible endo-scopes in the disinfection supply centers effectively enhances the quality of endoscope cleaning and disinfection,ensures their safe usage,and provides patients with efficient and secure care.

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.

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+

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.