OBJECTIVE To explore the clinical distribution and drug resistance of common species of pathogens iso-lated from a three-A hospital of Guangzhou from Jan.2017 to 2023 Dec.so as to provide bases for clinical diagno-sis and reasonable use of antibiotics.METHODS A total of 10,086 strains of aerobic bacteria were clinically isola-ted from the patients who were hospitalized in a three-A hospital of Guangzhou from 2017 to 2023.The constituent ratios of the common species of pathogens,specimen sources,distribution of departments and drug resistance rates to commonly used antibiotics were retrospectively analyzed.RESULTS Totally 10,086 strains of pathogens were isolated from the specimens of the hospitalized patients from 2017 to 2023.Klebsiella pneumoniae,Pseudo-monas aeruginosa,Escherichia coli,Acinetobacter baumannii and Staphylococcus aureus ranked the top 5 species of pathogens.The sputum,midstream urine and whole blood were the major specimen sources.The hospital-asso-ciated infection was highly prevalent in critical care medicine department,neurology department,geriatrics depart-ment,neurosurgery department and urology department.The result of drug resistance showed that the drug re-sistance rates of the K.pneumoniae and P.aeruginosa strains to various types of antibiotics showed upward trends(P＜0.05);the drug resistance rate of the A.baumannii strains to imipenem was decreased,while the drug resist-ance rates to most of the antibiotics were more than 45％.No gram-positive cocci strains that were resistant to vancomycin,teicoplanin or linezolid were found.CONCLUSIONS The common clinical isolates of pathogens are generally resistant to antibiotics.It is necessary for clinicians to attach great importance to the culture of pathogens and drug susceptibility testing and reasonably use antibiotics based on the result of drug susceptibility testing so as to reduce the occurrence and spread of drug-resistant strains.The hospital should strengthen the surveillance of drug resistance of bacteria so as to boost the clinical curative effect,standardize the management and use of antibi-otics and take effective measures to control of the hospital-associated infection.

Objective:To investigate the iodine nutrition level and the prevalence of thyroid nodules in pregnant women in Hubei Province, and to provide a basis for prevention and treatment of iodine deficiency disorders.Methods:According to the requirements of the National Iodine Deficiency Disorders Monitoring Program (2016 Edition), a cross-sectional survey of iodine nutrition status of pregnant women ( n = 321) was conducted from July to October 2020 in two mountainous counties (Tongcheng County and Xingshan County) and two plain counties (Liangzihu District and Xinzhou District) in Hubei Province. Among them, there were 43, 114, and 164 pregnant women in the early, middle, and late stages of pregnancy, respectively. Edible salt samples and once random urine samples were collected to detect salt iodine and urinary iodine, and thyroid ultrasound was performed to calculate the detection rate of thyroid nodules. Results:The coverage rate of iodized salt, qualified rate of iodized salt, and consumption rate of qualified iodized salt in Hubei Province were 99.69% (320/321), 95.94% (307/320) and 95.64% (307/321), respectively. The median urinary iodine level for pregnant women was 164.80 μg/L. Among them, the median urinary iodine levels in Liangzihu District, Tongcheng County, Xinzhou District, and Xingshan County were 175.90, 178.25, 155.80 and 143.00 μg/L, respectively. There was a statistically significant difference in urinary iodine levels among different regions ( H = 8.51, P = 0.037). The median urinary iodine levels of pregnant women in the early, middle, and late stages of pregnancy were 187.20, 144.45, and 172.05 μg/L, respectively. There was no statistically significant difference in urinary iodine levels among pregnant women in different stages of pregnancy ( H = 2.94, P = 0.230). Urinary iodine < 150, 150 - < 250, 250 - < 500, ≥500 μg/L accounted for 45.48% (146/321), 33.33% (107/321), 19.63% (63/321), 1.56% (5/321), respectively. The detection rate of thyroid nodules was 16.82% (54/321), and the goiter rate was 0.93% (3/321). Conclusions:In 2020, Hubei Province is in an appropriate state of iodine, and there are still a considerable proportion of pregnant women in a state of iodine deficiency. The detection rate of thyroid nodules is relatively low. It is necessary to continuously monitor the iodine nutrition of pregnant women, strengthen health promotion on the hazards of iodine deficiency during pregnancy, and minimize maternal and infant health damage caused by iodine deficiency.

Objective:To investigate the iodine nutrition level and the prevalence of thyroid nodules in pregnant women in Hubei Province, and to provide a basis for prevention and treatment of iodine deficiency disorders.Methods:According to the requirements of the National Iodine Deficiency Disorders Monitoring Program (2016 Edition), a cross-sectional survey of iodine nutrition status of pregnant women ( n = 321) was conducted from July to October 2020 in two mountainous counties (Tongcheng County and Xingshan County) and two plain counties (Liangzihu District and Xinzhou District) in Hubei Province. Among them, there were 43, 114, and 164 pregnant women in the early, middle, and late stages of pregnancy, respectively. Edible salt samples and once random urine samples were collected to detect salt iodine and urinary iodine, and thyroid ultrasound was performed to calculate the detection rate of thyroid nodules. Results:The coverage rate of iodized salt, qualified rate of iodized salt, and consumption rate of qualified iodized salt in Hubei Province were 99.69% (320/321), 95.94% (307/320) and 95.64% (307/321), respectively. The median urinary iodine level for pregnant women was 164.80 μg/L. Among them, the median urinary iodine levels in Liangzihu District, Tongcheng County, Xinzhou District, and Xingshan County were 175.90, 178.25, 155.80 and 143.00 μg/L, respectively. There was a statistically significant difference in urinary iodine levels among different regions ( H = 8.51, P = 0.037). The median urinary iodine levels of pregnant women in the early, middle, and late stages of pregnancy were 187.20, 144.45, and 172.05 μg/L, respectively. There was no statistically significant difference in urinary iodine levels among pregnant women in different stages of pregnancy ( H = 2.94, P = 0.230). Urinary iodine < 150, 150 - < 250, 250 - < 500, ≥500 μg/L accounted for 45.48% (146/321), 33.33% (107/321), 19.63% (63/321), 1.56% (5/321), respectively. The detection rate of thyroid nodules was 16.82% (54/321), and the goiter rate was 0.93% (3/321). Conclusions:In 2020, Hubei Province is in an appropriate state of iodine, and there are still a considerable proportion of pregnant women in a state of iodine deficiency. The detection rate of thyroid nodules is relatively low. It is necessary to continuously monitor the iodine nutrition of pregnant women, strengthen health promotion on the hazards of iodine deficiency during pregnancy, and minimize maternal and infant health damage caused by iodine deficiency.

OBJECTIVE To explore the clinical distribution and drug resistance of common species of pathogens iso-lated from a three-A hospital of Guangzhou from Jan.2017 to 2023 Dec.so as to provide bases for clinical diagno-sis and reasonable use of antibiotics.METHODS A total of 10,086 strains of aerobic bacteria were clinically isola-ted from the patients who were hospitalized in a three-A hospital of Guangzhou from 2017 to 2023.The constituent ratios of the common species of pathogens,specimen sources,distribution of departments and drug resistance rates to commonly used antibiotics were retrospectively analyzed.RESULTS Totally 10,086 strains of pathogens were isolated from the specimens of the hospitalized patients from 2017 to 2023.Klebsiella pneumoniae,Pseudo-monas aeruginosa,Escherichia coli,Acinetobacter baumannii and Staphylococcus aureus ranked the top 5 species of pathogens.The sputum,midstream urine and whole blood were the major specimen sources.The hospital-asso-ciated infection was highly prevalent in critical care medicine department,neurology department,geriatrics depart-ment,neurosurgery department and urology department.The result of drug resistance showed that the drug re-sistance rates of the K.pneumoniae and P.aeruginosa strains to various types of antibiotics showed upward trends(P＜0.05);the drug resistance rate of the A.baumannii strains to imipenem was decreased,while the drug resist-ance rates to most of the antibiotics were more than 45％.No gram-positive cocci strains that were resistant to vancomycin,teicoplanin or linezolid were found.CONCLUSIONS The common clinical isolates of pathogens are generally resistant to antibiotics.It is necessary for clinicians to attach great importance to the culture of pathogens and drug susceptibility testing and reasonably use antibiotics based on the result of drug susceptibility testing so as to reduce the occurrence and spread of drug-resistant strains.The hospital should strengthen the surveillance of drug resistance of bacteria so as to boost the clinical curative effect,standardize the management and use of antibi-otics and take effective measures to control of the hospital-associated infection.

Centralized monitoring is a risk-based remote monitoring mode that can effectively improve monitoring efficiency and quality. From July to September 2023, this study developed a centralized monitoring scheme for investigator initiated trials(IIT). This scheme utilized electronic data collection system and clinical research document management system, using programming techniques to compare the consistency of key project processes and data, monitor data filling, distribution trends, logical relationships, as well as documents such as informed consent forms, protocol violation records, and adverse event reports. It could timely identify problems in clinical trials and develop targeted response measures. From October to December 2023, 6 experts conducted centralized monitoring for 153 IIT projects using this scheme and found common issues in program execution(86 projects), ethical approvals(68 projects), and informed consent forms(67 projects), and so on. At the scome time, corresponding measures were developed. The process took a total of 20 days, with an average time of 6.27 hours per project. Compared with traditional on-site monitoring, the centralized monitoring scheme developed in this study had shown certain advantages in terms of timeliness, which could help guide the efficient implementation of on-site monitoring work and provide references for tertiary public hospitals to improve the quality of clinical trials.

Objective:To investigate the iodine nutrition level and thyroid function status of pregnant women in Hubei Province.Methods:According to the requirements of "the National Iodine Deficiency Disorders Monitoring Program (2016 Edition)", in 2020, using a cross-sectional survey method, two mountainous counties and two plain areas in Hubei Province were divided into five districts: east, west, south, north, and central. One township (street) was selected from each district, and 20 pregnant women were selected from each township (street) as survey subjects. Urine iodine content and thyroid function indicators [serum free triiodothyronine (FT 3), free thyroxine (FT 4), thyroid-stimulating hormone (TSH), thyroid peroxidase antibody (TPOAb), thyroglobulin antibody (TgAb)] were tested. Abnormal thyroid function rate and antibody positive rate were analyzed, and correlation analysis of thyroid function indicators was conducted (Spearman method). Results:A total of 321 pregnant women were included, including 43, 114, and 164 in early, middle, and late pregnancy, respectively; The median urinary iodine was 164.80 μg/L. The median serum FT 3, FT 4, TSH, TPOAb, TgAb levels were 4.10, 12.83 pmol/L, 1.85 mU/L, 15.84 and 13.35 U/ml, respectively. There were statistically significant differences in FT 3, FT 4, and TSH levels among different trimesters ( P < 0.05). According to Spearman's correlation analysis, FT 3 in early stage of pregnancy was negatively correlated with TSH and TPOAb levels ( r = - 0.46, - 0.33, P < 0.05), while TSH was positively correlated with TPOAb level ( r = 0.33, P = 0.032); there was a positive correlation between FT 4 and TgAb levels in middle stage of pregnancy ( r = 0.21, P = 0.032); there was a negative correlation between FT 3 and TPOAb levels in late stage of pregnancy ( r = - 0.19, P = 0.017); FT 3 and FT 4, TPOAb and TgAb levels were positively correlated throughout pregnancy ( P < 0.05). There was no correlation between urinary iodine content and thyroid function indicators ( P > 0.05). The total abnormal rate of thyroid function was 7.79% (25/321), with 16.28% (7/43), 5.26% (6/114), and 7.32% (12/164) in early, middle, and late pregnancy, respectively. There was no statistically significant difference in the abnormal rate of thyroid function among different pregnancy periods (χ 2 = 4.83, P = 0.097). The detection rates of hypothyroxinemia, hypothyroidism, subclinical hypothyroidism, hyperthyroidism, and subclinical hyperthyroidism were 4.36% (14/321), 0.31% (1/321), 2.49% (8/321), 0.31% (1/321), and 0.31% (1/321), respectively. The positive detection rate of autospecific antibodies was 10.28% (33/321), with a TPOAb positive detection rate of 9.97% (32/321) and a TgAb positive detection rate of 5.30% (17/321). Conclusions:The iodine nutrition level of pregnant women in Hubei Province is at a suitable level, and the rates of abnormal thyroid function and thyroid autospecific antibody positive are relatively low. It is necessary to continuously monitor the iodine nutrition and thyroid function indexes of pregnant women, strengthen health education on the hazards of iodine deficiency during pregnancy, and minimize the harm to maternal and infant health caused by iodine deficiency.

Centralized monitoring is a risk-based remote monitoring mode that can effectively improve monitoring efficiency and quality. From July to September 2023, this study developed a centralized monitoring scheme for investigator initiated trials(IIT). This scheme utilized electronic data collection system and clinical research document management system, using programming techniques to compare the consistency of key project processes and data, monitor data filling, distribution trends, logical relationships, as well as documents such as informed consent forms, protocol violation records, and adverse event reports. It could timely identify problems in clinical trials and develop targeted response measures. From October to December 2023, 6 experts conducted centralized monitoring for 153 IIT projects using this scheme and found common issues in program execution(86 projects), ethical approvals(68 projects), and informed consent forms(67 projects), and so on. At the scome time, corresponding measures were developed. The process took a total of 20 days, with an average time of 6.27 hours per project. Compared with traditional on-site monitoring, the centralized monitoring scheme developed in this study had shown certain advantages in terms of timeliness, which could help guide the efficient implementation of on-site monitoring work and provide references for tertiary public hospitals to improve the quality of clinical trials.

Effective supervision of the clinical research management department can guarantee and improve the quality of the investigator initiated trials(IIT). The authors analyzed relevant clinical research regulations and literature and summarized the current situation of risk-based IIT project process quality management. On such basis, they determined the risk-based IIT project process quality management method in combination with the previous research of the research group.From 2021 to 2022, this method was used to implement process quality management for 353 IIT projects in Shanghai′s tertiary hospitals. More than 3 000 risk points were identified through centralized supervision, and then on-site supervision was carried out to correct the problems found. As proven by the results, the method could find existing problems in time and define the risk level of the project, and also formulate an individualized risk supervision plan accordingly, so as to effectively ensure the data reliability and scientific results. It is suggested that the clinical research management department implement risk based management for the whole process of IIT projects, increase funding and staffing, and implement hierarchical management for the projects by research types, so as to promote the sustainable development of IITs.

Objective:To assess possible risk factors and their respective levels in the whole process of investigator initiated trial(IIT)projects proposed in the proposal stage, for reference in formulation of risk management plans.Methods:Through literature analysis and research group discussions, the risk factors of IIT projects and risk level assessment criteria were preliminarily identified, and a consultation questionnaire was developed as a result. Delphi method was used to further optimize the risk factors and determine their risk levels. Data obtained from the consulfation were analysied by descriptive.Results:The recovery rates of two rounds of expert consultation were both 100%, and the degree of expert authority was 0.942. The survey finalized 38 risk factors, including extremely high risk, high risk, medium risk, low risk and very low risk factors of 17(44.7%), 15(39.5%), 3(7.9%), 2(5.3%) and 1(2.6%) respectively.Conclusions:This study determined a risk evaluation system of IIT projects in the proposal stage. This system can identify risks of IIT projects at an early stage, facilitating early intervention of problems existing in such projects, and minimize risks to the rights and safety of patients.

Objective:To investigate the clinical feature, diagnosis, treatment and prognosis of childhood acute lymphoblastic leukemia (ALL) complicated with candida tropicalis bloodstream infection (CTBI), so as to improve the understanding of this disease.Methods:The general information, clinical manifestation, auxiliary examination, treatment and outcome of 14 childhood ALL who were diagnosed with tropical candidemia between January 2015 and December 2018 in 6 hospitals were analyzed retrospectively. Clinical data of non invasive fungal disease (IFD) ALL (28 cases) and other IFD children (9 cases) admitted in the same period were collected as control group. Logistic regression model was used to analyze the risk factor of CTBI.Results:Among 14 cases, there were 7 males and 7 females, with the age ranged from 17 months to 13 years. All the cases had fever, 9 cases had digestive system symptoms and stool fungal culture were positive in 3 of them; 7 cases had respiratory system symptoms and sputum fungal culture was positive in 1 of them; 2 cases had central nervous system symptoms and 10 cases progressed into septic shock. All 14 cases had neutropenia and the neutropenia duration was 1 to 53 days. Among 14 cases, the C-reactive protein was>50 mg/L in 8 cases, in which the proportion was significantly higher than that in other invasive fungal disease(IFD) (8/14 vs. 1/9, P<0.05), meanwhile the 1, 3-β-D-glucan detection, galactomannan detection and pulmonary imaging were not remarkable in all 14 cases. The blood culture results of 14 cases were all candida tropicalis, among which 13 cases finished drug susceptibility tests, the isolates of all cases were sensitive to flucytosine and amphotericin B, and the isolates of 4 cases were sensitive to fluconazole, voriconazole and itraconazole. Among 14 cases, 1 case lost to follow-up after giving up treatment, 1 case died before antifungal therapy and the remaining 12 cases received antifungal therapy; 7 of the 14 cases died. Univariate analysis showed that between ALL with CTBI group (14 cases) and ALL without invasive fungal disease (IFD) group (28 cases), the differences in variables such as ALL not in remission (χ2=37.847, P<0.01), length of hospital stay>15 days (χ 2=8.351, P=0.004), neutropenia (χ2=14.280, P<0.01), neutropenia duratio n>10 days (χ2=10.254, P=0.001), use of broad-spectrum antibiotics (χ2=13.888, P<0.01), skin and mucous membrane damage (χ2= 5.923, P=0.015) were statistically significant. Conclusions:In childhood ALL complicated with tropical candidemia, the drug resistance rate and mortality rate were high. For azole-resistant tropical candida, amphotericin B liposome or echinocandins(caspofungin) -fluorocytosine combined therapy was recommended to reduce treatment-related deaths.