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.Disease burden of acute viral hepatitis in Guangdong Province, 1990-2019
Jiamin QIU ; Fangfang ZENG ; Chen CHENG ; Huiyan WEN ; Shiqi HUANG ; Dan LIU ; Jinlei QI ; Peng YIN ; Maigeng ZHOU ; Ying XU ; Zhiping LIU ; Qingsong MEI ; Heng XIAO ; Zheng XIANG ; Xiaofeng LIANG
Chinese Journal of Epidemiology 2024;45(3):365-372
Objective:To examine the burden and trends of acute viral hepatitis in Guangdong Province from 1990 to 2019, and provide reference evidences for hepatitis prevention and control in the province.Methods:Data on acute viral hepatitis (hepatitis A, B, C, and E) in Guangdong from 1990 to 2019 were extracted from the Global Burden of Disease Study 2019 database. The incidence, prevalence, mortality, and disability-adjusted life years (DALY) data were analyzed by age and gender, and the estimated annual percentage change (EAPC) was calculated to describe the changing trends in disease burden.Results:From 1999 to 2019, the standardized incidence, prevalence, mortality, and DALY of acute viral hepatitis in Guangdong were higher than the national averages. In 2019, 51.43% (2 245 087/4 365 221) of acute viral hepatitis cases in Guangdong Province were mainly attributed to hepatitis B, and 77.18% (106/138) of deaths were due to acute hepatitis B. In different age groups, except for acute hepatitis B, which was more common in adults, the incidence rates of other types of viral hepatitis such as hepatitis A, B, and E showed an overall decreasing trend with age. The mortality rates of different types of acute viral hepatitis, except for the <5 age group, increased with age. The overall incidence and mortality rates of acute viral hepatitis were higher in men than in women.Conclusions:The overall burden of acute viral hepatitis in Guangdong declined in 2019, but remained higher than the national level. Further efforts are needed to strengthen hepatitis prevention and screening in different population in Guangdong Province, especially in children and the elderly.
3.Hemodynamic Analysis of Double-Fenestration Technique for Treating Complex Aortic Dissection
Xu WANG ; Qingsong HAN ; Libo BAI ; Haiquan FENG
Journal of Medical Biomechanics 2024;39(5):860-865
Objective Based on clinical surgical statistical instances,the influence of double fenestration branch stents on the blood flow field after different depths of implantation in the diseased thoracic aorta was investigated.Methods Thoracic aorta,thoracic aorta-coated stent,and branch vessel-coated stent were established.The finite element calculation method was used to analyze the branch stent implanted into the diseased aorta at different depths(5,10,and 15 mm),and experimental verification was performed using an in vitro tachymetry experimental platform.Results There were certain patterns for maintaining stable perfusion of the blood flow field with branch stent implantation at different depths in the thoracic aorta.The branch blood perfusion rate in Group D10-5(the implantation depths of the left common carotid artery branch stent and left subclavian artery branch stent were 10 mm and 5 mm,respectively)was at a good level,and TAWSSmax was at the lowest level(44.94 Pa),thereby showing the best simulation results.Conclusions When the left subclavian artery branch stent implantation in the thoracic aorta was short,the depth of the left common carotid artery branch stent implantation in the aorta was appropriately increased to obtain a more stable blood flow field.This study provides a theoretical reference for the double-fenestration technique in clinical practice.
4.Method exploration of telephone follow-up in clinical research
Xing WEI ; Qi ZHANG ; Xin GAO ; Wenwu LIU ; Yangjun LIU ; Wei DAI ; Peihong HU ; Yaqin WANG ; Jia LIAO ; Hongfan YU ; Ruoyan GONG ; Ding YANG ; Wei XU ; Yang PU ; Qingsong YU ; Yuanyuan YANG ; Qiuling SHI ; Qiang LI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(09):1235-1239
Telephone follow-up is one of the important ways to follow up patients. High-quality follow-up can benefit both doctors and patients. However, clinical research-related follow-up is often faced with problems such as time-consuming, laborious and poor patient compliance. The authors belong to a team that has been committed to the study of patient-reported outcomes for a long time. The team has carried out long-term follow-up of symptoms, daily function and postoperative complications of more than 1 000 patients after lung cancer surgery, and accumulated certain experience. In this paper, the experience of telephone follow-up was summarized and discussed with relevant literatures from the aspects of clarifying the purpose of clinical research follow-up, understanding the needs of patients in follow-up, and using follow-up skills.
5.Review on screen time among children and adolescents and impact on mental health
CAO Hui, LIAN Xinyao, CHEN Yuanyuan, SU Mintao, XU Qingsong, LIN Shujian, LIU Jufen
Chinese Journal of School Health 2023;44(3):462-465
Abstract
The popularization of the use of electronic has become a global trend, and children are exposed to devices at younger ages. A large proportion of children and adolescents spend on screen time more than 2 h which is recommended in most guidelines. The paper reviews possible effects of screen time on physical and mental health, as well as mental disorders in children and adolescents. It is found that excessive screen time showed negative impacts on mental health, including depression, anxiety, mood disorder, social adaptational problems, behavioral disorders, self injurious behaviors, and health risk behaviors. Much attention has been paid on the association between excessive screen time and mental health of children and adolescents, while possible mechanisms and influencing factors are lacking. Effective intervention studies are needed to provide a basis for child and adolescent health promotion.
6.Metagenomic next-generation sequencing of plasma for the identification of bloodstream infectious pathogens in severe aplastic anemia
Yuan LI ; Youzhen XIONG ; Huihui FAN ; Liping JING ; Jianping LI ; Qingsong LIN ; Chunhui XU ; Ying LI ; Lei YE ; Meng JIAO ; Yang YANG ; Yang LI ; Wenrui YANG ; Guangxin PENG ; Kang ZHOU ; Xin ZHAO ; Li ZHANG ; Fengkui ZHANG
Chinese Journal of Hematology 2023;44(3):236-241
Objective:To analyze the diagnostic value of cell-free plasma metagenomic next-generation sequencing (mNGS) pathogen identification for severe aplastic anemia (SAA) bloodstream infection.Methods:From February 2021 to February 2022, mNGS and conventional detection methods (blood culture, etc.) were used to detect 33 samples from 29 consecutive AA patients admitted to the Anemia Diagnosis and Treatment Center of the Hematology Hospital of the Chinese Academy of Medical Sciences to assess the diagnostic consistency of mNGS and conventional detection, as well as the impact on clinical treatment benefits and clinical accuracy.Results:①Among the 33 samples evaluated by mNGS and conventional detection methods, 25 cases (75.76%) carried potential pathogenic microorganisms. A total of 72 pathogenic microorganisms were identified from all cases, of which 65 (90.28%) were detected only by mNGS. ②All 33 cases were evaluated for diagnostic consistency, of which 2 cases (6.06%) were Composite, 18 cases (54.55%) were mNGS only, 2 cases (6.06%) were Conventional method only, 1 case (3.03%) was both common compliances (mNGS/Conventional testing) , and 10 cases (30.3%) were completely non-conforming (None) . ③All 33 cases were evaluated for clinical treatment benefit. Among them, 8 cases (24.24%) received Initiation of targeted treatment, 1 case (3.03%) received Treatment de-escalation, 13 cases (39.39%) received Confirmation, and the remaining 11 cases (33.33%) received No clinical benefit. ④ The sensitivity of 80.77%, specificity of 70.00%, positive predictive value of 63.64%, negative predictive value of 84.85%, positive likelihood ratio of 2.692, and negative likelihood ratio of 0.275 distinguished mNGS from conventional detection methods (21/12 vs 5/28, P<0.001) . Conclusion:mNGS can not only contribute to accurately diagnosing bloodstream infection in patients with aplastic anemia, but can also help to guide accurate anti-infection treatment, and the clinical accuracy is high.
7.Effect of septic shock rapid response group on compliance with hour-1 bundle therapy strategy
Peng ZHENG ; Zhiwei GAO ; Qingsong SUN ; Liang XU ; Shouxiang XIE ; Hongmei ZHAO ; Hong SUN ; Jie ZHEN
Chinese Journal of Emergency Medicine 2022;31(11):1457-1462
Objective:To investigate the effect of septic shock rapid response team (SSRRT) on the compliance and prognosis of hour-1 bundle therapy strategy in emergency department patients with septic shock.Methods:This study was conducted on emergency patients with septic shock who were admitted to Huai’an First Hospital Affiliated to Nanjing Medical University from January 2020 to December 2021. The inclusion criteria were emergency patients with septic shock who met the international guideline for surviving sepsis campaigns (Sepsis 3.0). Exclusion criteria: age<18 years, pregnant patients, patients transferred from another hospital who had received fluid resuscitation and/or vasoactive drugs, patients requiring emergency surgery, patients with emergency detention time<1 h, patients who refused to place central venous catheterization or had contraindications for catheterization, and patients who refused to give informed consent. SSRRT was established in January 2021. According to the establishment of SSRRT, patients were divided into the pre-SSRRT intervention group and the post-SSRRT intervention group. The general clinical data of the enrolled patients were collected, including vital signs, lactate, fluid resuscitation volume, maximum vasoactive drug pumping rate at the diagnosis of septic shock, implementation of hour-1 bundle therapy strategies, and ICU and 28-day mortality. Statistical software SPSS 25.0 was used. Pearson chi-squared test was used to compare categorical variables between groups, and Mann-Whitney U test was used to compare continuous variables between groups.Results:A total of 289 emergency patients met the inclusion criteria, 115 patients were excluded, and 174 patients were eventually included, including 83 patients in the pre-SSRRT group and 91 patients in the post-SSRRT group. Compared with the pre-SSRRT group, the proportion of lactate monitoring (54.2% vs. 100.0%, P<0.001), blood culture (27.7% vs. 93.4%, P<0.001), antibiotics (57.8% vs. 97.8%, P<0.001), fluid resuscitation volume ≥ 30 mL/kg (4.8% vs. 34.1%, P<0.001), and mean arterial pressure ≥ 65 mmHg (49.4% vs. 68.1%, P<0.001) were significantly increased. There was no significant difference in ICU mortality (50.6% vs. 37.4%, P=0.079) or 28-day mortality (53.0% vs. 38.5%, P=0.054) between the two groups. Conclusions:SSRRT can significantly improve the compliance of hour-1 bundle therapy strategy implementation in patients with emergency septic shock, and has a trend of decreasing mortality.
8.Two-stage repair of composite soft tissue defect of dorsal wrist: Free flap transfer followed by transplantation of allogeneic tendon
Xiang WANG ; Qingsong LI ; Wei LIANG ; Liang JI ; Xingfeng HU ; Bowei ZHANG ; Ding XU ; Wenke LIU
Chinese Journal of Microsurgery 2022;45(6):643-649
Objective:To explore the clinical effect of a two-staged repair and reconstruction of composite soft tissue defect of dorsal wrist with transfer of free flap (in stage-one) repair and followed by transplantation of allogeneic tendon (in stage-two) reconstruction.Methods:From December 2018 to January 2021, 6 cases with dorsal wrist composite tissue injury and extensor tendon defect were treated in the Department of Hand and Microsurgery of the Fourth People's Hospital of Guiyang City. Four cases were treated with free anterolateral thigh flap (ALTF) combined with allogeneic tendon in the first stage to reconstruct finger dorsiflexion function, and 2 cases were treated with free ilioinguinal flap combined with allogeneic tendon in the second stage to reconstruct finger dorsiflexion function. The age of the patients ranged from 22 to 62 years old. The areas of defect were 5.0 cm×12.0 cm-8.0 cm×20.0 cm. Two cases had 2 extensor tendons defect, 1 had 3 extensor tendons defect, 2 had 4 extensor tendons defect, and 1 had 5 extensor tendons defect. The length of extensor tendon defects was 7.0-22.0 cm. In 5 cases, the wounds were covered by VSD for 5 to 7 days after complete emergenly debridement. Then, after the wounds had been cleared and clean, the wounds of 3 cases were covered with free ALTF, 2 with free ilioinguinal flap, and 1 with free ALTF after skin graft scar resection. At 3-4 months later, the extension function of digit was reconstructed with the transplantation of allogeneic tendons. Postoperative appearance of the flaps and functions of digits were observed at the outpatient clinics during the follow-up.Results:The postoperative follow-up lasted for 10 to 26 (15 in average) months. All 6 flaps surrived completely, and 1 case was further treated with flap thinning at 4 months after the second surgery. During the follow-up, all flaps healed well and were good in appearance and texture. Meanwhile, the donor areas were all healed well with no dysfunction nor sensory disorder. All the transplanted tendons were in good glide without adhesion. The active motion of metacarpophalangeal joints ranged from (10±10) ° to (80±10) °. According to the Evaluation Trial Standards of Upper Limb Partial Functional of Hand Surgery of Chinese Medical Association, at the final follow-up, 4 cases were excellent and 2 cases were good.Conclusion:It is safe and effective that using the two-staged procedure in repair of composite tissue defect of dorsal wrist with stage-one ALTF or ilioinguinal flap transfer combined with stage-two reconstruction with transplantation of allogeneic tendon. It can minimize the adhesion after tendon transplantation and donor site damage
9.Association of smartphone addiction with daily behaviors and mental health during the COVID-19 pandemic among medical college students
Chinese Journal of School Health 2021;42(5):713-718
Objective:
To investigate the smartphone addiction among college students during the Coronavirus Disease 2019 (COVID-19) pandemic and its association with daily behaviors and mental health,and to provide reference for heath education and psychological counseling for college students.
Methods:
An observational study using online quyestionnaire was conducted among 10 357 college students of two provincial medical schools in Guangdong and Shanxi Province from February 24th to March 4th in 2020. Participants were investigated on demographic information, smartphone addiction, daily routine, physical activity, weight status, anxiety, and other health information. Logistic regression with inverse probability treatment weighting (IPTW) based on propensity score was used to analyze the association between smartphone addiction with daily behavior and mental health.
Results:
The prevalence of smartphone addiction was 59.42%. The prevalence of phone addiction was higher in postgraduates, senior undergraduates, students with non-medical major, students living in GuangDong and those without regular exercise habit before vacation(χ 2=47.91,17.78,42.75,138.58,P<0.05). With IPTW, there were significant associations between smartphone addiction and late bedtimes (OR=1.82, 95%CI=1.66-1.98) and wake-up times (OR=1.55, 95%CI=1.44-1.68), more sedentary behaviors (OR=1.21, 95%CI=1.12-1.31), less moderate to vigorous physical activity (OR=1.33, 95%CI=1.22-1.44), anxiety (OR=2.98, 95%CI=2.52-3.40), weight gain(OR=1.27,95%CI=1.17-1.37) and other detrimental daily behavior and feelings.
Conclusion
High prevalence of smartphone addiction has been observed during the COVID-19 pandemic, with impaired daily behavior and mental health.
10.Meta analysis of the effect of low microbiological diet in preventing infection in patients with malignant tumors during the agranulocytosis after chemotherapy
Qianqian ZHANG ; Wenjun XIE ; Junjie LI ; Qingsong LIN ; Chunhui XU ; Guoqing ZHU
Chinese Journal of Modern Nursing 2021;27(36):4983-4990
Objective:To systematically evaluate the effects of a low-microbiological diet on the incidence of infection in cancer patients with agranulocytosis.Methods:The Cochrane Library, PubMed, Embase, Web of Science, CNKI, China Biology Medicine disc (CBM) , Wanfang Database and VIP database were searched by computer. After two researchers independently carried out literature screening, data extraction and evidence quality evaluation, RevMan 5.3 software was used for Meta-analysis.Results:A total of 7 studies were included, including 5 RCT studies and 2 retrospective case-control trials. Meta-analysis results showed that in retrospective controlled studies [ RR=1.29, 95% CI (1.10, 1.50) , P=0.002], and between different subjects (transplanted and non-transplanted patients) [ RR=1.21, 95% CI (1.08, 1.36) , P=0.001], the incidence of infection in the routine diet group was lower than that in the low-microbial diet group. In the prospective randomized controlled study, there was no statistically significant difference in the infection rate between the two groups [ RR=1.08, 95% CI (0.92, 1.28) , P=0.340]. In terms of infection-related mortality, there was no statistically significant difference between the two groups [ RR=1.06, 95% CI (0.76, 1.47) , P=0.750]. Conclusions:Compared with patients with unrestricted diet, the low-microbial diet does reduce the infection rate and infection-related mortality of patients. Dietary restrictions for patients with granulocytic cancer may be appropriately relaxed, and a focus on safe food purchase and handling and good hand hygiene may provide better infection prevention for patients with agranulocytosis.


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