AIM: To establish an HPLC-MS method for simultaneously determining four effective components in Guilin Watermelon Frost(Mirabilitum Praeparatum,Rhizoma Coptidis,Radix Scutellariae,etc.). METHODS: The sample was extracted with methanol containing 20% chloroform under ultrasonication.The HPLC separation was performed on Zorbax SB C_(18)(3.0 mm?250 mm,5 ?m) column using water including 0.5% formic acid(A)-methanol(B) as mobile phase,with the gradient elution(0-2 min,60%B;2-5 min,60%→90%B;5 min to the end,90%B), at a flow rate of 0.40 mL/min.The compounds were analyzed by ESI-MS under ion monitoring mode(0-3 min,m/z 249;3-6 min,m/z 336;6-10 min,m/z 447;10-16 min,m/z 263). RESULTS: The linear ranges were 0.020-10.0 ?g/mL,0.010-40.0 ?g/mL,0.036-50.0 ?g/mL and 0.040-4.00 ?g/mL for matrine,berberine,baicalin and indirubin,with detection limits of 0.005,0.001,0.006 and 0.010 ?g/mL,respectively.The average recoveries ranged from 96% to 101% with all relative standard deviations less than 3%.CONCLUSION: (The method is rapid,accurate and suitable for the quality control of the four effective) components in Guilin Watermelon Frost.

Objective To explore the diagnostic value of serum procalcitonin ,C‐reactive protein and white blood cell count in children with different diseases .Methods Retrospective analysis 94 cases of pathogenic infectious children from June 2013 to May 2014 in our hospital ,according to the results of pathogen detection was divided into bacterial infection 36 cases ,mycoplasma infec‐tion group 28 cases ,30 cases of viral infection ,detection and analysis serum PCT ,CRP and WBC levels .Results Bacterial infection group serum PCT ,CRP and WBC were (2 .41 ± 0 .94)ng/mL ,(47 .91 ± 18 .26)mg/L and (13 .18 ± 6 .03) × 109/L ,significantly higher than the mycoplasma infection and viral infection group (F=133 .4 ,F=60 .1 ,F=8 .5 ,P<0 .05);diagnosis of bacterial in‐fections ,PCT sensitivity and specificity were 92 .11% and 91 .05% ,positive and negative predictive value of 89 .84 % and 94 .01%were significantly higher than CPR and WBC ,Mycoplasma infection as the control group ,PCT ,CRP and WBC in the diagnosis of bacterial infections ,the area of under the ROC curves were 0 .816 ,0 .728 and 0 .614 ,respectively .Conclusion Serum PCT for the i‐dentification of bacterial infections has a high diagnostic value ,worth generalizing and applying .

Objective:To explore the value of transesophageal echocardiography(TEE) guidance for transcatheter DragonFly? system edge-to-edge tricuspid regurgitation (TR) repair.Methods:Five cases who were chosen in the Second Affiliated Hospital, Zhejiang University School of Medicine from December 2020 to January 2021 with surgical high-risk and severe functional TR underwent transcatheter DragonFly edge-to-edge repair with the guidance of TEE. Preoperative TEE was used to evaluate the tricuspid valve anatomy and the origin and etiology of regurgitation in detail; intra-procedure guidance of TEE was performed during the DragonFly system for tricuspid valve edge-to-edge repair intervention and after release of the DragonFly clip, the effect of surgery was assessed immediately and compared with pre-procedure TEE.Results:A total of 10 DragonFly clips were implanted in 5 patients (3 in each of patients, 2 in 1 patient, and 1 in each of patients). One of the 3 clips in 1 patient fell off unilaterally from the septal valve after release, and the other 9 clips were well positioned and fixed. Immediately post-operation assessment by TEE depicted the TR in 3 patients declined to mild and 2 to moderate. The vena contracta area by using three-dimensional color blood flow quantitative assessment was reduced[(0.93±0.26)cm 2 vs (0.20±0.11)cm 2]. No complications such as serious tricuspid valve injury, pericardial tamponade, thromboembolism occurred in the 5 patients. Conclusions:TEE plays an important role in guiding and monitoring transcatheter DragonFly system edge-to-edge TR repair during the entire procedure.

Objective:To explore the development, application and practical experience of investigator-initiated integrated clinical research information platform.Methods:The process of developing and constructing an integrated clinical research platform in a tertiary hospital in Beijing was introduced, the functions and advantages of the platform were described and displayed, and the main problems and risk points in the development and construction process were analyzed.Results:The integrated clinical research platform meets the management requirements of clinical research initiated by investigators, and the standardized management of the whole life cycle of the project can be realized through the platform, and the key issues of data security, information capture, sharing and interoperability need to be further explored in terms of platform docking.Conclusions:The integrated clinical research platform effectively improves the standardization, management quality and efficiency of investigator-initiated clinical research.

Objective:To assess the current situation, advantages, and difficulties of standardized management in Investigator-Initiated Clinical Trials (IIT).Methods:This article summarized the requirements and policies for clinical research management, the development of clinical research domestically and internationally, the achievements and advantages of clinical research management development in China, and the main problems and difficulties with the standardized IIT management in China, and compiled the experiences and models of several medical institutions in IIT management.Results:While China has a large number of clinical medical publications and is ranked high in the world, the quality of the publications needs to be further improved. Domestic management requirements for IIT were gradually improving, providing a basis for medical institutions to implement standardized management throughout the lifecycle of IIT, and achieve certain progress. However, there were still challenges in the departmental divisions, the unification of management standards, whole-process management and quality control, the scientific review, high-risk project management, and registration.Conclusions:Drawing on the excellent experience of domestic medical institutions, measures including identifying a primary responsible department, establishing unified supervision and inspection standards, and implementing a whole life cycle management may help overcome the challenges in IIT management and improve the quality and efficiency of IIT management.

Objective:Lung ultrasound (LUS) has been used in the diagnosis of neonatal respiratory distress syndrome(RDS) successfully, but there have been no multicenter prospective studies to verify its reliability or determine how to grade RDS with LUS findings.This study aimed to discuss the necessity and feasibility of using LUS findings to determine RDS grades through a multicenter prospective study.Methods:Every researcher participated in the National Neonatal Lung Ultrasound Training Course and receiving 3-6 months of lung ultrasound system training at the National Neonatal Lung Ultrasound Training Center.Patients between June 2018 and May 2020 who met the RDS ultrasound diagnostic criteria and had full available clinical data were included in this study.The LUS examination was completed immediately after the patients were admitted to the hospital.Some of them also underwent chest X-ray examination.Arterial blood gas analysis was completed immediately before or after the LUS ultrasound examination.RDS grading was performed according to the LUS findings and whether the patient had serious complications.Results:A total of 275 qualifying cases were included in this study, which included 220 premature infants and 55 full-term infants, and the primary RDS occurred in 117 cases (42.5%), and secondary RDS occurred in 158 cases (57.5%). LUS manifestations of RDS patients can be divided into three categories: (1)A ground-glass opacity sign: which could be found among 50 infants when they were admitted to the hospital (that was, at their first LUS examination). Twenty-eight of these infants were considered to have wet lungs and were not sent for special management on admission, but LUS showed typical snowflake-like lung consolidation within 0.5 to 4 hours.Twenty-two of them were given mechanical ventilation with exogenous pulmonary surfactant; Eighteen cases were controlled within 6-12 hours, but the lung lesions became more severe in the other 4 infants (due to severe intrauterine infection). (2)Snowflake-like lung consolidations: the first LUS on admission showed typical snowflake-like lung consolidation involving areas ranging from 1-2 intercostal spaces to 12 lung divisions in 204 cases.Thirty-eight infants among them the lung consolidation only had involvement of 1-2 intercostal spaces at the time of admission; Fifteen of them received invasive respiratory support and recovered within 4-12 hours.Twelve patients received noninvasive respiratory support; Seven of them recovered, while five cases developed severe lung illness.The remaining 11 patients who were not given any form of ventilator support developed severe conditions within 1-4 hours.Thirty of them showed snowflake signs involving 12 lung regions at admission.The remaining 136 patients had lung consolidation degree between the two degree above condition.(3)Snowflake-like sign with complications: Twenty-one patients had severe complications such as pneumothorax, pulmonary hemorrhage or/and persistent pulmonary hypertension of the newborn or large area atelectasis, etc, although snowflake lung consolidation did not involve all lung regions.Conclusion:(1) LUS is reliable and accurate for diagnosing RDS.RDS has the same characteristics on ultrasound for both preterm and full-term infants, both primary and secondary RDS.(2) To facilitate the management of RDS, it is necessary to classify RDS according to the ultrasound findings and the presence of severe complications.(3) Based on the results of this study, it is recommended that RDS can be divided into mild, moderate and severe degrees.The exact standards for grading are as follows: Mild RDS: the early stage of RDS, in which lung consolidation shows as a ground-glass opacity sign on ultrasound; Moderate RDS: lung consolidation shows a snowflake sign on ultrasound, not all of the lung fields are involved; Severe RDS meets one or more of the following criteria: lung consolidation shows as a snowflake sign on ultrasound and all lung regions are involved, or regardless of its degree and extent, lung consolidation has caused serious complications, such as pulmonary hemorrhage, pneumothorax, persistent pulmonary hypertension of the newborn, or/and a large area of pulmonary atelectasis.

Objective:To study the neurodevelopmental outcomes and risk factors of premature infants with gestational age (GA) <34 weeks.Methods:From June 2016 to June 2018, premature infants with GA<34 weeks admitted to the Neonatology Department of our hospital were retrospectively reviewed. Bayley Scales of Infant DevelopmentⅡwas used to assess the neurodevelopmental outcomes at corrected GA 18~24 months. The incidence of neurodevelopmental impairment (NDI) was determined. Mental developmental index (MDI) and psychomotor developmental index (PDI) were calculated. The infants were assigned into three groups according to their MDI and PDI scores:≥85 group, 70~84 group and <70 group. Risk factors of low MDI and PDI scores were analyzed.Results:A total of 202 premature infants with GA<34 weeks were included, including 131 males (64.9%) and 71 females (35.1%). 91 cases (45.0%) developed NDI, including 77 mild NDI (38.1%) and 14 severe NDI (6.9%). Univariate analysis found that the incidences of severe asphyxia, multiple births, Grad≥3 ROP and endotracheal intubation in the MDI<70 group were higher. At corrected GA 40 weeks, 3, 6, 12 months, MDI<70 group showed less cases of head circumference >-2SD. PDI<70 group had higher incidences of intrauterine distress, maternal gestational hypertension, multiple birth, Grade 3~4 RDS, Grade 3~4 germinal matrix-intraventricular hemorrhage and tracheal intubation ( P<0.05). Logistic regression showed gestational hypertension, history of tracheal intubation and invasive ventilation were the risk factors for low PDI score ( OR=9.176, 4.547 and 3.227, P<0.05). The head circumference >-2SD at corrected age 6m was protective factor for low MDI and PDI scores ( OR=0.063 and 0.041, P<0.001). Conclusions:Preterm infants with GA<34 weeks are likely to develop severe NDI. Avoiding unnecessary tracheal intubation and invasive ventilation and improving gestational hypertension management may be beneficial to the neurodevelopmental outcomes of preterm infants.

Human genetic resources are an important strategic resource for the development of science and technology in China. In order to fully utilize and effectively protect human genetic resources in real-world studies, through analyzing the status and characteristics of real-world studies, this study found that the number of real-world studies was increasing year by year, and with some characteristics, such as many uncontrollable factors, strict requirements for evidence formation, and easy information acquisition and disclosure. Combined with the characteristics of real-world studies, the ethical issues of human genetic resource management in real-world studies were summarized into three aspects, including scientific and value of research development, informed consent and privacy protection of subjects, and fairness and justice in benefit sharing. Accordingly, the key points of ethical review were proposed as scientific rationality, fully informed consent and privacy, as well as data security and stakeholders. In addition, it is necessary to give full play to the role of ethical review in research access and process supervision responsibilities, guide researchers to make full use of human genetic resources by strengthening training and process management, and further promote the standardization of real-world studies.

According to the Ethical Review Measures for Life Sciences and Medical Research Involving Humans jointly issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology and the State Administration of Traditional Chinese Medicine in 2023, to optimize the ethical review process and reduce the burden on clinical researchers, it is proposed that some eligible situations can be "exempted from ethical review". This is a breakthrough progress in China’s ethical review management measures that firstly aimed at "exemption from ethical review". This paper reviewed and sorted out the relevant situations about exemption from review at home and abroad, focused on analyzing and exploring the four situations of exemption from review, especially discussed and analyzed the understanding of anonymization and personal sensitive information in exemption from review, and proposed practical suggestions for the four situations. Based on the actual situation of ethical review work, this paper also explored the establishment of practical standards and processes for exemption from review, providing reference for other medical institutions to implement the exemption from ethical review process.