OBJECTIVE To construct an evaluation index system for the core competencies of ethics committee members of drug clinical trial institution， providing a basis for optimizing the training system for committee members， improving the quality of ethical review， and fully safeguarding the safety and rights of subjects. METHODS Using methods such as literature research and expert consultation， a preliminary core competency evaluation index system was constructed. The Delphi method was employed to revise and validate it， ultimately forming an evaluation index system for the core competencies of ethics committee members. Based on this system， a questionnaire survey was conducted among 90 ethics committee members from 29 drug clinical trial institutions nationwide， comparing their importance rating and self-assessment scores of the core competency indexes. RESULTS The evaluation system constructed included 4 primary indicators （ethics and professional knowledge， ethics review ability， communication and expression ability， moral integrity and work style） and 39 secondary indicators （familiarity with the content of clinical trial-related laws and regulations， ability to complete project ethics review and identify ethical defects in research protocols within a short period of time， ability to judge the scientific value of clinical research， etc.）. The results of questionnaire survey showed that the interviewed ethics committee members had significant capability gaps in dimensions such as regulatory knowledge， ethical norms， review efficiency， risk judgment， and problem analysis. The differences between the importance rating scores of corresponding secondary indicators and the self-assessment scores were all no less than 0.38. CONCLUSIONS This study has developed a quantifiable and stratified core competency assessment tool for ethics committee members. It can provide a scientific framework for committee member training， qualification certification， and standardized management of ethics committees.

ObjectiveTo evaluate the effect and safety of Jiuxin Pill （救心丸） on exercise tolerance and quality of life in patients with stable angina pectoris （SAP）. MethodsA randomised， double-blind， placebo-controlled， multicentre study design was used to enroll 170 patients of SAP from nine centres， which were divided into 85 patients each in the trial group and control group with 1∶1 ratio. Both groups maintained the original western medicine treatment plan， and added Jiuxin Pill or placebo respectively， 2 pills （0.05 g） each time twicely for 28 days. The main outcomes were total exercise time （TED） in the exercise treadmill test and Seattle Angina Questionnaire （SAQ） scores including physical limitation （PL）， angina stability （AS）， angina frequency （AF）， treatment satisfaction （TS）， and disease perception （DP）. The secondary outcomes were exercise treadmill test indicators including heart rate recovery in 1 min （HRR1）， metabolic equivalents （METs）， maximum magnitude of ST-segment depression， and the Borg rating of perceived exertion scale， the average number of angina attacks per week， withdrawal and reduction rate of nitroglycerin， traditional Chinese medicine syndrome scores， incidence of major adverse cardiovascular events. Safety indicators were evaluated and the occurrence of adverse events during the trial was recorded. Data was collected before treatment， day 28±2 in treatment period， and follow-up at day 56 which is 28±2 days after treatment period finished. ResultsEighty-four and eighty-five patients respectively from trial group and control group were included to the full analysis set （FAS） and safety analysis set （SS）. Compared with the group before treatment and with the control group after treatment， the trial group had higher TED， HRR1， and METs， and lower maximum magnitude of ST-segment depression and Borg rating of perceived exertion scores after treatment （P＜0.01）. Compared with the group before treatment and with the control group after treatment and at follow-up， the total SAQ score and scores of AS， AF， TS and DP of the trial group after treatment and at follow-up elevated， while the average number of angina attacks per week and traditional Chinese medicine syndrome scores reduced （P＜0.01）. There was no statistically significant difference in the withdrawal and reduction rate of nitroglycerin between groups （P＞0.05）. Major adverse cardiovascular events occurred in 1 case （1/84， 1.19%） in the trial group and 1 case （1/85， 1.18%） in the control group， and the difference between groups was not statistically significant （P＞0.05）. A total of 3 cases of adverse events occurred in the trial group （3/84， 3.57%）， and a total of 6 cases of adverse events occurred in the control group （6/85， 7.06%）， and there was no statistically significant difference in the incidence of adverse events between groups （P＞0.05）. ConclusionIn the treatment of SAP， Jiuxin Pill combined with conventional western medicine can further enhance exercise tolerance， improve quality of life， and demonstrate great safety.

Objective:To investigate the ultrasonic characteristics and evolution pattern of fetal adrenal hematoma (AH).Methods:A retrospective analysis was conducted on the clinical data of one fetal AH diagnosed at the Affiliated Hospital of Jining Medical University. The study involved a comprehensive search of the relevant cases of fetal AH published from January 1, 1989, to December 31, 2022, in the Yiigle database, China National Knowledge Infrastructure Database, Wanfang Database, and PubMed Database. The clinical features, sonographic characteristics, interventions, and prognosis of fetal AH were summarized. Descriptive statistical analysis was used.Results:(1) Case: An ultrasound at 36 +3 weeks of pregnancy detected a mixed echogenic nodule at the fetal left adrenal region, with clear border and no obvious blood flow signal. Fetal AH was considered. Observations from the close ultrasound follow-up on the case before and after birth, and one year and eight months after birth presented a gradual transformation of the lesion from mixed echogenic to solid echogenic and a reduction following enlargement in lesion size. The lesion was ultimately liquefied and absorbed. (2) Literature review: A total of 12 cases of fetal AH that had clear diagnosis and ultrasound data were retrieved and added to the present case, for a total of 13 cases. Neither prenatal maternal nor postnatal typical clinical manifestations were observed in fetal AH cases. In cases with large hemorrhage and/or bilateral adrenal hemorrhage, mild jaundice and feeding difficulties may be present. Two cases were terminated, one live baby died of heart failure due to vein of Galen aneurysmal malformation, other ten had good prognosis. Fetal AH ultrasound image features demonstrated time-dependent changes, progressing in the sequence of anechoicity, solid echogenicity, mixed echogenicity, and complete absorption of the lesion, or residual hyperechogenicity. Conclusions:Fetal AH is a rare condition that exhibits characteristic transformations in ultrasound image features over time. Conducting close follow-up ultrasound examinations is the preferred and crucial approach to the diagnosis of fetal AH.

Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.

China prospective multicenter birth cohort (Prospective Omics Health Atlas birth cohort, POHA birth cohort) study was officially launched in 2022. This study, in collaboration with 12 participating units, aims to establish a high-quality, multidimensional cohort comprising 20 000 naturally conceived families and assisted reproductive families. The study involves long-term follow-up of parents and offspring, with corresponding biological samples collected at key time points. Through multi-omics testing and analysis, the study aims to conduct multi-omics big data research across the entire maternal and infant life cycle. The goal is to identify new biomarkers for maternal and infant diseases and provide scientific evidence for risk prediction related to maternal diseases and neonatal health.

Objective:To describe the characteristics and analyze risk factors for surgical items count near-miss errors stemming from the self-incident reports of staff nurses from operating room, to reduce the risk of counting surgical items and prevent the occurrence of the relative adverse events.Methods:This was a retrospective study. Used the self-made checklist to retrospect the surgical items count errors, relative characteristics and reasons from the operating room nurses of Department of Anesthesiology, Shandong Provincial Hospital Affiliated to Shandong First Medical University reported from January 2017 to December 2021. Grey Relational Analysis was used to analyze and identify the risk elements.Results:A total of 98 surgical items count near-miss errors were reported by nurses.The unclear items were mainly classified into 6 categories, of which 52.04% (51/98) were disposable surgical items, 24.49% (24/98) were fine parts of surgical instruments, 14.28% (14/98) were implants, 5.10% (5/98) were electrosurgical instruments, 3.06% (3/98) were power systems, and 1.02% (1/98) were medical lasers; the disposable surgical items were the highest risk of surgical items count near-miss errors (non-standard behaviors of surgeons ξ 1=0.333); among the 9 risk factors, non-standard behaviors of surgeons ( r1 = 0.673), instrument nurses improper operation ( r4 = 0.691) and surgeons errors ( r2 = 0.693) were the most important influence factors. Conclusions:Analyzing the possible system risk factors resulting from the near-miss error could be a useful method for nurses to generate hierarchical risk-control strategies and improve surgical items count safety for patients. This com prerent the occurrence of adverse events.

During coronavirus disease 2019 epidemic, the treatment of severe trauma has been impacted. The Consensus on emergency surgery and infection prevention and control for severe trauma patients with 2019 novel corona virus pneumonia was published online on February 12, 2020, providing a strong guidance for the emergency treatment of severe trauma and the self-protection of medical staffs in the early stage of the epidemic. With the Joint Prevention and Control Mechanism of the State Council renaming "novel coronavirus pneumonia" to "novel coronavirus infection" and the infection being managed with measures against class B infectious diseases since January 8, 2023, the consensus published in 2020 is no longer applicable to the emergency treatment of severe trauma in the new stage of epidemic prevention and control. In this context, led by the Chinese Traumatology Association, Chinese Trauma Surgeon Association, Trauma Medicine Branch of Chinese International Exchange and Promotive Association for Medical and Health Care, and Editorial Board of Chinese Journal of Traumatology, the Chinese expert consensus on emergency surgery for severe trauma and infection prevention during coronavirus disease 2019 epidemic ( version 2023) is formulated to ensure the effectiveness and safety in the treatment of severe trauma in the new stage. Based on the policy of the Joint Prevention and Control Mechanism of the State Council and by using evidence-based medical evidence as well as Delphi expert consultation and voting, 16 recommendations are put forward from the four aspects of the related definitions, infection prevention, preoperative assessment and preparation, emergency operation and postoperative management, hoping to provide a reference for severe trauma care in the new stage of the epidemic prevention and control.

ABSTRACT: Meningiomas are the most common primary intracranial neoplasm with diverse pathological types and complicated clinical manifestations. The fifth edition of the WHO Classification of Tumors of the Central Nervous System (WHO CNS5), published in 2021, introduces major changes that advance the role of molecular diagnostics in meningiomas. To follow the revision of WHO CNS5, this expert consensus statement was formed jointly by the Group of Neuro-Oncology, Society of Neurosurgery, Chinese Medical Association together with neuropathologists and evidence-based experts. The consensus provides reference points to integrate key biomarkers into stratification and clinical decision making for meningioma patients. REGISTRATION Practice guideline REgistration for transPAREncy (PREPARE), IPGRP-2022CN234.
Humans ; Meningioma/pathology* ; Consensus ; Neurosurgical Procedures ; Meningeal Neoplasms/pathology*

Objective:To understand the diagnostic value of tuberculosis (TB) pathogenic detection methods (TPDM) in pathological tissue for TB.Methods:A retrospective study was conducted with 190 pathological specimens from different tissues suspected with TB from Third People′s Hospital of Shenzhen during May 2016 and May 2019. Specimens were divided into four groups according to histomorphology: group one, necrotizing granulomatous inflammation (109 cases); group two, non-necrotic granulomatous inflammation (20 cases); group three, non-granulomatous inflammation (45 cases); group four, non-tuberculous lesions (16 cases). The positive rates of each TPDM among specimens from four groups were compared. The positive rates of all TPDM for specimens from group one were compared. Meanwhile, the influence of antituberculosis treatment course on the TPDM was analyzed. Chi-square test or Fisher′s exact test was used for statistical analysis.Results:The positive rates of Ziehl-Neelsen acid-fast staining among the four groups were 17.4%(19/109), 5.0%(1/20), 4.4%(2/45) and 0(0/16), respectively. The positive rates of Mycobacterium tuberculosis (MTB) complex culture were 32.0%(32/100), 4/19, 4.8%(2/42) and 0(0/16), respectively. The positive rates of Mycobacterium tuberculosis/rifampin resistance real-time quantitative nucleic acid amplification detection system (Xpert MTB/RIF) were 74.3%(81/109), 15.0%(3/20), 13.3%(6/45) and 0(0/16), respectively. The positive rates of fluorescent quantitative polymerase chain reaction (FQ-PCR) were 63.0%(58/92), 0(0/15), 2.6%(1/38) and 0(0/10), respectively. The positive rates of simultaneous amplification and testing (SAT) were 32.4%(24/74), 0(0/10), 0(0/15) and 0(0/10), respectively. The differences of each TPDM among four groups were all statistically significant (all P<0.05). The positive rate of Xpert MTB/RIF in group one specimens was significantly higher than those of acid-fast staining, MTB culture and SAT ( χ2=71.016, 37.162 and 35.679, respectively, all P<0.01), while the difference was not statistically significant when compared with FQ-PCR ( χ2=2.517, P=0.112). The positive rate of combined TPDM (85.3%(93/109)) was significantly higher than Xpert MTB/RIF(74.3%(81/109)) ( χ2=4.100, P=0.043). The positive rates of acid-fast staining group 1A (anti-tuberculosis treatment course was less than one month) and group 1B (anti-tuberculosis treatment course was longer than one month) were 14.3%(7/49) and 20.0% (12/60), respectively ( χ2=0.612, P=0.434); those of MTB culture were 48.9% (22/45) and 18.2% (10/55), respectively ( χ2=10.721, P=0.001); those of Xpert MTB/RIF were 69.4%(34/49) and 78.3%(47/60), respectively ( χ2=1.131, P=0.287); those of FQ-PCR were 55.0%(22/40) and 69.2%(36/52), respectively ( χ2=1.965, P=0.161); those of SAT were 43.3%(13/30) and 25.0%(11/44), respectively ( χ2=2.736, P=0.098). Conclusions:The results of TPDM correlate closely with the typical histomorphological features of tuberculosis. Xpert MTB/RIF possesses significantly higher sensitivity than any other single TPDM, and is not attenuated by early anti-tuberculosis treatment. Combined TPDM could significantly improve the sensitivity of TB pathogenic detection, which is suggested to be applied when the tissue specimen is sufficient.

Objective: To investigate the effect of LncRNA OIP5-AS1 on radiosensitivity of non-small cell lung cancer (NSCLC) cells and its mechanism. Methods: The radiation-resistant cell A549R was established by using A549 cells irradiated by X-ray 6Gy in 5 fractions. The expression levels of OIP5-AS1 and miR-34c-5p in A549 and A549R cells were detected by qRT-PCR. OIP5-AS1 inhibitor or miR-34c-5p mimetic was transfected into A549R cells, or OIP5-AS1 overexpression plasmid was transfected into A549 cells. Cell apoptosis was detected by flow cytometry. Cell radiosensitivity was analyzed by colony formation assay. The expression levels of p-Chk2 and p-ATM proteins were measured by Western blot. Dual luciferase assay was adopted to verify the relationship between OIP5-AS1 and miR-34c-5p. Results: Compared with A549 cells, the expression of OIP5-AS1 was significantly up-regulated in A549R cells (1.97±0.11 vs.1.01±0.05, P<0.05), whereas the expression of miR-34c-5p was remarkably down-regulated (0.43±0.02 vs.1.02±0.06, P<0.05). The expression levels of p-Chk2 and p-ATM proteins in A549R cells in the silencing OIP5-AS1+ 6Gy group were significantly lower (0.43±0.03 vs.1.39±0.15, 0.51±0.0 5 vs.1.21± 0.11, both P<0.05), whereas the apoptotic rate was significantly higher than those in the silencing control+ 6Gy group [(13.29±1.25)% vs. (28.47±2.31)%, P<0.05)]. The expression levels of p-Chk2 and p-ATM proteins in A549 cells in overexpressing OIP5-AS1+ 6Gy group were significantly higher than those in overexpression control+ 6Gy group (1.23±0.13 vs.0.75±0.06, 1.08±0.11 vs.0.59±0.04, both P<0.05). Inhibiting miR-34c-5p expression reversed the effect of silencing OIP5-AS1 on survival fraction of A549R cells (SER=1.42). OIP5-AS1 negatively regulated the expression of miR-34c-5p. Conclusion Silencing OIP5-AS1 enhances the radiosensitivity of radiation-resistant A549 cells by up-regulating the expression of miR-34c-5p, providing a potential target for radiotherapy of NSCLC cells.