Phase Ⅰ clinical trials play a crucial role in the research and development of new drugs, serving as the initial studies to assess their safety, tolerability, effectiveness, and pharmacokinetic properties in humans. These trials involve uncertainties regarding safety and efficacy. Comprehensive management of all aspects of phase Ⅰ clinical trials for anti-tumor drugs is crucial to protect the rights and safety of participants. This article provides an in-depth analysis of the key points and precautions necessary for effective quality control throughout the process. The analysis is informed by guidelines such as the “Good Clinical Practice for Drugs” “Key Points and Judgment Principles for Drug Registration Verification” “Key Points and Judgment Principles for Supervision and Inspection of Drug Clinical Trial Institutions” and the standard operating procedures for quality control of the center. Topics discussed include informed consent, inclusion criteria, experimental drugs, biological samples, adverse events, and serious adverse events. The goal is to standardize quality control in phase Ⅰ clinical trials of anti-tumor drugs, ensure the authenticity and reliability of clinical trial data, and protect the rights and safety of participants.

Talents are the main force for the development of traditional Chinese medicine（TCM）， and the construction of TCM talents and the reformation of talent evaluation system are essential to promote the inheritance and innovation of TCM. At present， we are still exploring and developing in the fields of the formulation， implementation and evaluation indicators of TCM talent evaluation system. However， there are shortcomings and difficulties. For instance， insufficient stratification in the evaluation， excessive emphasis on the quantity of achievements， neglecting the quality of the achievements and the actual contribution， imperfect assessment indicators， and the weak characteristics of TCM. Therefore， national ministries and commissions have jointly issued a document requesting to break the four only and set a new standard， in order to promote the construction of a scientific and technological talent evaluation system oriented by innovation value， ability and contribution. For the evaluation of TCM clinical talents， China Association for Science and Technology commissioned China Association of Chinese Medicine to build the China Clinical Cases Library of TCM（CCCL-TCM）， which aims at collecting the most authoritative and representative TCM clinical cases and exploring the advantages of applying clinical cases as masterpiece of achievement in TCM clinical talents evaluation. CCCL-TCM can promote the construction of a talent evaluation system that is more in line with the development characteristics of TCM industry， and to carry out relevant pilot in TCM colleges and institutions across the country in order to promote the reformation of TCM talent evaluation system.

Paroxysmal nocturnal hemoglobinuria (PNH) is an acquired clonal hematopoietic stem cell disease caused by abnormal expression of glycosylphosphatidylinositol (GPI) on the cell membrane due to mutations in the phosphatidylinositol glycan class A(PIGA) gene. It is commonly characterized by intravascular hemolysis, repeated thrombosis, and bone marrow failure, as well as multiple systemic involvement symptoms such as renal dysfunction, pulmonary hypertension, swallowing difficulties, chest pain, abdominal pain, and erectile dysfunction. Due to the rarity of PNH and its strong heterogeneity in clinical manifestations, multidisciplinary collaboration is often required for diagnosis and treatment. Peking Union Medical College Hospital, relying on the rare disease diagnosis and treatment platform, has invited multidisciplinary clinical experts to form a unified opinion on the diagnosis and treatment of PNH, and formulated the Expert Consensus of Multidisciplinary Diagnosis and Treatment for Paroxysmal Nocturnal Hemoglobinuria (2024), with the hope of promoting the standardization of PNH diagnosis and treatment.

Purpose/Significance To analyze the multidimensional interaction between the characteristics of traditional Chinese and western medicine in patients with type 2 diabetes mellitus and its influence on traditional Chinese medicine(TCM)syndrome differentia-tion.Method/Process Based on the real-world electronic medical record(EMR)data,the traditional association rule algorithm is im-proved,and the important TCM syndromes are screened out as dependent variables by increasing the respect index,and the logistic regres-sion algorithm is used to explore the influence of traditional Chinese and western medicine indexes on TCM syndromes.Result/Conclusion Based on 688 patients,112 association rules are obtained,of which 12 includes TCM syndromes.The respect of association rules between middle-earth stagnation syndrome and overweight/obesity is the highest,moreover,overweight/obesity patients have a higher prevalence rate of middle-earth stagnation syndrome.There is a strong correlation between middle-earth stagnation syndrome,peripheral neuropathy or hypertension and overweight/obesity.Patients with diabetic nephropathy are more likely to have qi and yin deficiency syndrome.

Objective:To explore the risk factors of postpartum hemorrhage in parturients undergoing vaginal delivery with a second child and establish a risk prediction model.Methods:Using the convenient sampling method, a total of 2 500 parturients undergoing vaginal delivery with a second child who underwent regular prenatal examinations at Peking University Third Hospital from July 2019 to March 2023 were selected as the research objects. According to the amount of blood loss, parturients with blood loss greater than or equal to 500 ml within 24 hours after delivery were selected as the case group ( n=278), while parturients with blood loss less than 500 ml within 24 hours after delivery in the same period were selected as the control group ( n=2 222). Univariate analysis and binomial Logistic regression were used to analyze the influencing factors of postpartum hemorrhage in parturients with vaginal delivery with a second child. Based on the selected risk factors, a nomogram prediction model was established using R software, and the consistency of the model was tested. Results:The incidence of postpartum hemorrhage in 2 500 parturients undergoing vaginal delivery with a second child was 11.12% (278/2 500). Binomial Logistic regression analysis showed that in in vitro fertilization-embryo transfer, pre-delivery body mass index, lateral perineal incision, neonatal weight, placenta previa, placenta implantation and manual extraction of placenta were the influencing factors for postpartum hemorrhage in parturients undergoing vaginal delivery with a second child ( P<0.05). According to the influencing factors, a nomogram model was established to predict the probability of postpartum hemorrhage in women who gave birth to a second child. The C- index of the prediction model was 0.706, the area under the receiver operating characteristic curve was 0.706, and the χ 2 value of the Hosmer-Lemeshow goodness-of-fit test was 7.720 ( P=0.461) . Conclusions:In vitro fertilization embryo transfer, pre-delivery body mass index, perineal lateral resection, neonatal weight, placenta previa, placental implantation and manual extraction of placenta are risk factors for postpartum hemorrhage in parturients undergoing vaginal delivery for a second child. The prediction model constructed based on risk factors has certain accuracy and clinical value for predicting postpartum hemorrhage in parturients with vaginal delivery of a second child.

Sonodynamic therapy is a novel treatment for killing malignant tumors with sonic sensitizers and low-intensity ultrasound,which via ultrasonic mechanical stress,the effects of ultrasonic cavitation and the combined production of ultrasound and acoustic sensitizers produce reactive oxygen species induces apoptosis co-destructing target cells.Compared with traditional approaches for the treatment of malignancy,sonodynamic therapy has advantages of greater accuracy,deeper tissue penetration,better patient dependency,and less side effects.Ultrasound microsphere contrast agents can significantly enhance the effects of cavitation as synthetic cavitation nuclei,and precise regulation of the effects of cavitation is a key factor in improving the efficiency of sonodynamic therapy.The combination of ultrasonic microspheres and adjustable cavitation have broad prospects in the field of sonodynamic therapy for malignant tumors.

Objective To monitor the quality of intravenous infusions in a constructed closed-loop tracking system,and to discuss its application effect.Methods The information program is reinvested in a team for the closed-loop tracking system of the intravenous infusion.There are modules of processing medical orders,pharmacy preparations,execution procedures with the doctor's orders,as well as the computing module.The system was put into clinical trial operation in November 2021 and officially applied in January 2022.Specifically,the number of infusion-related adverse events/red-light alert is recorded and compared before(January to December 2021)and after(January to December 2022)the application of the system.Random sampling method has been performed in a ward to investigate the amount of abnormal infusion for the comparison.Results It is shown that it occurred 3 times for the infusion-related adverse events before the operation of the system,and a time after that.In the neurological inpatients,we observe the amount of red-light alert as 5,120.25±775.82 before the system operation,and 1,518.25±74.77 after that.It is shown to decline by 70.35％on average with statistical significance on the total difference(P＜0.001).Monthly amount of infusion in the ward is 5,184 with 155 times of overfast(2.99％)for 775 minutes in total,and with 207 times of slow(3.99％)for 1,035 minutes in total.The average handling time per contact is 5 minutes.Conclusion The closed-loop tracking system for intravenous infusion quality monitoring can track and record the whole process of intravenous infusions.It is expected to provide accurate and objective data for closed-loop quality inspection on clinical nursing practice,which is conducive to nursing managers for any potential problems during infusion processing timely,to promote standardized nursing operations,and to further improve the safety of inpatients with intravenous infusion and medication.

Glioma is the most common primary intracranial malignant tumor in adult popularity. Due to the infiltrating characteristics, glioma can hardly be cleaned via surgical techniques alone. At present, the mainstream treatment is surgical resection combined with radiotherapy, chemotherapy or biological therapy. Nevertheless, multiple factors such as blood-brain barrier, tumor blood-brain barrier and enzyme barrier resist drugs reaching or penetrating tumor. Therefore, the 5-year survival rate of patients has rarely been significantly improved. Ultrasound targeted microbubble destruction technology can reversibly open the blood-brain barrier through ultrasonic cavitation effect, and promote the absorption of targeted drugs, gene therapy veihchel as well as the chemotherapy drug, which is of great significance in the treatment of glioma.

Objective To conduct a survey on the status of noise hazards in Tianjin in 2020, to analyze the main distribution characteristics of noise hazards, and to put forward corresponding preventive and control measures. Methods A unified questionnaire was used to investigate the city-wide enterprises with more than 5 employees, normal production and operation, and noise hazards. The χ² test was used to analyze the survey results. Results There were 8 560 enterprises with noise hazards, which were concentrated in the five outer suburban districts, the four districts around the city and the Binhai New Area, mainly small and medium-sized enterprises. Totally, 223 800 people were exposed to noise. The rates of noise hazard detection and physical examination of workers were 25.88% and 17.66%, and the rate of over standard detection and the rate of abnormal physical examination were 13.09% and 1.62%, respectively. The differences in noise detection rate, over standard detection rate and physical examination rate were significant in different administrative regions, enterprise scales and industries. The detection rate and physical examination rate of enterprises in the five outer suburban districts, micro-scale enterprises, and paper products industries were the lowest, while the rate of exceeding standards was the highest in the railway, shipping, aerospace and other transportation equipment manufacturing industries. Conclusion Noise is a common occupational hazard in enterprises in Tianjin. There are a large number of people who are exposed to noise. The detection rate and physical examination rate of noise are at a low level. Individual industries have a high rate of exceeding the standard. The current situation of noise hazard prevention and control is not optimistic. It is recommended to pay attention to it and take effective intervention measures.

Objective: Schizophrenia (SCZ) is a severe psychiatric disorder with unknown etiology and lacking specific biomarkers. Herein, we aimed to explore plasma biomarkers relevant to SCZ using targeted metabolomics. Methods: Sixty drug-naïve SCZ patients and 36 healthy controls were recruited. Psychotic symptoms were assessed using the Positive and Negative Syndrome Scale. We analyzed the levels of 271 metabolites in plasma samples from all subjects using targeted metabolomics, and identified metabolites that differed significantly between the two groups. Then we evaluated the diagnostic power of the metabolites based on receiver operating characteristic curves, and explored metabolites associated with the psychotic symptoms in SCZ patients. Results: Twenty-six metabolites showed significant differences between SCZ patients and healthy controls. Among them, 12 metabolites were phosphatidylcholines and cortisol, ceramide (d18:1/22:0), acetylcarnitine, and γ-aminobutyric acid, which could significantly distinguish SCZ from healthy controls with the area under the curve (AUC) above 0.7. Further, a panel consisting of the above 4 metabolites had an excellent performance with an AUC of 0.867. In SCZ patients, phosphatidylcholines were positively related with positive symptoms, and cholic acid was positively associated with negative symptoms. Conclusion Our study provides insights into the metabolite alterations associated with SCZ and potential biomarkers for its diagnosis and symptom severity assessment.