Objective:To compare the efficacy of anrikefon and tegileridine for analgesia in patients with moderate-to-severe pain after abdominal surgery with general anesthesia.Methods:In this multicenter, randomized, double-blind, active-controlled clinical trial, 101 patients with moderate to severe pain (numeric pain rating scale [NRS] score ≥4 within 4 h after operation) after abdominal surgery with general anesthesia between February 24 and April 1, 2025, aged 18-70 yr, with a body mass index of 18-40 kg/m 2, were assigned to anrikefon group ( n=50) and tegileridine group ( n=51) in a 1∶1 ratio using stratified blocked randomization. Double-dummy design was employed to maintain blinding. Each group received an initial intravenous injection of anrikefon 1 μg/kg or tegileridine 1 mg, followed by connection to a patient-controlled intravenous analgesia (PCIA) pump (the PCIA solution contained normal saline in anrikefon group; the PCIA solution contained tegileridine 5 mg in tegileridine pump) within 10 min. If the patient′s NRS score ≥4 at 8 and 16 h after the initial injection, anrikefon 1 μg/kg was intravenously injected in anrikefon group, and tegileridine group received the equal volume of normal saline. The primary efficacy endpoint was the sum of pain intensity difference (SPID) over the first 24 h after the initial dose (SPID 0-24h). The secondary efficacy endpoints included the incidence and severity of vomiting and nausea, incidence of postoperative nausea and vomiting(PONV), the proportion of patients who received antiemetic treatment, and total consumption of antiemetics within 0-24 h after the initial dose, NRS score at rest ≤ 1 at 24 h after the initial dose, and NRS score at rest ≤ 3 over the first 24 h after the initial dose. Safety indicators included adverse events, vital signs, physical examination findings, 12-lead ECG and laboratory test indicators, and adverse events of special interest. Results:Compared with tegileridine group, no significant change was found in the SPID 0-24h ( P>0.05), and the incidence of vomiting, PONV, proportion of patients requiring antiemetic medication, and total consumption of antiemetics were significantly decreased within the first 24 h after the initial dose in tegileridine group ( P<0.05). One treatment-emergent adverse event of Common Terminology Criteria for Adverse Events grade 3 or higher occurred in tegileridine group, while no treatment-emergent adverse events of Common Terminology Criteria for Adverse Events grade 3 or higher were found in anrikefon group. Among the adverse events of special interest, one case of respiratory depression and one case of cough occurred in tegileridine group, while one case of cough occurred in anrikefon group, with no respiratory depression. Conclusions:Anrikefon and tegileridine provide comparable analgesic efficacy for moderate-to-severe pain after abdominal surgery with general anesthesia. However, anrikefon exhibits an advantage in reducing the risk of PONV, with a superior safety profile.

Objective:Comparison of the U. S. Food and Drug Administration (FDA) Protocol Deviations for Clinical Investigation of Drugs, Biological Products, and Devices Guidance for Industry (Draft Guidance) and the Beijing Investigator-Initiated Trial (IIT) Supervision and Inspection Content and Assessment Principles with recommendations for managing protocol deviations in IITs.Methods:A comparative analysis was conducted focusing on the terminology, definitions, classifications, determination criteria, and management requirements for protocol deviations. The analysis was supplemented by practical experience from the 2024 IIT supervision and inspection in Beijing to explore the applicability of the FDA guidance in the local context.Results:The FDA guidance clearly defined the terminology and scope of protocol deviations, distinguishes between important and other deviations, emphasized the principle of quality by design, and clarified the responsibilities of relevant stakeholders and reporting procedures. The Beijing IIT Supervision and Inspection Assessment Principles, for the first time from a government regulatory perspective, introduced a quantitative classification system for determining the severity of protocol deviations. However, they had not fully addressed issues such as participant privacy protection and premature unblinding, and the management requirements remain to be refined. Findings from the 2024 IIT supervision and inspection in Beijing indicate that the most common protocol deviations were failure to follow the protocol-defined schedule or procedures for visits, tests, or outcome assessments; failure to collect critical data; and violations of inclusion/exclusion criteria.Conclusions:While Beijing has made progress in institutionalizing IIT management, the overall protocol deviation management system remains underdeveloped. This paper proposes the following recommendations: First, clearly define the responsibilities of various stakeholders within research institutions, strengthen coordination among administrative departments, ethics committees, and research teams, and fully leverage the support role of the Beijing Center for Advancing Quality in Clinical Research in methodological guidance and quality control. Second, enhance the capacity and ongoing training of research teams, and encourage medical institutions to provide methodological consultation and technical support. Third, improve the scientific rigor and feasibility of protocol design by tailoring inclusion/exclusion criteria and follow-up strategies to the specific study type and target population, optimizing study procedures, and developing risk-based management plans. Fourth, refine the classification criteria, reporting procedures, and timelines for protocol deviations, and implement a tiered management system based on the nature and severity of the deviation.

Objective:To explore the impulsivity characteristics of patients with attention deficit hyperactivity disorder(ADHD)comorbid with borderline personality disorder(BPD)and the mediating role of emotion regula-tion strategies.Methods:A total of 96 patients with ADHD meeting the diagnostic criteria of the American Diagnos-tic and Statistical Manual of Mental Disorders,Fourth Edition(DSM-Ⅳ)were enrolled,48 of whom had comorbid BPD.Impulsivity was assessed with the Barratt Impulse Scale(BIS)and the impulse control difficulty dimensions of Emotional Regulation Difficulty Scale(DERS).Emotion regulation strategies were evaluated with the Emotion Regulation Questionnaire(ERQ).Results:No significant differences were found between the ADHD with and with-out BPD group in cognitive impulsivity,motor impulsivity,or non-planning impulsivity as assessed with the BIS(Ps＞0.05).However,the ADHD with BPD group showed higher scores on the DERS impulse control difficulty subscale(P＜0.001)and less frequent use of cognitive reappraisal strategies(P＜0.001).Cognitive reappraisal partially mediated the relationship between ADHD with BPD and impulse control difficulties,with an effect size of 25.9％.Conclusion:ADHD patients comorbid with BPD exhibit heightened emotional impulsivity,which might be partially mediated by reduced use of cognitive reappraisal.

Objective:To compare the efficacy of anrikefon and tegileridine for analgesia in patients with moderate-to-severe pain after abdominal surgery with general anesthesia.Methods:In this multicenter, randomized, double-blind, active-controlled clinical trial, 101 patients with moderate to severe pain (numeric pain rating scale [NRS] score ≥4 within 4 h after operation) after abdominal surgery with general anesthesia between February 24 and April 1, 2025, aged 18-70 yr, with a body mass index of 18-40 kg/m 2, were assigned to anrikefon group ( n=50) and tegileridine group ( n=51) in a 1∶1 ratio using stratified blocked randomization. Double-dummy design was employed to maintain blinding. Each group received an initial intravenous injection of anrikefon 1 μg/kg or tegileridine 1 mg, followed by connection to a patient-controlled intravenous analgesia (PCIA) pump (the PCIA solution contained normal saline in anrikefon group; the PCIA solution contained tegileridine 5 mg in tegileridine pump) within 10 min. If the patient′s NRS score ≥4 at 8 and 16 h after the initial injection, anrikefon 1 μg/kg was intravenously injected in anrikefon group, and tegileridine group received the equal volume of normal saline. The primary efficacy endpoint was the sum of pain intensity difference (SPID) over the first 24 h after the initial dose (SPID 0-24h). The secondary efficacy endpoints included the incidence and severity of vomiting and nausea, incidence of postoperative nausea and vomiting(PONV), the proportion of patients who received antiemetic treatment, and total consumption of antiemetics within 0-24 h after the initial dose, NRS score at rest ≤ 1 at 24 h after the initial dose, and NRS score at rest ≤ 3 over the first 24 h after the initial dose. Safety indicators included adverse events, vital signs, physical examination findings, 12-lead ECG and laboratory test indicators, and adverse events of special interest. Results:Compared with tegileridine group, no significant change was found in the SPID 0-24h ( P>0.05), and the incidence of vomiting, PONV, proportion of patients requiring antiemetic medication, and total consumption of antiemetics were significantly decreased within the first 24 h after the initial dose in tegileridine group ( P<0.05). One treatment-emergent adverse event of Common Terminology Criteria for Adverse Events grade 3 or higher occurred in tegileridine group, while no treatment-emergent adverse events of Common Terminology Criteria for Adverse Events grade 3 or higher were found in anrikefon group. Among the adverse events of special interest, one case of respiratory depression and one case of cough occurred in tegileridine group, while one case of cough occurred in anrikefon group, with no respiratory depression. Conclusions:Anrikefon and tegileridine provide comparable analgesic efficacy for moderate-to-severe pain after abdominal surgery with general anesthesia. However, anrikefon exhibits an advantage in reducing the risk of PONV, with a superior safety profile.

Tic disorders in children refer to the neurodevelopmental disorders usually occurring in childhood and adolescence.Guided by the theory of five-zang-organ correlation,Professor Li Yirui approaches the treatment of tic disorders in children and comorbidities primarily from the perspective of liver-spleen disharmony,and points out that the pathogenesis is due to liver-spleen disharmony,wind-phlegm disturbance,and mutual involvement of the five zang organs.In clinical practice,Professor Li established the therapeutic principle of regulating the liver and spleen,extinguishing wind,and resolving phlegm,and adopted the four liver-regulating methods(calming liver,soothing liver,clearing liver,and softening liver)to extinguish wind and stop tics,as well as the four spleen-regulating methods(replenishing spleen,activating spleen,awakening spleen,and dredging spleen)to strengthen body resistance and support healthy qi.The self-formulated Fupi Xifeng Decoction(composed of Pseudostellariae Radix,Atractylodis Macrocephalae Rhizoma,Poria,Glycyrrhizae Radix et Rhizoma,Bupleuri Radix,Paeoniae Radix Alba,Uncariae Ramulus cum Uncis,Gastrodiae Rhizoma,Pinelliae Rhizoma Praeparatum,Citri Reticulatae Pericarpium,Os Draconis,etc.)serves as the basic formula,herbs directing to the affected regions were flexibly used,and insect drugs were occasionally adopted for refractory cases.The treatment for tic disorders in children focus on simultaneous regulation of the five zang-organs by modified use of herbs for dispersing wind and benefiting lung,tranquilizing heart and calming spirit,and supplementing liver and kidney to address comorbidities and secondary symptoms.Additionally,integrated internal-external treatment,relieving the discomforts physically and mentally,and family-centered comprehensive care are also taken into account to achieve optimal outcomes.

Objective:To explore the impulsivity characteristics of patients with attention deficit hyperactivity disorder(ADHD)comorbid with borderline personality disorder(BPD)and the mediating role of emotion regula-tion strategies.Methods:A total of 96 patients with ADHD meeting the diagnostic criteria of the American Diagnos-tic and Statistical Manual of Mental Disorders,Fourth Edition(DSM-Ⅳ)were enrolled,48 of whom had comorbid BPD.Impulsivity was assessed with the Barratt Impulse Scale(BIS)and the impulse control difficulty dimensions of Emotional Regulation Difficulty Scale(DERS).Emotion regulation strategies were evaluated with the Emotion Regulation Questionnaire(ERQ).Results:No significant differences were found between the ADHD with and with-out BPD group in cognitive impulsivity,motor impulsivity,or non-planning impulsivity as assessed with the BIS(Ps＞0.05).However,the ADHD with BPD group showed higher scores on the DERS impulse control difficulty subscale(P＜0.001)and less frequent use of cognitive reappraisal strategies(P＜0.001).Cognitive reappraisal partially mediated the relationship between ADHD with BPD and impulse control difficulties,with an effect size of 25.9％.Conclusion:ADHD patients comorbid with BPD exhibit heightened emotional impulsivity,which might be partially mediated by reduced use of cognitive reappraisal.

Objective:Comparison of the U. S. Food and Drug Administration (FDA) Protocol Deviations for Clinical Investigation of Drugs, Biological Products, and Devices Guidance for Industry (Draft Guidance) and the Beijing Investigator-Initiated Trial (IIT) Supervision and Inspection Content and Assessment Principles with recommendations for managing protocol deviations in IITs.Methods:A comparative analysis was conducted focusing on the terminology, definitions, classifications, determination criteria, and management requirements for protocol deviations. The analysis was supplemented by practical experience from the 2024 IIT supervision and inspection in Beijing to explore the applicability of the FDA guidance in the local context.Results:The FDA guidance clearly defined the terminology and scope of protocol deviations, distinguishes between important and other deviations, emphasized the principle of quality by design, and clarified the responsibilities of relevant stakeholders and reporting procedures. The Beijing IIT Supervision and Inspection Assessment Principles, for the first time from a government regulatory perspective, introduced a quantitative classification system for determining the severity of protocol deviations. However, they had not fully addressed issues such as participant privacy protection and premature unblinding, and the management requirements remain to be refined. Findings from the 2024 IIT supervision and inspection in Beijing indicate that the most common protocol deviations were failure to follow the protocol-defined schedule or procedures for visits, tests, or outcome assessments; failure to collect critical data; and violations of inclusion/exclusion criteria.Conclusions:While Beijing has made progress in institutionalizing IIT management, the overall protocol deviation management system remains underdeveloped. This paper proposes the following recommendations: First, clearly define the responsibilities of various stakeholders within research institutions, strengthen coordination among administrative departments, ethics committees, and research teams, and fully leverage the support role of the Beijing Center for Advancing Quality in Clinical Research in methodological guidance and quality control. Second, enhance the capacity and ongoing training of research teams, and encourage medical institutions to provide methodological consultation and technical support. Third, improve the scientific rigor and feasibility of protocol design by tailoring inclusion/exclusion criteria and follow-up strategies to the specific study type and target population, optimizing study procedures, and developing risk-based management plans. Fourth, refine the classification criteria, reporting procedures, and timelines for protocol deviations, and implement a tiered management system based on the nature and severity of the deviation.

Objective To construct and explore the clinical application effect of OEC nursing management model for emergency critically ill patients.Methods Haier's OEC management concept is integrated with the nursing management of emergency critically ill patients,and the OEC nursing management model for emergency critically ill patients is constructed from three aspects:goal system,daily cleaning system and incentive mechanism.Before and after the implementation of OEC nursing management model,the core abilities of nurses in critical cases,the results of nursing quality control for critically ill patients,the enthusiasm of nurses and the satisfaction of patients and doctors on nurses'work were compared.Results After the implementation of the project,the scores of all dimensions and total scores of the questionnaire of core abilities of nurses in critical cases were significantly higher than those before the implementation(P＜0.05).In addition to the implementation dimension of graded nursing,the scores of all dimensions and total scores of nursing quality control for critical ill patients were significantly higher than before implementation(P＜0.05).The working enthusiasm of nurses was significantly higher than before implementation(P＜0.05).Both patients and doctors'satisfaction with nurses was significantly higher than before implementation(P＜0.05).Conclusion OEC nursing management model for emergency critically ill patients can improve the core abilities of nurses in critical care,improve the quality of nursing for critically ill patients,stimulate nurses'work enthusiasm,and enhance patients'and doctors'satisfaction with nurses'work.

Acquired Hemophilia A is an acquired bleeding disorder characterized by reduced FⅧ activity due to the presence of autoantibodies against anticoagulant factor Ⅷ in the circulation. Laboratory tests are typically characterized by prolonged isolated activated partial thromboplastin time (APTT). Clinically, it often manifests as severe bleeding, and 50% of AHA patients can identify the cause. This article reports on a patient with post-traumatic AHA who rapidly improved after antibody removal and bypass replacement therapy, followed by wound healing following surgical intervention. A review of relevant literature is also conducted to enhance clinicians' awareness of AHA, which presents with normal coagulation initially and gradually develops into prolonged APTT accompanied by bleeding manifestations, aiming for early diagnosis and timely treatment.

Objective To analyze the correlation between the lung allocation score (LAS) and the risk of early death and complications in patients with idiopathic pulmonary fibrosis (IPF) after lung transplantation. Methods Clinical data of 275 patients with IPF were retrospectively analyzed. The correlation between LAS and the risk of early death in IPF patients after lung transplantation and the correlation between LAS and complications at postoperative 1 year was assessed by univariate and multivariate Cox regression analyses. Results Among 275 recipients, 62, 83, 95 and 108 cases died within postoperative 30, 90, 180 and 365 d, respectively. LAS was correlated with 30-, 90-, 180- and 365-d fatality of IPF patients (all P<0.05), whereas it was not correlated with the incidence of primary graft dysfunction (PGD) and acute kidney injury (AKI) at 365 d after lung transplantation (both P>0.05). Conclusions LAS is correlated with the risk of early death of IPF patients after lung transplantation. While, it is not correlated the incidence of PGD and AKI early after lung transplantation. Special attention should be paid to the effect of comprehensive factors upon PGD and AKI.