OBJECTIVE To investigate the effect of pharmaceutical services guided by root cause analysis （RCA） in a problem-oriented manner combined with knowledge-attitude-practice （KAP） theory on reducing the incidence of protocol violations of investigational medicinal products in pediatric clinical trials. METHODS A total of 617 participants from 69 drug clinical trial projects conducted in our hospital from January 2016 to December 2020 were selected as the control group， and 868 participants from 72 drug clinical trial projects from January 2022 to December 2025 as the observation group. RCA was performed on the protocol violations of investigational medicinal product in the control group to identify the types and underlying causes. The control group received routine pharmaceutical services for drug clinical trials， while the observation group was provided with precision pharmaceutical services from the three dimensions of knowledge， attitude and practice on the basis of routine pharmaceutical services， according to the root causes identified by RCA. The occurrence of investigational medicinal products protocol violations was compared between the two groups. RESULTS The total incidence of protocol violations of investigational medicinal products， as well as the incidences of minor and major protocol violations， were all significantly lower in the observation group than in the control group （ P ＜0.001）. The main types of protocol violations in both groups included missed/under-/over-dosing of medications， non-adherence to administration time， failure to adjust dosage as required， and combined medication/vaccination in violation of the protocol. Regarding the responsible subjects of protocol violations， the incidences of protocol violations attributed to participants and their guardians as well as investigators and accidental factors were significantly lower in the observation group than in the control group （ P ＜0.001， P ＜0.001， P ＝0.025）. However， there were no statistically significant differences in the incidences of protocol violations caused by sponsor-related reasons between the two groups （ P ＞0.05）. CONCLUSIONS Pharmaceutical services led by pharmacists， based on problem-oriented RCA and combined with KAP theory， can effectively reduce the protocol violations of investigational medicinal products rate in pediatric clinical trials， thereby safeguarding the safety and rights of study participants.

Objective:To investigate the efficacy and safety evaluation of omalizumab in patients with chronic urticaria who are not well treated with antihistamine and have a history of anaphylactic shock.Methods:A retrospective observational real-world study was conducted in which patients with chronic urticaria who were admitted to Peking University First Hospital from November 2018 to January 2024 who were poorly treated with antihistamine drugs and had a history of anaphylactic shock were selected as the study subjects, and 300 mg of omalizumab was injected subcutaneously every 4 weeks, and the occurrence of UCT (urticaria control test), the number of occurrences of anaphylactic shock and other adverse events were recorded during the treatment.Results:Among the 11 patients who started omalizumab treatment for 3 months, 10 patients had complete control of chronic urticaria (UCT=16), 1 patient was partially controlled (UCT=15), and 9 patients did not have anaphylactic shock during follow-up (10 cases after 12 months of follow-up and 1 case after 2 months of follow-up). Two patients developed anaphylactic shock after omalizumab injection. In this study, during the follow-up period (2-38 months), 11 patients were well tolerated with omalizumab, of which 4 continued to use omalizumab for urticaria, 6 stopped using omalizumab due to good urticaria control and no recurrence of anaphylactic shock, and 1 was lost to follow-up.Conclusion:Omalizumab may have good efficacy and safety in patients with chronic urticaria who are poorly treated with antihistamines and have a history of anaphylactic shock, and may have a potential role in preventing anaphylactic shock.

Objective:To investigate the pathogenesis and clinical manifestations of anaphylactic shock and to evaluate the effectiveness of existing treatments, so as to improve the understanding of anaphylactic shock and to properly manage patients with anaphylactic shock.Methods:A retrospective observational study was conducted to select 63 patients with anaphylactic shock who were diagnosed and treated in Peking University First Hospital from July 2017 to June 2023 as the study objects, and the clinical data including basic information, present medical history, vital signs, past medical history, emergency treatment measures and prognosis were collected, and the causes, clinical manifestations and emergency treatment measures of anaphylactic shock were descriptively analyzed.Results:The causes of anaphylactic shock in 63 subjects could be divided into drug allergy (50.79%), food allergy (15.87%), blood product allergy (11.11%), others (3.17%), radiotherapy (1.59%), strenuous exercise (1.59%), hemodialysis (1.59%), and the triggers in 9 cases (14.29%) were unclear. The clinical manifestations can be abnormalities of the skin, respiratory system, cardiovascular system, gastrointestinal system and urinary system, among which the most common skin manifestations are wheal rash, itching, redness and swelling (79.37%), the most common manifestation of the respiratory system is dyspnea (30.16%), and the highest proportion of cardiovascular manifestations is blood pressure lower than 90 mmHg or baseline blood pressure drop of 30 mmHg (100.00%). The most commonly used therapeutic drugs were epinephrine (49.2%), glucocorticoids (69.8%), antihistamines (52.4%), vasopressors (12.7%), and others.Conclusion:The causes of anaphylactic shock are different, and the clinical manifestations are complex and diverse, and the condition can be severe and life-threatening. Clinically, attention should be paid to the early and accurate identification of high-risk patients, the prevention of anaphylactic shock, and the timely taking of corresponding measures to protect the life safety of patients once anaphylactic shock occurs. Early diagnosis and prompt treatment are key to managing anaphylactic shock.

The neuroimmune mechanism of rosacea has not been fully elucidated, and it is believed that the innate immune system, immune cells, immune regulation, neuroimmune system, signaling pathway abnormalities and microbial dysbiosis are involved in the progress of the neuroimmune mechanism of rosacea. This article reviews the neuroimmune mechanism of rosacea.

Objective:To investigate the efficacy and safety evaluation of omalizumab in patients with chronic urticaria who are not well treated with antihistamine and have a history of anaphylactic shock.Methods:A retrospective observational real-world study was conducted in which patients with chronic urticaria who were admitted to Peking University First Hospital from November 2018 to January 2024 who were poorly treated with antihistamine drugs and had a history of anaphylactic shock were selected as the study subjects, and 300 mg of omalizumab was injected subcutaneously every 4 weeks, and the occurrence of UCT (urticaria control test), the number of occurrences of anaphylactic shock and other adverse events were recorded during the treatment.Results:Among the 11 patients who started omalizumab treatment for 3 months, 10 patients had complete control of chronic urticaria (UCT=16), 1 patient was partially controlled (UCT=15), and 9 patients did not have anaphylactic shock during follow-up (10 cases after 12 months of follow-up and 1 case after 2 months of follow-up). Two patients developed anaphylactic shock after omalizumab injection. In this study, during the follow-up period (2-38 months), 11 patients were well tolerated with omalizumab, of which 4 continued to use omalizumab for urticaria, 6 stopped using omalizumab due to good urticaria control and no recurrence of anaphylactic shock, and 1 was lost to follow-up.Conclusion:Omalizumab may have good efficacy and safety in patients with chronic urticaria who are poorly treated with antihistamines and have a history of anaphylactic shock, and may have a potential role in preventing anaphylactic shock.

Objective:To investigate the pathogenesis and clinical manifestations of anaphylactic shock and to evaluate the effectiveness of existing treatments, so as to improve the understanding of anaphylactic shock and to properly manage patients with anaphylactic shock.Methods:A retrospective observational study was conducted to select 63 patients with anaphylactic shock who were diagnosed and treated in Peking University First Hospital from July 2017 to June 2023 as the study objects, and the clinical data including basic information, present medical history, vital signs, past medical history, emergency treatment measures and prognosis were collected, and the causes, clinical manifestations and emergency treatment measures of anaphylactic shock were descriptively analyzed.Results:The causes of anaphylactic shock in 63 subjects could be divided into drug allergy (50.79%), food allergy (15.87%), blood product allergy (11.11%), others (3.17%), radiotherapy (1.59%), strenuous exercise (1.59%), hemodialysis (1.59%), and the triggers in 9 cases (14.29%) were unclear. The clinical manifestations can be abnormalities of the skin, respiratory system, cardiovascular system, gastrointestinal system and urinary system, among which the most common skin manifestations are wheal rash, itching, redness and swelling (79.37%), the most common manifestation of the respiratory system is dyspnea (30.16%), and the highest proportion of cardiovascular manifestations is blood pressure lower than 90 mmHg or baseline blood pressure drop of 30 mmHg (100.00%). The most commonly used therapeutic drugs were epinephrine (49.2%), glucocorticoids (69.8%), antihistamines (52.4%), vasopressors (12.7%), and others.Conclusion:The causes of anaphylactic shock are different, and the clinical manifestations are complex and diverse, and the condition can be severe and life-threatening. Clinically, attention should be paid to the early and accurate identification of high-risk patients, the prevention of anaphylactic shock, and the timely taking of corresponding measures to protect the life safety of patients once anaphylactic shock occurs. Early diagnosis and prompt treatment are key to managing anaphylactic shock.

The neuroimmune mechanism of rosacea has not been fully elucidated, and it is believed that the innate immune system, immune cells, immune regulation, neuroimmune system, signaling pathway abnormalities and microbial dysbiosis are involved in the progress of the neuroimmune mechanism of rosacea. This article reviews the neuroimmune mechanism of rosacea.

Six new ent-abietane diterpenoids, abientaphlogatones A-F (1-6), along with two undescribed ent-abietane diterpenoid glucosides, abientaphlogasides A-B (7-8) and four known analogs were isolated from the aerial parts ofPhlogacanthus curviflorus (P. curviflorus). The structures of these compounds were determined using high-resolution electrospray ionization mass spectrometry (HR-ESI-MS), one-dimensional and two-dimensional nuclear magnetic resonance (NMR) spectroscopy, electronic circular dichroism (ECD) spectra, and quantum chemical calculations. Notably, compounds 5 and 6 represented the first reported instances of ent-norabietane diterpenoids from the genus Phlogacanthus. In the β-hematin formation inhibition assay, compounds 2, 4, 7-10, and 12 displayed antimalarial activity, with IC₅₀ values of 12.97-65.01 μmol·L^-1. Furthermore, compounds 4, 5, 8, and 10 demonstrated neuroprotective activity in PC12 cell injury models induced by H₂O₂ and MPP⁺.
Abietanes/pharmacology* ; Antimalarials ; Hydrogen Peroxide ; Biological Assay ; Plant Components, Aerial

Objective To analyze the phenomenon of sleep benefit in Parkinson's disease (PD)and its correlation factors.Methods One hundred PD patients in Department of Neurology,Qilu Hospital of Shandong University from February 2017 to November 2017 were included.They were recorded in detail the clinical information and clinical classification.Sleep conditions were assessed by Pittsburgh Sleep Quality Index,Parkinson Disease Sleep Scale,Epworth Sleepiness Disorder Scale and Rapid Eye Movement Sleep Behavior Disorder Screening Questionnaire.The general information,disease duration,medication,movement function,sleep condition and anxiety status were compared between sleep benefit group and without sleep benefit group.The correlation factors of sleep benefit was evaluated using unconditional Logistic regression analysis.Results Fifty-one cases (51％) of sleep benefit were determined in our cohort of 100 PD patients.Sleep benefit group adminstered lower levodopa equivalent daily dose (LEDD,(354.77 ± 279.64) mg/d) compared with patients without sleep benefit ((510.76 ± 266.26) mg/d,t =-2.734,P =0.006),including levodopa ((289.04 ± 228.73) mg/d vs (392.65 ± 211.20) mg/d,t =-2.366,P =0.021) and dopamine agonist dose ((41.13 ± 51.48) mg/d vs (68.01 ± 57.10) mg/d,t =-1.950,P =0.054).Sleep benefit group had higher percentage of using dopamine agonist (23(45.1％) vs 35 (71.4％),x2 =7.112,P=0.008) and longer duration of nocturnal sleep episode ((6.51 ± 1.31) h vs (5.89 ± 1.29) h,t =2.412,P =0.018).In addition,sleep benefit had a higher prevalence in tremor-dominant subtype of PD (19/27 (70.4％) vs 20/46 (43.5％),x2 =4.855,P =0.025).Logistic regression indicated that sleep benefit had a positive correlation with duration of nocturnal sleep episode and tremor-dominant subtype,as well as a negative correlation with LEDD and dose of levodopa.LEDD and duration of nocturnal sleep episode were the independent factors of sleep benefit (OR =0.998,95％CI 0.997-1.000,P＜0.05;OR=1.407,95％CI1.004-1.972,P＜0.05).Conclusion PD patients with sleep benefit administered low dose of dopamine and took long nocturnal sleep,which may relate to the relativelv preserved dopamine storage function of dopaminergic neurons.