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 feasibility of using Cariostat test for caries risk assessment in adult outpatients and provide a reference basis for caries prevention and treatment in adult outpatients of different ages.Methods Fifty-two adult patients of different ages(18-24,25-34,35-44,45-54,and≥55 years old)attending outpatient clinics of The Affiliated Stomatological Hospital of Nanjing Medical University were tested for caries activity using the Cariostat test.Oral examinations were conducted according to the criteria of the 5th edition of the Basic Methods of Oral Health Surveys of the World Health Organization,and on-site questionnaire sur-veys were performed for the Cariogram assessment system.Oral examinations included assessments of dental arch conditions and caries status,while questionnaire surveys covered dietary habits,oral health care habits,etc.The caries status of adult outpatients of different age groups was analyzed,and caries activity was assessed using the Cariostat test.The caries risk levels were determined,and the con-sistency between the Cariostat test and the Cariogram assessment system was evaluated.Results It was found that there was a differ-ence in mean decayed,missing and filled surfaces(DMFS)between the low-risk group of adult outpatients with different caries risk levels classed by the Cariostat test and the intermediate and high-risk groups(P＜0.05).There was a difference in mean decayed,missing and filled teeth(DMFT)and mean DMFS between the low-risk group of adult outpatients with different caries risk levels classed by Cariogram and the intermediate and high-risk groups(P＜0.05).The evaluation results of caries risk levels in adult outpa-tients classed by the Cariostat test and the Cariogram assessment system showed a Kappa value of 0.467(P＜0.05)in the≥55 years old group,indicating moderate consistency.Conclusion The Cariostat test is useful in understanding the caries activity of adult outpa-tients and is particularly accurate and effective in patients at the age of 55 or older.

Objective To develop a framework and indicators system for disability-related service data in China. Methods Using International Classification of Functioning, Disability and Health (ICF) framework and approach, the framework and indicators system were developed using content analysis, logical reasoning and expert consultation. Results A system with nine aspects, 35 dimensions and 115 indicators was established. Eleven experts with disability-related background all accepted the system, and satisfied in the importance and operability.Conclusion A data framework and indicators system with nine aspects, 35 dimensions and 115 indicators has been established for disability-related service, which can be used in further data collection.

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.

Objective:To study the feasibility of a new composite mineralized collagen membrane in alveolar ridge preservation.Methods:The third mandibular premolars on both sides were extracted from 12 dogs,the 24 alveolar sockets were randomly assigned into A,B and C groups(n =8).The distal alveolar sockets of group A was immediately implanted with the new composite mineralized collagen membrane and bone graft material,those of group B with bone graft material,group C was the blank control.The healing of sockets was evaluated by gross observation,morphological measurements,X-ray microscope and photographs of spiral CT.Results:The horizontal width of the alveolar process of group A was bigger than that of group B (P ＜ 0.05),that of group B was bigger than that of group C (P ＜ 0.05).The region of extraction interest in spiral CT value was higher in group A than that in group B and C (P ＜ 0.05).The extraction sockets were generated new bone and the degree of reconstruction measurements was higher in group A than that in group B and C (P ＜ 0.05).Conclusion:The new composite mineralized collagen membrane can induce the regeneration of new bone,and preserve the alveolar.

BACKGROUNDA variety of inflammatory mediators and effector cells participate together in acute lung injury, and lead to secondary injury that is due to an inflammatory cascade and secondary diffuse lung parenchyma injury. Inflammation is associated with an oxidative stress reaction, which is produced in the development of airway inflammation, and which has positive feedback on inflammation itself. Resolvin D1 can reduce the infiltration of neutrophils, regulate cytokine levels and reduce the inflammation reaction, and thereby promote the resolution of inflammation. The purpose of this study is to investigate the effects of resolvin D1 on an inflammatory response and oxidative stress during lipopolysaccharide (LPS)-induced acute lung injury.

METHODSLPS (3 mg/kg) was used to induce the acute lung injury model. Pretreatment resolvin D1 (100 ng/mouse) was given to mice 30 minutes before inducing acute lung injury. Mice were observed at 6 hours, 12 hours, 1 day, 2 days, 3 days, 4 days and 7 days after LPS was administrated, then they were humanely sacrificed. We collected bronchoalveolar lavage fluid (BALF) and the lung tissues for further analysis. Paraffin section and HE staining of the lung tissues were made for histopathology observations. Parts of the lung tissues were evaluated for wet-to-dry (W/D) weight ratio. tumor necrosis factor (TNF)-α, inter leukin (IL)-1β, IL-10 and myeloperoxidase (MPO) were detected by enzyme-linked immunosorbent assay (ELISA). A lipid peroxidation malondialdehyde (MDA) assay kit was used to detect MDA. A total superoxide dismutase assay kit with WST-1 was used to analyze superoxide dismutase (SOD). We determined the apoptosis of neutrophils by Flow Cytometry. A real-time quantitative PCR Detecting System detected the expression of mRNA for heme oxygenase (HO)-1.

RESULTSPretreatment with resolvin D1 reduced the pathological damage in the lung, decreased the recruitment of neutrophils and stimulated their apoptosis. It markedly decreased the expressions of TNF-α, IL-1β and increased the expressions of IL-10, and decreased the production of MDA and increased the expressions of SOD. The mRNA expression of HO-1 was also significantly increased.

CONCLUSIONSResolvin D1 displays potent anti-inflammatory actions by regulating cytokines, inhibiting aberrant neutrophil recruitment and stimulating apoptosis of neutrophils. Resolvin D1 can also relieve the injury due to oxidative stress. The mechanisms might be related to increase HO-1 expression.

Acute Lung Injury ; chemically induced ; drug therapy ; immunology ; Animals ; Bronchoalveolar Lavage Fluid ; immunology ; Docosahexaenoic Acids ; therapeutic use ; Interleukin-10 ; metabolism ; Interleukin-1beta ; metabolism ; Lipopolysaccharides ; toxicity ; Male ; Mice ; Mice, Inbred BALB C ; Oxidative Stress ; drug effects ; Peroxidase ; metabolism ; Superoxide Dismutase ; metabolism ; Tumor Necrosis Factor-alpha ; metabolism

OBJECTIVE:To improve the formula of urea cream and establish its quality control methods.METHODS:The matrix component of formula was adjusted to prepare O/W matrix.Prednisone was added into matrix to prepare urea cream;UV spectrophotometry was applied to determine the content of urea and evaluate the quality of preparation and the stability of 3 batches of samples setting for 40 days under different conditions.RESULTS:The preparation was white cream and its inspection results were in line with the standards stated in Chinese Pharmacopoeia(2005 edition).The linear range of urea was 30.5～180.2 ?g?mL-1(r=0.999 0) with an average recovery of 99.68%(RSD=0.49%).The quality of 3 batches of samples kept stable during observation.CONCLUSION:Improved formula is reasonable,simple in preparation technology and quality control.