Objective To standardize the management of clinical trials in our hospital,reduce the incidence of protocol deviations,and provide a reference for improving the quality of clinical trials.Methods The healthcare failure mode and effect analysis(HFMEA)method was used to determine the potential failure modes of the current protocol deviation.The frequency,severity and detectability of failure modes were quantified and evaluated.The risk priority number(RPN)was calculated and the corresponding improvement measures were proposed.The RPN values before and after the implementation of HFMEA were statistically analyzed to evaluate the improvement effect.Results After the implementation of HFMEA activities,the RPN values of 14 potential failure modes decreased significantly(P<0.05);The risk level of 12 potential failure modes decreased.The HFMEA team members'ability in finding and solving problems,communication and cooperation were significantly improved.Conclusions The implementation of HFMEA activities contributes to the management of protocol deviation in clinical trials,can effectively reduce the occurrence of protocol deviation,and provides experience for improving the quality of drug clinical trials.

Background::Although overnight fasting is recommended prior to endoscopic retrograde cholangiopancreatography (ERCP), the benefits and safety of high-carbohydrate fluid diet (CFD) intake 2 h before ERCP remain unclear. This study aimed to analyze whether high-CFD intake 2 h before ERCP can be safe and accelerate patients’ recovery.Methods::This prospective, multicenter, randomized controlled trial involved 15 tertiary ERCP centers. A total of 1330 patients were randomized into CFD group ( n = 665) and fasting group ( n = 665). The CFD group received 400 mL of maltodextrin orally 2 h before ERCP, while the control group abstained from food/water overnight (>6 h) before ERCP. All ERCP procedures were performed using deep sedation with intravenous propofol. The investigators were blinded but not the patients. The primary outcomes included postoperative fatigue and abdominal pain score, and the secondary outcomes included complications and changes in metabolic indicators. The outcomes were analyzed according to a modified intention-to-treat principle. Results::The post-ERCP fatigue scores were significantly lower at 4 h (4.1 ± 2.6 vs. 4.8 ± 2.8, t = 4.23, P <0.001) and 20 h (2.4 ± 2.1 vs. 3.4 ± 2.4, t= 7.94, P <0.001) in the CFD group, with least-squares mean differences of 0.48 (95% confidence interval [CI]: 0.26–0.71, P <0.001) and 0.76 (95% CI: 0.57–0.95, P <0.001), respectively. The 4-h pain scores (2.1 ± 1.7 vs. 2.2 ± 1.7, t = 2.60, P = 0.009, with a least-squares mean difference of 0.21 [95% CI: 0.05–0.37]) and positive urine ketone levels (7.7% [39/509] vs. 15.4% [82/533], χ2 = 15.13, P <0.001) were lower in the CFD group. The CFD group had significantly less cholangitis (2.1% [13/634] vs. 4.0% [26/658], χ2 = 3.99, P = 0.046) but not pancreatitis (5.5% [35/634] vs. 6.5% [43/658], χ2 = 0.59, P = 0.444). Subgroup analysis revealed that CFD reduced the incidence of complications in patients with native papilla (odds ratio [OR]: 0.61, 95% CI: 0.39–0.95, P = 0.028) in the multivariable models. Conclusion::Ingesting 400 mL of CFD 2 h before ERCP is safe, with a reduction in post-ERCP fatigue, abdominal pain, and cholangitis during recovery.Trail Registration::ClinicalTrials.gov, No. NCT03075280.

The lingnan liver-soothing and spirit-regulating acupuncture and moxibustion technique,developed by Professor FU Wen-Bin,a renowned traditional Chinese medicine expert in Guangdong Province,represents an innovative achievement in acupuncture therapy for depression-related disorders.Drawing upon the rich legacy of master scholars,meticulous study of medical literature,and over three decades of continuous research and innovation,Professor FU has formulated this technique with profound influence and widespread application.By tracing the developmental trajectory of the Lingnan liver-soothing and spirit-regulating technique,this paper sheds light on its significant guiding principles and reference value for the development of other distinctive acupuncture techniques.Furthermore,it offers insights and inspiration for advancement in various fields of traditional Chinese medicine.

Objective: To study the long-term morphological stability of three-dimensional (3D) printed photosensitive resin dental models under natural light and dark conditions. Methods: Eighty sets of resin dental models were made by the desktop 3D printer from one digital standard model set, and randomly divided into two groups, namely natural light group (40 sets) and dark group (40 sets). All resin models were stored in sealed bags, with 4 model sets from each group randomly collected after 1, 3, 5, 7, 14, 21, 28, 40, 60, or 90 days of storage and 3D scanned using an optical model scanner. The root-mean-square error (RMSE) was calculated to represent the mean deviation of the difference between the digital standard model and the scanned resin model. Meanwhile, three linear indexes (the width between the canines, the width between the first molars, and the arch length) of the resin dental model were measured and compared with the corresponding values of the standard model. RMSE and the linear measurements between the digital standard model and the scanned resin models were compared between the natural light group and the dark group and among models from different time points. Results: Compared with the digital standard model, the RMSE values of 96.9% (155/160) resin dental models were less than 0.1 mm within 90-day storage. Also, at the same time point, there was no significant difference in the RMSE between the natural light group and the dark group (P>0.05). 75.0% (360/480) of the absolute values of the linear differences (differences in inter-canine width, intra-molar width, and arch length between the digital standard model and the scanned resin model) were within 0.2 mm, and about 0.1% (3/480) of the linear differences were greater than 0.5 mm, and all of the linear differences were within 0.6 mm. Conclusions: 3D-printed resin dental models can be stored stably under natural light and dark conditions for a long time.

OBJECTIVES: To study the left heart structure and functional characteristics of term neonates with intrauterine growth restriction (IUGR). METHODS: This study included 86 term neonates with IUGR admitted to the Neonatal Ward of Beijing Friendship Hospital, Capital Medical University from January 2019 to January 2022 as the IUGR group, as well as randomly selected 86 term neonates without IUGR born during the same period as the non-IUGR group. The clinical data and echocardiographic data were compared between the two groups. RESULTS: The analysis of left heart structure and function showed that compared with the non-IUGR group, the IUGR group had significantly lower left ventricular mass, left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left atrial diameter, end-diastolic interventricular septal thickness, left ventricular posterior wall thickness, left ventricular end-diastolic volume, left ventricular end-systolic volume, and stroke volume (P<0.05) and significantly higher ratio of end-diastolic interventricular septal thickness to left ventricular posterior wall thickness, proportion of neonates with a mitral peak E/A ratio of ≥1, and cardiac index (P<0.05). The Spearman correlation analysis suggested that stroke volume was positively correlated with birth weight and body surface area (r_s=0.241 and 0.241 respectively; P<0.05) and that the ratio of end-diastolic interventricular septal thickness to left ventricular posterior wall thickness was negatively correlated with birth weight and body surface area (r_s=-0.229 and -0.225 respectively; P<0.05). CONCLUSIONS The left ventricular systolic function of neonates with IUGR is not significantly different from that of neonates without IUGR. However, the ventricular septum is thicker in neonates with IUGR. This change is negatively correlated with birth weight and body surface area. The left ventricular diastolic function may be impaired in neonates with IUGR.
Humans ; Infant, Newborn ; Birth Weight ; Echocardiography ; Fetal Growth Retardation ; Heart ; Heart Ventricles/diagnostic imaging* ; Ventricular Function, Left

Objective To evaluate the effects of fasting and high-fat diet on the pharmacokinetics of moxifloxacin in Chinese healthy adult subjects.Methods A single-center,randomized,open,single-dose trial design was used in this study,healthy subjects were assigned to receive single dose of moxifloxacin tablets 0.4 g in either fasting or high-fat diet state,and blood samples were taken at different time points,respectively.The concentrations of moxifloxacin in plasma were determined by liquid chromatography-tandem mass spectrometry.Results The main pharmacokinetic parameters of moxifloxacin in fasting state and high-fat diet states were as follows:Cmax were(2 286.09±802.64)and(1 963.33±474.99)ng·mL-1;t1/2 were(12.32±1.42)and(13.56±1.38)h;AUC0-twere(2.70±0.51)×104 and(2.60±0.55)×104 ng·mL-1·h;AUC0-∞ were(2.88±0.54)×104 and(2.85±0.63)×104 ng·mL-1·h;tmax were 1.50 and 2.00 h.After high-fat diet,the AUC was not significantly changed,Cmax was decreased by 14.12％,and tmax was indistinctively delayed(all P＞0.05).Conclusion Food had no effects on the absorption rate and degree of moxifloxacin.

Aim To explore whether sea-buckthorn slows down-regulation of hepatic cytochrome P450 2C(CYP 2C)in mice with liver injury by BCG vaccine(BCG)-induced via PXR/NF-κB pathway.Methods The mouse model of liver injury was induced by a single tail vein injection of BCG 125 mg·kg-1 for hepatitis B research,and the mice were randomly di-vided into control group,BCG group,BCG+sea-buckthorn granules(SG)group(gavage 50,100,200 mg·kg-1,twice a day),BCG+PCN group(intraper-itoneal injection 100 mg·kg-1,once a day).The levels of serum transaminase and TNF-α and IL-1β in liver tissue were detected by ELISA.The nuclear pro-tein expression NF-κB p65 and the total protein expres-sion of pregnane X receptor(PXR),CYP2C in liver were detected by Western blot.Liver pathological changes were observed by HE staining.Results Sea-buckthorn inhibited overexpression of TNF-α,IL-1βand NF-κB p65,alleviated the down-regulation of CYP2C and PXR protein expression,and improved liv-er pathology and serum transaminase in a dose-depend-ent manner.After intervention with PCN,a mouse specific agonist of PXR,it was similar to the high dose group of SG.Conclusion Sea-buckthorn slows down-regulation of CYP2C in mice with liver injury by BCG-induced via PXR/NF-κB pathway.

Objective To understand the current practice status of central venous access device(CVAD)maintenance among intensive care unit(ICU)nurses in secondary and above medical institutions in Shandong province,and to provide a basis for further implementation of effective measures to reduce the incidence of central catheter-related bloodstream infections.Methods The CVAD maintenance practice questionnaire was compiled based on domestic and international evidence related to CVAD maintenance,and a survey was conducted in October 2022 to investigate the status of ICU nurses' CVAD maintenance practice in secondary and above medical institutions in Shandong Province.Results There were 1 492 nurses participated in the survey and 1 461 valid questionnaires were recovered,with a valid recovery rate of 97.92％.The type of CVAD used by the nurses was mainly central venous catheters[92.3％(1349/1461)],and the item with the best assessment at each operation was patency of the catheter[81.1％(1185/1461)],and the worst was the patient's feeling[40.7％(594/1 461)].When assessing catheter patency,[59.8％(873/1 461)]of nurses drew back blood into the catheter.In the use of infusion connectors,three-way connectors[76.0％(1 110/1 461)]and heparin caps[62.3％(910/1 461)]were most frequently used.When sterilizing needleless connectors,most nurses could follow the correct range of disinfection,but the time of disinfection needed to be extended,and the most used items for disinfection were povidone-iodine cotton balls/swabs[44.3％(647/1 461)].The timing of changing infusion connectors needs to be standardized.Most nurses would choose saline for catheter flushing,and the number of nurses choosing saline versus heparinized saline when locking the catheter was about 50％.Most nurses can use correct size syringes and follow standardized techniques for flushing and locking.When performing CVAD maintenance,84.7％(1 237/1 461)of nurses chose a specialized care package kit.The most used skin antiseptic was povidone-iodine[63.7％(931/1 461)].Most nurses could follow the standardized range of skin disinfection,but awareness of drying needs to be improved.Dressings covering puncture points were most frequently transparent[99.7％(1 457/1 461)]and gauze[94.7％(1 383/1 461)],and the frequency of gauze dressing changes needs to be standardized.Hand hygiene and aseptic awareness of nurses during CVAD maintenance was good,but hand hygiene and the timing of wearing sterile gloves need to be standardized.Conclusions ICU nurses' CVAD maintenance practices were generally in line with the latest evidence-based recommendations,but assessment,use of maintenance-related items,and hand hygiene and aseptic technique need to be further standardized.It is recommended that nursing administrators enhance ICU nursing human resource allocation as much as possible and form a central line associated bloodstream infection(CLABSI)prevention and control management system to gradually reduce the morbidity of CLABSI within the ICU.

In recent years, artificial intelligence technology has developed rapidly and has been gradually applied to the fields of clinical image data processing, auxiliary diagnosis and prognosis evaluation. Research has shown that it can simplify doctors’ clinical tasks, quickly provide analysis and processing results, and has high accuracy. In terms of orthodontic diagnosis and treatment, artificial intelligence can assist in the rapid fixation of two-dimensional and three-dimensional cephalometric measurements. In addition, it is also widely used in the efficient processing and analysis of three-dimensional dental molds data, and shows considerable advantages in determining deciding whether orthodontic treatment needs tooth extraction, thus assisting in judging the stage of growth and development, orthodontic prognosis and aesthetic evaluation. Although the application of artificial intelligence technology is limited by the quantity and quality of training data, combining it with orthodontic clinical diagnosis and treatment can provide faster and more effective analysis and diagnosis and support more accurate diagnosis and treatment decisions. This paper reviews the current application of artificial intelligence technology in orthodontic diagnosis and treatment in the hope that orthodontists can rationally treat and use artificial intelligence technology in the clinic, and make artificial intelligence better serve orthodontic clinical diagnosis and treatment, so as to promote the further development of intelligent orthodontic diagnosis and treatment processes.

OBJECTIVES: To investigate the clinical treatment outcomes and the changes of the outcomes over time in extremely preterm twins in Guangdong Province, China. METHODS: A retrospective analysis was performed for 269 pairs of extremely preterm twins with a gestational age of <28 weeks who were admitted to the department of neonatology in 26 grade A tertiary hospitals in Guangdong Province from January 2008 to December 2017. According to the admission time, they were divided into two groups: 2008-2012 and 2013-2017. Besides, each pair of twins was divided into the heavier infant and the lighter infant subgroups according to birth weight. The perinatal data of mothers and hospitalization data of neonates were collected. The survival rate of twins and the incidence rate of complications were compared between the 2008-2012 and 2013-2017 groups. RESULTS: Compared with the 2008-2012 group, the 2013-2017 group (both the heavier infant and lighter infant subgroups) had lower incidence rates of severe asphyxia and smaller head circumference at birth (P<0.05). The mortality rates of both of the twins, the heavier infant of the twins, and the lighter infant of the twins were lower in the 2013-2017 group compared with the 2008-2012 group (P<0.05). Compared with the 2008-2012 group, the 2013-2017 group (both the heavier infant and lighter infant subgroups) had lower incidence rates of pulmonary hemorrhage, patent ductus arteriosus (PDA), periventricular-intraventricular hemorrhage (P-IVH), and neonatal respiratory distress syndrome (NRDS) and a higher incidence rate of bronchopulmonary dysplasia (P<0.05). CONCLUSIONS There is a significant increase in the survival rate over time in extremely preterm twins with a gestational age of <28 weeks in the 26 grade A tertiary hospitals in Guangdong Province. The incidences of severe asphyxia, pulmonary hemorrhage, PDA, P-IVH, and NRDS decrease in both the heavier and lighter infants of the twins, but the incidence of bronchopulmonary dysplasia increases. With the improvement of diagnosis and treatment, the multidisciplinary collaboration between different fields of fetal medicine including prenatal diagnosis, obstetrics, and neonatology is needed in the future to jointly develop management strategies for twin pregnancy.
Bronchopulmonary Dysplasia/epidemiology* ; Female ; Gestational Age ; Humans ; Infant ; Infant, Extremely Premature ; Infant, Newborn ; Pregnancy ; Respiratory Distress Syndrome, Newborn/epidemiology* ; Retrospective Studies ; Treatment Outcome