ObjectiveTo review the characteristics of registered industry-sponsored clinical trials of pediatric drugs and vaccines in China and to provide references for promoting the development of new pediatric drugs. MethodsWe searched ClinicalTrials.gov and the Chinese Clinical Trial Registry for completed registered industry-sponsored clinical trials of pediatric drugs and vaccines from the database inception to September 11, 2022. Data including the date the trial was first posted, product type (drug or vaccine), sample size, and other information to describe the general characteristics of pediatric clinical trials were collected. The studies were divided into 2 phases based on the trial posted date, 2005―2010 and 2011―2022, reflecting the enactment of pediatric drug clinical trial policies in recent years. The quality of trial registration and the main characteristics of interventional trials in the 2 phases were then compared. Exploring the results attached to industry and non-industry sponsored clinical trials. ResultsData for 145 trials were collected, and the largest proportion (63.4%) involved vaccines. Randomized control trial (RCT) was the study type with the highest percentage (68.3%). The average report completion rate for registered interventional trials was 81.0%. Compared with 2005―2010, the percentage of average report completions, pediatric drug clinical studies, multicenter, RCTs, and double-blinded registered trials increased in 2011―2022. The proportion of positive outcomes in pediatric clinical trials sponsored by industries was higher than those sponsored by non-industry. ConclusionThe majority of completed pediatric clinical trials sponsored by industries are for vaccines, in line with the promotion of pediatric policies. The quality of trial registration has improved, but not significantly, and some characteristics of trial design have changed. The proportion of positive outcomes in pediatric clinical trials sponsored by industries is higher. And further promotion of pediatric clinical trials is needed.
ObjectiveTo explore the appropriate intervention measures to reduce the influence of drug repercussion by pediatric hospital inpatients on nursing work. MethodBetween March 1st and 28th, 2014, statistical analysis on the characteristics of pediatric drug-return by drug repercussion questionnaires was carried out. ResultsEach drug repercussion took much time of the nurses (median of 5.00 minutes per time). The frequency of drug repercussion in the internal medicine department was more than that in the surgical department; the most drug repercussions were found in the respiratory medicine department, reaching 26.84%. The main category of drug repercussion was aerosolized medication (39.32%). The drug repercussion mainly resulted from lack of patients' education and doctor-related administration, which had a proportion of 31.44% and 27.19%, respectively. ConclusionsThe wards which have more drug repercussions should be under the supervision according to the analysis of drug repercussion. Meanwhile, improving patients' education and training of medical staff can reduce the pediatric hospital inpatients' drug repercussion and also may reduce the bad effects on nursing work.
ObjectiveTo analyze the perdictive value of Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP) for malnutrition or postoperative complications in children with critical congenital heart disease (CHD).MethodsA total of 875 children with critical CHD who were hospitalized in West China Hospital, Sichuan University form August 2019 to February 2021, including 442 males and 433 females with a median age of 30 (12, 48) months, were assessed by STAMP in Health Information System. Clinical data of postoperative complications were collected.Results(1) Based on World Health Organization Z-score as gold standard, 24.5% had malnutrition risk, and 34.3% were diagnosed with malnutrition. According to STAMP, the children were with medium malnutrition risk of 37.9% and high malnutrition risk of 62.1%. There was a statistical difference of incidence rate of malnutrition and detection rate of STAMP malnutrition risk in gender, age, ICU stay or length of mechanical ventilation (P<0.05); (2) with the optimal cut-off point of 5.5 in STAMP for malnutrition, the sensitivity, specificity, positive predictive value, negative predictive value and area under the curve (AUC) were 68.3%, 84.3%, 48.1%, 88.3% and 0.82, respectively; (3) 12.0% of the children were with postoperative complications; (4) with the optimal cut-off point of 5.5 in STAMP for postoperative complications, the sensitivity, specificity, positive predictive value, negative predictive value and AUC were 83.8%, 73.1%, 18.8%, 99.1% and 0.85, respectively.ConclusionChildren with critical CHD have a higher incidence of malnutrition risk and postoperative complications. STAMP has a good perdictive value for malnutrition or postoperative complications, however, the sensitivity and specificity of STAMP are affected by the gold standard or the cut-off point.
Objective To explore the interference of recent use of antibiotics in the sensitivities of different methods for the detection of Helicobacter pylori (Hp) in children. Methods From June 2015 to December 2017, children who were highly suspected of Hp infection and required gastroscopy were divided into the antibiotic group and the control group according to the recent use of antibiotics, with 200 cases in each group. The use of antibiotics of children in the antibiotic group was analyzed. The children in the two groups completed five methods of Hp detection, including rapid urease test (RUT), 13C-urea breath test (13C-UBT), pathological Warthin-Starry staining, colloidal gold method for measuring Hp immunoglobulin M (IgM) antibody, and enzyme linked immunosorbent assay method for measuring Hp stool antigen (HpSA). Comparative analyses of data were done. Results The positive rate of RUT was 36.5% in the antibiotic group and 75.0% in the control group (P<0.05). The positive rate and value of13C-UBT were 59.0% and 13.6±4.7 in the antibiotic group, and 78.0% and 41.7±6.6 in the control group (P<0.05). The positive rate of pathological biopsy was 48.0% in the antibiotic group and 68.0% in the control group (P<0.05), and L-forms were found in 80.9% of the Hp-positive specimens in the antibiotic group. The positive rate of IgM antibody was 54.5% in the antibiotic group and 65.5% in the control group (P<0.05). The positive rate of HpSA was 38.0% in the antibiotic group and 69.0% in the control group (P<0.05). In the antibiotic group, only 12.5% of the children used antibiotics for eradication of Hp and 87.5% for non Hp eradication. Conclusions Under the interference of antibiotics use, the sensitivity of 13C-UBT is the highest among the five methods for Hp detection, and the sensitivities of RUT and HpSA are very low. For children who could not cooperate with 13C-UBT, the sensitivity of IgM detection is relatively high. For children who need gastroscopy, prolonged chromogenic time for RUT and multi-point pathological biopsy can reduce misdiagnosis.
Lumbar puncture for children is a difficult technique and is an important aspect of clinical teaching for residents and interns in the neurological department of pediatrics. In this article, we summarized techniques and experiences of clinical teaching in pediatric lumbar puncture, and discussed difficulty, variability and remedial strategy for lumbar puncture in children. Narrow intervertebral space, poor compliance and resistance of children are the main difficulty for pediatric lumbar puncture. The causes of failure for medical students include different sensations of breakthrough when using different needles, choice of un-preferable intervertebral space, excessive vertical angle for needling performance, deviation from the longitudinal midline of the body, incorrect anesthesia, and exceeding resistance of children patients. Corresponding remedial strategy for failure of puncture includes informing students of the technique and variability of puncture, training experienced staff for second- and third-line substitutes, and reinforcing nursing after surgery. This summary of techniques for pediatric lumbar puncture and experiences of clinical teaching will benefit pediatricians and their clinical training.
ObjectiveTo systematically evaluate the efficacy and safety of anatomical landmark method (ALM) versus ultrasound (US)-guided internal jugular vein (IJV) catheterization in pediatric patients. MethodsDatabases including PubMed, EMbase, The Cochrane Library (Issue 10, 2016), CNKI, CBM, WanFang Data and CNKI were searched from inception to October 2016 to collect randomized controlled trials (RCTs) of landmark-guided versus ultrasound-guided IJV catheterization in pediatric patients who underwent elective surgery. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then RevMan 5.3 software was used to perform meta-analysis. ResultsA total of 13 RCTs involving 1 026 pediatric patients were included. The results of meta-analysis showed that, the overall success rate (RR=1.21, 95%CI 1.09 to 1.34, P=0.000 5) and arterial puncture rate (RR=0.19, 95%CI 0.07 to 0.50, P=0.000 7) of US-guided IJV catheterization were both significantly superior to the ALM group. Whereas there was no significant difference between two groups as for the incidence of hematoma formation (RR=0.35, 95%CI 0.09 to 1.31, P=0.12). ConclusionCurrent evidence shows that, for IJV catheterization of pediatric patients, both the effectiveness and safety of ultrasound-guided technique are better than the landmark-guided. Since the quantity and quality of included studies are limited, the conclusion of this study needs more high quality studies to verify.
Objective To determine the extent of off-label drug use in pediatric outpatients of West China Second University Hospital in 2010, and to analyze its possible risk factors, so as to provide baseline data for getting acquainted with the extent of off-label drug use in pediatrics in China and developing policy of off-label drug use. Methods The stratified random sampling was conducted to select prescriptions of children aged 0 to 18 years in pediatric outpatients of the West China Second University Hospital in 2010. According to drug instructions, off-label drug use of prescriptions of all selected children was analyzed in the following aspects, the category of off-label drug use, age, category of drugs. In addition, an analysis was conducted to check the relationship between off-label use and following possible risk factors: age, sex, essential medicines and over-the-counter drugs. Results A total of 2 640 prescriptions with 8 588 medical advices involving 329 drugs were extracted and analyzed, with incidence rates of off-label drug use accounting for 76.59%, 40.88% and 83.89%, respectively. The main categories of off-label drug use were no pediatric information (35.57%), indication (25.44%), and dosage (25.31%). The top 2 age groups with highest incidence rate of off-label drug were neonates (54.35%) and adolescents (49.64%). The top 4 drugs with highest incidence rate of off-label drug were respiratory system medicines (48.12%), Chinese patent medicines (48.12%), digestive and metabolic system medicines (33.36%), and systemic anti-infectives (16.27%). The off-label use risks in all age groups in the hospital were indifferent, and the essential medicines and prescription medicines were likely to present higher risks of drug off-label. Conclusion Off-label drug use in pediatric outpatients is common with growth trend in pediatric outpatients of the West China Second University Hospital. On the one hand, drug instructions lack pediatric information, and on the other hand, it’s badly in need of developing relevant legislation, regulations or guidelines to regulate off-label drug use, providing more evidence by conducting clinical trials on pediatric drugs, encouraging the development and production of the applicable drugs and dosage forms for children, and establishing the children essential medicine list, so as to avoid doctor’s professional risk and ensure the safety of pediatric drug use.
Objective To systematically review the risk factors of tic disorder (TD) in children. Methods Databases including PubMed, EMbase, The Cochrane Library, Web of Science, CNKI, CBM, VIP, and WanFang Data were electronically searched to collect observational studies on children with TD from inception to June 29th 2021. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.3 software. Results A total of 32 studies involving 556 560 children were included. The results of meta-analysis showed that the risk factors for TD were as follows: male (OR=2.23, 95%CI 1.08 to 4.61, P=0.03), premature delivery (OR=1.66, 95%CI 1.04 to 2.64, P=0.03), low birth weight (OR=1.27, 95%CI 1.07 to 1.50, P=0.005), history of neonatal jaundice (OR=7.46, 95%CI 1.15 to 48.42, P=0.04), other adverse factors in the perinatal period (OR=2.74, 95%CI 1.89 to 3.98, P<0.000 01), poor eating habits (OR=2.11, 95%CI 1.52 to 2.93, P<0.000 01), long-term viewing of electronic products (OR=2.22, 95%CI 1.31 to 3.75, P=0.003), history of febrile convulsions (OR=2.43, 95%CI 1.21 to 4.86, P=0.01), recurrent respiratory infection (OR=2.63, 95%CI 1.49 to 4.64, P=0.000 8), chronic tonsillitis (OR=2.01, 95%CI 1.31 to 3.09, P=0.001), rhinopathy (OR=1.77, 95%CI 1.35 to 2.31, P<0.000 1), attention deficit hyperactivity disorder (ADHD) (OR=5.32, 95%CI 3.77 to 7.51, P<0.000 01), decreased blood iron content (OR=3.68, 95%CI 1.56 to 8.67, P=0.003), family history of TD (OR=6.33, 95%CI 3.20 to 12.53, P<0.000 01), family history of mental illness (OR=2.39, 95%CI 2.03 to 2.83, P<0.000 01), maternal mental disorder during pregnancy (OR=2.49, 95%CI 1.99 to 3.11, P<0.000 01), alcohol drinking during pregnancy (OR=1.40, 95%CI 1.09 to1.79, P=0.007), smoking or passive smoking during pregnancy (OR=1.84, 95%CI 1.68 to 2.01, P<0.000 01), and corporal punishment (OR=3.57, 95%CI 1.52 to 8.34, P=0.003). Parity (second birth and above) (OR=0.41, 95%CI 0.25 to 0.68, P=0.000 6) was a protective factor for tic disorder. Conclusions Current evidence shows that the incidence of TD is related to gender, family history of mental illness, maternal life habits during pregnancy, perinatal history, chronic respiratory diseases, abnormal trace elements, and strict education methods, etc. Moreover, parity is a protective factor for the occurrence of TD. Due to the limited quantity and quality of included studies, more high-quality studies are required to verify the above conclusions.
Objective To explore the use of ChatGPT (Chat Generative Pre-trained Transformer) in pediatric diagnosis, treatment and doctor-patient communication, evaluate the professionalism and accuracy of the medical advice provided, and assess its ability to provide psychological support. Methods The knowledge databases of ChatGPT 3.5 and 4.0 versions as of April 2023 were selected. A total of 30 diagnosis and treatment questions and 10 doctor-patient communication questions regarding the pediatric urinary system were submitted to ChatGPT versions 3.5 and 4.0, and the answers to ChatGPT were evaluated. Results The answers to the 40 questions answered by ChatGPT versions 3.5 and 4.0 all reached the qualified level. The answers to 30 diagnostic and treatment questions in ChatGPT 4.0 version were superior to those in ChatGPT 3.5 version (P=0.024). There was no statistically significant difference in the answers to the 10 doctor-patient communication questions answered by ChatGPT 3.5 and 4.0 versions (P=0.727). For prevention, single symptom, and disease diagnosis and treatment questions, ChatGPT’s answer scores were relatively high. For questions related to the diagnosis and treatment of complex medical conditions, ChatGPT’s answer scores were relatively low. Conclusion ChatGPT has certain value in assisting pediatric diagnosis, treatment and doctor-patient communication, but the medical advice provided by ChatGPT cannot completely replace the professional judgment and personal care of doctors.