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.
The clinical practice guideline on traditional Chinese medicine alone or combined with antibiotics for patients with acute upper respiratory infection in children was issued by China Association of Chinese Medicine in June 2017. Base on the evidence, consensus and experience, five manage groups, steering committee, consensus expert group, systematic review group, drafting group and secretary group, have promoted the project. The main work process refers to up-to-date clinical practice guideline definitions of institute of medicine and quick recommendations guide of guidelines international network and WHO. In order to provide readers with a better understanding of the guideline, the drafting process of guideline principle, main work process, and basis policy were described in detail in this paper. The guidelines’ scientific characteristics, accuracy and practicability were better exhibited in attempt to enhance its promotion and application.
ObjectiveTo investigate the current situation of ketogenic diet treatment centers in China, including the target, quantity, indication diseases, staffing and regional distribution of ketogenic diet therapy centers.MethodsMembers from the China Association Against Epilepsy (CAAE) received an investigation on the development situation of ketogenic diet therapy in their own epilepsy centers through an online survey. ResultsAt present, there are 91 centers for ketogenic diet therapy in China, and among them, there are 74 centers (81.32%) only treat pediatric patients. 59 centers of them (64.83%) were established between 2010 and 2020; patients of 63 centers (69.23%) have been treated with ketogenic therapy for status epilepticus (SE), among which only 9 centers (14.29%) have 5 or more epileptic patients on averge per month. 35 centers (38.46%) are offering ketogenic diet treatment for indications other than epilepsy. The main diseases are autism spectrum disorder, encephalitis, febrile infection related epilepsy syndrome (FIRES), rare diseases and glycolipid metabolic diseases. All ketogenic diet treatment centers are equipped with high-quality professionals, mainly neurologists and pediatric physicians; There are significant differences in regional distribution, with centers in the eastern region accounting for more than half (53.85%). ConclusionsThe development of ketogenic diet therapy in China has achieved initial results, but there are still some problems such as small number of patients treated and uneven geographical distribution.
The developing status of pediatric day-care surgery is comprehensively analyzed based on SWOT model from the following four dimensions: strength (S), weakness (W), opportunities (O) and threats (T). Day-care surgery strategy is in line with the characteristics of pediatric diseases, which can improve medical efficiency and reduce medical costs. However, it is limited by both the particularity of pediatric patients and the complexity of postoperative management. In terms of external environment at present, there are many opportunities for its development of day-care surgery such as national policy support, medical technology innovation, and regional medical center construction. Nevertheless, some threats cannot yet be ignored such as medical safety risks, unfair resource allocation, traditional habit of medical treatment and medical insurance payment policies. In order to promote the high-quality development of pediatric day-care surgery in the future, it is recommended to innovate medical service models, improve medical quality management systems, train medical qualified personnel, and enhance national policy support.
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.
ObjectiveTo evaluate the effectiveness of the screw-based intermaxillary traction combined with occlusal splint in the treatment of pediatric mandibular condylar fracture.
MethodsBetween June 2005 and December 2013, 35 pediatric patients with 49 mandibular condylar fractures were treated, and the clinical data were retrospectively reviewed. There were 25 boys and 10 girls, aged 3-13 years (mean, 7.3 years). The injury causes included falling (18 cases), traffic accident (14 cases), and violence (3 cases). The time between injury and treatment was 2-30 days (mean, 6.8 days). Restricted mouth opening was observed, and the maximal mouth opening was (22.74±7.22) mm except 3 patients who were too young to measure. Condylar fractures were located at the left (12 cases), at the right (9 cases), at bilateral (14 cases) based on the sites; and fractures were classified as intra-capsular (35 fractures), neck (10 fractures), and subcondylar (4 fractures) based on the fracture line. Four self-drilling titanium screws were inserted into the alveolar bone of both maxilla and mandible. After screw inserting, an occlusal splint with a fulcrum was used on the affected side and elastic band was put to perform anterior intermaxillary traction. After 1 month, the screws and splint were removed. Follow-up examinations were carried out on schedule.
ResultsAll the patients were followed up from 6 months to 8 years and 10 months (median, 71 months). No screw-related complication occurred in the others except one case of screw loosening. The postoperative maximal mouth opening was (38.82±2.02)mm. Mild joint noise was found in 4 cases and opening deviation occurred in 6 cases. Radiographic results demonstrated complete condyle remodeling was achieved in 24 cases (32 fractures), and moderate remodeling in 11 cases (17 fractures) at last follow-up.
ConclusionThe screw-based intermaxillary traction combined with occlusal splint might be an effective method for pediatric mandibular condylar fracture. The screw-related complications may be avoided by careful preoperative investigations.
ObjectiveTo analyze the short- and long-term therapeutic effects of heart transplantation in children. MethodsA retrospective study was conducted on recipients and donors who underwent heart transplantation at the 7th People’s Hospital of Zhengzhou from May 2018 to August 2023, analyzing their clinical characteristics, surgical data, postoperative complications, and survival rates. ResultsA total of 22 children underwent heart transplantation, including 14 males and 8 females, with a median age of 13.5 (10.0, 15.0) years and a median weight of 41.9 (30.5, 55.4) kg. The primary diseases included: dilated cardiomyopathy in 16 patients, hypertrophic cardiomyopathy in 1 patient, myocardial dysplasia in 3 patients, right ventricular dysplasia in 1 patient, and congenital heart disease with abnormal coronary artery origin in 1 patient. The median age of the donors was 21.0 (13.0, 29.0) years, and the median weight was 50.5 (47.3, 75.0) kg. The blood types of the donors and recipients were the same, with type A in 10 patients, type B in 5 patients, type O in 5 patients, and type AB in 2 patients. Before transplantation, all children had a New York Heart Association cardiac function grade Ⅳ, with 1 patient assisted by intra-aortic balloon pump (IABP), 3 patients assisted by extracorporeal membrane oxygenation (ECMO), 2 patients assisted by continuous renal replacement therapy (CRRT), and 2 patients on mechanical ventilation. Nine patients met the criteria for emergency child status allocation, and the panel reactive antibody level in the patients was<10%. The median cold ischemic time of the donor heart was 355.0 (262.0, 395.5) min, the median aortic cross-clamping time was 45.0 (38.3, 51.3) min, the median mechanical ventilation time was 22.5 (16.8, 52.5) h, the median postoperative hospital stay was 29.5 (20.0, 43.0) d, and the median intensive care unit stay was 6.0 (5.0, 8.3) d. After surgery, 4 patients were assisted by ECMO, 2 patients by CRRT, and 7 patients developed complications, including lung fungal infection in 6 patients, liver and kidney dysfunction in 1 patient, local wound non-union and mediastinal infection in 1 patient, and multiple organ failure in 1 patient. Kaplan-Meier curve analysis showed that the survival rates of children after surgery were 91.3% at 1 year and 3 years; the survival rates of adult heart transplant recipients at our center were 86.7% and 73.8% at 1 year and 3 years, respectively, indicating that the survival rate of children with heart transplantation was higher than that of adult patients. ConclusionHeart transplantation is an effective treatment for end-stage heart failure in children, and the short- and long-term survival rates of children with heart transplantation are superior to those of adults. There are still many difficulties to be solved in pediatric heart transplantation, requiring joint efforts from society and the medical community.
Based on the existing clinical research of pediatric Tuina, this paper introduced the current types of pediatric Tuina and their applications in the aspect of growth of newborn babies, emotion problems, pain, respiratory system diseases, digestive system diseases, jaundice, brain and nerve system diseases. As for the clinical researches of pediatric Tuina, the authors found the challenges including different understandings of pediatric Tuina, poor quality of clinical researches, and lack of basic data regarding pediatric Tuina. Meanwhile, the authors suggested three corresponding strategies to improve the clinical researches, i.e. to extract valuable intervention methods based on clinical practice; to conduct high quality clinical studies; to gradually collect and accumulate basic data according to a certain plan.
ObjectiveTo systematically review the research on pediatric treatment satisfaction of medication (TS-M). MethodsThe PubMed, Embase, Cochrane Library, CBM, WanFang Data, VIP, CNKI databases and medical scale websites were electronically searched to collect studies on pediatric TS-M from inception to November 2022. Two reviewers independently screened literature, and extracted data. Using descriptive analysis, we comprehensively reviewed the TS-M assessment tool selected for the studies of children. We evaluated the methodological quality and measurement properties of existing TS-M scales for children using the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) assessment criteria. ResultsA total of 157 studies were included, including 150 pediatric studies using TS-M evaluation tools and 7 studies on the development and validation of TS-M scales for children, covering 7 specific TS-M scales for children. Our review revealed that 67.3% of the pediatric studies used unvalidated self-administered TS-M questionnaires or interviews, 24.7% used adult TS-M scales, and only 6.0% used two pediatric-specific TS-M scales. The results of the quality assessment indicated that the development quality of existing TS-M pediatric scales was considered "doubtful" or "inadequate", and the internal consistency was "sufficient" but the structural validity was probably "uncertain". High-quality research on the content validity, test-retest reliability and construct validity of the pediatric TS-M scale was still lacking. ConclusionCurrently, the use of TS-M evaluation tools in pediatric studies has irrationalities: over 90% of pediatric studies use self-made questionnaires or adult scales to evaluate children's TS-M; and the existing pediatric TS-M scales globally have narrow applications, questionable development quality, and lack some measurement performance studies. Pediatric TS-M scales with a wide range of applications are lacking.
ObjectiveTo review the advances in perioperative pain management of pediatric and adolescent spinal deformity corrective surgery.MethodsRegular analgesics, drug administrations, and analgesic regimens were reviewed and summarized by consulting domestic and overseas related literatures about perioperative pain management of pediatric and adolescent spinal deformity corrective surgery in recent years.ResultsAs for perioperative analgesis regimens of pediatric and adolescent spinal deformity corrective surgery, regular analgesics include non-steroidal anti-inflammatory drugs, opioids, antiepileptic drugs, adrenergic agonists, and local anesthetic, etc. Besides drug administration by mouth, intravenous injection, and intramuscular injection, the administration also includes patient controlled analgesia, epidural injection, and intrathecal injection. Multimodal analgesia is the most important regimen currently.ConclusionHeretofore, a number of perioperative pain managements of pediatric and adolescent spinal deformity corrective surgery have been applied clinically, but the ideal regimen has not been developed. To design a safe and effective analgesic regimen needs further investigations.
