Objective To assess the global situation of off-label drug use in outpatient children.Methods A search was conducted in PubMed, EMbase, CBM, CNKI and VIP for collecting studies on off-label drug use in outpatient children aged 0 to 18 years, and the publication language was limited to English and Chinese. The quality assessment was based on Crombie Criteria for cross-sectional studies, and the descriptive analysis was performed to analyze the incidence of off-label drug use at all levels of medical institutes and different age groups, the common types of off-label used drugs, and the constitution ratio of off-label use drugs. Results A total of 20 cross-sectional studies were included, involving 1 933 760 children and 5 262 573 prescriptions. The results of descriptive analysis showed: a) The incidence of off-label drug use in outpatient children in primary care and tertiary care institutes were 19.5% (IQR 13.5%, 24.5%) and 26.0% (IQR 24.0%, 35.0%), respectively; b) The primary studies reported that neonate, infant and adolescent had the highest incidence of off-label drug use, while the other children had the lowest incidence; c) Drugs for respiratory system, anti-infection, sensory organs, and dermatosis were listed as the top 5 frequently used off-label drugs by more than half of the studies; d) The studies with issue of “lack of instruction for children” showed it was exactly the type with highest incidence of off-label use, while other studies without that issue showed the highest incidence was over aged off-label use. Conclusion a) Off-label drug use is common in outpatient children. The incidence of off-label drug use may be higher in tertiary care institutes than primary care institutes, and it is higher in neonate, infant and adolescent rather than other age groups of children; b) Incidence of off-label use may be higher in inpatient children than outpatient ones; c) Drugs for respiratory system, anti-infection, sensory organs, and dermatosis were most common types of off-label use; and d) Off-label use due to both “lack of instruction for children” and “over aged use” is more common. So it suggests that further studies trials should focus on fields in which clinical trials of drugs are totally absent.
ObjectivesTo investigate the occurrence and parents’ cognition of accidental injury among pre-school children in Nanchong city, and provide advice and countermeasures to reduce accidental child injuries.MethodsUsing the multi-stage cluster sampling method, a total of 945 students and parents from 3 classes in each of 4 kindergartens in three districts of Nanchong city were surveyed with questionnaire.ResultsA total of 945 questionnaires were issued and 858 valid questionnaires were returned and the effective response rate was 90.79%. The incidence of incidental injury of pre-school children in Nanchong city was 25.99%, with no difference between boys and girls, and no difference between age groups. The top three injuries were falling (35.64%), smashing/touching/squeezing (22.11%), cutting/stabbing (10.56%). The child smashing/touching/squeezing rate was higher in boys than in girls, the difference was statistically significant (χ2=5.549, P=0.018). The top three places of the occurred injury were outdoor (53.67%), home (43.58%), and playground and kindergarten (13.76%). Between parents who possess injury-related knowledge and those who didn’t, there was no difference in the incidence of accidental injuries among their children. Parents often learned from cell phone (23.88%), TV (21.76%) and computer (18.11%). Ways in which they most hoped to learn from were the school advertised education (22.67%), TV (18.80%) and cell phones (17.75%). Of all types of emergency management skills, the top three figures acquired by the largest population were post-burn emergency treatment (72.03%), emergency treatment for traumatic bleeding (52.56%) and emergency treatment of animal bites (37.53%).ConclusionsThe incidence of accident injuries is high in urban areas of Nanchong city. The safety management of home and kindergarten should be strengthened, including schools' safety education and skills training for children and parents.
ObjectiveTo compare the efficacy of totally transanal endorectal pull-through and laparoscopic assistance endorectal pull-through in the treatment of Hirschsprung’s disease (HD).MethodsPubMed, EMBASE, The Cochrane Library, CNKI, Wanfang, and VIP Database were searched to screen out the comparative studies published between January 1998 and May 2020 on the treatment of HD with totally transanal endorectal pull-through and laparoscopic assistance endorectal pull-through. Then two reviewers independently completed the literatures screening, data extraction, and quality evaluation. The Review Manager 5.3 software was used to combine the effect size of the postoperative effect indicators included in the literatures. Stata 14.0 software was used to perform Begg’s and Egger’s tests on the publication bias of the included literatures.ResultsA total of 8 clinical studies conforming to the standards were included and 702 cases of children undergoing HD radical resection were recorded, including 335 cases in the totally transanal endorectal pull-through group and 367 cases in the laparoscopic assistance endorectal pull-through group. Compared with the laparoscopic assistance endorectal pull-through group, the totally transanal endorectal pull-through group had an advantage in the incidence of postoperative faecal incontinence/soiling [OR=0.20, 95%CI was (0.07, 0.54), P=0.001], and the postoperative constipation recurrence rate was higher than the laparoscopic assistance endorectal pull-through group [OR=2.39, 95%CI was (1.05, 5.42), P=0.04]. There were no statistically significant differences between the two groups in terms of postoperative enterocolitis [OR=1.01, 95%CI was (0.59, 1.75), P=0.96], postoperative adhesion intestinal obstruction [OR=0.74, 95%CI was (0.28, 1.95), P=0.54], and postoperative anastomotic stenosis [OR=1.14, 95%CI was (0.51, 2.56), P=0.74].ConclusionsCompared with laparoscopic assistance endorectal pull-through, the totally transanal endorectal pull-through can reduce the incidence of postoperative faecal incontinence/soiling, but the rate of recurrence of postoperative constipation is higher. The two surgical procedures for HD have similar incidences of postoperative enterocolitis, anastomotic stenosis, and adhesive intestinal obstruction.
Objective To summarize our experience on leaflet extension in reoperation after tricuspid valve repair in children at age≤15 years and to explore the application indicators and skills of this technique. Methods We retrospectively analyzed the clinical data of 23 children who underwent reoperation after tricuspid valve repair in Xinhua Hospital between January 2006 and October 2015. There were 15 males and 8 females with a mean age of 8.7 years, ranging from 5 to 15 years. The leaflet was extended by artificial pericardium patch. After surgery, warfarin anticoagulation therapy was done, and international normalized ratio was maintained 2.0 to 3.0. Results The average cardiopulmonary bypass time was 87-132 (98.5±35.7) minutes, and average aortic cross-clamping time was 56-97 (68.40±23.78) minutes. One patient died in hospital. There were 3 patients with complications including respiratory failure in 1 patient, acute renal failure in 1 patient, and right heart insufficiency in 1 patient. All the children cured and were followed up for 5 months to 10 years, with a mean follow-up of 3.5 years. One patient died during the follow-up. Six patients suffered mild to moderate tricuspid regurgitation and tricuspid valve function of the rest patients was good. No other redo-valve surgery or complications correlated to anticoagulation occurred. Conclusion Leaflet extension in reoperation after tricuspid valve repair in children is useful with optimistic middle to long term efficacy and needs intensive care therapy during the perioperative period.
ObjectiveTo explore the safety and feasibility of spleen-preserving distal pancreatectomy for children with distal pancreatic injures.MethodsClinical data of 10 patients with severe distal pancreatic injures in The Second Affiliated Hospital of Guilin Medical University from January 2012 to July 2017 were retrospectively analyzed. The intraoperative and postoperative situation including operation time, intraoperative blood loss, postoperative blood platelet count, and perioperative complications were observed.ResultsAll the 10 patients underwent spleen-preserving distal pancreatectomy successfully. The median operation time was 3 h (2–6 h), the median intraoperative blood loss was100 mL (50–300 mL), the postoperative blood platelet count ranged from 75×109/L to 260×109/L with the median postoperative blood platelet count was 175×109/L. Two patients suffered from pancreatic leakage, one patient suffered from subphrenic infection, and one patient suffered from pulmonary infection. All patients suffered from complication recovered after symptomatic treatments. All patients were followed up in the outpatient department, the follow-up time was 4–60 months with a median of 30 months. Reexamination of abdominal ultrasound and blood routine (every 3 months after surgery) showed that, no abnormalities in blood supply, morphology, and structure of spleen, and platelet counts fluctuated within the normal range. During the follow-up period, none of the children suffered from severe infection due to hyposplenic function.ConclusionSpleen-preserving distal pancreatectomy is a safe and effective method for children with distal pancreatic injures.
ObjectiveTo explore the clinical efficacy of thoracoscopy-assisted modified Nuss procedure for pectus excavatum (PE) in children.MethodsThe clinical data of patients with PE who underwent thoracoscopy-assisted modified Nuss procedure from October 2013 to October 2020 in Daping Hospital were retrospectively analyzed.ResultsA total of 86 patients were collected, including 79 males and 7 females with a mean age of 14.03±3.36 years. The operations were performed successfully in all patients without intraoperative cardiac vascular injury or perioperative death. The mean operation time was 87.30±33.45 min, bleeding volume was 19.94±14.60 mL, and the postoperative hospitalization stay time was 6.89±2.59 d. Early postoperative complications included 2 patients of pneumothorax, 2 patients of wound fat liquefaction and infection, 2 patients of bar flipping and displacement. One patient had bar displacement 1 year after the surgery. The total complication rate was 8.14%. All patients were followed up for 3-42 months. The bars were taken out about 36 months after the surgery. According to the evaluation criteria of orthopedic effect, 68 (79.07%) patients were excellent, 10 (11.63%) patients were good, 5 (5.81%) patients were moderate and 3 (3.49%) patients were poor.ConclusionMinimally invasive and individualized shaping via the Nuss procedure for PE children is safe and convenient, with satisfied effect. It is worthy of popularization in the clinic.
Objective To research whether systemic family therapy is a useful intervention for behavioral problems. Methods Two hundred and seventy six children who were in the fourth grade of elementary school were assessed by family dynamics questionnaires and their parents were tested by Achenbach Child Behavioral Checklist. Fifty-seven children with behavioral problems were divided into two groups: 20 children and their parents agreed to receive systemic therapy for four weeks and 37 children and their parents who refused this therapy formed the control group.All children and their parents were reassessed after four months. Data were analyzed by SPSS 11.5. Results The characteristics of family dymanmic and children’s behavior improved significantly after systemic therapy. The "depressing and hostile family" at mosphere became "harmonious and open" (P=0.000) and this was also significantly better than the control group after therapy(P=0.000). "Self-differentiation of family members" was significantly improved after therapy (P=0.000) and also was significantly better than the control group after therapy (P=0.005). "Patient is helpless victim" changed to "Patient can do something" (P=0.000) and this was significantly better than the control group after therapy (P=0.003) . Total CBCL score decreased in the treatment group after therapy (P=0.003 for father, P=0.000 for mother). Compared with the control group. Total CBCL score also showed decreases (P=0.033 for father, P=0.014 for mother). Conclusions The techniques of systemic family therapy are practical and effective methods to intervene children’s behavioral problems.
Objective To assess the global situation of off-label drug use in hospitalized children. Methods The databases such as PubMed, EMbase, CBM, CNKI and VIP were searched to collect studies on off-label drug use in hospitalized children at age of 0 to 18 years old. The publication language was limited to English and Chinese. The quality assessment was based on Crombie Criteria for cross-sectional studies. The incidence of off-label drug use was described in different wards and age groups, and the proportion of different off-label used drugs was analyzed. Results The total 29 cross-sectional studies were included, involving 8 560 children and 41 655 prescriptions. a) Median (IQR) of off-label use incidence: Neonatal ICU 52.5% (23.0% to 44.8%), Pediatric ICU 43.5% (34.5% to 60%), General pediatric ward 35.5% (23.8% to 43.3%), Pediatric surgical ward 27.5% (23.0% to 44.8%); b) The results of off-label incidence in different age groups were inconsistent among different studies; and c) The off-label drug use for “no pediatric information” had the largest proportion, followed by dose and age. Conclusion a) Off-label drug use exists widely around the world, but the incidence varies a lot in different countries and different types of wards; b) The incidence of off-label drug use may be higher in ICU than in non-ICU, and higher in the neonatal ward than the pediatric ward; c) The off-label drug use for no pediatric information is the commonest type, and further clinical studies should focus on areas in which high quality evidence is totally absent; and d) The multi-center studies with unified design on off-label drug use in hospitalized children in China are urgently needed to provide evidence for policy-making.
ObjectiveTo analyze the early- and middle-term prognosis of various surgical methods in children with congenital aortic valve diseases, to provide reference for surgical methods in children with aortic valve stenosis or regurgitation.MethodsThe clinical data of 85 children with various aortic valve diseases treated in the Children’s Hospital of Fudan University from January 2005 to December 2018 were retrospectively analyzed. There were 64 males and 21 females, with an average age of 45 months ranging from 5 days to 15 years. Among them 18 patients underwent balloon aortic valvuloplasty (BAV), 8 surgical aortic valvotomy (SAV), 27 aortic valve autogenous pericardium repair, 16 mechanical arterial valve replacement and 16 Ross operation. They were followed up for 6.25±2.76 years. The re-intervention and survival status after different operations were analyzed.ResultsThere were 3 deaths and 17 reoperations in 85 children. The 5-year survival rate of the patients with SAV, BAV, aortic valve autogenous pericardium repair, mechanical arterial valve replacement and Ross operation was 87.4%, 88.9%, 100.0%, 100.0% and 100.0%, respectively; there was no statistical difference in the early and middle-term survival rates among various operations (P>0.05). The 5-year free from re-intervention rate of the patients with SAV, BAV, aortic valve autogenous pericardium repair, mechanical arterial valve replacement and Ross operation was 44.4%, 18.4%, 100.0%, 66.9% and 80.5%, respectively; there was a statistical difference in the early and middle-term re-intervention rate among various operations (P<0.05).ConclusionThe operation of congenital aortic stenosis or regurgitation needs to be performed according to the pathological changes of the valvular tissues. For children with severe lesions, SAV is recommended for the first intervention. For congenital aortic stenosis, SAV and BAV are both palliative operations which need further evaluation and re-intervention. Ross operation and mechanical arterial valve replacement have low re-intervention rate, and the middle- and long-term follow-up shows that the effect is accurate. Aortic valve autogenous pericardium repair is expected to become a method to delay or replace Ross operation and valve replacement.
Objective To evaluate the surgical approach of left superior vena cava（LSVC） distal abnormalities in infant and young children. Methods From April 1999 to December 2004, 19 cases of LSVC distal abnormalities were corrected by primary repair. There were 10 males and 9 females. Their age ranged from 2.7 months to 6.5 years and body weight from 3. 1 to 15.0 kg. Diseases complicated with LSVC included complex congenital cardiac disease 9 cases, ostium secundum atrial septal defect 4, partial abnormal pulmonary venous drainage （PAPVD） with atrial septal defect（ASI）） 2, tetralogy of Fallot（TOF） 3, and double outlet of right ventricle （DORV） 1 case. The ways for surgical treatment of distal abnormalities of LSVC were reconstruction of atrial septum, translocation of LSVC and reconstruction of atrial septum, right atrium and LSVC anastomosis, cavopulmonary anastomosis and repair of partially unroofed coronary sinus. Results One patient died and the diagnosis for the patient was LSVC with DORV and pulmonary hypertension （PH）. This patient died from crisis of PH , obstruction of blood flow in the left cavopulmonary anastomosis, severe low cardiac output,low arterial oxygen saturation and abnormal function of kidney. The mean pressure of right atrium was 9 to 18 mmHg. The percutaneous oxygen saturation （SpO2） was 0.98 1.00 for biventricular repair and 0.79-0. 88 for single ventricular repair and palliative repair. The echocardiography showed no obstruction of the blood flow in LSVC and pulmonary veins. The results of follow-up were satisfactory, from 3 months to 2 years. Conclusions Key for success of surgical approach of LSVC distal abnormalities is precise evaluation of different kinds of LSVC and different surgical approaches. Cavopulmonary anastomosis can not be used in the case of LSVC with PH.