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.
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.
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.
ObjectivesTo evaluate the intention of having a second child among females of childbearing age after the implementation of China’s universal two-child policy so as to provide evidence for further studies.MethodsCNKI, VIP, WanFang Data, CSSCI, PubMed, EMbase and ScienceDirect databases were electronically searched to collect cross-sectional studies on the intention of females of childbearing age to have a second child from January 1st, 2016 to August 31st, 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Then, meta-analysis was performed by using R software.ResultsA total of 15 studies involving 18 820 cases were included. The results of meta-analysis showed that the fertility rate for the second child of females of childbearing age was 0.42 (95%CI 0.37 to 0.47), and the result was stable. Subgroup analysis showed that the fertility rate of second child in eastern region was higher than that in western region (0.44 vs. 0.40), in rural areas was higher than that in non-rural areas (0.46 vs. 0.35), females aged 18 to 34 was higher than those aged above 35 (0.49 vs. 0.29), and non-working females was higher than that among working females (0.48 vs. 0.40). The fertility rate of the sex of the first child being female was higher than the sex of the first child was male (0.48 vs. 0.39). The fertility rate of the couple who were both the non-only child was higher than the couple who were both the only child and who was only child while the other was non-only child (0.46 vs. 0.41 vs. 0.40).ConclusionsSince the implementation of the “universal two-child policy” in China, the fertility rate of females of childbearing age with the intention of having a second child is lower, especially those females who are from the western regions and non-rural areas, aged above 35 and the sex of the first child is male and non-dual-non-couples. Due to the quantity and quality of the included studies, more high quality studies are required to verify the above conclusions in future.
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.
Objective To systematically review and analyze the risk factors of epilepsy in children, to explore the related etiology of epilepsy in children, and to provide evidence-based strategies for reducing the occurrence of epilepsy in children. Methods PubMed, Embase, VIP, CNKI, Web of science, Cohrane, and CBM were searched for relevant studies on risk factors for childhood epilepsy since the establishment of the database, and the study type was selected as a case-control study. After screening and quality evaluation, the literatures that met the requirements were finally selected for inclusion in the study, and the extracted target data were statistically analyzed by RevMan5.3 software. Results A total of 9 literatures were included for Meta-analysis of the risk factors of epilepsy in children. A total of 3792 cases were studied, including 1 922 cases in the control group and 1 870 cases in the case group. Meta-analysis results showed that adverse perinatal period, family history of epilepsy, febrile seizures, and central nervous system infection were closely related to the occurrence of epilepsy in children, and the OR values were OR=3.46, 95%CI (2.51, 4.79), OR=4.77, 95%CI (3.83, 5.95), OR=7.81, 95%CI ( 5.64, 10.80), OR=3.00, 95%CI (1.44, 6.26), P values were all less than 0.05. Conclusions Adverse perinatal period, family history of epilepsy, febrile seizures, and central nervous system infection are the current risk factors for childhood epilepsy.
Objective To investigate the application and effectiveness of metatarsal mortise and tenon shortening osteotomy in the treatment of macrodactyly in children. Methods The clinical data of 17 children with macrodactyly (18 feet and 27 toes) admitted between January 2018 and January 2020 were retrospectively analyzed. There were 12 males (12 feet and 18 toes) and 5 females (6 feet and 9 toes); the age ranged from 1 to 13 years, with a median age of 5 years. All children were treated with metatarsal mortise and tenon shortening osteotomy. Ten cases of single-segment metatarsals were shortened, 7 cases of 2-segment metatarsals, and 1 case of 3-segment metatarsals; involved 1 foot of single toe, 9 feet of 2 toes, 3 feet of 3 toes, 3 feet of 4 toes, and 2 feet of 5 toes. Five cases had lameness, and 1 case had limited walking with the big toes of both feet, and there was no obvious pain in all children. X-ray films showed that the involved phalanges were thickened and increased in 18 feet, and the deformity of the distal segment was heavier than that of the proximal segment in 13 feet, and the two were similar in 5 feet. The length of metatarsal shortening was 0.7-2.5 cm, with an average of 1.2 cm. The clinical healing of shortened metatarsal fractures in children was observed after operation, and the occurrence of related complications was recorded. ResultsAll 17 children were followed up 6-22 months, with an average of 14 months. All incisions healed by first intention. The osteotomy ends of 27 toes were clinically healed after operation, and the healing time was 4-8 weeks. No nonunion, fracture displacement, malunion, epiphyseal plate premature closure, and needle tract infection occurred. ConclusionMetatarsal mortise and tenon shortening osteotomy is a good osteotomy method. It can improve the stability of the osteotomy end and increase the contact surface of the osteotomy end, which is conducive to the healing of the osteotomy end and is suitable for the treatment of macrodactyly.
ObjectiveTo share the experience of treating special cardiac malformations by applying minimally invasive techniques.MethodsEight children with special cardiac malformations admitted to our hospital from July 2014 to September 2020 were recruited, including 3 males and 5 females, aged 0.8-1.2 (1.1±0.4) years, and weighted 7.8-11.5 (9.6±2.9) kg. There were 2 patients of huge muscular ventricular septal defect (VSD), 3 perimembranous cribriform VSD, 1 right coronary-right atrial fistula, 1 right coronary-right ventricular fistula, and 1 young, low-weight child with large aortopulmonary. All were treated with minimally invasive techniques using transesophageal echocardiography (TEE) as a guiding tool. All children received intraoperative TEE immediately to evaluate the curative effect of the surgery, and all went to outpatient clinic for reexamination of echocardiography, electrocardiogram and chest X-ray after discharge.ResultsEight children underwent minimally invasive surgery successfully without any incision infection, intracardiac infection, arrhythmia or pericardial effusion. None of the 8 children were lost to follow-up, and the results of all reexaminations were satisfactory.ConclusionThe application of minimally invasive techniques is a bold and innovative attempt for the treatment of a few special types of cardiac malformations. It has significant advantages in reducing trauma and medical costs in some suitable patients, and has certain clinical reference values.
ObjectiveTo compare the effectiveness of subtalar arthroereisis (STA) combined with modified Kidner procedure versus STA alone in the treatment of flexible flatfoot combined with painful accessory navicular bone in children. MethodsThe clinical data of 33 children with flexible flatfoot combined with painful accessory navicular bone who were admitted between August 2018 and August 2021 and met the selection criteria were retrospectively analyzed. They were divided into a combination group (17 cases, treated by STA combined with modified Kidner procedure) and a control group (16 cases, treated by STA alone) according to the surgical methods. There was no significant difference in baseline data between the two groups (P>0.05), such as gender, age, affected side of the foot, disease duration, and preoperative visual analogue scale (VAS) score, American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, talus-first metatarsal angle (T1MT), talus-second metatarsal angle (T2MT), talonavicular coverage angle (TCA), talus first plantar angle (Meary angle), calcaneal inclination angle (Pitch angle), and heel valgus angle (HV). The operation time, incision length, intraoperative blood loss, number of intraoperative fluoroscopies, and perioperative complications were recorded in both groups. The anteroposterior, lateral, and calcaneal axial X-ray films for the affected feet were taken regularly, and T1MT, T2MT, TCA, Meary angle, Pitch angle, and HV were measured. The VAS score, AOFAS ankle-hindfoot score were used to evaluate pain and functional recovery before and after operation. ResultsSurgeries in both groups were successfully performed without surgical complication such as vascular, nerve, or tendon injuries. Less operation time, shorter incision length, less intraoperative blood loss, and fewer intraoperative fluoroscopies were found in the control group than in the combination group (P<0.05). One case in the combination group had partial necrosis of the skin at the edge of the incision, which healed after the dressing change and infrared light therapy, and the rest of the incisions healed by first intention. All children were followed up 12-36 months, with a mean of 19.6 months. At last follow-up, VAS score and AOFAS ankle-hindfoot score significantly improved in both groups when compared with preoperative ones (P<0.05), and the differences of these scores between before and after operation improved more significantly in the combination group than in the control group (P<0.05). Imaging results showed that the T1MT, T2MT, TCA, Meary angle, and HV significantly improved in both groups at last follow-up when compared with preoperative ones (P<0.05), and the Pitch angle had no significant difference when compared with preoperative one (P>0.05). But there was no significant difference in the difference of these indicators between before and after operation between the two groups (P>0.05).ConclusionBoth procedures are effective in the treatment of flexible flatfoot children with painful accessory navicular bone. STA has the advantage of minimally invasive, while STA combined with modified Kidner procedure has better effectiveness.