ObjectiveTo systematically review the medication adherence in children with tic disorder to assist in the selection of clinical treatment options and enhance the efficacy of medications for tic disorder.MethodsDatabases including Medline (Ovid), EMbase (Ovid), The Cochrane Library, PsycINFO (EBSCOhost), CINAHL Plus (EBSCOhost), CNKI, WanFang Data and VIP were searched from inception to August 2020, and original studies on medication adherence in children with tic disorder were included. Two researchers independently screened literature, extracted data on the definition of compliance, compliance rate, and factors affecting compliance, and evaluated risk bias of included studies. Systematic review was performed to analyze the status of medication adherence in children with tic disorder.ResultsA total of 12 studies were included, involving seven randomized controlled trials, two case series studies, and three cross-sectional studies. Most studies failed to specify the definition of compliance. The results of cross-sectional studies showed that the proportion of children with good medication compliance was 29.3% to 47.1%. The first-line treatment drugs, tiapride, risperidone, aripiprazole, and clonidine, had relatively good adherence. Medication adherence was affected by drug factors, patient and family factors, and environmental factors.ConclusionsThe adherence rate of medications for tic disorder varies between studies. Few studies have analyzed the factors that affect medication adherence for tic disorder, and some influencing factors are controversial. The first-line treatment drugs, tiapride, risperidone, aripiprazole, and clonidine, have high medication adherence and are recommended for clinical use.
Objective We aimed to develop a self-management assessment scale for children with epilepsy and test its reliability and validity. Methods A research group was established, and the items were revised through literature review, group discussion and pre-investigation, and 280 patients with epilepsy in children were included, and the reliability and validity of the scale were tested. Results 28 items in 4 dimensions were developed to form the scale, namely, knowledge and belief of diseases and medication, compliance of medication and treatment, self-efficacy of medication and obstacles of medication. Confirmatory factor analysis extracted four common factors with characteristic roots greater than 1, and the cumulative variance explanation rate was 65.639%. The factor load of all items is > 0.5. The overall Cronbach’s alpha is 0.880, and the coefficients in seven measurement dimensions are all greater than 0.8. Conclusion The self-management assessment scale for children’s epilepsy drugs has good reliability and validity, and can provide a measuring tool for the drug management of children’s epilepsy diseases.
ObjectivesTo evaluate the level and variation of Chinese scholars' scientific research capability in the world by analysing the status of literature published on top-five global biomedicine journals by Chinese scholars in the past 10 years.MethodsLiterature published on NEJM, JAMA, BMJ, Lancet and PLoS Medicine from 2007 to 2016 were searched in PubMed database. Types of diseases were classified by using International Classification of Diseases (version 10) (ICD-10). Quantitatively analysis were used to classify the different authors, institutes, studies designs, quality of publication and variation.ResultsLiterature (56.4%) published on Lancet had the largest quantity among the top-five journals. Infectious and parasitic diseases, circulation system diseases, cancers, endocrine, nutrition and metabolic diseases and neuropsychiatric diseases were the top-five in disease categories list, accounting for 38.4%. In different study design, reviews (non-experimental research) and randomized controlled trials were the first and the second study types, separately.ConclusionsFor productivity of Chinese scholars’ diseases publications on top-five medical journals, the top-five specific diseases are from the top-five disease categories-infectious and parasitic diseases, circulation system diseases, cancer, endocrine, nutrition and metabolic diseases and neuropsychiatric diseases. The main study types are reviews, randomized controlled trials and cross-sectional studies.
ObjectiveTo systematically review the efficacy and safety of deproteinized calf blood extractives (DCBE) for diabetic complications. MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, CBM and VIP databases were electronically searched to collect studies on the efficacy and safety of DCBE for diabetic complications from inception to July 8th, 2020. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies; then, meta-analysis was performed using RevMan 5.3 software. ResultsA total of 69 studies were included. The results of meta-analysis showed that for diabetic neuropathy, the effect rate of DCBE was superior to control, mecobalamin, vitamin B12, vitamin B1+vitamin B12, and vitamin B2, etc. For diabetic foot, the effect rate of DCBE was superior to control, sensitive antibiotic and compound salvia-miltiorrhiza injection. For diabetic retinopathy, the effect rate of DCBE was superior to control. The incidence of adverse events associated with DCBE was 4.59%. However, there was no significant difference with the control group. ConclusionCurrent evidence shows that DCBE has good efficacy and safety in diabetic neuropathy, diabetic foot, diabetic dry eye, diabetic retinopathy, and other diseases. Due to limited quality and quantity of the included studies, more high quality studies are required to verify the above conclusion.
Objective To systematically evaluate the influencing factors, intervention measures and management mode of epilepsy patients in China, so as to provide evidence support for ensuring the therapeutic effect of epilepsy patients. Methods PubMed, EMBASE, Cochrane Library, CBM, CNKI, VIP, Wanfang and other domestic and foreign databases were systematically searched, and the literature on influencing factors, intervention measures and management modes of self-management behavior of epilepsy patients in China was included. Descriptive methods were used to analyze the results. Results A total of 21 studies were included, including 2 studies on influencing factors, 14 studies on intervention measures and 5 studies on management mode. The participants of 20 studies is adult epilepsy patients, and one study is adolescent epilepsy aged 13 ~ 17, with a sample size of 40 ~ 327 cases and a median sample size of 70 cases. The results showed that self-management behavior is positively correlated with self-efficacy, bachelor degree or above, female and operation duration < 3 hours, and negatively correlated with 30 ~ 50 years old. The self-management behavior scale score, medication compliance, treatment satisfaction, quality of life, seizure frequency, symptom checklist, anxiety and depression score in the intervention group were better than those in the control group. After the intervention of self- management mode, the self-management score, treatment efficiency, quality of life and medication compliance of the intervention group were better than those of the control group. Conclusions The level of self-management of epilepsy patients in China is insufficient, and the influencing factors and intervention measures are single, lacking integrated intervention measures and management models based on different levels of individuals, families, medical system and society. It is suggested that the self-management model of epileptic patients should be constructed based on evidence to improve self-efficacy and self-management level.
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.
ObjectiveTo systematically review the efficacy and safety of deproteinized calf blood extractives (DCBE) for dry eye syndrome. MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, CBM and VIP databases were electronically searched to collect studies on efficacy and safety of DCBE for dry eye syndrome from inception to August 31st, 2021. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies; then, meta-analysis was performed by using RevMan 5.3 software. ResultsA total of 59 studies were included. The results of meta-analysis showed that: the total effective rate of DCBE for dry eye syndrome was better than that of control (RR=1.20, 95%CI 1.12 to 1.29, P<0.000 01), sodium hyaluronate eye drops (RR=1.21, 95%CI 1.15 to 1.28, P<0.000 01), and hydroxyl sugar eye drops (RR=1.15, 95%CI 1.04 to 1.27, P=0.006). The incidence of adverse events had no statistical differences between the DCBE and the control or the sodium hyaluronate eye drops.ConclusionCurrent evidence shows that DCBE for dry eye syndrome can improve the total effective rate, and the safety is acceptable. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusion.
Objective To determine the extent of off-label drug use in Pediatric Wards of West China Second University Hospital in 2010 and analyze its risk factors, so as to provide baseline data for getting acquainted with the extent of off-label drug use in pediatrics in China, and for making policies of off-label drug use. Methods The proportionate stratified random sampling was conducted to select medical advice and discharge medication for hospitalized children in Pediatric Wards in 2010. According to drug instructions, the 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 and wards. In addition, a logistic regression was done that modeled the odds of receiving an off-label prescription as a function of the following possible risk factors: age, sex and the rank of doctors. Results The total 749 children were selected, and 14 374 prescriptions involving 385 drugs were analyzed. The rate of off-label drug use was 98.00%, 78.96% and 88.05% in children, prescriptions and drug categories, respectively. The main categories of off-label drug use were no pediatric information (29.41%), indication (18.35%), dosage (17.61%) and dosage range (±20%) (13.52%). The top 2 age groups of off-label drug use were adolescents (83.56%) and children (80.58%). The top 4 drugs of off-label use were those for alimentary tract and metabolism (82.28%), anti-infectives for systemic use (75.06%), blood and blood forming organs (79.27%) and respiratory (58.27%). The top 2 wards of off-label drug use were Pediatric Hematology (88.27%) and Neonates (79.12%). In hospital, children, adolescents and male patients had higher risk factors of off-label drug use, and doctors with senior rank prescribed more off-label prescriptions than those with intermediate rank. Conclusion The off-label drug use in Pediatric Wards is common in West China Second University Hospital. On the one hand, drug instructions lack the pediatric information, and, on the other hand, it’s badly in need of developing relevant legislations, regulations or guidelines to regulate off-label drug use, in order to avoid doctor’s professional risks and ensure the safety of pediatric drug use.
ObjectiveThe growth potential of children with short stature in middle and late adolescence may be limited by the effect of estrogen on epiphyseal closure. In recent years, the third generation of non-steroidal aromatase inhibitors (AIs) have been used in the treatment of short stature but with off-label. This study aimed to systematically review the efficacy and safety of the third-generation non-steroidal AIs in the treatment of children with short stature, and to provide evidences for rational drug use in clinical practice. MethodsWe searched PubMed, Embase, Cochrane Library, CNKI, WanFang Data, VIP and CBM from inception to December 28, 2022. Relevant studies on the treatment for children with short stature using the recombinant human growth hormone (rhGH) combined with or without the third-generation non-steroidal AIs were collected. Two reviewers independently screened the literature, extracted data, and evaluated the risk of bias of the included studies. Meta-analysis was performed using RevMan 5.3 software. ResultsA total of 18 articles were finally included, involving 9 randomized controlled trials and 9 cohort studies, with a total of 1 053 patients. The Meta-analysis showed that: (1) in terms of efficacy, the final adult height (MD=2.48, 95%CI 2.02 to 2.94, P<0.01), predicted adult height (MD=4.27, 95%CI 2.71 to 5.83, P<0.01), predicted adult height difference (MD=4.26, 95%CI 3.23 to 5.28, P<0.01), bone age (MD=−0.62, 95%CI −0.89 to −0.36, P<0.01), bone age difference/actual age difference (MD=−0.47, 95%CI −0.56 to −0.37, P<0.01), and growth velocity (MD=1.34, 95%CI 0.89 to 1.78, P<0.01) at the end of treatment in the experimental group were better than those in the control group, but there was no statistical difference in the height at the end of treatment between the two groups (MD=4.03, 95%CI −0.01 to 8.06, P=0.05). (2) in terms of safety, the total incidence of adverse events in the experimental group (RR=2.10, 95%CI 1.48 to 2.99, P<0.01) was higher than that in the control group, among which the incidence of adverse events in the endocrine system and skin and subcutaneous tissue system was statistically different between the two groups (P<0.05), and the incidence of adverse events in the hepatobiliary system, kidney and urinary system, metabolism and nutrition, gastrointestinal system, musculoskeletal system, blood and lymph system, vascular and lymphatic system, and neuropsychiatric system was not statistically different between the two groups (P>0.05). ConclusionCurrent evidence shows that the third-generation non-steroidal AIs combined with rhGH can effectively improve the final height of children with short stature, but it may increase the incidence of adverse drug events. Limited by the quality and the follow-up period of the included studies, high-quality studies are still needed to demonstrate the above conclusions and further evaluate the long-term safety of AIs in children with short stature.
ObjectiveTo evaluate the efficacy, safety, and economics of omalizumab for the treatment of pediatric asthma through a rapid health technology assessment (HTA). MethodsThe search was conducted on INAHTA website and databases such as PubMed, Embase, Cochrane Library, SinoMed, CNKI, VIP, and WanFang Data from inception to August 2024. Literature screening, quality evaluation, and data extraction were conducted independently by two investigators. An interview was conducted to consult the medication and treatment opinions of doctors and patients to investigate its clinical application. ResultsA total of 28 articles, including HTA articles (4), SR/Meta analyses (18), and pharmacoeconomics articles (6) were included. Omalizumab could reduce the incidence of clinical exacerbations, decrease the number of asthma attacks/days with asthma symptoms, and improve qualification of life. The results of the safety evaluation showed that omalizumab could reduce the rate of serious adverse events, especially those related to worsening asthma. Foreign pharmacoeconomic studies showed ICER ranging from £30 109 to £78 009. A pharmacoeconomic study in China found an ICER of $211 217/QALY for omalizumab, which were both above the pre-set thresholds. ConclusionOmalizumab is a treatment for patients who suffer from moderate to severe persistent allergic asthma or moderate to severe allergic asthma. It has been found to improve disease symptoms without increasing serious adverse events. However, it is not considered cost-effective due to its high price.