目的 补充与替代医学(complementary and alternative medicine, CAM)干预的安全性和有效性与儿科医疗工作者关系密切.本研究旨在确认CAM的儿科随机对照试验(RCT)的来源.方法 通过检索MEDLINE和其他12个期刊数据库以及根据已有儿科CAM系统评价的参考文献来检索相关RCT.结果 共查到908篇关于18岁以下儿童的CAM治疗的RCT.1965年以来,这类公开发表的RCT数量一直稳步增加.发表RCT最多的4本杂志是lt;美国临床营养杂志gt;、lt;儿科gt;、lt;儿科杂志gt;和lt;柳叶刀gt;.MEDLINE, CABHealth和EMBASE是检索这类研究最好的数据库;分别收录了93.2%,58.4%和42.2%发表儿科CAM RCT的杂志.结论 从事儿科CAM或对此感兴趣的人应定期检索MEDLINE, CABHealth和EMBASE数据库.上述的4种核心期刊也应在查阅之列.
Objective Inappropriate drug dosage is a serious problem in pediatrics, mainly due to the lack of clinical evidence in children, suitable preparation formulation, and standardized methods for dose adjustment. A method for evaluating and monitoring appropriate dosage in pediatrics is urgently needed. The drug utilization index (DUI) based on the Anatomical Therapeutic Chemical/Defined Daily Dose (ATC/DDD) has been widely used in the assessment of appropriate dosage in adults. We explored possible methods for assessing appropriate dosage in children. Methods Based on our previous studies, we discuss cDUI in the assessment of appropriate dosage in children as follows: the meaning of cDDD, the establishment of a standardized system, and the classified evaluation of dosage in pediatrics. Results Although the definition of cDDD draws on the concept of defined daily dose (DDD), the meaning of cDDD is different from that of the latter. Specifically, the purpose of cDDD is to evaluate appropriate pediatric dose, while DDD is a unit of measurement. cDDD could be used to assess dose rationality for common and serious pediatric diseases, and would be refined over time. A single cDDD should be assigned per drug and indication and given per drug and route of administration. The influence of age, weight, diagnosis, and administration route on the dosage should be considered. Classified evaluation should be used and weight should be given to the above mentioned factors in order to evaluate the appropriate dose objectively and comprehensively. Conclusion Dosage regulation in pediatrics has an important role in improving medical quality and protecting the safety, effectiveness, and economy of medical therapy in children. The establishment of a cDUI system is a good try in pediatric dosage evaluation. Although there are still defects within this proposed system and methodology, the principle seems feasible.
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.
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 investigate the off-label prescriptions in pediatrics in West China Second University Hospital and to analyze the reasons and performance, so as to provide the baseline data for improving the rationality drug use in pediatrics in China. Methods The prescriptions of pediatrics outpatient department were randomly selected from May 2008 to April 2009; and the off-label use was analyzed according to the package inserts in the following aspects, the types of off-label use, the rate of off-label use in different age groups and categories of medicine. Results Of the total 2 400 prescriptions, 1 398 (58.25%) involving off-label use. All sample prescriptions contained 6028 records, 1 923 (31.90%) involving off-label use. The problems such as dosage (45.98%), frequency (21.17%) and age (18.19%) were the top-three types of off-label use. The rate in different age groups ranked as the top-three were school-age (61.56%), followed by preschool (60.77%) and infants (57.56). The top-five categories of medicines in off-label use were anti-allergy drugs (49.45%), digestive system drugs (49.32%), externally applied drugs (41.49%), Chinese patent drugs (34.60%) and nervous system drugs (33.78%). Conclusion The off-label drug use is widespread in pediatrics outpatient department. It is an effective approach to reduce off-label use and improve drug safety through strictly abiding by the instruction of usage and dosage as well as selecting a suitable dosage form.
Objective We aimed to determine the efficacy and complication of sevoflurane maintenance in children. Methods Trials were collected through electronic searches of MEDLINE, EBSCO, OVID, Springer, Foreign Journals Integration System, CNKI, and CMBdisk (from the date of building the database to April 2008). We also checked the bibliographies of retrieved articles. Results A total of 20 trials involving 1 592 patients were included. The Metaanalysis showed: ① Recovery time: sevoflurane was similar with propofol [WMD=0.22, 95%CI (–2.86, 3.30)], but slower than desflurane [WMD=5.01, 95%CI (2.87, 7.16)], and faster than isoflurane [WMD= –0.55, 95%CI (– 0.74, –0.37)]; ② Discharge time: sevoflurane was similar with propofol [WMD= –4.39, 95%CI (–10.02, 1.25)], desflurane[WMD=1.13, 95%CI (–3.25, 5.51)], and isoflurane [WMD= –8.17, 95%CI (–17.94, 1.60)]; ③ Postoperative agitation: sevoflurane was much more obvious than propofol [RR=5.53, 95%CI (2.99, 10.21)], but superior than desflurane [RR=0.55, 95%CI (0.35, 0.88)], and similar with isoflurane [RR=1.24, 95%CI (0.85, 1.800]; ④ Postoperative nausea and vomiting (PONV): sevoflurane was much more severe than propofol [RR=2.17, 95%CI (1.21, 3.90)], and no difference with desflurane [RR=0.88, 95%CI (0.61, 1.25)]; ⑤ Oculocardiac reflex: sevoflurane was less than propofol [RD= – 0.42, 95%CI (–0.56, –0.27)], and no difference with desflurane [RR=0.93, 95%CI (0.61, 1.41)]. Conclusion The limited current evidence shows no difference between sevoflurane and propofol in recovery time, while the effect of sevoflurane is faster than isoflurane and slower than desflurane. There are no differences among sevoflurane, desflurane, isoflurane, and propofol in discharge time. The incidence of postoperative agitation of sevoflurane is higher than that of propofol, but lower than that of other inhaled anesthetics. The incidence of PONV of sevoflurane is higher than that of propofol. The incidence of oculocardiac reflex of sevoflurane is lower than that of propofol and similar with that of desflurane.
目的 评估儿科补充与替代医学(Complementary and alternative medicine,CAM)随机对照试验报告的质量,检验报告质量是否随时间而变化.方法 以包含251篇CAM干预的RCT报告作为系统样本,对每一篇报告质量用CONSORT清单的部分项目,如分配隐藏不清楚的比例和5级质量评价来进行评估.结果 有近一半(40%)的CONSORT清单项目在所有RCT报告中列出,且有增多趋势.大多数RCT(81 3%)未清楚报告分配隐藏方案,且多年无改进.报告质量评分约为Jadad评估最高总评分的40%,且多年无改进.仅有约1/4(22%)的RCT报道了不良反应,而关于医疗成本的报道仅占很小比例(4%).结论 RCT是循证卫生保健决策的重要工具.如果这些研究要作为对CAM评估的一部分,那么高质量地实施和报告这些试验就显得十分重要.应加倍努力以确保儿童及其家庭进入实施和报告偏倚最小的RCT.这样的研究可以让利益共享者的范围更宽广,更具使用价值.