2016年中国儿科医生抗菌药物合理使用状况调查

目的 获取我国儿科医生对儿童临床使用抗菌药物的基线信息数据,为后续制定儿童临床用药相关诊疗指南、规范并制定合理用药管理措施提供依据.方法 采用多中心横断面研究,经整群抽样,对全国各省、直辖市医院具有儿童处方权的医生进行网络电子问卷调查,了解2016年抗菌药物临床用药现状.结果 最终纳入三级医院3 494名儿科医生的调查信息.(1)对儿童抗菌药物使用关注点的重要性排序:54.5%的医生将"安全性"排名首位,43.5%将"疗效"排名第2位.(2)对于儿童患者最紧缺的抗菌药物依次报告为:大环内酯类(11.9%)、第3代头孢菌素(4.8%)、青霉素类(4.2%)、磺胺类(2.5%)和碳青霉烯类(2.4%).(3)认为目前急需获得儿童适应证的前5类药物依次为:大环内酯类(26.4%)、喹诺酮类(19.9%)、氨基糖苷类(10.4%)、其他类抗菌药物(9.0%)和第3代头孢菌素类(5.1%).(4)对于细菌性上呼吸道感染患儿使用的抗菌药物,选择排名依次为青霉素类、第2代头孢菌素类、第3代头孢菌素类、阿奇霉素或红霉素、麦迪霉素或依托红霉素或环酯红霉素.(5)经验使用抗菌药物的最主要依据,42.0%的医生选择"临床症状体征",其次为影像学结果(41.0%).(6)87.0%的医生选择"用药前读药品说明书加以了解"作为了解药物的主要途径;对抗菌药物不良反应,被调查医生关注度排序前3位的依次为"过敏反应"(93.3%)、"肝/肾功能副作用"(91.1%)和"骨髓抑制"(48.2%).(7)被调查医生选择的儿童用药隐患最主要的3个问题依次为"缺少儿童用药适应证"(85.5%)、"滥用抗菌药物"(71.2%)和"缺少儿童药物的剂型和规格"(69.2%).(8)儿童合理用药关键环节,被调查医生的选择依次为"明确和完善儿童用药适应证"(89.0%)、"加强儿童合理用药及临床指南的培训"(66.2%)和"研发生产儿童专用的药品剂型及其规格"(62.6%).结论 儿科医生对抗菌药物合理使用的基本概念和知识、态度和实践的情况总体较为合理:能够将用药安全放在首位,重视用药前读药品说明书,关注儿童用药不良反应,对可能造成患儿不良反应的药物急需了解其适应证,儿科医生以临床症状、体征和影像学所见作为经验性用药依据,对细菌性上呼吸道感染,抗菌药物的选择顺序基本合理.调查获知大环内酯类、第3代头孢菌素、青霉素类等药物为儿科临床最紧缺的抗菌药物,并发现相当数量抗菌药物缺少儿童用药适应证、缺少儿童药物的剂型和规格、存在滥用等问题,令儿童抗菌药物使用存在隐患.调查认为:对儿科医生,抗菌药物合理使用的基本概念和知识、态度和实践仍有继续加强的必要.对现有抗菌药物完善儿童用药适应证、对临床医生加强儿童合理用药及临床指南的培训、大力研发和生产儿童专用的药品剂型及其规格等环节,均是目前儿童合理用药关键环节.

Objective To obtain baseline data of pediatricians' clinical use of antibacterial agents in children in China, and provide evidence for the follow-up of guidelines for the diagnosis and treatment of children's clinical medications and the development of rational drug management measures and norms. Methods A multi-center cross-sectional study was designed to conduct a network electronic questionnaire survey of doctors with child prescription rights in hospitals of all provinces, municipalities and autonomous regions across the country through cluster sampling to understand the current status of antibacterial drugs use in 2016. Results The survey information of 3 494 pediatricians in tertiary hospitals was finally included. (1) Ranking of the importance of children's medication focus: 54.5% of doctors ranked first the"safety" and 43.5% ranked second the"efficacy". (2) The most urgent antibacterial agents for children are reported as macrolides (11.9%), third-generation cephalosporins (4.8%), penicillins (4.2%), sulfonamides (2.5%), and carbapenems (2.4%). (3) The top five drugs that are urgently needed to obtain children's indications are: macrolides (26.4%), quinolones (19.9%), aminoglycosides (10.4%), and other antibacterials (9.0%) and the 3rd generation cephalosporins (5.1%). (4) For children with bacterial upper respiratory tract infections, antibacterial drugs should be used in the order of penicillins, second-generation cephalosporins, third-generation cephalosporins, azithromycin or erythromycin, medicamycin or unscented erythromycin or ester erythromycin. (5) The most important basis for empirical use of antibacterials, 42.0% of doctors chose"clinical signs and symptoms", followed by " imaging results" (41.0%). (6) 87.0% of the doctors chose" to read the drug instructions manual before using the drug" as the main way to understand the drug; for the adverse reactions of the antibacterial drugs, the top three rankings of the surveyed doctors were "allergic reactions" (93.3%). "hepatic/kidney functional side effects" (91.1%) and "myelosuppression" (48.2%). (7) The three main problems of children's drug risk selected by the surveyed doctors are "lack of indications for children's medication" (85.5%), "abuse of antimicrobials" (71.2%) and"formulations and specifications for lack of children's drugs". (69.2%). (8) The key link for children's rational drug use, the choice of the doctors to investigate is "clarifying and improving the indications for children's medication" (89.0%),"strengthening the rational use of drugs and clinical guidelines for children" (66.2%) and "developing and producing pharmaceutical dosage form for children and its specifications" (62.6%). Conclusions Pediatricians are generally reasonable in the basic concepts and knowledge, attitudes and practices of rational use of antibiotics: they can put the safety of medications first, pay attention to reading the instructions before using drugs, and pay attention to the adverse reactions of children. For the drugs that result in adverse reactions in children, it is urgent to understand their indications. Pediatricians use clinical symptoms, signs and imaging findings as an empirical basis for the selection of drugs for bacterial upper respiratory tract infections and antimicrobial agents. The investigation found that macrolides, third-generation cephalosporins, penicillins and other drugs are the most urgent antibacterial drugs in pediatrics, and found that a considerable number of antibacterials lack the indications for children, lack of dosage forms and specifications for children, presence of abuse, etc. The problem is that there are hidden dangers in the use of antibiotics in children. The survey concluded that for pediatricians, the basic concepts and knowledge, attitudes and practices of the rational use of antimicrobials continue to be strengthened. It is necessary to clarify and improve the indications for children's medications, strengthen the training of rational medications and clinical guidelines, and vigorously develop and produce children's medicine dosage forms and their specifications for existing antibacterial drugs. All these are the key links for children's rational use of antibacterials.