目的 建立吸入用布地奈德混悬液(以下简称“布地奈德”)临床应用标准并加以实证研究。方法 通过计算机检索Pubmed、EMbase、Cochrane library、CNKI、CBM、万方数据库以及指南数据库(GIN和NGC)获取原始文献。采用分级策略筛选原始文献,对纳入的指南或共识使用AGREE Ⅱ、系统评价使用OQAQ量表进行质量评价,采用描述性分析法总结各个文献证据,并基于证据信息建立布地奈德临床应用标准。根据上述标准,对使用布地奈德的病例进行抽样评价。结果 初次检索文献2 396篇,纳入评价文献26篇,涉及布地奈德超说明书适应证11条,其中慢性阻塞性肺病急性加重或稳定期具有发作高风险的患者、义膜性喉炎、支气管扩张合并气流阻塞或气道高反应性的患者使用布地奈德具有高强度证据支持;外科围术期及咽喉部急性炎症期使用证据强度低,经医院多学科专家组讨论,前者仅限经气管插管的全麻手术、胸外科手术或咽喉部手术,且患者具有气道炎症及肺部并发症高危因素;咽喉部炎症期使用仅限存在明显气道阻塞的急性会厌炎、急性喉炎、急性桃体炎及急性咽炎。对某三甲医院使用布地奈德的病例进行抽样评价,240份病例中不合理使用布地奈德95例,不合理用药比例为39.58%,其中以外科围术期及肺部感染患者不合理使用最为常见。结论 本研究基于循证医学评价体系建立了布地奈德临床应用标准,该标准具有实用性和可操作性,对规范布地奈德的临床使用具有借鉴意义。
Abstract
OBJECTIVE To establish evaluation standard for clinical use of inhaled budesonide suspension (referred as “budesonide” below) and apply in clinical practice. METHODS Primary literatures of budesonide inhalation were retrieved from online databases including PubMed, EMbase, Cochrane Library, CNKI, CBM, Wanfang, GIN and NGC. Classification strategy and descriptive analysis were used to screen and summarize the evidence of each literature. The evidence quality of guidelines and consensus were assessed by AGREE Ⅱ, and that of the systematic reviews were assessed by OQAQ. The evidence-based standard for evaluation of budesonide prescription was established. Followed this criteria, a sampling review of budesonide cases was conducted. RESULTS A total of 2 396 articles were initially retrieved and 26 literatures including 11 off-label indications met the inclusion criteria. Among them, COPD patients with acute exacerbation or high risk of relapses, acute croup, bronchiectasis with airflow obstruction or hyper responsiveness of the airway were supported by high-quality evidence. The perioperative period use of budesonide was limited to general anesthesia via endotracheal intubation, thoracic surgery or throat surgery, and patients should have high risk factors. Acute inflammation of the throat was only considered for patients who were with obvious airway obstruction and diagnosed as acute epiglottitis, acute laryngitis, acute tonsillitis and acute pharyngitis. The sampling review from a 3A hospital was showed that, among the 240 cases, 95 cases(rate 39.58%) was irrational use of budesonide, the most common misuse were perioperative period and pulmonary infection. CONCLUSION The prescription evaluation standard of inhaled budesonide is established by evidence-based evaluation, which proves as practical and operable, and of great significance to standardize the clinical use of budesonide.
关键词
循证评价 /
糖皮质激素 /
布地奈德 /
雾化吸入
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Key words
evidence-based review /
glucocorticoid /
budesonide /
inhalation
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脚注
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基金
重庆市卫计委医学科研面上项目资助(2017MSXM012)
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