摘要
目的基于疾病负担,循证评价与遴选我国乡镇卫生院合理治疗慢性阻塞性肺疾病(COPD)的基本药物。方法按本系列研究之二制定的方法、标准和流程,参考国内外循证或权威指南的推荐意见,结合国内相关临床研究证据,循证评价并推荐相关药物。主要采用RevMan 5.1、GRADEpro 3.6等软件处理数据和评价证据质量。结果①共纳入指南9个(国外8个,国内1个),其中7个为循证制定,2个为结合专家意见制定。②国内1个RCT(n=72,高质量)显示:噻托溴铵可明显改善重度COPD患者合并呼吸衰竭者的肺功能,提高健康相关生活质量(SGRQ)[MD=–10.8%,95%CI(–12.2%,–9.4%)]。1个随访3月的RCT(n=156,中等质量)显示,噻托溴铵可明显改善轻中度COPD稳定期患者的FEV1占预测值比例[MD=10.3%,95%CI(8.1%,12.5%)]。2个RCT(n=160,低质量)显示,复方异丙托溴铵治疗中、重度COPD有效率达84.2%～87.5%。1个RCT(n=60,中等质量)显示,吸入舒利迭(沙美特罗/氟替卡松)治疗改善轻、中度稳定期COPD效果优于安慰剂组。1个RCT(n=725,中等质量)显示噻托溴铵联合舒利迭治疗稳定期COPD优于单用噻托溴铵组。1个RCT(n=110,低质量)显示,雾化吸入布地奈德治疗COPD急性加重的有效率为86.8%,主要不良反应发生率为7.9%,主要为咽部刺激症状。③亚胺培南、美罗培南、头孢哌酮/舒巴坦、头孢他啶均是治疗COPD的有效药物,且对非ICU病原菌耐药率较低(<8%)。结论①强推荐噻托溴铵、异丙托溴铵、沙丁胺醇、福莫特罗、沙美特罗、茶碱治疗稳定期和急性加重期COPD;肺炎球菌及流感疫苗预防COPD恶化;吸入糖皮质激素治疗COPD稳定期,口服糖皮质激素治疗急性加重期。②强推荐头孢哌/酮舒巴坦、亚胺培南、美罗培南治疗中、重度COPD急性加重;③弱推荐头孢他啶、环丙沙星、左氧氟沙星、莫西沙星、阿莫西林克拉维酸钾、阿莫西林、阿奇霉素、克拉霉素和多西环素作为轻、中度COPD急性加重的一线或二线用药;复方磺胺甲噁唑、头孢曲松、头孢噻肟、头孢呋辛治疗重度、极重度COPD、黏液溶解药缓解稳定期COPD咳痰困难;④不推荐抗生素、止咳药物及口服糖皮质激素治疗稳定期COPD。
Objective To evaluate and select essential medicine for chronic obstructive pulmonary diseases （COPD） using evidence-based methods based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager （RevMan） 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results （1） Nine guidelines were included （eight foreign guidelines, one do- mestic guideline; seven based on evidence, two based on expert consensus）. （2） A result of one domestic RCT （n--72, high quality） indicated that tiotropium could significantly improve pulmonary function of severe COPD patient complicated with respiratory failure and increase their quality of life （SGRQ score： MD=- 10.8%, 95%CI -l 2.2% to -9.4%）. A result of one RCT （n=156, moderate quality） with 3-month follow-up indicated that tiotropium could significantly improve the proportion of measured value to expected value of FEV1 in patients with mild and moderate COPD in stationary phase （MD=10.3%, 95%CI 8.1% to 12.5%）. A result of two RCTs （n=160, low quality） indicated that compound ipratropium bromide had efficiencies of 84.2% to 87.5% for moderate and severe COPD. A result of one RCT （n=60, moderate quality） indicated that salmeterol/fluticasone （inhalation） was superior to placebo for improving mild and moderate COPD in stationary phase. A result of one RCT （n=725, moderate quality） indicated that tiotropium combined with salmeterol/ fluticasone for COPD in stationary phase was superior to tiotropium alone. A result of one RCT （n= 110, low quality） indicated that nebulized budesonide inhalation had an efficiency of 86.8% for acute exacerbation of COPD （AECOPD） and an incidence of 7.9% as to adverse reaction that mainly included laryngo-pharyngeal irritation. （3） Imipenem, meropenem, cefoperazone/sulbactam and ceftazidime were effective for COPD with low drug resistance rates in treating COPD caused by non-ICU pathogens （less than 8%）. Conclusion （1） We offer a strong recommendation for tiotropium, ipratropium, salbutamol, formoterol, salmeterol and theophylline used in the treatment of COPD in stationary and exacerbation phases, a strong recommendation for streptococcus pneumoniae and influenza vaccines in preventing the deterioration of COPD, a strong recommendation for inhaled corticosteroids （ICS） used in the treatment of COPD in stationary phase and a strong recommendation for corticosteroids （for oral use） for AECOPD. （2） We offer a strong recommendation for cefoperazone/sulbactam, imipenem and meropenem used in the treatment of moderate and severe AECOPD. （3） We offer a weak recommendation for ceftazidime, ciprofloxacin, lavofloxacin, moxifloxacin, amoxicillin ＆ clavulanate potassium, amoxicillin, azithromycin, clarithromycin and doxycycline as first-line and second-line antibiotics for mild and moderate AECOPD, and a weak recommendation for compound sulfamethoxazole, cefatriaxone, cefotaxime and cefuroxime used in the treatment of severe and extremely severe COPD, mucolytic agents used in the treatment of stable COPD with dif- ficult expectoration. （4） We make a recommendation against antibiotics, expectorants and corticosteroids （for oral use） as routine use in stationary phase of COPD.
出处
《中国循证医学杂志》
CSCD
2012年第8期907-922,共16页
Chinese Journal of Evidence-based Medicine
基金
"十一五"国家科技支撑计划重点项目"不同类型乡镇卫生院科技综合示范及相关产品开发"--"乡镇卫生院药物配置与物流关键技术研究与产品开发"课题(编号:2008BAI65B22)
关键词
乡镇卫生院
基本药物
循证评价与遴选
慢性阻塞性肺疾病
COPD
Township health center
Essential medicine
Evidence-based evaluation and selection
Chronic obstruc-tive pulmonary diseases （COPD）
