我国示范乡镇卫生院基本药物循证评价与遴选之四:慢性支气管炎急性加重  

Evidence-Based Evaluation and Selection of Essential Medicine for Township Health Centre in China: 4.Acute Exacerbation of Chronic Bronchitis

作　　者：王应强[1] 李鸿浩[1] 李幼平[1] 李萃萃[1] 杨宗霞[1] 沈建通[1] 李筱[1] 杨晓妍[1] 王莉[1] 李向莲[1] 

机构地区：[1]四川大学华西医院中国循证医学中心,成都610041

出　　处：《中国循证医学杂志》2012年第8期878-887,共10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)

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支气管炎急性加重的基本药物。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。主要用RevMan 5.1、GRADEpro 3.6等软件处理数据、评价证据质量。结果①纳入指南5个(国外4个,国内1个),3个为循证制定,2个为结合专家意见制定;②被指南推荐≥2次,且被我国基本药物目录(2009版)或处方集收录的药物:异丙托溴铵4次,阿莫西林克拉维酸钾、糖皮质激素各3次,头孢呋辛、环丙沙星、左氧氟沙星、沙丁胺醇、右美沙芬各2次;③国内研究证据:1个RCT(n=77,低质量)显示阿莫西林克拉维酸钾的有效率达92.3%～94.7%;3个RCT(n=275,低质量)显示头孢呋辛钠有效率为67.6%～90%,不良反应发生率为5%,主要为皮疹和腹泻;2个RCT(n=120,低质量)显示环丙沙星的有效率为78.3%～86.6%,细菌清除率为72.7%～86.5%,不良反应发生率为8.7%～16.2%,主要为胃肠反应和皮疹等;7个RCT(n=523,低质量)显示左氧氟沙星的有效率为72.5%～94.5%,细菌清除率为82.1%～95.8%,不良反应发生率为5%～7.5%;2个RCT(n=239,低质量)显示沙丁胺醇的有效率为85.4%～96.7%;1个RCT(n=95,低质量)显示异丙托溴铵的有效率为98%;5个RCT(n=466,低质量)显示糖皮质激素布地奈德与支气管舒张剂联用的有效率93.4%～97.8%;结论①强推荐头孢呋辛钠、阿莫西林克拉维酸钾、环丙沙星和左氧氟沙星治疗慢性支气管炎急性加重;②强推荐糖皮质激素(布地奈德气雾剂)和抗胆碱能支气管舒张药(异丙托溴铵);弱推荐短效β2激动支气管舒张药(沙丁胺醇)和止咳药(右美沙芬);③不推荐常规使用黏液溶解药和茶碱类药物;④建议尽量报道大样本对照研究,完善结局指标,以便生产高质量本土化证据。Objective To evaluate and select essential medicine for acute exacerbation of chronic bronchitis（AECB） 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） Five guidelines were included（four foreign guidelines,one domestic guideline;three based on evidence,two based on expert consensus）.（2） Medicines recommended at least twice by the National Essential Medicine List（NEML,2009 version） and Chinese National Formulary（CNF） contained： ipratropium bromide（four times）,amoxicillin ＆ clavulanate potassium（three times）,and corticosteroid（three times）,cefuroxime（twice）,ciprofloxacin（twice）,levofloxacin（twice）,salbutamol（twice） and dextromethorphan（twice）.（3） As for domestic study evidence,a result of one RCT indicated that amoxicillin ＆ clavulanate potassium had efficiencies of 92.3% to 94.7%（n=77,low quality）.A result of three RCTs（n=275,low quality） indicated that cefuroxime had efficiencies of 67.6% to 90% and an incidence of 5% as to adverse reaction that mainly included skin rashes,diarrhea,etc.A result of two RCTs（n=120,low quality） indicated that ciprofloxacin had efficiencies of 78.3% to 86.6%,bacterial clearance rates of 72.7% to 86.5% and the incidences of 8.7% to 16.2% as to adverse reaction that mainly included gastrointestinal reaction,skin rashes,etc.A result of seven RCTs（n=523,low quality） indicated that levofloxacin had efficiencies of 72.5% to 94.5%,bacterial clearance rates of 82.1% to 95.8% and the incidences of 5% to 7.5% as to adverse reaction.A result of two RCTs�

关 键 词：乡镇卫生院 基本药物 循证评价与遴选 慢性支气管炎 急性加重 

分 类 号：R974[医药卫生—药品]