摘要
目的基于疾病负担,循证评价与遴选我国示范乡镇卫生院治疗急性支气管炎的药物。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,并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RevMan5.1、GRADEpro 3.6等软件处理数据、评价证据质量。结果①共纳入指南8个(国外7个,国内1个),其中5个为循证制定,3个为结合专家意见制定;②6个RCT(n=816,低质量)结果显示喷托维林止咳有效率为53%~82%,其中3个RCT(n=283)结果显示喷托维林疗效略低于丙卡特罗[RR=0.86,95%CI(0.78,0.94),P=0.001],2个RCT(n=233)表明喷妥维林疗效略低于中药汤剂[RR=0.82,95%CI(0.74,0.91),P<0.001];其不良反应主要为恶心、心悸等,发生率为0~2.4%。每日费用成人约为0.20元,儿童为0.08元,均为口服用药,适用性较好;③6个RCT(n=403,低质量)结果显示右美沙芬缓解咳嗽有效率为47.0%~95.3%,其中1个RCT(n=60,低质量)显示氢溴酸右美沙芬滴鼻剂优于空白组[RR=3.71,95%C(I1.91,7.21)],1个RCT(n=43,低质量)表明口服右美沙芬有效率优于安慰剂[RR 1.74,95%CI(1.13,2.66)],1个RCT(n=300,中等质量)显示右美沙芬有效率优于喷托维林[RR=1.16,95%CI(1.07,1.26)],1个观察性研究(n=121,低质量)显示右美沙芬5天有效率为66.5%;其不良反应主要有口干、头晕、恶心等,发生率为2%~30%。结论①强推荐右美沙芬用于缓解急性支气管炎引起的干咳;②弱推荐喷妥维林对症止咳治疗;③不推荐常规使用抗生素、β2受体支气管激动剂及黏液溶解药物;④建议开展针对急性支气管炎的大规模多中心随机双盲对照临床及经济学研究,以生产高质量本土化证据。
Objective To evaluate and select essential medicine for acute bronchitis 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) Eight guidelines were included(seven foreign guidelines,one domestic guideline;five based on evidence,three based on expert consensus).(2) A result of six RCTs(n=816,low quality) indicated that pentoxyverine had efficiencies of 53% to 82% for cough relief.Among the six RCTs,a result of three RCTs(n=283) indicated that pentoxyverine was slightly less efficient than procaterol(RR=0.86,95%CI 0.78 to 0.94,P=0.001);a result of two RCTs(n=233) indicated that pentoxyverine was slightly less efficient than Chinese medicinals decoction(RR=0.82,95%CI 0.74 to 0.91,P〈0.001).Adverse reaction of pentoxyverine(incidence: 0% to 2.4%) mainly covered nausea,palpitation,etc.Pentoxyverine cost 0.20 yuan(for adult) or 0.08 yuan(for child) daily,which was orally taken and applicable to the target population.(3) A result of six RCTs(n=403,low quality) indicated that the efficiencies of dextromethorphan for cough relief was 47.0% to 95.3%.Among the six RCTs,a result of one RCT(n=283) indicated that dextromethorphan hydrobromide(nasal drop) was more efficient than blank intervention(RR=3.71,95%CI 1.91 to 7.21);a result of one RCT(n=43) indicated that dextromethorphan(for oral use) was more efficient than placebo(RR=1.74,95%CI 1.13 to 2.66);a result of one RCT(n=300,moderate quality) indicated that dextromethorphan was more efficient than pentoxyverine(RR=1.16,95%CI 1.07 to 1.26);a result of one observational study(n=121,low quality) indicated that dextromethorphan given for 5 days had an efficiency of 66.5%.Adverse reaction of dextromethorphan(incidence: 2% to 30%) mainly covered mouth dryness,dizziness,nausea,etc.Conclusion (1) We offer a strong recommendation for dextromethorphan used in relieving dry cough due to acute bronchitis.(2) We offer a weak recommendation for pentoxyverine as symptomatic treatment for cough relief.(3) We make a recommendation against antibiotics,β2-agonist bronchodilators and mucolytic agents as routine use.(4) More large-scale,multi-center,double-blinded RCTs are needed in clinical and pharmacoeconomic studies of acute bronchitis in hopes of producing high-quality local evidence.
出处
《中国循证医学杂志》
CSCD
2012年第8期888-894,共7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
急性支气管炎
Township health center; Essential medicine; Evidence-based evaluation and selection; Acute bronchitis;