摘要
目的 评价溴己新治疗急性支气管炎的疗效和安全性。方法 计算机检索以下8个数据库: 计算机检索Cochrane图书馆、PubMed数据库、Embase数据库、ISI数据库、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)和万方数据库。纳入溴己新对比安慰剂、氨溴索、痰热清和N-乙酰半胱氨酸治疗急性支气管炎的随机对照试验、系统评价和Meta分析,对纳入的随机对照试验进行方法学质量评价和Meta分析,并参考现有的系统评价和Meta分析结论。结果 符合纳入标准的随机对照试验(RCT)共有10个,均为中文文献,未检索到相关的系统评价或Meta分析。结果显示,溴己新组对比安慰剂组:共纳入5个随机对照试验,临床总有效率的比较:RR=1.22,95%CI(0.88,1.69),P=0.24,差异没有统计学意义;溴己新组肺部湿啰音消失时间[MD=-2.32,95%CI(-3.34,-1.29),P<0.000 01]和咳嗽消失时间(MD=-2.85,95%CI[-3.12,-2.59],P<0.000 01)明显短于安慰机组,其差异有统计学意义;不良反应发生率的比较:RR=17.00,95%CI(1.01,286.82),P=0.05,差异有统计学意义。溴己新组对比氨溴索组:共纳入3个,各研究结局指标不能合并分析。溴己新组对比痰热清组:共纳入1个随机对照试验,未能进行Meta分析。溴己新组对比N-乙酰半胱氨酸:共纳入1个随机对照试验,未能进行Meta分析。结论 基于现有证据,溴己新缩短患者咳嗽时间和肺部湿啰音时间效果优于安慰剂,在临床总有效率上与安慰剂相似,且具有潜在的不良反应发生风险;氨溴索、痰热清、N-乙酰半胱氨酸治疗急性支气管炎的疗效均优于溴己新,但鉴于纳入文献数量较少,尚需更多研究予以进一步证实。
Abstract
OBJECTIVE To evaluate the effectiveness and safety of bromhexine for acute bronchitis. METHODS Cochrane Library, PubMed, Embase, ISI, CBMdisc, CNKI, VIP and WanFang database were retrieved. Systematic review, meta-analysis or randomized controlled trials (RCT) comparing bromhexine with placebo, ambroxol, tanreqing and N-acetylcysteine for acute bronchitis were included. Quality assessment and Meta-analysis were performed for RCT that met the inclusion and exclusion criteria. In addition, the conclusions of the systematic review and Meta-analysis in this aspect were referred. RESULTS Ten RCTs met the inclusion criteria, all in Chinese. No systematic review or Meta-analysis was retrieved. Five RCTs of bromhexine versus placebo were included. There was no significant difference in clinical overall efficacy [RR=1.22, 95%CI(0.88,1.69), P=0.24]. The pulmonary rale vanishing time and cough vanishing time of bromhexine were obviously shorter than that of placebo with significant difference [MD=-2.32, 95%CI (-3.34,-1.29), P<0.000 01; MD=-2.85, 95%CI(-3.12,-2.59), P<0.000 01]. Significant difference was demonstrated in adverse reaction incidence [RR=17.00,95%CI(1.01,286.82),P=0.05]. Three RCT of bromhexine versus ambroxol were included. Outcomes of these studies could not be combined. One RCT of bromhexine versus Tanreqing were included. Meta-analysis could not be performed. One RCT of bromhexine versus N-acetylcysteine were included. Meta-analysis could not be performed. CONCLUSION Based on current evidence, the effectiveness of bromhexine in decurtating course of pulmonary rale and cough are superior to placebo. Clinical overall efficacy is similar between bromhexine and placebo. High risk of adverse reaction incidence still exists with bromhexine. Ambroxol, Tanreqing and N-acetylcysteine exhibit better effectiveness than bromhexine, but more studies are needed to testify the results from the small quantity of studies.
关键词
溴己新 /
氨溴索 /
痰热清 /
N-乙酰半胱氨酸 /
急性支气管炎 /
溴己新 /
氨溴索 /
痰热清 /
N-乙酰半胱氨酸 /
急性支气管炎
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Key words
bromhexine /
ambroxol /
tanreqing /
N-acetylcysteine /
placebo /
bromhexine /
ambroxol /
tanreqing /
N-acetylcysteine /
placebo
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周俊翔,吴逢波,徐珽*.
溴己新治疗急性支气管炎的系统评价[J]. 中国药学杂志, 2012, 47(14): 1149-1153
ZHOU Jun-xiang,WU Feng-bo,XU Ting.
Bromhexine For Acute Bronchitis: a Systematic Review[J]. Chinese Pharmaceutical Journal, 2012, 47(14): 1149-1153
中图分类号:
R969
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参考文献
[1] HIGGINS J P T, GREEN S. Cochrane handbook for systematic reviews of interventions version 5.0 [DB]. The Cochrane Collaboration, 2008. Available at:www. Cochranehandbook. org[2] CHEN Q, LIU J M, LI L, et al. Observe of the effect of ceftazidime combined with bromhexine hydrochloride in injection on children’s pneumonia [J]. Acta Acad Med Jiangxi(江西医学院学报), 2007, 47(1):66-67.[3] LI C H, GONG X M, HUANG H Z. Clinical observation of treating capillarity bronchitis with bromhexine hydrochloride[J]. Hainan Med (海南医学), 2007, 18(7):10-11.[4] LI L J. Efficacy analysis of bromhexine by intravenous drip or aerosol inhalation in children pneumonia[J].Clin Med China(中国综合临床), 2003, 19(9):89.[5] WANG X Y, XIE Y L, SHI L. Efficacy observation of children pneumonia with bromhexine injection by aerosol inhalation[J]. Chin Nurs Res (护理研究), 2004, 18(9B):1686.[6] WANG X Y, YUAN X K, SHI L. Observation on curative effect of bromhexine to treat asthmatic suffocating pneumonia cases[J]. Chin Nurs Res (护理研究), 2005, 19 (6):1011.[7] QI L J. Effect of ambroxol for acute bronchiolitis[J]. Chin J Cur Clin Med (中华现代临床医学杂志), 2004, 2(7B):1119-1120.[8] FENG J S, LI H. Therapeutic efficacy of ambroxol hydrochloride for acute bronchiolitis[J]. Shanxi Med J (山西医药杂志), 2005, 34(2):152.[9] DONG R P, HUANG J. Efficacy observation of ambroxol as adjunctive treatment for eighty patients with bronchopneumonia[J].J Chin Commun Doct(中国社区医师), 2004, 20(1):34.[10] YANG X Y. Efficacy observation of tanreqing injection for thirty six patients with acute bronchitis[J]. J Emerg Traditional Syndromes Tradit Chin Med (中国中医急症), 2006, 15(2):131, 173.[11] WU Q F. The therapeutic effect of fluimucil on children with acute bronchitis[J]. Chin J New Clin Med (中国临床新医学), 2009, 2(2):147-149.
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脚注
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基金
科技部“十一五”科技支撑项目(2009BAI76B030202)
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