溴己新治疗急性支气管炎的系统评价

Bromhexine For Acute Bronchitis:a Systematic Review

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。

OBJECTIVE To evaluate the effectiveness and safety of bromhexine for acute bronchitis. METHODS Cochrane Li- brary, PubMed, Embase, ISI, CBMdisc, CNKI, VIP and WanFang database were retrieved. Systematic review, meta-analysis or ran- domized 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 crite- ria, 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〈0.00001; MD= -2.85, 95%CI（ -3.12, -2.59）, P〈0.00001]. Significant differ- ence was demonstrated in adverse reaction incidence [ RR = 17.00,95 % CI （ 1.01,286. 82） ,P = 0. 05 ]. Three RCT of bromhexine ver- sus ambroxol were included. Outcomes of these studies could not be combined. One RCT of bromhexine versus Tanreqing were includ- ed. 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 inci- dence still exists with brombexine. 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.