国产注射用盐酸氨溴索祛痰作用有效性和安全性的Meta分析  

Meta analysis of effectiveness and safety of domestic ambroxol hydrochloride injection

作　　者：戚世钦 吴春玲 冯真英 黄丽平[3] Qi Shiqin Wu Chunling Feng Zhenying et al(Tuberculosis Prevention and Treatment Center of Zhanjiang City, Zhanjiang 52400)

机构地区：[1]广东省湛江市肺结核病防治所,524003 [2]广东省湛江市第二人民医院 [3]海南医学院

出　　处：《中国现代医药杂志》2017年第5期20-24,共5页Modern Medicine Journal of China

基　　金：2014年度湛江市第三批非资助科技攻关计划项目(编号:2014B01190)

摘　　要：目的评价国产注射用盐酸氨溴索用于急慢性呼吸道疾病祛痰作用的有效性和安全性。方法全面检索与国产注射用盐酸氨溴索相关的随机对照研究文献,进行质量评价,采用Rev Man5.3软件将纳入的文献进行Meta分析。结果 11个随机对照试验(包括989例患者)被纳入系统评价,文献中Jadad量表评分≥3分的高质量研究4篇,评分≤1分的低质量研究7篇。Meta分析结果显示国产注射用盐酸氨溴索与进口对照药物沐舒坦注射液或其他口服制剂比较,祛痰有效率[OR=1.60,95%CI(0.80,3.22)]和不良反应发生率[OR=1.19,95%CI(0.65,2.16)]相似,均无统计学差异(P>0.05)。结论与进口祛痰药比较,国产注射用盐酸氨溴索是一种安全、有效的祛痰药物,值得临床推广使用,但所纳入的大部分研究方法学质量较差,须谨慎应用。Objective To evaluate the effectiveness and safety of domestic ambroxol hydrochloride injection on expectorant effect in the adjuvant treatment of respiratory disease. Methods Randomized controlled trial （RCT） studies about domestic ambroxol hydrochloride injection were searched and quality evaluated, and RevMan 5.3 software was ap-plied for Meta analysis. Results Eleven RCTs involving 989 patients were included.Among them,four high quality lit-eratures with Jadad scores more than or equal to 3,and seven poor quality literatures with Jadad scores less than or equal to 1.Meta analysis results showed that there were no significant differences between domestic ambroxol hydrochlo-ride injection and mucosolvan injection or other oral preparations in the comprehensive clinical effective rate[OR=1.60, 95%CI（0.80,3.22）] and the adverse drug reaction rate[OR=1.19,95% CI（0.65,2.16）]. Conclusion Domestic ambroxol hydrochloride injection is an effective and safe expectorant, but the conclusion should be cautious to be interpreted for the low methodological quality of the included studies.

关 键 词：国产注射用盐酸氨溴索 祛痰作用 META分析 随机对照试验 

分 类 号：R974.1[医药卫生—药品]