摘要
目的初步评价国内溴己新临床应用的安全性。方法检索中国知网、维普、万方数据库,纳入有关溴己新随机对照实验(RTC)的临床研究,采用Rev Man5.1软件,对溴己新的不良反应进行Meta分析,并按照PRISMA指南,对不同剂型(注射剂和片剂)、不同适应证(肺炎和支气管炎)、不同对照措施(常规治疗和其他药物治疗)的不良反应发生率进行亚组分析。结果符合纳入标准的随机对照实验有10个,涉及到临床病例1987例。Meta分析结果显示,溴己新不良反应发生率高于对照组,合并OR=4.42,95%CI[2.55,7.66],P<0.00001,差异有统计学意义。这一差异同样存在于各亚组分析中,注射剂亚组OR=4.41,95%CI[2.35,8.28];片剂亚组OR=4.44,95%CI[1.44,13.68];肺炎亚组OR=4.41,95%CI[3.25,8.28],P<0.00001;支气管炎亚组OR=4.1,95%CI[1.22,13.79],P=0.02;常规治疗组OR=5.92,95%CI[2.71,12.91],P<0.00001;其他药物治疗组OR=2.96,95%CI[1.34,6.53],P=0.007,均具有统计学差异。结论溴己新的不良反应发生率高于对照组,临床应用需要注意,但这个结果还需要更多高质量的随机对照试验进行验证。
Objective To preliminarily evaluate the safety of bromhexine in domestic application. Methods CNKI, VIP and WanFang database were retrieved, and randomized controlled trials involving bromhexine were included. Meta-analysis for adverse reaction rates of bromhexine was performed by using RevMan5.1. In addition, subgroup analysis including different formulations （injections and tablets）, different indications （pneumonia and bronchitis） and different controlling measures （conventional measures and other medications） were performed according to Plq, ISAM guidelines. Results Ten RCTs which involved 1987 patients met the inclusion criteria. The experimental group showed higher adverse reaction incidence than controlling group [OR=4.42, 95%CI （2.55, 7.66）, P 〈0.00001], the difference was statistically significant. This difference also exists in each subgroup analysis： injection subgroup （OIL=4.41, 95%CI[2.35, 8.28]）; tablets subgroup（OR=4.44, 95%CI[1.44, 13.68]）; pneumonia subgroup（OIL=4.41, 95%CI[3.25, 8.28], P〈0.00001）; bronchitis subgroup（OR=4.1, 95%CI[1.22, 13.79], P =0.02）; conventional measures subgroup（OR=5.92, 95%CI [2.71, 12.91] P 〈0.00001）; other medications subgroup （OR=2.96, 95%CI [1.34, 6.53], P=0.007）. Conclusion Bromhexine treatment exhibits higher adverse reaction incidence than other treatment, and this risk should be concerned in clinical use, but the results need more high-quality randomized controlled trials to testify.
出处
《中国药物警戒》
2015年第1期49-52,共4页
Chinese Journal of Pharmacovigilance
