摘要
目的评价大剂量氨溴索治疗重症肺炎的疗效和安全性。方法计算机检索Cochrane图书馆、PubMed数据库、万方数字化期刊全文数据库、中文科技期刊全文数据库和中国期刊全文数据库,纳入大剂量(>120mg/d)氨溴索(试验组)对比常规剂量(≤120mg/d)氨溴索(对照组)治疗重症肺炎的随机对照试验(randomized controlled trial,RCT),对纳入的RCT进行方法学质量评价和meta分析。结果共纳入23项RCT,合计2017例患者。Meta分析结果显示,与对照组相比,试验组可以提高重症肺炎患者的治疗有效率(RR=1.25,95%CI 1.17～1.34,P<0.01)、氧分压指标(MD=10.62,95%CI 8.90～12.34,P<0.01)和氧饱和度指标(MD=6.63,95%CI 3.75～9.51,P<0.01),降低重症肺炎患者的C反应蛋白(MD=-8.76,95%CI-13.55～-3.96,P<0.01)、降钙素原(MD=-0.26,95%CI-0.35～-0.17,P<0.01)、机械通气时间(MD=-3.87,95%CI-5.29～-2.44,P<0.01)、ICU停留时间(MD=-4.33,95%CI-5.50～-3.15,P<0.01)和肺部感染评分(MD=-1.37,95%CI-2.38～-0.36,P<0.01),且无明显不良反应。结论大剂量氨溴索治疗重症肺炎疗效较好,虽未发现严重不良反应,但目前数据仍然无法否定其在安全性方面潜在的风险。由于纳入的临床研究质量普遍较低,因此期待通过更多高质量、大规模的临床RCT加以验证。
Objective To investigate the efficacy and safety of very-high-dose ambroxol in the treatment of severe pneumonia.Method Randomized controlled trials(RCT s)of very-high-dose(>120 mg/d)ambroxol versus conventional(≤120 mg/d)ambroxol for severe pneumonia was retrieved from Cochrane Library,Pubmed,VIP,Wanfang,and CNKI databases.Quality evaluation and meta-analysis of included studies were conducted.Result Twenty-three RCTs involving 2017 patients were included.Meta-analysis showed that,compared with the conventional dose group,very-high-dose group could improve the effective rate(RR=1.25,95%CI 1.17 to 1.34,P<0.01),elevate PaO2(MD=10.62,95%CI 8.90 to 12.34,P<0.01)and SaO2(MD=6.63,95%CI 3.75 to 9.51,P<0.01),decrease CRP(MD=-8.76,95%CI-13.55 to-3.96,P<0.01)and PCT(MD=-0.26,95%CI-0.35 to-0.17,P<0.01),shorten the duration of mechanical ventilation(MD=-3.87,95%CI-5.29 to-2.44,P<0.01)and the length of ICU stay(MD=-4.33,95%CI-5.50 to-3.15,P<0.01),reduce the CPIS(MD=-1.37,95%CI-2.38 to-0.36,P<0.01),with no significant adverse reactions observed.Conclusion Very-high-dose ambroxol is effective in the treatment of severe pneumonia.Although no serious adverse reactions have been found,it cannot negate its safety risk.Since the quality of the included clinical studies is generally low,more high-quality,large-scale randomized controlled clinical trial are still needed for demonstration.
作者
张杨
任悦
李丹丹
沈素
ZHANG Yang;REN Yue;LI Dan-dan;SHEN Su(Department of Pharmacy,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;School of Pharmaceutical Sciences,Capital Medical University,Beijing 100069,China)
出处
《中国医刊》
CAS
2019年第5期558-564,共7页
Chinese Journal of Medicine
关键词
氨溴索
重症肺炎
疗效
安全性
系统评价
Ambroxol
Severe pneumonia
Efficiency
Safety
Systematic review
