中国药物警戒 ›› 2017, Vol. 14 ›› Issue (5): 262-265.

• 基础与临床研究专栏 • 上一篇    下一篇

盐酸氨溴索雾化吸入与静脉注射给药治疗慢性支气管炎急性发作的疗效与安全性研究

陈楠, 方圆, 徐玲   

  1. 郑州人民医院临床药学科,河南 郑州 450003
  • 收稿日期:2017-07-12 修回日期:2017-07-12 出版日期:2017-05-20 发布日期:2017-07-12
  • 基金资助:
    郑州市科技局指导性科研项目基金（CZSYJJ11013）

Efficacy and Safety Comparison of Ambroxol Hydrochloride Between Aerosol Inhalation and Intravenous Injection In Acute Exacerbations of Chronic Bronchitis：A Prospective Randomized Controlled Clinical Study

CHEN Nan, FANG Yuan, XU Ling   

  1. Department of Clinical Pharmacy, People’s Hospital of Zhengzhou, Henan Zhengzhou 450003,China
  • Received:2017-07-12 Revised:2017-07-12 Online:2017-05-20 Published:2017-07-12

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摘要： 目的 对比评价盐酸氨溴索雾化吸入与静脉注射给药治疗慢性支气管炎急性发作疗效与安全性。方法 120例慢性支气管炎急性发作期患者随机分为观察组（60例）和对照组（60例）,观察组使用盐酸氨溴索注射液雾化吸入,对照组使用静脉注射给药,治疗5~7天。比较两组临床综合疗效及包括咳嗽、昼夜痰量、痰的性状、咳痰难度、肺部啰音在内的五项单项指标改善情况,并记录两组药品不良反应情况。结果 综合疗效比较,观察组总有效率为96.7%,明显高于对照组的88.3%,差异具有统计学意义((P<0.05)。单项指标比较,观察组在咳嗽方面的治疗效果与对照组无显著差异,但在痰量、痰的性状、咳痰难度、肺部啰音等方面的治疗效果,总有效率分别为98.3%、100%、98.3%、98.3%,明显高于对照组的88.3%、96.7%、85.0%、86.7%,差异具有统计学意义(P<0.05)。安全性比较,观察组未发生药品不良反应,对照组药品不良反应发生率为1.7%,差异不具有统计学意义((P>0.05)。结论 盐酸氨溴索雾化吸入用于慢性支气管炎急性发作的临床疗效显著优于静脉注射给药,尤其在痰量、痰的性状、咳痰难度、肺部啰音的临床症状改善方面。

关键词: 疗效, 雾化吸入, 盐酸氨溴索, 超说明书用药

Abstract: Objective To compare and analyze the efficacy and safety of different administration routes (aerosol inhalation and intravenous injection) of ambroxol hydrochloride in treating acute exacerbations of chronic bronchitis. Methods Patients with acute exacerbations of chronic bronchitis (n=120) were randomly assigned to two groups: observation group（n=60）and control group（n=60）.Two groups were treated with ambroxol hydrochloride by aerosol inhalation or intravenous injection respectively for 5~7 days. Clinical efficacy was measured by treatment outcomes and improvements of 5 symptom indicators: cough, sputum volume, sputum properties, expectoration difficulty and rales. Adverse events were also recorded. Results More overall improvements were observed in the observation group（96.7%） than in the control group（88.3%）(P<0.05). For the five symptom indicators, except for the treatment effect of cough, the observation group showed more significant improvements in the aspects of sputum volume(98.3%), sputum properties(100%), expectoration difficulty(98.3% ) and rales(98.3%) than those of the control group (88.3%、96.7%、85.0%、86.7%)( P<0.05). In the aspect of safety, adverse events were not observed in the observation group, meanwhile, 1 adverse effect was recorded in the control group(the incidence of adverse effects was 1.7%, P>0.05). Conclusion The result shows the better clinical effects of aerosol inhalation of ambroxol hydrochloride in the treatment of acute exacerbations of chronic bronchitis than those of the intravenous administration,especially in the improvements of sputum volume, sputum properties, expectoration difficulty and rales.

Key words: efficacy, aerosol inhalation, ambroxol hydrochloride, off-label use

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