Objective To evaluate the efficacy and safety of domestic ambroxol hydrochloride injection in the treatment of lower respiratory tract infection.
Methods A total of 120 patients with respiratory tract infections were included and randomized into the treatment group (ambroxol hydrochloride injection 30mg, iv, q12h) and the control group (mucosolvan ampoule 30mg, iv, q12h). The duration of treatment was 6 days.
Results 118 patients completed the trial, 59 in each group. From Day 1 to Day 6, the severity scores of cough, sputum amount, difficulty in expectoration and rales were similar between the two groups (P gt;0.05), but a significant difference was observed in the nature of sputum (P lt;0.05). The total effective rates of the treatment group and the control group were 96.6% (FAS analysis and PP analysis) or 93.3% (FAS analysis), and 94.9% (PP analysis), respectively. There was no significant difference between the two groups (P gt;0.05). The incidence of adverse effects was comparable between the two groups (1.7% vs. 0%, P gt;0.05), and no severe adverse effect was observed.
Conclusion The efficacy of domestic ambroxol hydrochloride injection in the treatment of lower respiratory infection was equal to that of mucosolvan ampoule, and it can even further improve the nature of sputum. Ambroxol hydrochloride was as safe as mucosolvan ampoule.
Citation：
CHEN Xuerong,DU Xinmiao,LIU Chuntao,WANG Ke,FENG Yulin,YANG Heping,ZHANG Chunling. A Multi-center Randomized Controlled Trial of Ambroxol Hydrochloride Injection in the Treatment of Lower Respiratory Tract Infection. Chinese Journal of Evidence-Based Medicine, 2007, 07(7): 483-486. doi:
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Copyright © the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
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Zu KM, Deng XM. The protection mechanism of Ambroxol to respiratory system. Shanghai Medical Journal, 2000, 23(10): 637-639.
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Yin KS, Liu W, Dai LJ, et al. Effect and security of Ambroxol hydrochloride on removing the sputum. Chinese Journal of New Drugs, 1999, 8(8): 539-540.
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Shi Y, Xiao YY, Su X, et al. A multicenter randomized controlled clinical trials of Ambroxol hydrochloride injection in adjuvant treatment of respiratory diseases. J Clin Intern Med, 2005, 22(9): 598-600.
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Lou HG, Liu F, Zhai SD. Aerosol Inhalation of Ambroxol for Pneumonia: A Systematic Review. Chin J Evid-Based Med, 2006, 6(6): 421-429.
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Houtmeyerse. Effects of drugs on mucus clearance. Eur Respir J, 1999, 14(2): 452-467.
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殷凯生, 刘文, 戴令娟, 等. 国产与进口盐酸氨溴索祛痰疗效及安全性比较. 中国新药杂志, 1999, 8(8): 539-540.
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施毅, 肖永营, 苏欣, 等. 注射用盐酸氨溴索粘痰溶解与祛痰作用的多中心临床随机对照研究. 临床内科杂志, 2005, 22(9): 598-600.
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楼洪刚, 刘芳, 翟所迪. 氨溴索雾化吸入治疗肺炎的系统评价. 中国循证医学杂志, 2006, 6(6): 421-429.
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- 1. Ye RG, Lu ZY, et al. Internal Medicine. 6th edition. Beijing: The People’s Medical Publishing House, 2004. p. 11-67.
- 2. Zu KM, Deng XM. The protection mechanism of Ambroxol to respiratory system. Shanghai Medical Journal, 2000, 23(10): 637-639.
- 3. Yin KS, Liu W, Dai LJ, et al. Effect and security of Ambroxol hydrochloride on removing the sputum. Chinese Journal of New Drugs, 1999, 8(8): 539-540.
- 4. Shi Y, Xiao YY, Su X, et al. A multicenter randomized controlled clinical trials of Ambroxol hydrochloride injection in adjuvant treatment of respiratory diseases. J Clin Intern Med, 2005, 22(9): 598-600.
- 5. Lou HG, Liu F, Zhai SD. Aerosol Inhalation of Ambroxol for Pneumonia: A Systematic Review. Chin J Evid-Based Med, 2006, 6(6): 421-429.
- 6. 叶任高, 陆再英, 等. 主编. 内科学. 第6版. 北京: 人民卫生出版社, 2004. p. 11-67.
- 7. 朱科明, 邓小明. 沐舒坦对呼吸系统的保护机制. 上海医学, 2000, 23(10): 637-639.
- 8. Houtmeyerse. Effects of drugs on mucus clearance. Eur Respir J, 1999, 14(2): 452-467.
- 9. 殷凯生, 刘文, 戴令娟, 等. 国产与进口盐酸氨溴索祛痰疗效及安全性比较. 中国新药杂志, 1999, 8(8): 539-540.
- 10. 施毅, 肖永营, 苏欣, 等. 注射用盐酸氨溴索粘痰溶解与祛痰作用的多中心临床随机对照研究. 临床内科杂志, 2005, 22(9): 598-600.
- 11. 楼洪刚, 刘芳, 翟所迪. 氨溴索雾化吸入治疗肺炎的系统评价. 中国循证医学杂志, 2006, 6(6): 421-429.
