摘要
目的采用多中心、随机、盲法、平行对照试验,评价国产注射用盐酸氨溴索的粘痰溶解、祛痰作用的临床疗效和安全性.方法选择呼吸道感染伴咯痰、痰液粘稠患者132例,随机分为两组,试验组每次给予注射用盐酸氨溴索30 mg,对照组每次给予沐舒坦注射液30 mg,均用静脉注射,每日2次,疗程为5～7天.结果临床综合疗效意向性(ITT)分析:试验组和对照组的临床控制率分别为54.55%和46.97%,有效率分别为74.24%和77.27%;符合方案集(PP)分析:试验组和对照组的临床控制率分别为54.69%和47.54%,有效率分别为73.44%和77.05%,两组比较差异无显著性(P>0.05).试验组与对照组的不良反应发生率分别为6.06%和3.03%(P>0.05).结论国产注射用盐酸氨溴索祛痰疗效好,不良反应轻微,对于治疗常见呼吸系统疾病所致咳痰是一种安全、有效的祛痰药物.
Objective To evaluate the efficacy and safety of domestic ambroxol hydrochloride injection in the adjuvant treatment of respiratory diseases. Methods The trial design was randomized, double blind and multicenter. A total of 132 patients of acute respiratory tract infections were randomly divided into treatment group, treated with ambroxol hydrochloride injection 30mg, iv, ql2h, and control group,treated with mucosolvan ampoule 30mg,iv,q12h,both for 5-7d. Results The toltal clinical control rate and effective rate （ITT analysis） were 54.55% and 74.24% in treatment group, and 46.97% and 77.27% in control group,respictively. PP analysis also showed that the tohal clinical control rate and effective rate were 54.69% and 73.44% in treatment group, and 47.54% and 77.05% in control group, respictively. There was no significant difference （ P 〉 0.05 ） between two group. It was seldom to find the adverse reactions in both groups （6.06% vs 3.03% ,P 〉 0.05）. Conclusion Domestic ambroxol hydrochloride injection is an effective and safe adjuvant treatment of respiratory diseases in the removal of tenacious secretions and reduction of mucus stasis.
出处
《临床内科杂志》
CAS
2005年第9期598-600,共3页
Journal of Clinical Internal Medicine
关键词
呼吸系统疾病
盐酸氨溴索
多中心研究
随机对照试验
Respiratory diseases
Ambroxol hydrochloride
Multicenter studies
Randomized controlled trial
