国产注射用盐酸氨溴索治疗下呼吸道感染的多中心随机对照临床试验

A Multi-center Randomized Controlled Trial of Ambroxol Hydrochloride Injection in the Treatment of Lower Respiratory Tract Infection

目的观察国产注射用盐酸氨溴索(冻干粉针剂)治疗合并呼吸道分泌物增加痰液粘稠的下呼吸道感染的疗效与安全性。方法募集120例合并呼吸道分泌物增加、痰液粘稠的肺部疾病患者,随机分为两组。试验组60例,采用国产注射用盐酸氨溴索30mg静脉滴注,每日2次。对照组60例,采用沐舒坦注射液30mg静脉滴注,每日2次,疗程6天。结果共有118例完成了试验,其中对照组与试验组各59例。①随着用药时间推进,试验组和对照组咳嗽严重程度、痰量、痰液性状、咳痰难易程度、罗音严重程度分值均呈降低的趋势。疗程1～6日试验组的痰液性状改善程度优于对照组外(P<0.05),其他各项指标如咳嗽严重程度、痰量、咳痰难易程度及罗音严重程度的差异无统计学意义(P>0.05)。②试验组的有效率为96.6%(FAS集和PP集),对照组为93.3%(FAS集)、94.9%(PP集),但两组间差异无统计学意义。③试验组和对照组不良反应发生率分别为1.7%与0%,其差异无统计学意义(P>0.05),且两组均无严重不良反应发生。结论本研究结果显示,国产注射用盐酸氨溴索用于下呼吸道感染治疗,对患者痰液性状改善情况优于沐舒坦,其余疗效指标与沐舒坦相当,且安全性良好。

Objective To evaluate the efficacy and safety of domesticambroxol 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 30 mg, iv, q12 h） and the control group （mucosolvan ampoule 30 mg, iv, q12 h）. The duration of treatment was 6 days. Results 118 patients completed the trial, 59 in eachgroup. From Day I to Day 6, the severity scores of cough, sputum amount, difficulty in expectoration and rales were similar between the two groups （P〉0.05）, but a significant difference was observed in the nature of sputum （P〈0.05） The total effective rates of the treatment group and the control group were 96.6% （FAS analysis and PPanalysis） or 93.3% （FAS analysis）, and 94.9% （PPanalysis）, respectively. There was no significant difference between the two groups （P〉0.05）. The incidence of adverse effects was comparable between the two groups （1.7% vs. 0%, P〉0.05）, and no severe adverse effect was observed. Conclusion The efficacy of domesticambroxol 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.