喜炎平注射液治疗急性支气管炎有效性和安全性的多中心、双盲、随机对照试验

A Multicenter,Double-blind,Randomized Controlled Trial on Efficacy and Safety of Xiyanping Injection in Treatment of Acute Bronchitis

目的评价喜炎平注射液治疗急性支气管炎的疗效与安全性。方法采用前瞻性、多中心、安慰剂随机对照临床研究,选取了南昌大学第一附属医院等10家医院收治的急性支气管炎148名患者,随机分为2组。其中试验组73例,对照组75例。试验组给予喜炎平注射液,对照组给予喜炎平注射液模拟剂(安慰剂)。每次10~20 mL,1日1次。比较2组患者的疾病持续时间、单项症状持续时间(发热、咳嗽、发冷/出汗、肺部啰音)、单项症状历时性变化等,并进行安全性评价。结果治疗结束后与对照组比较,试验组患者的中位疾病持续时间、中位咳嗽缓解时间均明显减少,差异有统计学意义(P<0.05);结果还显示喜炎平注射液能一定程度上减少患者的发冷/出汗、发热缓解时间,但由于样本量较少,差异无统计学意义(P>0.05)。不良反应大多较轻,基本与说明书表现一致,所有与研究药物相关的不良事件在用药结束或终止治疗后均可恢复。结论喜炎平注射液治疗急性支气管炎临床疗效确切,可改善患者临床症状,缩短疾病治疗时间,且安全性良好,值得在临床推广使用。

Objective To evaluate the efficacy and safety of Xiyanping injection in the treatment of acute bronchitis.Methods A prospective,multicenter,placebo randomized controlled clinical study was conducted.A total of 148 patients with acute bronchitis from 10 hospitals including the First Affiliated Hospital of Nanchang University were randomly divided into two groups.The experimental group was given Xiyanping injection,and the control group was given Xiyanping injection simulant(placebo).10~20mL a day,once a day.The duration of disease,duration of single symptoms(fever,cough,chills/sweating,pulmonary rales)and diachronic changes of single symptoms were compared between the two groups,and the safety was evaluated.Results A total of 148 patients were enrolled,including 73 in the experimental group and 75 in the control group.After treatment,the median disease duration and median cough relief time of patients in the experimental group were significantly reduced compared with those in the control group(P<0.05).Xiyanping injection could reduce the relief time of chills/sweating and fever to a certain extent,but due to the small sample size,the difference was not statistically significant(P>0.05).Most of the adverse reactions were mild and basically consistent with the instructions.All the adverse events related to the study drug could be recovered after the end of medication or termination of treatment.Conclusion Xiyanping injection has definite clinical effect in the treatment of acute bronchitis,which can improve the clinical symptoms of patients,shorten the treatment time of the disease,and has good safety,which is worthy of clinical application.