罗红霉素氨溴索治疗下呼吸道细菌性感染疗效和安全性被引量：2

Efficacy and safety of roxithromycin/ambroxol in patients with lower respiratory tract infection

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摘要目的评价罗红霉素氨溴索片治疗急性支气管炎和慢性支气管炎急性发作的疗效和安全性。方法本研究是来自在中国20家医院的一项多中心前瞻性研究。临床试验从2017年10月30日至2019年共招募591例支气管炎患者,根据症状分为急性支气管炎组550例,慢性支气管炎急性发作组41例,所有患者均口服罗红霉素溴索150 mg,疗程为5~10 d。疗效终点是药物的抗菌疗效、细菌学清除率、祛痰疗效。安全性终点为研究期间与研究药物相关的不良事件。结果急性支气管炎组无论是抗菌疗效(90.2%比75.6%),还是祛痰疗效(93.8%比63.4%)都优于慢性支气管炎急性发作组(P<0.05)。9.0%(53/591)的患者发生与研究药物相关的不良事件。结论罗红霉素氨溴索片治疗急性支气管炎的综合疗效优于慢性支气管炎急性发作,且安全性良好。 Objective To evaluate the efficacy and safety of roxithromycin/ambroxol on acute bronchitis and acute exacerbation of chronic bronchitis.Methods It was a multi-center prospective study from 20 hospitals in China.The clinical trial was recruited in 591 patients with bronchitis from October 30,2017 to 2019.The patients were divided into 550 cases with acute bronchitis and 41 cases with acute exacerbation of chronic bronchitis.All patients were given oral roxithromycin/bromoxol 150 mg/d,and the treatment course was 5-10 days.The efficacy endpoints were the antibacterial efficacy,bacteriological clearance and expectorant efficacy.The safety endpoint was the adverse events during the study.Results Both antibacterial and antibacterial effects were significantly better in acute bronchitis group than in acute exacerbation of chronic bronchitis group(90.2%vs.75.6%,93.8%vs.63.4%,both P<0.05).The adverse reactions in two groups were 49 cases(8.8%)compared to 4 cases(9.3%),but the difference was no statistically significant(P>0.05).Conclusions The comprehensive efficacy of roxithromycin/ambroxol on acute bronchitis was better than that of acute exacerbation of chronic bronchitis,and roxithromycin/ambroxol showed good safety during the treatment.

作者佘君白春学焦深山刘锦郭忠良刘冬明高俊珍卢慧宇杨青茹李静丽毛毅敏杨红忠聂秀红黄天霞 She Jun;Bai Chunxue;Jiao Shenshan;Liu Jin;Guo Zhongliang;Liu Dongming;Gao Junzhen;Lu Huiyu;Yang Qingru;Li Jingli;Mao Yimin;Yang Hongzhong;Nie Xiuhong;Huang Tianxia(Department of Respiratory and Critical Care Medicine,Zhongshan Hospital,Fudan University,Shanghai 200032,China;Department of Respiratory and Critical Care Medicine,the Third Hospital of Nanchang,330009,China;Department of Respiratory Medicine,Jinzhou Central Hospital,Jinzhou 121001,China;Department of Respiratory Medicine,Shanghai East Hospital,Tongji University School of Medicine 200120,China;Second Department of Respiratory Medicine,Pingxiang People′s Hospital,Pingxiang 337000,China;Department of Respiratory and Critical Care Medicine,the Affiliated Hospital of Inner Mongolia Medical University,Hohhot 010050,China;Department of Respiratory Medicine,Taizhou People′s Hospital,Taizhou 225300,China;Department of Respiratory and Critical Care Medicine,Xuzhou Central Hospital,Xuzhou 221009,China;Department of Respiratory and Critical Care Medicine,Beijing Shijitan Hospital Affiliated to Capital Medical University,Beijing 100038,China;Department of Respiratory and Critical Care Medicine,the First Affiliated Hospital,Henan University of Science and technology,Luoyang 471003,China;Department of Respiratory and Critical Care Medicine,Changsha Central Hospital,Changsha 410004,China;Department of Respiratory and Critical Care Medicine,Xuanwu Hospital of Capital Medical University,Beijing 100053,China;Department of Respiratory Medicine,the First People′s Hospital of Nanning,Nanning 530022,China)