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联合清肺抑火胶囊治疗支气管扩张症急性加重的多中心随机对照研究
Combination treatment of Qingfei Yihuo capsules in brochiectasis exacerbation:a multi-center randomized controlled clinical trial
【摘要】 目的评价在常规抗生素及黏痰溶解剂基础上联合清肺抑火胶囊在减轻支气管扩张症急性加重时的发作症状、缩短急性期天数、减轻病情中的辅助作用。方法本研究为前瞻性、多中心、随机对照临床试验。通过随机双盲的方法,使用清肺抑火胶囊或安慰剂联合抗生素及黏痰溶解剂进行治疗,总治疗天数为10 d。评价患者用药前后咳嗽、咳痰、呼吸困难症状评分和日记卡评分,以及肺功能、圣乔治呼吸问卷评分。结果本项目研究时间为2017年6月至2018年8月,来自上海市6家二级、三级医院的7个中心共190例支气管扩张症急性加重的患者入组了本研究。联合清肺抑火胶囊治疗组较联合安慰剂治疗组可显著改善治疗第9、第10 d的咳嗽、咳痰和呼吸困难症状评分,呼吸系统症状改善更快。结论清肺抑火胶囊对支气管扩张症急性加重的临床症状改善有辅助促进作用。
【Abstract】 Objective To evaluate the combination efficacy with Qingfei Yihuo capsule and routine antibiotics as well as mucopolytic agents in the treatment of bronchiectasis acute exacerbation. Methods This was a prospective, multicenter, randomized controlled clinical study. The efficacy of Qingfei Yihuo capsule combine with routine antibiotics and mucopolytic agents in the treatment of bronchiectasis acute exacerbation was compared according to the symptom control as well as exacerbation duration. Through randomization, patients received Qingfei Yihuo capsule or placebo combine with routine antibiotics and mucopolytic agents treatment for 10 days. Symptom score of cough, sputum, short of breath pre-and post-treatment as well as the symptom score in daily card were compared between the two groups. The spirometry and St. George respiratory questionnaire(SGRQ) before and after treatment were compared. Results This study was conducted from June 2017 to August 2018. One hundred and ninety patients from 7 centers in 6 hospitals with bronchiectasis acute exacerbation were enrolled in the study. There was statistically improvement of symptom score(including the 9th and 10th treatment days) according to the daily card recording in Qingfei Yihuo capsule group compared to the placebo group, but no statistically significant difference was found in spirometry results or SGRQ. Conclusion Qingfei Yihuo capsule has assistant effect on improving respiratory symptoms of bronchiectasis exacerbation.
- 【文献出处】 中国呼吸与危重监护杂志 ,Chinese Journal of Respiratory and Critical Care Medicine , 编辑部邮箱 ,2019年04期
- 【分类号】R562.22
- 【被引频次】12
- 【下载频次】141