| 引用本文:孙香娟1，常克1，韩新民2，李卉3.小儿紫贝宣肺糖浆治疗儿童急性支气管炎多中心随机对照临床研究[J].世界中医药,2024,(24):. |
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| 小儿紫贝宣肺糖浆治疗儿童急性支气管炎多中心随机对照临床研究 |
| A Multicenter Randomized Controlled Clinical Trial for Xiao'er Zibei Xuanfei Syrup in Treatment of Children with Acute Bronchitis |
| 投稿时间：2024-05-31 |
| DOI：10.3969/j.issn.1673-7202.2024.24.016 |
| 中文关键词: 小儿紫贝宣肺糖浆 儿童 急性支气管炎 风热犯肺证 阳性对照 多中心 临床研究 |
| English Keywords:Xiao'er Zibei Xuanfei Syrup Child Acute bronchitis Syndrome of wind-heat invading lung Positive control Multi-center Clinical trial |
| 基金项目:国家科技重大专项（2016ZX09101077） |
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| 中文摘要: |
| 目的：分析小儿紫贝宣肺糖浆治疗儿童急性支气管炎风热犯肺证的临床效果和安全性。方法：选取2014年2月至2015年12月江苏省中医院、成都中医药大学附属医院、湖北省中医院收治的232例急性支气管炎（风热犯肺证）患儿作为研究对象。按1:1比例随机分为观察组和对照组，观察组口服小儿紫贝宣肺糖浆，对照组口服急支糖浆，2组均为3次/d，疗程7 d。观察2组患儿用药后第7天各症状的变化情况和不良反应。结果：观察组咳嗽症状改善的总有效率、咯痰症状改善的总有效率及中医证候改善总有效率均高于对照组，差异均有统计学意义（均P<0.05）；中医证候单项症状消失率“发热”“有汗”“鼻流浊涕”观察组优于对照组，差异均有统计学意义（均P<0.05）；观察组不良事件发生率为1.72%，对照组不良事件发生率为1.72%，差异无统计学意义（P>0.05）。结论：小儿紫贝宣肺糖浆对儿童急性支气管炎风热犯肺证具有较好的疗效和安全性。 |
| English Summary: |
| To analyze the clinical efficacy and safety of Xiao'er Zibei Xuanfei Syrup in the treatment of children with acute bronchitis complicated with syndrome of wind-heat invading lung.Methods:A total of 232 children with acute bronchitis complicated with syndrome of wind-heat invading lung admitted to Jiangsu Province Hospital of Chinese Medicine，Hospital of Chengdu University of Traditional Chinese Medicine，and Hubei Province Hospital of TCM between February 2014 and December 2015 were selected for the study.They were randomly divided into the observation group and control group according to a 1:1 ratio.The observation group was given Xiao'er Zibei Xuanfei Syrup，and the control group was given Jizhi Syrup.Both groups took the drugs three times per day，and the treatment lasted for seven days.The changes in symptoms and adverse reactions were observed on the 7th day after medication in the two groups.Results:The total effective rate of cough symptom improvement，phlegm symptom improvement，and TCM syndrome improvement in the observation group were higher than those in the control group.The differences were statistically significant(all P<0.05).The disappearance rate of single TCM syndrome of “fever”，“sweating”，and “runny nose” in the observation group was better than that in the control group(P<0.05).The incidence of adverse events was 1.72% in the observation group and 1.72% in the control group，with no statistically significant difference(P>0.05).Conclusion:Xiao'er Zibei Xuanfei Syrup shows significant clinical efficacy and good safety in the treatment of children with acute bronchitis complicated with syndrome of wind-heat invading lung． |
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