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目的 评价小儿定喘颗粒干预儿童呼吸道合胞病毒肺炎(痰热闭肺证)临床疗效。方法 采用分层区组随机化、单盲、平行对照、多中心临床研究方法，将2022年10月—2024年6月于10家分中心儿科住院纳入试验的受试患儿240例，随机分为对照组和试验组，对照组采取基础治疗，试验组在对照组的基础上加服小儿定喘颗粒，记录病历观察表，试验结束后观察比较两组疾病的总有效率、临床痊愈时间、中医证候疗效、主要症状与体征的疗效、患儿喘息评分、不良反应以及随访出院后是否再发喘息等情况。结果 共纳入240例患儿(试验组120例，对照组120例)，治疗后，疾病总有效率、临床痊愈时间及中医证候疗效试验组优于对照组，差异具有统计学意义(P<0.05);主要症状与体征的有效率及起效时间试验组优于对照组，差异均具有统计学意义(P<0.05)，尤其以喉间痰鸣症状效果显著;治疗后试验组患儿喘息评分小于对照组，差异具有统计学意义(P<0.05);不良反应发生率组间比较差异均无统计学意义(P > 0.05)，随访患儿出院后再发喘息次数试验组明显少于对照组，差异有统计学意义(P<0.01)。结论 应用小儿定喘颗粒治疗小儿呼吸道合胞病毒肺炎(痰热闭肺证)具有较好的临床疗效，在改善喘息与喉间痰鸣症状方面疗效显著，缩短病程急性期，临床应用安全性较高，减少日后喘息再发，值得临床推广。
Abstract：Objective To evaluate the clinical effect of Xiaoer Dingchuan s(小儿定喘颗粒) in children with respiratory syncytial virus pneumonia(phlegm-heat blocking lung syndrome). Method A stratified block randomized,single-blind,parallel controlled and multi-center clinical study was conducted. A total of 240 children hospitalized in 10 pediatric centers from October 2022 to June 2024 were randomly divided into control group and experimental group. The control group received the basic treatment,and the experimental group received Xiaoer Dingchuan Granules on the basis of the control group. The medical record observation table was recorded,and the total effective rate,clinical cure time,curative effect of TCM syndromes,curative effect of main symptoms and signs,wheezing score,adverse reactions and wheezing recurrence after discharge were observed and compared between the two groups after the trial. Results A total of 240 children were included(120 cases in the experimental group and 120 cases in the control group). After treatment,the total effective rate,clinical healing time and TCM syndrome efficacy of the experimental group were better than those of the control group,and the total effective rate and TCM syndrome efficacy of the experimental group were higher than those of the control group,with statistical significance(P < 0. 05). The effective rate and onset time of main symptoms and signs in the experimental group were better than those in the control group,and the differences were statistically significant(P < 0. 05),especially in the symptom of wheezing and phlegm in the throat. After treatment,the wheezing score of the experimental group was lower than that of the control group,and the difference was statistically significant(P < 0. 05).There was no significant difference in the incidence of adverse reactions between the groups(P > 0. 05). The number of recurrent wheezing after discharge in the experimental group was significantly lower than that in the control group,with statistical significance(P < 0. 01). Conclusion The application of Xiaoer Dingchuan Granules in the treatment of children with respiratory syncytial virus pneumonia(phlegm-heat blocking lung syndrome) has a good clinical effect,and has a significant effect in improving the symptoms of wheezing and phlegm in the throat,shortening the acute period and reducing the wheezing recurrence,with high clinical application safety. It is worthy of clinical promotion.
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基本信息:
DOI：10.13193/j.issn.1673-7717.2026.03.001
中图分类号:R272
引用信息:
[1]王雪峰,陈玉燕,张葆青,等.小儿定喘颗粒治疗呼吸道合胞病毒肺炎（痰热闭肺证）多中心随机对照临床研究[J].中华中医药学刊,2026,44(03):1-6+267.DOI:10.13193/j.issn.1673-7717.2026.03.001.
基金信息:
国家中医药管理局中医药传承创新中心重点病种项目(2023-247);国家中医药管理局中医药传承创新平台建设项目(2020-1);国家中医药管理局王雪峰全国名老中医药专家传承工作室建设项目(国中医药人教函[2022]75号)