| 引用本文:江金霞1，肖飞1，汪绍懿2，王登科2，胡天成3，刘小凡3，谢学礼4，蒋宝娣4.小儿宣肺止咳颗粒对于外感咳嗽的随机、多中心、平行对照临床试验[J].世界中医药,2023,(06):. |
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| 小儿宣肺止咳颗粒对于外感咳嗽的随机、多中心、平行对照临床试验 |
| Randomized，Multicenter，and Parallel Controlled Clinical Trial of Xiaoer Xuanfei Zhike Granules on Exogenous Cough |
| 投稿时间：2022-08-12 |
| DOI：10.3969/j.issn.1673-7202.2023.06.017 |
| 中文关键词: 小儿宣肺止咳颗粒 外感咳嗽 外感风寒 痰热郁肺 道地药材 随机 单盲 多中心 |
| English Keywords:Xiaoer Xuanfei Zhike Granules Exogenous cough External-contraction cold Phlegm-heat stagnation in lung Genuine herbs Random Single blind Multicenter |
| 基金项目:国家自然科学基金项目(30873104） |
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| 中文摘要: |
| 目的：评价小儿宣肺止咳颗粒治疗外感咳嗽（外感风寒、痰热郁肺）的有效性和安全性。方法：选取1993年12月至1994年5月成都中医药大学附属医院、云南省人民医院、昆明医科大学第一附属医院、云南省红十字会医院收治的外感咳嗽（外感风寒、痰热郁肺）患儿450例作为研究对象，随机分为观察组和对照组。观察组患儿口服小儿宣肺止咳颗粒，对照组患儿口服通宣理肺冲剂，疗程均为3 d。观察2组患者的治疗效果和安全性。结果：观察组总有效率为93.33%，与对照组的76.67%比较，差异有统计学意义（P<0.01）；与对照组比较，观察组对咳嗽、痰鸣、发热、恶寒、鼻塞、流涕、喷嚏、食减等症状疗效较好，差异有统计学意义（P<0.05或P<0.01）；观察组的平均退热起效时间和平均体温恢复正常时间明显优于对照组，2组比较差异均有统计学意义（P<0.05或P<0.01）。2组患者治疗后白细胞和中性粒细胞恢复正常率比较，差异无统计学意义（P>0.05）；小儿宣肺止咳颗粒对年龄及病情程度无选择性且未出现明显的不良反应。结论：小儿宣肺止咳颗粒治疗小儿外感咳嗽（外感风寒、痰热郁肺）疗效确切，服用方便，临床研究过程中，未见明显的不良反应，安全性可靠，值得临床推广。 |
| English Summary: |
| To evaluate the efficacy and safety of Xiaoer Xuanfei Zhike Granule in the treatment of exogenous cough(external-contraction cold and phlegm-heat stagnation in lung).Methods:A total of 450 children with exogenous cough were selected as the research objects in the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine，Yunnan Provincial People's Hospital，the First Affiliated Hospital of Kunming Medical College，and Yunnan Red Cross Hospital from December 1993 to May 1994.They were randomly divided into an observation group and a control group.The observation group was given Xiaoer Xuanfei Zhike Granules，and the control group was treated with Tongxuan Lifei Granules.The courses were 3 days.The efficacy and safety of the two groups after medication were observed.Results:The total effective rate of the observation group was 93.33% and that of the control group was 76.67%(P<0.01).Compared with the control group，the observation group had a better curative effect on cough，phlegm，fever，aversion to cold，nasal obstruction，sneeze，anorexia，and other symptoms(P<0.05 or P<0.01).The average onset time of fever reduction and the average recovery time of body temperature in the observation group were significantly better than those in the control group(P<0.05 or P<0.01).There was no significant difference in the normal rate of leukocyte and neutrophil after treatment between the two groups(P>0.05).Xiaoer Xuanfei Zhike Granules had no selectivity on age and severity of disease，and no obvious adverse effects were observed.Conclusion:Xiaoer Xuanfei Zhike Granules have significant efficacy in the treatment of exogenous cough(external-contraction cold and phlegm-heat stagnation in lung)，which are convenient to take.In the course of clinical research，no obvious adverse reactions have been observed，and it is safe，reliable，and worthy of clinical promotion. |
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