暗紫贝母和梭砂贝母治疗急性支气管炎(痰热咳嗽)的多中心、随机、双盲、对照试验

中国临床药理学与治疗学 ›› 2010, Vol. 15 ›› Issue (5): 524-529.

暗紫贝母和梭砂贝母治疗急性支气管炎(痰热咳嗽)的多中心、随机、双盲、对照试验

丁红¹, 阎博华¹, 刘松山¹, 杨仁旭¹, 张瑞明², 曾代文³, 陈云凤⁴, 李明权¹, 曾洁萍¹, 李继书⁵, 周宜⁵, 黄晓燕⁶

¹四川省中医医院,成都 610075,四川;
²四川大学华西医院,成都 610041,四川;
³四川省人民医院,成都 610072,四川;
⁴成都市第一人民医院,成都 610041,四川;
⁵成都中医药大学,成都 610072,四川;
⁶成都康弘制药有限公司,成都 610041,四川

收稿日期:2010-03-18 修回日期:2010-03-26 出版日期:2010-05-26 发布日期:2020-09-16
作者简介:丁红,女,副主任医师,主要从事中药临床药理研究。Tel: 028-87765620 E-mail: gcpdh@163.com
基金资助:
国家“十一五”科技支撑计划“不同基源川贝母、黄连功效差异性及相关成方制剂的临床再评价研究”(2007BAI40B06)

A mutli-center randomized double-blind controlled trial on the functional difference between Fritillaria unibracteata Hsiao et K.C.Hsia and Fritillaria delavayi Ftanch in relieving acute bronchitis (heat phlegm cough)

DING Hong¹, YAN Bo-hua¹, LIU Song-shan¹, YANG Ren-xu¹, ZHANG Rui-ming², ZENG Dai-wen³, CHEN Yun-feng⁴, LI Ming-quan¹, ZENG Jie-ping¹, LI Ji-shu⁵, ZHOU Yi⁵, HUANG Xiao-yan⁶

¹Sichuan Province Hospital of Traditional Chinese Medicine,Chengdu 610075,Sichuan, China;
²West China Hospital of Sichuan University,Chengdu 610041,Sichuan,China;
³Sichuan Provincial People's Hospital,Chengdu 610072,Sichuan,China;
⁴Chengdu First People's Hospital,Chengdu 610041, Sichuan,China;
⁵Chengdu University of Traditional Chinese Medicine Chengdu 610075,Sichuan,China;
⁶Chengdu Kanghong Pharmaceutical Co .Ltd. Chengdu 610041, Sichuan, China

Received:2010-03-18 Revised:2010-03-26 Online:2010-05-26 Published:2020-09-16

摘要/Abstract

摘要： 目的: 比较不同基源川贝母(暗紫贝母、梭砂贝母)止咳、化痰功效差异性,确定最能代表川贝母止咳、化痰功效的基源种。方法: 募集216例急性支气管炎(痰热咳嗽)的患者,随机分为两组。暗紫贝母组108例,采用暗紫贝母超细粉2 g,口服,每日3次,疗程 5 d。梭砂贝母组108例,采用梭砂贝母超细粉 2 g,口服,每日3次,疗程 5 d。结果: 共有210例完成了试验,其中暗紫贝母组106例、梭砂贝母组104例。随着用药时间的推进,暗紫贝母组和梭砂贝母组咳嗽、咯痰不爽及其他中医证候分值均呈降低的趋势。暗紫贝母组、梭砂贝母组主证(咳嗽、咯痰不爽)改善程度差异无统计学意义(P>0.05),次证(咽干、大便干结)改善程度差异有统计学意义(P<0.05)。暗紫贝母组、梭砂贝母组中医证候疗效比较有统计学差异(P<0.05)。暗紫贝母组和梭砂贝母组不良事件发生率比较,两组差异无统计学意义(P>0.05),且两组无严重不良事件发生。结论: 暗紫贝母与梭砂贝母单独用于治疗“痰热咳嗽”,均能缓解咳嗽、咯痰不爽、胸闷、咽干、尿黄、大便干结的症状,在改善咽干、大便干结症状方面暗紫贝母优于梭砂贝母。两种基源川贝母中,暗紫贝母可能更能代表川贝母清热润肺、止咳化痰之功。

关键词: 基源, 暗紫贝母, 梭砂贝母, 止咳, 化痰

Abstract: AIM: To study the effect of relieving cough and resolving phlegm between different species of Chuan Fritillaria (Fritillaria unibracteata Hsiao et K.C.Hsia and Fritillaria delavayi Ftanch) and identify the most effective ChuanBeiMu in relieving cough and resolving phlegm. METHODS: A total of 216 patients with acute bronchitis (Cough due to Heat Phlegm) were included and randomized into the Fritillaria unibracteata Hsiao et K.C.Hsia group (Superfine powder of Fritillaria unibracteata Hsiao et K.C.Hsia 2g, po, tid.) and Fritillaria delavayi Ftanch group (Superfine powder of Fritillaria delavayi Ftanch 2g, po, tid.). RESULTS: The clinical trial include 210 patients was completed, 106 in Fritillaria unibracteata Hsiao et K.C.Hsia group and 104 in Fritillaria delavayi Ftanch group. From Day 1 to Day 5, the scores of cough the difficult phlegm and the symptom scores of TCM were reduced. The changing of main symptoms in cough and the difficult phlegm were similar between the two groups (P>0.05), The changing of the secondary symptoms in dry throat, yellow urine and dry movement were significant different between the two groups (P<0.05). The total effective rates of Fritillaria unibracteata Hsiao et K.C.Hsia group in relieving cough was 96.3% and the other group was 92.3%. There was no significant different between the two groups (P>0.05). The incidences of adverse effects were similar between the two groups (P>0.05), and no severe adverse effect was observed. CONCLUSION: Either Fritillaria unibracteata Hsiao et K.C.Hsia or Fritillaria delavayi Ftanch can be separately used to treat “heat phlegm cough”. Both of them can release the symptoms of cough, the difficult phlegm, chest tightness, dry throat, yellow urine and dry movement. There is significant different between the two groups in improving dry throat and dry movement, the Fritillaria unibracteata Hsiao et K.C.Hsia may has a better effect than the Fritillaria delavayi Ftanch.

Key words: Species, Fritillaria unibracteata Hsiao et K.C.Hsia, Fritillaria delavayi Ftanch, Relieving cough, Resolving phlegm

中图分类号:

R969

丁红, 阎博华, 刘松山, 杨仁旭, 张瑞明, 曾代文, 陈云凤, 李明权, 曾洁萍, 李继书, 周宜, 黄晓燕. 暗紫贝母和梭砂贝母治疗急性支气管炎(痰热咳嗽)的多中心、随机、双盲、对照试验[J]. 中国临床药理学与治疗学, 2010, 15(5): 524-529.

DING Hong, YAN Bo-hua, LIU Song-shan, YANG Ren-xu, ZHANG Rui-ming, ZENG Dai-wen, CHEN Yun-feng, LI Ming-quan, ZENG Jie-ping, LI Ji-shu, ZHOU Yi, HUANG Xiao-yan. A mutli-center randomized double-blind controlled trial on the functional difference between Fritillaria unibracteata Hsiao et K.C.Hsia and Fritillaria delavayi Ftanch in relieving acute bronchitis (heat phlegm cough)[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2010, 15(5): 524-529.

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