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

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)

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2g,口服,每日3次,疗程5d。梭砂贝母组108例,采用梭砂贝母超细粉2g,口服,每日3次,疗程5d。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。

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.