雅连、味连治疗急性感染性腹泻疗效差异性研究——分层区组、随机双盲、平行对照、多中心临床试验报告

A stratified blocked,mutli-center,randomized double-blind,and parallel controlled trial on the functional difference between Coptis deltoidea C.Y. Cheng et Hsiao and Coptis chinensis Franch.in curing acute infectious diarrhea

目的:比较不同基源黄连(雅连、味连)治疗急性感染性腹泻疗效差异,确定最能代表黄连清热燥湿、泻火解毒功效的基源种。方法:急性感染性腹泻(胃肠湿热证)的患者,随机分为2组。雅连组口服雅连提取物3 g,每日3次,味连组口服味连提取物3 g,每日3次,疗程3天。结果:共有130例受试者入组,其中味连组65例、雅连组65例;治疗3天后比较,两组疾病疗效差异无统计学意义(P<0.05),雅连与味连相当;治疗3天后比较,两组胃肠湿热证疗效差异无统计学意义(P<0.05),雅连与味连相当;治疗3天后比较,两组主证(大便次数)改善程度差异有统计学意义(P<0.05),雅连优于味连;味连组和雅连组均无不良事件发生。结论:雅连在改善大便次数方面优于味连;两种基源黄连中,雅连可能更能代表黄连清热燥湿、泻火解毒之功。

Objective： To compare the curative effect on acute infectious diarrhea of Yalian（Coptis deltoidea C.Y. Cheng et Hsiao） with Weilian（Coptis chinensis Franch.）, and to identify the most representative species of Huanglian in clearing heat and drying dampness, alleviating pathogenic fire and disintoxicating. Method： The patients with acute infectious diarrhea（gastrointestinal damp-heat syndrome） were randomly divided into two groups. Coptis deltoidea C.Y. Cheng et Hsiao group（Superfine powder of Coptis deltoidea C.Y. Cheng et Hsiao 3g, po, tid, for 3 days.） and Coptis chinensis Franch. group（Superfine powder of Coptis chinensis Franch. 3g, po, tid, for 3 days）. Result： 130 cases were included in the trial with 65 cases in Coptis deltoidea C.Y. Cheng et Hsiao group and 65 cases in Coptis chinensis Franch. group. After 3 days treatment, no statistical significance was found of the curative effect between two groups on acute infectious diarrhea（P〈0.05） which suggested that both groups had equivalent efficacy. After 3 days treatment, no statistical significance was observed of the effect between two groups on clearing gastrointestinal damp-heat syndrome（P〉0.05） which suggested that both groups had equivalent efficacy. Significant different was observed in the improvement of main symptoms such as increased defecation frequence between the two group（P〈0.05） which suggest that the curative effect of the Coptis deltoidea C.Y. Cheng et Hsiao group was better than the Coptis chinensis Franch. group. No severe adverse effect was observed in two groups. Conclusion： The Coptis deltoidea C.Y. Cheng et Hsiao has a better effect than the Coptis chinensis Franch. in reducing defecation frequence. Between both species, the Coptis deltoidea C.Y. Cheng et Hsiao may be more representative species of Huanglian in clearing heat and drying dampness, alleviating pathogenic fire and disintoxicating.