雅连、味连治疗复发性口疮疗效差异性——分层区组、随机双盲、平行对照、多中心临床试验报告  

Mutli-center Randomized Double-blind Controlled Trial on Functional Difference between Coptis deltoidea and Coptis chinensis in Relieving Recurrent Aphthae

作　　者：曾洁萍[1] 丁红[1] 阎博华[1] 张瑞明[2] 张蓉[3] 左渝陵[3] 张庆[4] 刘松山[1] 李明权[1] 李继书[5] 周宜[5] 

机构地区：[1]四川省中医医院GCP中心,成都610075 [2]四川大学华西医院GCP中心,成都610041 [3]成都市第五人民医院口腔科,成都611130 [4]成都市第五人民医院消化科,成都611130 [5]成都中医药大学基础医学院,成都610072

出　　处：《中国实验方剂学杂志》2011年第20期265-268,共4页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家"十一五"科技支撑计划(2007BAI40B06)

摘　　要：目的:比较不同基源黄连(雅连、味连)治疗复发性口疮疗效差异,确定最能代表黄连清热燥湿、泻火解毒功效的基源种。方法:复发性口疮(心胃热盛证)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7 d。结果:①共有131例受试者入并完成试验,其中味连组65例、雅连组66例。②治疗7 d后比较,两组疾病疗效差异有统计学意义(P<0.05),雅连优于味连;③治疗7 d后比较,两组心胃热盛证疗效差异有统计学意义(P<0.05),雅连优于味连。④治疗7 d后比较,两组主证(口疮疼痛、口疮溃疡大小)改善程度差异有统计学意义(P<0.05),雅连优于味连。⑤味连组和雅连组均无不良事件发生。结论:雅连在口疮疗效、心胃热盛证疗效以及改善口疮疼痛、口疮溃疡大小症状方面优于味连。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 with the different species of Chuan Fritillaria（Coptis deltoidea and Coptis chinensis）,and to identify the most effective species in clearing heat and drying damp.Method： Patients with recurrent aphthae（the syndrome of excessive heat in heart and stomach） were included and randomized into the C.deltoidea group（superfine powder of C.deltoidea 3 g,po,tid,for 7 days.） and C.chinensis group（superfine powder of C.chinensis 3 g,po,tid,for 7 days）.Result： ①131 patients entered the trial,66 cases in C.deltoidea group,65 cases in C.chinensis group.After 7 days of treatment.② The curative effect of the C.deltoidea group in relieving recurrent aphthae is better than the C.chinensis group（P0.05）.③The curative effect of the C.deltoidea group in relieving drying dampness is better than the C.chinensis group（P0.05）.④The changes in main symptoms such as aphthous pain and the area of aphthous ulcer were significantly different between the two group（P0.05）.⑤No severe adverse effect was observed in two groups.Conclusion： The C.deltoidea may have a better effect than the C.chinensis in relieving recurrent aphthae,and in remedying the syndrome of excessive heat in heart and stomach,also in attenuating pain and reducing the area of aphthous ulcer.The species of C.deltoidea is more effective in clearing heat and drying dampness,alleviating pathogenic fire and deoxication than the species of C.chinensis.

关 键 词：基源 雅连 味连 泻火燥湿 泻火解毒 

分 类 号：R287[医药卫生—中药学]