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目的:制备口溃宁颗粒并观察其在50例复发性口腔溃疡(recurrent aphthous ulcer,RAU)患者中的治疗效果。方法:以传统中医药理论为指导,处方由黄连、黄芩等纯中药组成,采用湿法制粒工艺制备成口溃宁颗粒。将中医辨证为心火亢盛型RAU且符合标准的100例门诊患者按1∶1比例随机分为治疗组和对照组,治疗组患者饭后口服口溃宁颗粒,每天3次,每次1袋,10 d为1个疗程。1个疗程结束后休息3 d,再服1个疗程;对照组口服维生素C、复合维生素B2,用药2个疗程。观察治疗效果,采用SPSS11.5软件包对数据进行统计学分析。结果:该品种制备工艺操作可控,质量稳定,对RAU的治疗总有效率为88.0%,与对照组相比有显著差异。结论:口溃宁颗粒的制备方法简便易行,质量稳定可控,对于心火亢盛型RAU临床疗效确切,有较大的临床应用价值。
Objective: To prepare Koukui ning granules and observe its curative effect in 50 patients with recurrent aphthous ulcer (RAU). Methods: Guided by the traditional Chinese medicine theory, the prescription consisted of pure Chinese herbs such as Coptis chinensis and Scutellaria baicalensis Georgi. 100 cases of outpatients diagnosed as heart-heart-hyperactive RAU with standard of TCM syndrome differentiation were randomly divided into treatment group and control group according to the ratio of 1: 1. The patients in treatment group were given oral Cunninghamine granules 3 times a day Bag, 10 d for a course of treatment. 1 rest after a course of treatment 3 d, then take a course of treatment; the control group oral vitamin C, vitamin B2, medication 2 courses. Observed the treatment effect, using SPSS11.5 software package for statistical analysis of the data. Results: The preparation process was controlled and the quality was stable. The total effective rate of RAU treatment was 88.0%, which was significantly different from the control group. Conclusion: The preparation method of Koukui-ning Granule is simple and easy, the quality is stable and controllable, and it has definite clinical value for the clinical treatment of RAH-RAU. It has great clinical value.