To assess the efficacy and safety of Gastrosis No.1 compound in the treatment of functional dyspepsia with Spleen （Pi） and Stomach （Wei） deficiency-cold syndrome. Methods： A randomized, double-blind, placebo-cont...To assess the efficacy and safety of Gastrosis No.1 compound in the treatment of functional dyspepsia with Spleen （Pi） and Stomach （Wei） deficiency-cold syndrome. Methods： A randomized, double-blind, placebo-controlled trial was performed in 5 centers. Patients with functional dyspepsia （FD） of Spleen-deficiency and qi-stagnation syndrome （162 cases） were randomly assigned to groups given Chinese herbal medicine （CHM） Gastrosis No.1 compound or placebo in a 2：1 ratio. This trial included a 4-week treatment period and a 4-week follow-up period. The outcomes were the dyspepsia symptom scores （measured by total dyspepsia symptom scale and single dyspepsia symptom scale） and syndromes of traditional Chinese medicine score （measured by traditional Chinese medicine syndrome scale）. The outcomes were noted at weeks 0, 4 and 8. Results： Compared with patients in the placebo group, patients in the CHM group showed significant improvement in the dyspepsia symptom scores as rated by patients and investigators （P〈0.01）, and also showed improvement in syndromes of traditional Chinese medicine score （P〈0.01）. No serious adverse event was reported. Safety tests obtained after 4 weeks of treatment showed no abnormal values. Conclusion： CHM Gastrosis No.1 compound was effective and safe in the treatment of functional dyspepsia with Spleen and Stomach deficiency-cold syndrome.展开更多
目的探究功能性消化不良的中医辨证分型及用药规律,为该病的中医治疗提供参考。方法检索中国知网(CNKI)、万方数据库(Wangfang)、维普数据库(VIP)、PubMed、Web of Science数据库中有关中医药治疗功能性消化不良的临床研究文献,收集中...目的探究功能性消化不良的中医辨证分型及用药规律,为该病的中医治疗提供参考。方法检索中国知网(CNKI)、万方数据库(Wangfang)、维普数据库(VIP)、PubMed、Web of Science数据库中有关中医药治疗功能性消化不良的临床研究文献,收集中药复方,建立数据库,使用Excel 2019、Clementine 12.0和SPSS 21.0对功能性消化不良的中医证型、中药使用频次、功效分类、性味归经进行频次统计,并对高频药物进行关联规则分析、因子分析和聚类分析。结果共纳入文献428篇,提取处方442首,涉及中药225味,高频药物24味,其中党参、茯苓、陈皮、柴胡的使用频次最多,功效分类以补虚药、理气药最为常见,药性以温为主,药味以苦、辛、甘为主,多归脾、肺、胃经;关联规则分析得到20种药物组合,因子分析提取了9个公因子,聚类分析可将药物分为4类。功能性消化不良肝胃不和证最多,对其进行关联规则分析得到12种药物组合,因子分析提取了3个公因子,聚类分析可将药物分为2类。结论中医临床治疗功能性消化不良以益气健脾、疏肝行气药为主,甘温补虚、辛开苦降,辨证配伍化湿、解表、清热等药物。展开更多
基金Supported by the Eleventh Five-Year National Key Technology R&D Program(No.2007BAI20B092)
文摘To assess the efficacy and safety of Gastrosis No.1 compound in the treatment of functional dyspepsia with Spleen （Pi） and Stomach （Wei） deficiency-cold syndrome. Methods： A randomized, double-blind, placebo-controlled trial was performed in 5 centers. Patients with functional dyspepsia （FD） of Spleen-deficiency and qi-stagnation syndrome （162 cases） were randomly assigned to groups given Chinese herbal medicine （CHM） Gastrosis No.1 compound or placebo in a 2：1 ratio. This trial included a 4-week treatment period and a 4-week follow-up period. The outcomes were the dyspepsia symptom scores （measured by total dyspepsia symptom scale and single dyspepsia symptom scale） and syndromes of traditional Chinese medicine score （measured by traditional Chinese medicine syndrome scale）. The outcomes were noted at weeks 0, 4 and 8. Results： Compared with patients in the placebo group, patients in the CHM group showed significant improvement in the dyspepsia symptom scores as rated by patients and investigators （P〈0.01）, and also showed improvement in syndromes of traditional Chinese medicine score （P〈0.01）. No serious adverse event was reported. Safety tests obtained after 4 weeks of treatment showed no abnormal values. Conclusion： CHM Gastrosis No.1 compound was effective and safe in the treatment of functional dyspepsia with Spleen and Stomach deficiency-cold syndrome.
