大柴胡颗粒治疗慢性胆囊炎肝胆郁热证的临床研究

发布时间：2018-11-13 16:02

【摘要】：目的评价大柴胡颗粒治疗慢性胆囊炎胆腑郁热证的有效性、安全性。方法采用分层区组随机、双盲、安慰剂及阳性药对照法,选取8个中心慢性胆囊炎患者600例,试验组∶安慰剂组∶利胆片组为360∶120∶120例。分别口服大柴胡颗粒及利胆片模拟剂、大柴胡颗粒模拟剂及利胆片模拟剂、大柴胡颗粒模拟剂及利胆片,7d后进行疗效及安全性评价。结果 (1)中医证候综合疗效;右上腹部疼痛记分减少分布情况及消失率;患者对右上腹疼痛缓解的评价;症状总积分;口苦、口渴、大便秘结、小便黄记分减少分布情况及阳性症状消失率、呕吐症状消失率、超声莫菲氏征变化,试验组与阳性药组无差异,试验组、阳性药组均优于安慰剂组(P0.05~0.01)。(2)发热、恶心治疗后记分减少分布情况及阳性症状消失率、呕吐记分减少分布情况,试验组、阳性药组与安慰剂组无显著性差异。(3)安全性良好。结论大柴胡颗粒治疗慢性胆囊炎胆腑郁热证安全有效。
[Abstract]:Objective to evaluate the efficacy and safety of Dachaihu granule in the treatment of chronic cholecystitis. Methods 600 patients with chronic cholecystitis in 8 centers were randomly divided into two groups: placebo group, double-blind group, placebo group and positive drug control group. Dachaihu granules and Lidan tablets, Dachaihu granules and Lidan tablets were taken orally respectively. The efficacy and safety were evaluated 7 days later. Results (1) the comprehensive curative effect of TCM syndromes, the distribution and disappearance rate of right epigastric pain score, the evaluation of the relief of right epigastric pain, the total score of symptoms; Bitter mouth, thirst, constipation, yellow score of urine decreased the distribution and the rate of disappearance of positive symptoms, the disappearance rate of vomiting symptoms, the change of Mofie's sign of ultrasound, there was no difference between the test group and the positive drug group, the test group, The positive drug group was superior to the placebo group (P0.050.01). (2) in fever, the distribution of score and the disappearance rate of positive symptoms were decreased after nausea treatment, and the score of vomiting was decreased in the trial group. There was no significant difference between the positive group and the placebo group. (3) the safety was good. Conclusion Dachaihu granule is safe and effective in the treatment of chronic cholecystitis.
【作者单位】：南京中医药大学附属医院;福建中医药大学附属人民医院;湖北省中医院肝胆外科;江西中医药大学附属医院;辽宁中医药大学附属医院;南京市中医院消化科;山西省中医药研究院脾胃病科;天津中医药大学第一附属医院;
【基金】：国家食品药品监督管理资助项目(2003L04434)
【分类号】：R259

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