大柴胡颗粒治疗慢性胆囊炎肝胆郁热证的临床研究  

Clinical Research on Dachaihu Granule in Treating Chronic Cholecystitis Due to Stagnant Heat in Liver and Gallbladder

作　　者：陈静[1] 沈洪[1] 林越汉[2] 廖恒祥[3] 江一平[4] 王垂杰[5] 金小晶[6] 苏娟萍[7] 邵凤珍[8] 邹建东[1] 刘芳[1] CHEN Jing SHEN Hong LIN Yue-han LIAO Heng-xiang JIANG Yi-ping WANG Chui-jie JIN Xiao-jing SU Juan-ping SHAO Feng-zhen ZOU Jian-dongI LIU Fang(Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, 210029, China Fujian Research Institute of Traditional Chinese Medicine, Fuzhou, 350003, China Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, 430061, China The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang, 330000, China The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shen yang , 110000, China Nanjing City Hospital of Traditional Chinese Medicine, Nanjing, 210000, China Shanxi Research Institute of Traditional Chinese Medicine, Taiyuan, 030000, China The First Affiliated Hospital of Tianjin University of Tra- ditional Chinese Medicine, Tianjin, 300000, China)

机构地区：[1]南京中医药大学附属医院,江苏南京210029 [2]福建中医药大学附属人民医院,福建福州350003 [3]湖北省中医院肝胆外科,湖北武汉430061 [4]江西中医药大学附属医院,江西南昌330000 [5]辽宁中医药大学附属医院,辽宁沈阳110000 [6]南京市中医院消化科,江苏南京210000 [7]山西省中医药研究院脾胃病科,山西太原030000 [8]天津中医药大学第一附属医院,天津300000

出　　处：《南京中医药大学学报》2017年第4期354-358,共5页Journal of Nanjing University of Traditional Chinese Medicine

基　　金：国家食品药品监督管理资助项目(2003L04434)

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(P<0.05~0.01)。(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。OBJECTIVE To evaluate the validity and safety of Dachaihu Granule in treating chronic cholecystitis due to Stag- nant Heat in Liver and Gallbladder. METHODS A stratified-block randomized, double-blind, double-dummy, parallel, place- bo-controlled trial was designed, with 600 cases with chronic eholeeystitis from 8 centers being selected and the ratio of treat- ment group, placebo group and cholagogic tablet group being 360 ： 120 . 120. Patients in different groups were separately giv- en Dachaihu Granule and eholagogie tablet simulator, Dachaihu Granule simulator and cholagogie tablet simulator, Daehaihu Granule simulator and cholagogic tablet. Then the validity and safety were assessed after 7 days＂ treatment. RESULTS OIn terms of the comprehensive curative effect of TCM syndromes, it was noticed that there existed no difference between the treatment group and positive medicine group in the integral reduction and disappearance of upper quadrant pain and tenderness, quadrant pain relief evaluated by patients, total symptom scores, integral reduction and disappearance of bitter taste, thirst, constipation and yellow urine, disappearance of vomit, change of gallbladder wall thickness and ultrasonic Murphy＇s character before and after the treatment, while both the treatment group and positive medicine group were superior to the placebo group （P〈0.05-0.01）. ②The treatment group and positive medicine group has no difference from the placebo group in integral re- duction and disappearance o ffever and nausea integral reduction of vomit, change of gallbladder size and inside diameter of common bile duct. ③Good safety was noticed. CONCLUSION Chronic cholecystitis due to stagnant heat in liver and gallblad- der treated by Dachaihu Granule is safe and effective.

关 键 词：慢性胆囊炎 胆腑郁热证 大柴胡颗粒 利胆片 临床研究 

分 类 号：R256.43[医药卫生—中医内科学]