琥珀消石颗粒治疗胆石症肝胆湿热、气血瘀滞证的临床研究  

Clinical Study on Hupo Xiaoshi Granule in the Treatment of Cholelithiasis with Liver and Gallbladder Damp-Heat and Qi-Blood Stagnation Syndrome

作　　者：陈静[1] 孙云霞[1] 沈洪[1] 刘芳[1] 邹建东[1] 周万辉[2] CHEN Jing;SUN Yun-xia;SHEN Hong;LIU Fang;ZOU Jian-dong;ZHOU Wan-hui(Affiliated Hospital of Nanjing University of Traditional Chinese Medicine,Nanjing 210029,China;Shandong Wohua Pharmaceuticals Co.,Ltd.,Weifang 261011,China)

机构地区：[1]南京中医药大学附属医院,南京210029 [2]山东沃华医药科技股份有限公司,潍坊261011

出　　处：《中国合理用药探索》2020年第11期34-38,共5页Chinese Journal of Rational Drug Use

摘　　要：目的:评价琥珀消石颗粒治疗胆石症肝胆湿热、气血瘀滞证的有效性和安全性。方法:从6家医院选取218例胆石症患者,根据分层区组、随机双盲、平行对照法分为试验组(113例)和对照组(105例),在常规治疗(低脂、低蛋白饮食、忌酒、忌饱餐)的基础上,对照组加用安慰剂治疗、试验组加用琥珀消石颗粒治疗,4周后进行疗效及安全性评价。结果:排石疗效方面,试验组总有效率(58. 41%)高于对照组(24. 76%),有显著统计学差异(P <0. 01)。症状治疗方面,试验组治疗后疼痛发作次数、疼痛程度、疼痛消失情况,以及纳差、嗳气、便秘、恶心、口苦、尿黄各指标评分优于对照组,均有统计学差异(P <0. 01)。安全性方面,两组均未发生不良反应及不良事件。结论:琥珀消石颗粒治疗胆石症具有一定的安全性和治疗效果,可推广。Objective:To evaluate the efficacy and safety of Hupo Xiaoshi granule in the treatment of cholelithiasis with liver and gallbladder dampness and Qi stagnation syndrome.Methods:According to the randomized,double-blind,parallel control method of stratified block,218 patients from 6 hospitals with cholelithiasis were selected and divided into experimental group(113 patients)and control group(105 patients).Based on the conventional therapy(low-fat,low-protein diet,avoid alcohol,prohibition of overeating),control group was provided with additional placebo and experimental group with additional amber stone particles.Efficacy and safety evaluation were carried out after 4 weeks of treatment.Results:In terms of the removal of urinary calculus,the total effective rate of the experimental group and the control group were 58.41%and 24.76%,respectively(P<0.01).In terms of symptomatic treatment,the number of pain episodes,pain degree,pain disappearance,hernia,constipation,nausea,bitter taste and yellow urine in the experimental group were better in the experimental group than those in the control group(P<0.01).Conclusion:Hupo Xiaoshi granule has certain safety and therapeutic effect in the treatment of cholelithiasis,and is worthy of promotion.

关 键 词：胆石症 肝胆湿热 气血瘀滞 琥珀消石颗粒 临床研究 

分 类 号：R979.9[医药卫生—药品]