不同剂量的宝儿康散治疗小儿急性水样便腹泻病(脾虚湿困证)有效性和安全性的随机、双盲双模拟、阳性药平行对照、多中心临床试验  

Efficacy and safety of two different doses of Baoerkang Powder in treatment of acute watery diarrhea in children with syndrome of dampness stagnancy due to spleen deficiency: A randomized, parallel, positive-controlled, double-blind,double-dummy, multi-cen

作　　者：李晓璇 胡思源[1] 李新民[1] 冯伟 韩选明 谢晓丽 潘树强 徐桂萍[7] 湛治萍 全惜春 苏保玲[10] 杜永刚 刘玉凤[12] 马斯风 洪丽军 邵荣昌 王爱珍[16] 李学明[17] LI Xiaoxuan;HU Siyuan;LI Xinmin;FENG Wei;HAN Xuanming;XIE Xiaoli;PAN Shuqiang;XU Guiping;ZHAN Zhiping;QUAN Xichun;SU Baoling;DU Yonggang;LIU Yufeng;MA Sifeng;HONG Lijun;SHAO Rongchang;WANG Aizhen;LI Xueming(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;Heji Hospital Affiliated of Changzhi Medical College,Changzhi 046000,China;Changzhi People's Hospital,Changzhi 046000,China;The Fourth Hospital Affiliated of Liaoning University of Traditional Chinese Medicine,.Shenyang 110000,China;Daqing Chinese Medicine Hospital,Daqing 163000,China;Mudanjiang Chinese Medicine Hospital,Mudanjiang 157000,China;Ezhou Central Hospital,Ezhou 436000,China;Taizhou Traditional Chinese Medicine Hospital,Taizhou 225300,China;Handan Traditional Chinese Medicine Hospital,Handan 056000,China;Tianjin Binhai New Area Tanggu Women and Children's Health Care Center,Tianjin 300459,China;The Second Hospital Affiliated of University of South China,Hengyang 421001,China;The First Hospital Affiliated of Shanxi University of Traditional Chinese Medicine,Xianyang 712000,China;Chengdu Women and Children Center Hospital,Chengdu 610000,China;Qinzhou City Maternal and Child Health Hospital,Qinzhou 535000,China;Huizhou Traditional Chinese Medicine Hospital,Huizhou 516000,China;Guizhou Province Qiannan Buyi and Miao Autonomous Prefecture Chinese Medicine Hospital,Duyun 558000,China;Nanyang Traditional Chinese Medicine Hospital,Nanyang 473000,China)

机构地区：[1]天津中医药大学第一附属医院,天津300193 [10]长治医学院附属和济医院,山西长治046000 [11]长治市人民医院,山西长治046000 [12]辽宁中医药大学附属第四医院,辽宁沈阳110000 [13]大庆市中医医院,黑龙江大庆163000 [14]牡丹江市中医医院,黑龙江牡丹江157000 [15]鄂州市中心医院,湖北鄂州436000 [16]泰州市中医院,江苏泰州225300 [17]邯郸市中医院,河北邯郸056000 [2]天津市滨海新区塘沽妇女儿童保健中心,天津300459 [3]南华大学附属第二医院,湖南衡阳421001 [4]陕西中医药大学第二附属医院,陕西咸阳712000 [5]成都市妇女儿童中心医院,四川成都610000 [6]钦州市妇幼保健院,广西钦州535000 [7]惠州市中医医院,广东惠州516000 [8]贵州省黔南布衣族苗族自治州中医医院,贵州都匀558000 [9]南阳市中医院,河南南阳473000

出　　处：《药物评价研究》2018年第12期2160-2165,共6页Drug Evaluation Research

摘　　要：目的评价不同剂量宝儿康散对于小儿急性水样便腹泻病(脾虚湿困证)的疾病疗效、缩短病程作用和中医证候改善作用,同时观察临床应用的安全性。方法采用随机、双盲双模拟、阳性药平行对照、多中心临床试验的方法,16家医疗机构纳入受试者360例,按照1∶1∶1的比例随机分配为高剂量组、低剂量组、阳性对照药组(止泻灵颗粒)。分别给予不同的试药,疗程为3 d。观察疾病疗效、止泻时间、中医证候疗效、中医单项症状,并对其安全性进行评价。结果疾病疗效总有效率,高剂量组为87.29%,低剂量组为76.67%,阳性对照组为66.67%,3组组间比较差异有统计学意义(P<0.05),高剂量组优于低剂量组和阳性对照组。中位止泻时间,高剂量组与低剂量均为3 d,阳性对照组未观察到中位止泻时间,3组组间比较差异有统计学意义(P<0.05),高剂量组与低剂量组均短于阳性对照组。中医证候疗效的总有效率,高剂量组为92.37%,低剂量组为86.67%,阳性对照组为77.50%,3组组间比较差异有统计学意义(P<0.05),且高剂量组优于阳性对照组。中医单项症状(大便稀溏、便次增多、肢体困倦、神疲、食欲不振和面色少华)总有效率,3组组间比较差异有统计学意义,高剂量组均优于阳性对照组。试验过程中,共发生5例不良事件,其中低剂量组发生不良事件2例,发生率1.67%;阳性对照药组发生不良事件3例,发生率2.50%,研究者判断所有不良事件均与试验药物无关。结论加倍剂量宝儿康散治疗小儿急性水样便腹泻(脾虚湿困证),疗效优于原剂量宝儿康散和止泻灵颗粒,具有缩短腹泻病程、改善中医证候和中医单项症状的作用,且安全性良好。Objective To evaluate the efficacy and safety of two different doses of Baoerkang Powder in the treatment of acute watery diarrhea in children with the syndrome of dampness stagnancy due to spleen deficiency.Methods By the methods of randomized,double-blind,double-dummy,parallel,active-controlled,and multi-center clinical trail,a total of 168 patients were enrolled and randomly divided into 3 groups within the ratio of 1:1:1,including high dose group,low dose group and positive control group(Zhixie Ling Granules).The course of treatment was 3 d.The disease efficacy,anti-diarrheal time,traditional Chinese medicine syndrome efficacy,single symptom efficacy and the safety of the three different regimens were evaluated.Results The total effective rate of disease efficacy was 87.29% in the high dose group,76.67% in the low dose group and 66.67% in the positive control group.There was statistical difference among the three groups(P<0.05),and the high dose group was superior to the other two groups.The median anti-diarrheal time was remarkably shortened to 3 d in both the high dose group and the low dose group which wasn't observed in the positive control group.The total effective rate of traditional Chinese medicine syndrome efficacy in the high dose group(92.37%)was superior to the positive control group(86.67%),which was 77.50% in the low dose group.The single symptom efficacy in the high dose group was also superior to the positive control group(P<0.05),such as thin stool even like water,increased defecation frequency,etc.During the study,there were 2(1.67%)adverse event in the low dose group and 3(2.50%)adverse event in the positive control group.The researchers concluded that all the adverse events were unrelated to the test drug.Conclusion The efficacy of Baoerkang Powder in high dose in the treatment of acute watery diarrhea in children with the syndrome of dampness stagnancy due to spleen deficiency was superior to the positive control group(Zhixie Ling Granules)and Baoerkang Powder in low dose(the dosage of in

关 键 词：宝儿康散 止泻灵颗粒 随机对照试验 小儿腹泻病 

分 类 号：R969.4[医药卫生—药理学]