复方丁香开胃贴治疗儿童功能性腹痛脾胃虚寒证上市后再评价  

Post-marketing revaluation of Compound Dingxiang Kaiwei Paste in treatment of functional abdominal pain with deficient cold of spleen and stomach syndrome in children

作　　者：郭恒昌 胡思源[1] 李新民[1] 白晓红[2] 韩子明[3] 徐辉甫[4] 李学明[5] 梁彩桃 蔡建新[7] 赖维阳 潘树强 刘平定 温凤[11] 马立吉 蔡秋晗 伍戈 GUO Hengchang;HU Siyuan;LI Xinmin;BAI Xiaohong;HAN Ziming;XU Huifu;LI Xueming;LIANG Caitao;CAI Jianxin;LAI Weiyang;PAN Shuqiang;LIU Pingding;WEN Feng;MA Liji;CAI Qiuhan;WU Ge(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;Maternal and Child Health Care Hospital ofWeinan,Weinan 714000,China;Changchun Children's Hospital,Changchun 130061,China;Central HospitaI ofZibo,Zibo 255000,China;Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110032,China;The First Affiliated Hospital of Xinxiang Medical College,Xinxiang 453100,China;Wuhan Hospital Integrated Traditional Chinese and Western Medicine,Wuhan 430022,China;Handan Hospital of Traditional Chinese Medicine,Handan 056000,China;Shaaxi Lu'an Mining (Group)Co.,Ltd.General Hospital,Changzhi 046204,China;Wuhan hospital of Traditional Chinese Medicine,Wuhan 430014,China;Affiliated Hospital of Hebei Engineering University,Handan 056002,China;Maternal and Child Health Care Hospital of Qinzhou,Qinzhou 535000,China)

机构地区：[1]天津中医药大学第一附属医院,天津300193 [2]辽宁中医药大学附属医院,辽宁沈阳110032 [3]新乡医学院第一附属医院,河南新乡453100 [4]武汉市中西医结合医院,湖北武汉430022 [5]邯郸市中医院,河北邯郸056000 [6]潞安矿业(集团)有限责任公司总医院,山西长治046204 [7]武汉市中医医院,湖北武汉430014 [8]河北工程大学附属医院,河北邯郸056002 [9]钦州市妇幼保健院,广西钦州535000 [10]渭南市妇幼保健院,陕西渭南714000 [11]长春市儿童医院,吉林长春130061 [12]淄博市中心医院,山东淄博255000

出　　处：《药物评价研究》2018年第12期2166-2170,共5页Drug Evaluation Research

摘　　要：目的评价复方丁香开胃贴治疗儿童功能性腹痛脾胃虚寒证的有效性及安全性。方法采用随机双盲、安慰剂平行对照、多中心的方法。计划纳入240例患儿,按照1:1的比例随机分为试验组和对照组。两组分别外用复方丁香开胃贴、模拟贴,疗程2周。结果共纳入239例患儿,230例进入全分析数据(FAS)集,217例进入符合方案数据(PPS)集,238例进入安全数据(SS)集。两组治疗第2周的腹痛发作天数平均值分别为1.600、2.026,经协方差分析,差异有统计学意义(P=0.0070),且试验组优于对照组。两组腹痛程度的改善率分别为80.00%、67.83%,中医证候有效率分别为86.09%、59.13%,组间比较,差异均有统计学意义(P=0.0355、 0.0001),试验组也优于对照组的。试验组发现不良事件9例(7.63%),对照组10例(8.33%);判断为不良反应者,试验组4例(3.39%),对照组3例(2.50%),均表现为皮肤刺激症状。不良事件、不良反应的组间比较,差异均无统计学意义。结论复方丁香开胃贴治疗儿童功能性腹痛脾胃虚寒证,可以减少腹痛发作天数,改善腹痛程度及中医证候,且安全性好。Objective To reevaluate the clinical efficacy and safety of Compound Dingxiang Kaiwei Paste in the treatment of syndrome of deficient cold of spleen and stomach in children with functional abdominal pain.Methods A random,double-blind,placebo parallel controll and multi-centered observational clinical approach were used.The tir al intended to include 240 paients,who were randomly divided into treatment group and control group according to 1:1 ratio.The treatment group was given Compound Dingxiang Kaiwei Paste and the control group with placebo for 2 weeks.Results A total of 239 patients were assigned to this study,and 230 of which entered full analysis set.Totally 217 patients were fitted in per-protocol set and 238 in safety set.The frequency of abdominal pain in the second week,the treatment group and the control group were 1.600 and 2.026(covariance analysis,P=0.0070),respectively.Improvement rate of the intensity of abdominal pain in the second week were 80.00% and 67.83%(P=0.0355),respectively.And the effective rate of traditional Chinese medicine(TCM)syndromes were 86.09% and 59.13%(P=0.001),respectively.In this clinical trial,there were 9 cases(7.63%)of adverse events were reported in the treatment group and 10 cases(8.33%)in the control group(P >0.05).Four cases(3.39%)in the treatment group and 3 cases(2.50%)in the control group were judged by investigators as adverse reaction(P >0.05).Conclusion Compound Dingxiang Kaiwei Paste can reduce the frequency and the duration of abdominal pain and improve TCM syndromes functional abdominal pain with deficient cold of spleen and stomach syndrome in children,and the security is good.

关 键 词：复方丁香开胃贴 儿童 功能性腹痛 脾胃虚寒证 上市后临床再评价 

分 类 号：R969.4[医药卫生—药理学]