摘要
目的:评价王氏保赤丸治疗儿童功能性消化不良症状与积滞脾虚夹积证候改善作用,以及临床应用的安全性。方法:采用随机、双盲、阳性药平行对照、多中心、非劣效检验的设计方法。11家中心共入选236例患者,试验组、对照组各118例。两组分别服用王氏保赤丸+双歧杆菌三联活菌散模拟剂、双歧杆菌三联活菌散+王氏保赤丸模拟剂,疗程2周。结果:试验组和对照组功能性消化不良(FD)症状综合有效率分别为90. 27%和86. 73%(FAS),率差的95%CI为3. 54%(-4. 78%,11. 86%),提示试验组不劣于对照组(P=0. 436)。其他次要指标包括中医证候疗效、FD单项症状疗效的组间比较差异均无统计学意义。本次研究共报告7例次临床不良事件,试验组3例(2. 56%),对照组4例(3. 39%),两组不良事件发生率比较差异无统计学意义。结论:王氏保赤丸治疗FD疾病症状的综合有效率非劣于对照药双歧杆菌三联活菌散,且能改善中医证候,临床应用安全性较好。
Objective:To evaluate the efficacy and clinical safety of WangshiBaochi Pills in the treatment of functional dyspepsia and stagnant spleen deficiency with food retention syndrome in children.Methods: Random,double-blind,positive-drug parallel control,multi-centered design and non-inferiority test were used in this study.A total of 236 patients from 11 centers were divided into two groups,with 118 in each.The control group was given WangshiBaochi Pills for 2 weeks,while the experimental group was given Bifid Triple Viable powder for the same duration.Results:The effective rates of the experimental and control group were 90.27% and 86.73% (FAS),respectively,and the difference between groups was 3.54% (95% CI:-4.78%,11.86%), which indicated that the efficacy of the experimental group was not inferior to that of the control group (P = 0.436).There was no significance difference in the TCM syndrome curative effect and individual syndromes curative effect between the two groups.Seven adverse events were reported,including 3 cases (2.56%) in the experimental group and 4 cases (3.39%) in the control group.There was no significant difference in AE occurrence rates.Conclusion:WangshiBaochi pills is not inferior to Bifid Triple Viable Powder in effective rate for functional dyspepsia in children and can improve the TCM syndromes,with desirable safety in clinical use.
作者
胡思源
马融
光军秀
冯自威
徐辉甫
李学明
白晓红
马清平
向希雄
朱凤莲
李微微
刘平定
蔡建新
张卉
HU Si-yuan;MA Rong;GUANG Jun-xiu;FENG Zi-wei;XU Hui-fu;LI Xue-ming;BAI Xiao-hong;MA Qing-ping;XIANG Xi-xiong;ZHU Feng-lian;LI Wei-wei;LIU Ping-ding;CAI Jian-xin;ZHANG Hui(First Teaching Hospital of Tianjin University of TCM,Tianjin 300193,China;Weinan Maternal and Child Health Hospital,Weinan 714000,China;Wuhan Hospital of Traditional Chinese Medicine,Wuhan 430014,China;Affiliated Hospital of Shanxi University of Traditional Chinese Medicine,Xianyang 712000,China;Luohe Hospital of Chinese Medicine,Luohe 452000,China;Wuhan Hospital of Traditional ChineseAnd Western Medicine,Wuhan 430022, China;Handan Hospital of Chinese Medicine,Handan 056000 China;Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110032,China;Affiliated Hospital of Hebei University of Engineering Handan 056002,China;Hubei Provincial Hospital of TCM Wuhan 430061,China;The First AffiliatedHospital of Xinxiang Medical University Xinxiang 453100,China;TCM Hospital of Harbin Hospital, Harbin 150076,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2019年第2期179-183,共5页
Chinese Journal of New Drugs
关键词
王氏保赤丸
儿童功能性消化不良
积滞
脾虚夹积证
临床研究
WangshiBaochi Pills
pediactirc functional dyspepsia
stagnant
spleen deficiency with foodretention syndrome
clinical trial
