小儿复方鸡内金咀嚼片治疗小儿厌食症(脾胃不和证)多中心随机双盲对照研究  

Multi-center randomized double-blind controlled study on children′s anorexia (spleen-stomach disharmony) treated with Child Compound Endothelium Corneum

作　　者：王艳 仲丹丹[2] 冀晓华[3] 程艳波 高晓丹 郑艳梅[5] 赵莉[6] 李开为[7] WANG Yan;ZHONG Dan-dan;JI Xiao-hua;CHENG Yan-bo;GAO Xiao-dan;ZHENG Yan-mei;ZHAO Li;LI Kai-wei(Paediatrics in Henan Provincial People's Hospital,People's Hospital of Zhengzhou University,People's Hospital of Henan University,Zhengzhou 450003,China;Zhengzhou First People's Hospital,Zhengzhou 450004,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Beihai Hospital of Traditional Chinese Medicine,Beihai 536000,China;Taiyuan Maternal and Child Health Care Hospital,Taiyuan 030012,China;Shijiazhuang First Hospital,Shijiazhuang 050000,China;Huangshi Central Hospital,Huangshi 435000,China)

机构地区：[1]河南省人民医院儿科,郑州大学人民医院,河南大学人民医院,河南郑州450003 [2]郑州市第一人民医院,河南郑州450004 [3]中国中医科学院西苑医院,北京100091 [4]北海市中医医院,广西北海536000 [5]太原市妇幼保健院,山西太原030012 [6]石家庄市第一医院,河北石家庄050000 [7]黄石市中心医院,湖北黄石435000

出　　处：《中国中药杂志》2021年第9期2298-2303,共6页China Journal of Chinese Materia Medica

基　　金：国家卫计委药政司示范项目(Erke-sfxm-012)。

摘　　要：小儿复方鸡内金咀嚼片具有健脾开胃,消食化积的功效。现代研究证实其可发挥改善胃肠道动力不足,恢复生理性胃肠蠕动,增加胃肠道消化动力,增强食欲的药理作用。因此,为评价临床治疗小儿厌食症(脾胃不和证)的有效性及安全性而进行该试验。共选取符合纳排标准的厌食症患儿240例,随机分为试验组和对照组,每组120例。试验组予小儿复方鸡内金咀嚼片+儿脾醒颗粒模拟剂;对照组予儿脾醒颗粒+小儿复方鸡内金咀嚼片模拟剂,疗程均为21 d。治疗后2组食欲不振、食量减少的复常率、进食时间、体质量变化、中医证候疗效、单项症状疗效、微量元素Zn复常率相比无统计学差异,经非劣效检验,试验组疗效非劣于对照组。但小儿复方鸡内金咀嚼片对厌食患儿食量减少症状的改善作用优于对照组(P<0.05)。试验过程中2组不良事件和不良反应发生率亦无统计学差异。该试验证实小儿复方鸡内金咀嚼片治疗小儿厌食症(脾胃不和证)的疗效及安全性不劣效于儿脾醒颗粒,临床应用安全可靠。并且针对以食量减少为主要表现的厌食患儿,小儿复方鸡内金咀嚼片为更优选择,同时咀嚼片剂相较颗粒剂在临床上服用亦更为方便。因此,小儿复方鸡内金咀嚼片是治疗小儿厌食症(脾胃不和证)安全可靠且使用更为方便的药物。但该试验样本量较少,疗效结果只出现一个趋势,建议进一步开展大样本的临床研究,明确小儿复方鸡内金咀嚼片的临床优势。Child Compound Endothelium Corneum(CCEC)has the effects in invigorating the spleen and appetizing the appetite, and dissolving the accumulation of food. The recent studies have proved that it could improve gastrointestinal motility, restore physiological gastrointestinal peristalsis, increase gastrointestinal digestive motility, and enhance appetite. This trial aimed to evaluate its clinical efficacy and safety in the treatment of children′s anorexia(spleen-stomach disharmony). A total of 240 children with anorexia in line with the inclusion and exclusion criteria were selected and randomly divided into experimental group and control group, with 120 in each group. Patients in the experimental group took CCEC and Erpixing Granules simulant. Patients in the control group took Erpi-xing Granules and CCEC simulant. After 21 days of treatment, there was no statistical difference in the recovery rate of anorexia, reduced food intake, eating time, weight change, traditional Chinese medicine syndrome effect, single symptom effect, and trace element Zn recovery rate between the two groups. Based on the non-inferiority test, the experimental group was not inferior to the control group in efficacy. How-ever, the effect of CCEC in reducing appetite in children with anorexia was better than that of control drugs(P<0.05). There was no statistical difference in the incidence of adverse events and adverse reactions between the two groups during the trial. This experiment confirmed the efficacy and safety of CCEC in the treatment of children′s anorexia(spleen-stomach disharmony), with a safety and re-liability in clinical application. In addition, it was a better choice for children with anorexia who were mainly manifested by reduced appetite. Meanwhile, compared with granule, chewable tablets were more convenient to take in clinic. Therefore, the efficacy and safety of CCEC for the treatment of children′s anorexia(spleen-stomach disharmony) were not inferior to those of Erpixing Granules, with a safety and reliability in c

关 键 词：厌食症 脾胃不和 食欲不振 食量减少 小儿复方鸡内金咀嚼片 

分 类 号：R272[医药卫生—中医儿科学]