口服中成药治疗小儿厌食的临床概况性评价

Clinical Study of Oral Chinese Patent Medicine in the Treatment of Anorexia in Children:A Scoping Review

目的:明确口服中成药治疗小儿厌食的临床研究进展和目前存在的问题。方法:检索药智数据库、国家重要药物目录和中英文相关数据库,获得治疗小儿厌食的口服中成药,同时检索中英文数据库,采用概况性综述方法,结合可视化图表对中成药的药物组成、功能主治、文献基本特征、干预措施、结局指标、说明书儿童用法用量进行综合分析与评价。结果:研究纳入的64种中成药药味频次出现较多的为山楂、麦芽、陈皮、茯苓、山药等,与小儿厌食的基本治则运脾开胃相对应。在纳入的217篇临床研究中,31.38%为中成药和其他中医治疗相比较,说明中医药对于本病治疗有一定的优势。结局指标主要包括治疗前后血红蛋白、微量元素、食欲和(或)食量变化、体重和(或)身高和(或)BMI变化、临床疗效总有效率、不良反应、中医证候积分、症状积分/改善等。关于治疗前后胃肠激素变化的相关研究尚缺少。进入临床研究的中成药,53.95%说明书无明确儿童用法用量,一部分由研究者自行根据年龄段用药,一部分不根据年龄段用药。结论:近年来口服中成药治疗小儿厌食的临床研究逐渐增加,但仍存在不同程度的不规范用药,未来需要开展更规范的临床试验,为完善说明书儿童用法用量提供依据,为儿童的健康成长提供保障。

Objective To clarify the clinical research progress and existing problems of oral Chinese patent medicine in the treatment of anorexia in children.Methods To obtain oral Proprietary Chinese medicines for the treatment of anorexia in children,pharmacognosy database,National List of Important Drugs and Relevant Databases in Both Chinese and English were searched.Combined with visual charts,the composition,functions and indications of Proprietary Chinese medicines,basic literature characteristics,intervention measures,outcome indicators,and whether the instructions have specific usage and dosage for children were comprehensively analyzed and evaluated.Results Shanzha,Maiya,Chenpi,Fuling,Shanyao and so on appeared more frequently in the 64 kinds of Chinese patent medicines included in the study,which was corresponding to the basic treatment of children anorexia,spleen and appetite.Of the 217 clinical studies included,31.38%were proprietary Chinese medicines compared with other TCM treatments,indicating that TCM has certain advantages in the treatment of this disease.The outcome indicators mainly included hemoglobin,trace elements,changes in appetite and/or food intake,changes in body weight and/or height and/or BMI,total effective rate of clinical efficacy,adverse reactions,TCM syndrome score and symptom score/improvement before and after treatment.Studies on gastrointestinal hormone changes before and after treatment are still lacking.For 53.95%of Chinese patent medicines entered into clinical studies,the instructions did not specify the usage and dosage of children.Some of them were used by researchers according to their age,and some were not.Conclusion In recent years,the clinical studies of oral Chinese patent medicine in the treatment of anorexia in children have gradually increased,but there are still different degrees of non-standard drug use,the future needs to carry out more standardized clinical trials,to provide a basis for improving the use and dosage of children's instructions,to provide protection for the healthy growth of children.