中成药治疗儿童消化系统疾病临床研究证据的概况性综述

Scoping review of clinical evidence of Chinese patent medicines for digestive system diseases in children

该研究采用概况性综述对治疗儿童消化系统疾病中成药的基本信息和临床研究证据进行分析报告。通过检索三大药物目录,基于药品说明书,获得治疗儿童消化系统疾病中成药的基本信息。同时检索中、英文数据库获得相关临床研究文献,检索时间从建库至2022年3月7日。根据纳入、排除标准进行筛选,最终纳入39种中成药,涉及8种剂型,所含高频中药有山楂、茯苓、陈皮、麦芽、槟榔、六神曲、山药、白术等,功效以健脾、止泻、消食、清热、和胃等为主。中成药适应症主要为小儿腹泻、小儿厌食、小儿食积、消化不良以及小儿轮状病毒肠炎等,其中仅4种药品说明书中提及了不良反应,6种提及了服用禁忌。纳入临床研究92篇,包括随机对照研究84篇、系统评价与Meta分析2篇、回顾性研究1篇、病例系列5篇。文献仅涉及21种中成药,以醒脾养儿颗粒相关研究最多,占总文献量的32.6%;样本量主要集中在51~200例,以51~100例的文献最多(34.45%);试验组干预措施主要为中成药或中成药联合西药;疗程以0~7 d的文献量占比最大(51.10%);结局指标以有效率和症状改善时间为主;不良反应主要有呕吐、便秘、恶心、皮疹、感冒、腹泻、脐周皮肤发红或皮肤红痒等。研究结果发现中成药治疗儿童消化系统疾病有较好的治疗优势和研究前景,但目前多数临床研究证据存在结局指标较为局限、缺少中医药特色,各种中成药相关文献量不均、质量不高,说明书信息不规范等问题。未来应积极开展高质量的临床研究,并加强药品经济性与临床综合评价,探索治疗特色和优势,为找准临床定位,促进治疗儿童消化系统疾病中成药的临床合理运用提供决策依据。

This study analyzed and reported the basic information and clinical evidence of Chinese patent medicines for digestive system diseases in children in a scoping review manner.Based on the drug instructions,the basic information of Chinese patent medicines for digestive system diseases in children was obtained by searching the three lists of national medicines.At the same time,the relevant clinical literatures from the first day of establishment to March 7,2022 were obtained from Chinese and English databases.According to the screening criteria,39 Chinese patent medicines were included,involving 8 dosage forms.Eight Chinese medicines including Crataegi Fructus,Poria,Citri Reticulatae Pericarpium,Hordei Fructus Germinatus,Arecae Semen,Massa Medicata Fermentata,Dioscoreae Rhizoma,and Atractylodis Macrocephalae Rhizoma were frequently used,and the main effects were invigorating spleen,checking diarrhea,promoting digestion,clearing heat,and harmonizing stomach.The indications for Chinese patent medicines were mainly diarrhea,anorexia,food accumulation,dyspepsia,and rotavirus enteritis in children.Among all drug instructions,only 4 mentioned adverse reactions and 6 mentioned contraindications.Ninety-two clinical studies were included ultimately,including 84 randomized controlled studies,2 systematic reviews/Meta-analysis,1 retrospective study,and 5 case series.The literatures only covered 21 kinds of Chinese patent medicines,with the most studies related to Xingpi Yanger Granules,accounting for 32.6%of the total literature volume.The sample size in the literatures was mainly focused on 51-200 cases,and 51-100 cases were selected by the most literatures,accounting for 34.45%.The interventions of the experimental group were mainly Chinese patent medicines or Chinese patent medicines combined with western medicines.The literatures with treatment course of 0-7 d accounted for the largest proportion(51.10%).The effective rate and symptom improvement time were used as the indexes to evaluate the results.The main adverse reactions were vomiting,constipation,nausea,rash,cold,diarrhea,redness of the skin around the umbilicus,or red itchy skin.The analysis of this study found that Chinese patent medicines have good curative effect and research prospects in the treatment of digestive system diseases in children.However,most clinical evidence has problems,such as limited indexes to evaluate the results,lack of traditional Chinese medicine characteristics,uneven quantity and low quality of Chinese patent medicine literatures,and insufficient specification of instructions.In the future,high-quality clinical studies on this field should be actively carried out,and economic studies and clinical comprehensive evaluation of Chinese patent medicines should be strengthened to explore the characteristics and advantages of its treatment,so as to provide decision-making basis for finding the accurate clinical positioning and promoting the rational clinical application of Chinese patent medicines for treating digestive system diseases in children.