耳鼻喉科口服中成药临床证据的概况性综述

Clinical Evidence on Treatment of Otorhinolaryngologic Diseases with Oral Chinese Patent Medicine:A Scoping Review

采用概况性综述的方法,系统检索和梳理耳鼻喉科口服中成药的临床证据,分析耳鼻喉科的证据现状,以期为临床实践和医疗卫生决策提供参考。本研究系统检索7个中英文数据库,检索时限均从建库至2022年3月,纳入口服中成药防治耳鼻喉科疾病临床研究证据,对证据分布特点进行分析。共纳入核心期刊/《科学引文索引》(SCI)文献248篇,包括238篇临床研究(随机对照试验185篇,半/非随机对照试验46篇,病例系列研究7篇)、5篇系统评价、4篇指南/专家共识和1篇药物经济学研究。文献涉及口服中成药26种,耳鼻喉科疾病40种(耳病5种,鼻病22种,咽喉病13种)。临床研究的样本量主要集中在100~300例,试验组干预措施主要为中成药联合西药,结局指标以有效率和临床症状改善情况为主,常见的不良事件包括恶心、呕吐、皮疹、头痛、胃肠道不适、乏力等。耳鼻喉科口服中成药的临床证据相对缺乏,结局指标选择、临床研究质量及药物经济学评价均存在不足。未来需要加强对研究质量的重视,开展少而精的临床研究和二次研究,增强药物经济学评价,进一步探索中成药治疗耳鼻喉科疾病的优势,促进卫生资源更加合理的配置和应用。

This paper aims to systematically retrieve and summarize the clinical evidence on oral Chinese patent medicine in otorhinolaryngology by scoping review and analyze the distribution of the evidence,which is expected to serve as a reference for clinical practice and healthcare decision-making.Seven databases were searched(from inception to March 2022)for the clinical evidence of oral Chinese patent medicine in the prevention and treatment of otorhinolaryngologic diseases,and the distribution of the evidence was discussed.A total of 248 papers from core journals/SCI were included:238 clinical studies(185 randomized controlled trials,46 semi-/non-randomized controlled trials,7 case series studies),5 systematic reviews,4 guidelines/expert consensuses,and 1 pharmacoeconomic study.The papers covered 26 oral Chinese patent medicines and40 otorhinolaryngological diseases(5 ear diseases,22 nose diseases,and 13 throat diseases).The majority of the clinical studies included 100-300 cases.The combination of Chinese patent medicine and western medicine is the common intervention in the experimental group.The outcomes were mainly“cure rate”and improvement of clinical symptoms.Common adverse events were nausea,vomiting,rash,headache,gastrointestinal discomfort,fatigue,etc.In summary,there is a lack of high-quality clinical evidence on oral Chinese patent medicine in otorhinolaryngology.In addition,the available studies have such problems as seldom use of recognized outcomes,low quality of clinical studies,and lack of pharmacoeconomic study.In future,efforts should be made to carry out more rigorous primary and secondary research and enhance the pharmacoeconomic evaluation,in a bid to explore the advantages of Chinese patent medicine in the treatment of otorhinolaryngologic diseases and promote the more rational allocation and application of health resources.