喉咽清口服液治疗急性咽炎的临床综合评价

Clinical comprehensive evaluation of Houyanqing Oral Liquid in treatment of acute pharyngitis

该研究系统梳理喉咽清口服液治疗急性咽炎的安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色(“6+1”维度)的现有证据,并将各维度资料进行定性与定量相结合分析,运用多准则决策分析(MCDA)模型与CSC v2.0软件综合评价其临床价值,以期为耳鼻喉科基本药物的遴选以及医疗卫生决策提供证据。各维度评价结果分为A、B、C、D 4个等级。喉咽清口服液治疗急性咽炎的不良反应主要表现为偶见腹痛、腹泻、皮疹等,停药后症状缓解,愈后较好,安全性研究有证据支持,认为风险较可控,安全性较好,评为B级。喉咽清口服液联合利巴韦林气雾剂相比于单用利巴韦林气雾剂能够明显提高急性咽炎的临床总有效率,加快退烧、缩短咽痛和黏膜充血消失时间,改善黏膜充血程度与咳嗽咳痰症状,有效性证据质量中等,临床价值较大,有效性较好,评为B级。喉咽清口服液联合利巴韦林气雾剂治疗急性咽炎相比于单用利巴韦林气雾剂更具成本-效果优势,经济性有证据支持,证据报告质量一般,结果基本明确,经济性结果一般,评为C级。针对急性咽炎,喉咽清口服液可缩短病程,明显改善咽痛症状,同时还可用于放射性咽炎和口腔溃疡的治疗,创新性较好,评为B级。医护给药与患者用药便捷,易于掌握,可基本满足临床用药需求,药品信息规范、完整,适宜性较好,评为B级。喉咽清口服液疗程费用占城镇/农村居民可支配收入比例低,可负担性好,销售范围广,产能高,药材资源可持续,总体可及性较好,评为B级。喉咽清口服液组方来源于湖南民间验方,作为耳鼻喉科用药有一定样本量的真实世界研究,中医药特色较突出,评为B级。综合各维度得分,计算喉咽清口服液治疗急性咽炎临床综合评价为B级,证据较充分,建议按程序有条件地转化为基本临床用药管理的相关政策结果。

This study systematically combed the existing evidence of Houyanqing Oral Liquid in the treatment of acute pharyngitis from the "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) and carried out qualitative and quantitative analysis of the data from each dimension. The multi-criteria decision analysis(MCDA) model and CSC v2.0 were used to evaluate the clinical value of this drug, so as to provide evidence for the selection of essential drugs in the department of otolaryngology and for medical and health decision-making. The dimensions are graded A, B, C, or D. The adverse reactions of Houyanqing Oral Liquid in the treatment of acute pharyngitis were mainly manifested as abdominal pain, diarrhea, rash, etc., which were relieved after drug withdrawal. In terms of safety, it was considered that Houyanqing Oral Liquid had controllable risk and high safety, which was rated as grade B. Compared with ribavirin aerosol alone, Houyanqing Oral Liquid combined with ribavirin aerosol can significantly improve the total response rate, shorten the time to abatement of fever and di-sappearance of throat pain and mucosal congestion, and alleviate mucosal congestion and cough with sputum. With medium-quality evidence, the effectiveness was rated as grade B. Compared with ribavirin aerosol alone, Houyanqing Oral Liquid combined with ribavirin aerosol had cost-effectiveness advantages in the treatment of acute pharyngitis, and its economy was rated as grade C with the evidence of general quality. For acute pharyngitis, Houyanqing Oral Liquid can shorten the disease course and obviously relieve sore throat. Moreover, it can be used for the treatment of radioactive pharyngitis and oral ulcer, and thus its innovation was rated as grade B. With convenient and simple administration and standard and complete drug information, the suitability of this drug was rated as grade B. Houyanqing Oral Liquid is derived from the folk prescription in Hunan province and has been subjected to real-world studies, and thus the TCM characteristics was rated as grade B. According to the ratings of all the dimensions, the comprehensive value of Houyanqing Oral Liquid in the clinical treatment of acute pharyngitis was determined as grade B, with sufficient evidence and clear results. It is suggested that the results should be conditionally converted into relevant policy of clinical basic drug management according to procedures.