[关键词]
[摘要]
腺样体肥大主要表现为鼻塞、打鼾、张口呼吸等症状,严重影响患儿生活质量、生长发育。近年来中药治疗儿童腺样体肥大的临床随机对照试验逐渐增多,由于不同随机对照试验文章结局指标繁多或同一结局指标判定标准不一致,制约了儿童腺样体肥大高质量的循证医学依据的产生。目前国内外药物治疗儿童腺样体肥大的临床试验主要以改善临床症状、减小腺样体体积、改善生活质量、提高临床疗效、改善中医证候和评估药物的远期效果为研究目的。基于此,综述了儿童腺样体肥大的疗效评价指标,以期为临床和科研工作者开展儿童腺样体肥大临床研究时选择合适的疗效评价指标提供指导。
[Key word]
[Abstract]
The main clinical manifestations of adenoid hypertrophy are nasal congestion, snoring, and open mouth breathing, which seriously affect the quality of life and growth and development of children. In recent years, clinical randomized controlled trials of traditional Chinese medicine in treatment of adenoid hypertrophy in children have gradually increased. Due to the variety of outcome indicators in different randomized controlled trials, or inconsistent criteria for determining the same outcome indicator, the emergence of high-quality evidence-based medical evidence for adenoid hypertrophy in children is restricted. At present, drug clinical trials for adenoid hypertrophy in children at home and abroad mainly focus on improving clinical symptoms, reducing adenoid volume, improving quality of life, improving clinical efficacy, improving traditional Chinese medicine syndromes, and evaluating the long-term effects of drugs. Therefore, this article reviews the efficacy evaluation indicators for adenoid hypertrophy in children, in order to provide guidance for clinical and scientific researchers to choose appropriate efficacy evaluation indicators when conducting clinical research on adenoid hypertrophy in children.
[中图分类号]
R985
[基金项目]
国家科技重大专项(民口)课题(2020ZX09201-008)