OBJECTIVE: The objectives of this systematic literature review (SLR) were to identify and characterize the current published body of evidence for the efficacy and safety of treatments for RCC or UCC.
METHODS: The SLR was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The SLRs pre-defined population included patients ≥18 years of age who were diagnosed with chronic cough. The review was not restricted to any intervention type or study comparator, nor by timeframe.
RESULTS: A total of 20 eligible publications from 19 unique trials were included. Seventeen of these trials were randomized controlled trials and most (14/17) were placebo-controlled. There was considerable variability between trials in the definition of RCC or UCC, participant exclusion and inclusion criteria, outcome measurement timepoints, and the safety and efficacy outcomes assessed. Several trials identified significant improvements in cough frequency, severity, or health-related quality of life measures while participants were on treatment, although these improvements did not persist in any of the studies that included a post-treatment follow-up timepoint.
CONCLUSIONS: In the absence of an approved therapy, placebo remains the most common comparator in trials of potential RCC or UCC treatments. The between-study comparability of the published evidence is limited by heterogeneity of study design, study populations, and outcomes measures, as well as by concerns regarding study size and risk of bias.
目的:本系统文献综述(SLR)的目的是确定和表征当前已发表的RCC或UCC治疗的有效性和安全性的证据。
方法:根据系统评价和荟萃分析指南的首选报告项目进行SLR。SLR预定义的人群包括诊断为慢性咳嗽的年龄≥18岁的患者。审查不限于任何干预类型或研究比较,也不是按时间范围。
结果:共纳入来自19项独特试验的20篇合格出版物。这些试验中有17项是随机对照试验,大多数(14/17)是安慰剂对照。在RCC或UCC的定义中,试验之间存在相当大的差异,参与者排除和纳入标准,结果测量时间点,并评估安全性和有效性结果。几项试验发现咳嗽频率有显著改善,严重程度,或与健康相关的生活质量测量,而参与者在治疗,尽管这些改善在包括治疗后随访时间点的任何研究中都没有持续.
结论:在没有批准的治疗方法的情况下,安慰剂仍然是潜在RCC或UCC治疗试验中最常见的对照品.已发表证据的研究间可比性受到研究设计异质性的限制,研究人群,和成果衡量标准,以及对研究规模和偏见风险的担忧。