UNASSIGNED:为了回顾有关苯并钠的治疗效果和疗效的现有文献,需要更好地告知患者,提供者,和监管机构评估其在现代医学治疗中的作用。
未经评估:在PubMed中进行了全面的文献检索,Embase(Elsevier),科克伦图书馆,和Scopus用于评估有效性的原始研究文章,耐受性,和1956年1月至2022年8月的苄酸酯的安全概况。
UNASSIGNED:对已确定的研究进行相关性筛选,然后通过全文审查对纳入进行评估。数据提取,并由多个审阅者使用在线软件Covidence进行质量评估。
未经评估:选择过程产生了37篇文章,包括21项队列研究,5个实验研究,和11个案例研究和系列。探索潜在治疗益处的初步临床研究从非常小的人群和有限的临床环境中收集数据。安全性主要根据过量或不适当使用引起的毒性进行评估。质量评估引起了人们对主要与有限样本量有关的高度偏见的担忧,数据收集,概括性,和研究设计。
UNASSIGNED:本综述揭示了与苯并钠的安全性和临床有效性有关的现有证据的实质性局限性,因此,需要大型观察性研究或随机试验,以更好地描述其在现代医学实践中的作用和价值。
UNASSIGNED:不断上升的安全问题应该会对苯并钠的处方进行更严格的审查,该处方的批准是基于无法经得起当前监管审查的证据。
To
review the available literature regarding the treatment effects and efficacy of benzonatate needed to better inform patients, providers, and regulators evaluating its role in modern medical therapies.
Comprehensive literature searches were conducted in PubMed, Embase (Elsevier), Cochrane Library, and Scopus for original research articles evaluating the effectiveness, tolerability, and safety profile of benzonatate from January 1956 through August 2022.
The identified studies were screened for relevance and then assessed for inclusion through a full-text
review, data extraction, and quality assessment by multiple reviewers using the online software Covidence.
The selection process resulted in 37 articles consisting of 21 cohort studies, 5 experimental studies, and 11 case studies and series. Initial clinical studies exploring potential therapeutic benefits collected data from very small populations and limited clinical settings. Safety is primarily assessed in terms of toxicity due to overdose or inappropriate use. Quality assessment raised concerns for high degrees of biases primarily related to the limited sample size, data collection, generalizability, and study design.
This
review reveals substantial limitations within existing evidence pertaining to the safety and clinical effectiveness of benzonatate and thus, a need for large observational studies or randomized trials to better characterize its role and value in modern medical practice.
Rising safety concerns should bring closer scrutiny upon the prescription of benzonatate whose approval is founded upon evidence that would not stand up to current regulatory
review.