Elshaug Adam G, Moss John R, Southcott Anne Marie, Hiller Janet E
Discipline of Public Health, The University of Adelaide, Australia.
Sleep. 2007 Apr;30(4):461-7. doi: 10.1093/sleep/30.4.461.
The role of upper airway surgery as a treatment for adult obstructive sleep apnea (OSA) remains controversial, with perspectives on treatment efficacy varying considerably. Though debate may occur in the clinical sphere, it is necessary to appreciate the ever-increasing funding and policy focus on cost effectiveness and "efficacy" in health care.
In this review, we examine contemporary evidence that highlights the importance of "highly effective treatment" over "sub-therapeutic treatment" as a necessity to confer improved health outcomes in OSA. We highlight that assumptions of surgical success inherent in most articles fail to assimilate contemporary, clinically significant indicators of success. We performed a literature search and present interpolated meta-analyses data from 18 surgical articles. Statistical meta-analyses highlight how surgical success decreases when new evidence-based criteria of success are applied.
Specifically, when the traditional definition is applied (50% reduction in apnea-hypopnea index [AHI] and/or < or = 20) the pooled success rate for Phase I procedures is 55% (45% fail). However, at AHI < or = 10, success reduces to 31.5% (68.5% fail) and, at AHI < or = 5, success is reduced to 13% (87% fail). According to these definitions, Phase II success (fail) rates decrease from 86% (14%) to 45% (55%) and 43% (57%), respectively.
The evidence for clinical efficacy must define treatment "success". We propose all future surgical audits report "objective cure" rates with success based on AHI outcomes of < or = 5 and/or < or = 10. We hope this paper serves as a catalyst for debate and consensus.
上气道手术作为成人阻塞性睡眠呼吸暂停(OSA)的一种治疗方法,其作用仍存在争议,对于治疗效果的观点差异很大。尽管在临床领域可能会有争论,但有必要认识到医疗保健领域对成本效益和“疗效”的资金投入和政策关注在不断增加。
在本综述中,我们研究了当代证据,这些证据强调了“高效治疗”相对于“亚治疗性治疗”的重要性,认为这是改善OSA患者健康结局的必要条件。我们强调,大多数文章中固有的手术成功假设未能纳入当代具有临床意义的成功指标。我们进行了文献检索,并展示了来自18篇外科手术文章的内插荟萃分析数据。统计荟萃分析突出了应用基于新证据的成功标准时手术成功率如何降低。
具体而言,当应用传统定义(呼吸暂停低通气指数[AHI]降低50%和/或≤20)时,I期手术的合并成功率为55%(45%失败)。然而,当AHI≤10时,成功率降至31.5%(68.5%失败),当AHI≤5时,成功率降至13%(87%失败)。根据这些定义,II期手术的成功率(失败率)分别从86%(14%)降至45%(55%)和43%(57%)。
临床疗效的证据必须明确治疗“成功”的定义。我们建议未来所有的手术审计报告基于AHI结果≤5和/或≤10的“客观治愈”率。我们希望本文能成为引发讨论和达成共识的催化剂。