Unit of Otolaryngology, UOS ORL TI, Campus Bio-Medico University, Rome, Italy.
Unit of Otolaryngology, University of Foggia, Foggia, Italy.
Sleep Breath. 2020 Jun;24(2):399-411. doi: 10.1007/s11325-019-01923-2. Epub 2019 Aug 15.
To perform a systematic review and meta-analysis for studies evaluating hypoglossal nerve stimulation (HNS) clinical outcomes in the treatment of moderate to severe obstructive sleep apnea (OSA).
Two authors conducted a literature search to identify prospective studies in PubMed/MEDLINE, Google Scholar, and Cochrane Library databases. The last search was performed on November 17, 2018.
A total of 350 patients (median age 54.3 (IQR 53-56.25) years, BMI 29.8 (IQR 28.8-31.6) kg/m) from 12 studies were included. The procedure has obtained a surgical success rate of 72.4% (Inspire), 76.9% (ImThera), 55% (Apnex) at 12 months, and 75% (Inspire) at 60-month follow-up. At 12 months, the apnea-hypopnea index (AHI) mean differences was - 17.50 (Inspire; 95% CI: - 20.01 to - 14.98, P < 0.001), - 24.20 (ImThera; 95% CI: - 37.39 to 11.01, P < 0.001), and - 20.10 (Apnex; 95% CI: - 29.62 to - 10.58, P < 0.001). The AHI mean reduction after 5 years was - 18.00 (Inspire, - 22.38 to - 13.62, P < 0.001). The Epworth sleepiness scale (ESS) mean reduction was - 5.27 (Inspire), - 2.90 (ImThera), and - 4.20 (Apnex) at 12 months and - 4.40 (Inspire) at 60 months, respectively. Only 6% of patients reported serious device-related adverse events after 1- and 5-year follow-up.
HNS has obtained a high surgical success rate with reasonable long-term complication rate related to the device implanted. The procedure represents an effective and safe surgical treatment for moderate-severe OSA in selected adult patients who had difficulty accepting or adhering to CPAP treatment.
对评估舌下神经刺激（HNS）治疗中重度阻塞性睡眠呼吸暂停（OSA）的临床疗效的研究进行系统评价和荟萃分析。
两位作者对 PubMed/MEDLINE、Google Scholar 和 Cochrane Library 数据库中的前瞻性研究进行了文献检索。最后一次检索时间为 2018 年 11 月 17 日。
共有 12 项研究的 350 例患者（中位数年龄 54.3（IQR 53-56.25）岁，BMI 29.8（IQR 28.8-31.6）kg/m2）纳入研究。该手术在 12 个月时的手术成功率为 72.4%（Inspire）、76.9%（ImThera）、55%（Apnex），60 个月时的随访成功率为 75%（Inspire）。在 12 个月时，呼吸暂停低通气指数（AHI）的平均差值为 -17.50（Inspire；95%CI：-20.01 至 -14.98，P<0.001）、-24.20（ImThera；95%CI：-37.39 至 11.01，P<0.001）和 -20.10（Apnex；95%CI：-29.62 至 -10.58，P<0.001）。5 年后 AHI 的平均降低值为-18.00（Inspire，-22.38 至 -13.62，P<0.001）。在 12 个月时，Epworth 睡眠量表（ESS）的平均降低值为-5.27（Inspire）、-2.90（ImThera）和-4.20（Apnex），在 60 个月时分别为-4.40（Inspire）。在 1 年和 5 年的随访后，仅有 6%的患者报告了严重的与设备相关的不良事件。
HNS 手术成功率高，与植入设备相关的长期并发症发生率合理。对于难以接受或坚持 CPAP 治疗的中重度 OSA 患者，该手术是一种有效且安全的治疗选择。
