Three-Year Outcomes of Proximal Hypoglossal Nerve Stimulation in OSA.

research_question

What are the long-term safety and efficacy of pHGNS, and how do they compare with dHGNS?

pHGNS的长期安全性和有效性如何，它们与dHGNS相比有何不同？

study_design_and_methods

THN3 (NCT02263859) enrollees had an apnea-hypopnea index (AHI) 20-65/hr and BMI ≤ 35 kg/m2.

THN3 (NCT02263859) 的参与者有20-65/hr的呼吸暂停低通气指数（AHI）和BMI ≤ 35 kg/m2。

Participants completing the prespecified 3-year visit were analyzed.

完成规定3年随访的参与者被纳入分析。

Outcomes included adverse events, AHI, Oxygen Desaturation Index, percentage of sleep time with oxygen saturation <90%, and QOL. pHGNS responses at 24 and 36 months were compared with baseline and 11 months of therapy (months 12/15). pHGNS and dHGNS results were compared through 36 months.

结果包括不良事件、呼吸暂停低通气指数（AHI）、氧饱和指数、睡眠时间中氧饱和度低于90%的百分比以及生活质量。在24个月和36个月时，对pHGNS反应与基线和治疗11个月（第12/15个月）进行了比较。通过36个月，比较了pHGNS和dHGNS的结果。

Results

One hundred four of 138 (75%) THN3 participants completed 3-year follow-up. pHGNS delivered sustained improvements in sleep-disordered breathing, oxygenation, and QOL at months 24 and 36 vs baseline.

138名THN3参与者中有104名（75%）完成了3年的随访。与基线相比，pHGNS在24个月和36个月时持续改善了睡眠呼吸障碍、氧合和生活质量。

Long-term outcomes were comparable to those at 11 months of treatment: median AHI reductions were -15.1/h (95% CI, -18.6, -12.6) and -17.7/h (-21.9, -15.3) with large effect sizes; probabilities of superiority vs baseline were 0.79 (0.72-.87) and 0.79 (0.70-.87), respectively.

长期结果与治疗11个月时的结果相当：中位数AHI（睡眠呼吸暂停低通气指数）分别降低了-15.1/h（95%置信区间，-18.6, -12.6）和-17.7/h（-21.9, -15.3），效果量大；与基线相比，优势概率分别为0.79（0.72-0.87）和0.79（0.70-0.87）。

Benefits in sleep-disordered breathing and QOL were sustained at 36 months and appeared to be comparable to those reported for dHGNS at 3 years.

在36个月时，睡眠呼吸障碍和生活质量的改善得以维持，并且似乎与3年时报告的dHGNS（双侧舌下神经刺激）结果相当。

interpretation

Therapeutic responses to pHGNS at 1 year were maintained through 3 years with relatively few adverse events.

在1年时对pHGNS的治疗反应在3年内得到了维持，且不良事件相对较少。

Similarities in responses to dHGNS suggest that pHGNS provides safe and efficacious long-term OSA treatment.

对dHGNS反应的相似性表明，pHGNS为OSA提供了安全且有效的长期治疗。

clinical_trial_registration

ClinicalTrials.gov; No.: NCT02263859; URL: www.

ClinicalTrials.gov; 编号: NCT02263859; 网址: www.

clinicaltrials

gov.

5年总生存率为75%，95%置信区间为68%至82%。