PDF(Pubmed)
Abstract：
UNASSIGNED: To assess long-term safety and effectiveness of a multipoint, impedance-controlled, RF ablation device for treatment of chronic rhinitis through 12-month follow-up.
UNASSIGNED: A prospective, multicenter study. Bilateral posterior nasal nerve (PNN) ablation was performed on all participants. Assessments at 6-, 9-, and 12-month visits included Visual Analog Scale Nasal Symptom Score (VAS NSS), reflective Total Nasal Symptom Score (rTNSS), mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ), and adverse events.
UNASSIGNED: Thirty-six participants were enrolled and 35 completed the 12-month follow-up. All 5 VAS NSS items demonstrated statistically significant improvement (p < .0001) over baseline at all 3 time points. The total rTNSS improved from 7.9 ± 1.8 at baseline to 4.3 ± 2.1 at 6-months, 3.8 ± 2.4 at 9-months, and 4.0 ± 2.1 at 12-months (all p < .0001). At 12-months, 91% (31/35) of participants had achieved the minimum clinically important difference (MCID) of a reduction from baseline of ≥1 point and 80% (28/35) of the participants met the responder criteria of ≥30% reduction from baseline. The total mean mini RQLQ was reduced from 3.0 ± 1.0 at baseline to 1.4 ± 0.8 at 6-months, 1.4 ± 1.0 at 9-months, and 1.3 ± 0.8 at 12-months (all p < .0001). At 12-months, 86% (30/35) of participants achieved the MCID of a reduction from baseline of ≥0.4 points for the mini RQLQ. No related serious adverse events occurred during the study.
UNASSIGNED: Impedance-controlled RF ablation of the PNN is safe and resulted in durable, significant improvement in rhinitis symptoms and quality of life through 12-month follow-up.
UNASSIGNED: The study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397.
UNASSIGNED: 4.
UNASSIGNED: A prospective, multicenter study. Bilateral posterior nasal nerve (PNN) ablation was performed on all participants. Assessments at 6-, 9-, and 12-month visits included Visual Analog Scale Nasal Symptom Score (VAS NSS), reflective Total Nasal Symptom Score (rTNSS), mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ), and adverse events.
UNASSIGNED: Thirty-six participants were enrolled and 35 completed the 12-month follow-up. All 5 VAS NSS items demonstrated statistically significant improvement (p < .0001) over baseline at all 3 time points. The total rTNSS improved from 7.9 ± 1.8 at baseline to 4.3 ± 2.1 at 6-months, 3.8 ± 2.4 at 9-months, and 4.0 ± 2.1 at 12-months (all p < .0001). At 12-months, 91% (31/35) of participants had achieved the minimum clinically important difference (MCID) of a reduction from baseline of ≥1 point and 80% (28/35) of the participants met the responder criteria of ≥30% reduction from baseline. The total mean mini RQLQ was reduced from 3.0 ± 1.0 at baseline to 1.4 ± 0.8 at 6-months, 1.4 ± 1.0 at 9-months, and 1.3 ± 0.8 at 12-months (all p < .0001). At 12-months, 86% (30/35) of participants achieved the MCID of a reduction from baseline of ≥0.4 points for the mini RQLQ. No related serious adverse events occurred during the study.
UNASSIGNED: Impedance-controlled RF ablation of the PNN is safe and resulted in durable, significant improvement in rhinitis symptoms and quality of life through 12-month follow-up.
UNASSIGNED: The study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397.
UNASSIGNED: 4.
摘要：
■为了评估多点的长期安全性和有效性，阻抗控制，射频消融装置治疗慢性鼻炎12个月随访。
■预期，多中心研究。对所有参与者进行双侧后鼻神经（PNN）消融。评估在6-，9-，和12个月的访问包括视觉模拟量表鼻部症状评分（VASNSS），反射鼻部症状总评分（rTNSS），迷你鼻结膜炎生活质量问卷（迷你RQLQ），和不良事件。
■参加了36名参与者，35名参与者完成了12个月的随访。在所有3个时间点,所有5个VASNSS项目均显示相对于基线的统计学显著改善(p<0.0001)。总rTNSS从基线时的7.9±1.8提高到6个月时的4.3±2.1，9个月时3.8±2.4，12个月时为4.0±2.1（所有p<0.0001）。12个月时,91%(31/35)的参与者达到了从基线降低≥1分的最小临床重要差异(MCID),80%(28/35)的参与者符合从基线降低≥30%的应答者标准。总平均迷你RQLQ从基线时的3.0±1.0降至6个月时的1.4±0.8，9个月时1.4±1.0，12个月时为1.3±0.8（所有p<0.0001）。12个月时,86％（30/35）的参与者实现了微型RQLQ的MCID比基线降低≥0.4点。研究期间无相关严重不良事件发生。
■PNN的阻抗控制射频消融是安全的，并导致持久的，通过12个月的随访，鼻炎症状和生活质量得到显着改善。
■该研究已在www注册。clinicaltrials.gov，唯一标识符为NCT05324397。
■4.
■预期，多中心研究。对所有参与者进行双侧后鼻神经（PNN）消融。评估在6-，9-，和12个月的访问包括视觉模拟量表鼻部症状评分（VASNSS），反射鼻部症状总评分（rTNSS），迷你鼻结膜炎生活质量问卷（迷你RQLQ），和不良事件。
■参加了36名参与者，35名参与者完成了12个月的随访。在所有3个时间点,所有5个VASNSS项目均显示相对于基线的统计学显著改善(p<0.0001)。总rTNSS从基线时的7.9±1.8提高到6个月时的4.3±2.1，9个月时3.8±2.4，12个月时为4.0±2.1（所有p<0.0001）。12个月时,91%(31/35)的参与者达到了从基线降低≥1分的最小临床重要差异(MCID),80%(28/35)的参与者符合从基线降低≥30%的应答者标准。总平均迷你RQLQ从基线时的3.0±1.0降至6个月时的1.4±0.8，9个月时1.4±1.0，12个月时为1.3±0.8（所有p<0.0001）。12个月时,86％（30/35）的参与者实现了微型RQLQ的MCID比基线降低≥0.4点。研究期间无相关严重不良事件发生。
■PNN的阻抗控制射频消融是安全的，并导致持久的，通过12个月的随访，鼻炎症状和生活质量得到显着改善。
■该研究已在www注册。clinicaltrials.gov，唯一标识符为NCT05324397。
■4.
