Smith T L, Correa A J, Kuo T, Reinisch L
Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin, Milwaukee 53226-3522, USA.
Laryngoscope. 1999 Nov;109(11):1760-5. doi: 10.1097/00005537-199911000-00007.
The objective of this clinical trial was to assess the safety and efficacy of radiofrequency (RF) tissue ablation of the inferior turbinates in the treatment of nasal obstruction using an RF energy delivery system with a thermocouple feedback electrode.
A prospective, nonrandomized study of 11 patients (mean age, 47+/-12 y) with chronic nasal obstruction was conducted. Using patient-based visual analogue scales (VAS), symptom parameters were assessed. These included degree of nasal obstruction, frequency of nasal obstruction, and pain. Physician assessment of nasal obstruction was also collected by the principal investigator. Follow-up was conducted at 24 hours, 1 week, 4 weeks, 8 weeks, and 1 year. ANOVA was carried out to determine statistically significant differences in the data. Data were fit to a regression model, and confidence intervals were determined from a 95% confidence level.
In patient-assessed degree of nasal obstruction, statistical significance was seen among baseline and 4 weeks, 8 weeks, and 1 year (P<.001, P<.0001, and P<.0008, respectively). There was no difference between 8 weeks and 1 year (P<.15). The data appeared to follow an exponential decay to a constant value. The pretreatment baseline average degree of obstruction was 7.5+/-0.5 on a scale of 0 to 10. The degree of obstruction after 8 weeks was 2.7+/-0.6. The time constant for this change was 21 days to reach 90% of the final value. At 1 year, degree of obstruction was 3.3+/-0.7. For frequency of nasal obstruction, statistical significance was seen among baseline and 4 weeks, 8 weeks, and 1 year (P<.0001, P<.0001, and P<.0001, respectively). There was no difference between 8 weeks and 1 year (P<.15). The pretreatment baseline average frequency of obstruction was 7.8+/-0.5. The remaining frequency of obstruction after 8 weeks was 2.9+/-0.6. The time constant was 18 days. At 1 year, frequency of obstruction was 3.3+/-0.6. Physician assessment of nasal obstruction revealed statistical significance among baseline and 4 weeks, and baseline and 8 weeks (P<.0055 and P<.0056, respectively). There was no difference between 4 weeks and 8 weeks (P<.24). The average initial obstruction was 83%+/-4%. The remaining obstruction after 8 weeks was 58% +/-5%. The time constant was 14 days. Mild pain was reported by 55% of patients during the procedure; the remaining 45% reported no pain. Only one patient required pain medication consisting of acetaminophen after the procedure. There were no significant complications.
Degree and frequency of nasal obstruction, as reported by patients, decreased following RF tissue ablation of the inferior turbinates. This improvement in symptoms was still evident after 1 year (P<.001). Physician assessment of obstruction also correlated with patient reports for the initial 8-week study period. The procedure was safe and well tolerated. Thermocouples within the active electrode provided additional feedback to the operating surgeon allowing the use of relatively lower tissue temperatures, power, and energy as compared with traditional techniques. These results support the need for continued research to evaluate this modality as a treatment for chronic nasal obstruction.
本临床试验的目的是使用带有热电偶反馈电极的射频能量传输系统，评估下鼻甲射频组织消融治疗鼻塞的安全性和有效性。
对11例（平均年龄47±12岁）慢性鼻塞患者进行了一项前瞻性、非随机研究。使用基于患者的视觉模拟量表（VAS）评估症状参数。这些参数包括鼻塞程度、鼻塞频率和疼痛。主要研究者还收集了医生对鼻塞的评估。在24小时、1周、4周、8周和1年时进行随访。进行方差分析以确定数据中的统计学显著差异。数据拟合回归模型，并从95%置信水平确定置信区间。
在患者评估的鼻塞程度方面，基线与4周、8周和1年之间存在统计学显著差异（分别为P<0.001、P<0.0001和P<0.0008）。8周和1年之间无差异（P<0.15）。数据似乎呈指数衰减至恒定值。治疗前基线平均阻塞程度在0至10分的量表上为7.5±0.5。8周后阻塞程度为2.7±0.6。这种变化的时间常数为21天，达到最终值的90%。1年时，阻塞程度为3.3±0.7。对于鼻塞频率，基线与4周、8周和1年之间存在统计学显著差异（分别为P<0.0001、P<0.0001和P<0.0001）。8周和1年之间无差异（P<0.15）。治疗前基线平均阻塞频率为7.8±0.5。8周后剩余阻塞频率为2.9±0.6。时间常数为18天。1年时，阻塞频率为3.3±0.6。医生对鼻塞的评估显示基线与4周以及基线与8周之间存在统计学显著差异（分别为P<0.0055和P<0.0056）。4周和8周之间无差异（P<0.24）。初始平均阻塞率为83%±4%。8周后剩余阻塞率为58%±5%。时间常数为14天。55%的患者在手术过程中报告有轻度疼痛；其余45%报告无疼痛。术后只有1例患者需要使用对乙酰氨基酚进行止痛治疗。无明显并发症。
患者报告的鼻塞程度和频率在下鼻甲射频组织消融后降低。这种症状改善在1年后仍然明显（P<0.001）。在最初的8周研究期间，医生对阻塞的评估也与患者报告相关。该手术安全且耐受性良好。有源电极内的热电偶为手术医生提供了额外反馈，与传统技术相比，允许使用相对较低的组织温度、功率和能量。这些结果支持继续进行研究以评估这种治疗慢性鼻塞的方式。
