全身麻醉下行脉冲射频治疗带状疱疹性三叉神经痛的安全性与有效性

Safety and efficacy of pulsed radiofrequency therapy for zoster-associated trigeminal neuralgia under general anesthesia

摘要

目的 经卵圆孔穿刺三叉神经节脉冲射频(pulsed radiofrequency，PRF)治疗带状疱疹性三叉神经痛时，需在感觉运动刺激下根据患者反馈进行操作，临床上常采用局部麻醉(regional anesthesia，RA)。但在RA下穿刺与射频治疗过程中，疼痛与恐惧常导致患者舒适度下降，且在调节射频针位置及提高输出电压时患者疼痛感剧烈，进而导致治疗电压设置偏低，患者配合困难，甚至导致治疗中断或拒绝治疗。中南大学湘雅医院麻醉科开展了CT三维重建定位引导及全身麻醉(general anesthesia，GA)下三叉神经节PRF治疗带状疱疹性三叉神经痛。目前，尚无直接比较GA与RA 2种麻醉方式下该术式疗效的研究。因此，本研究拟比较GA与RA用于三叉神经节PRF治疗带状疱疹性三叉神经痛的安全性与有效性，以期为临床提供更优麻醉方案的选择依据。 方法 回顾性收集2022年7月至2025年1月期间于中南大学湘雅医院住院治疗，并接受三叉神经节PRF治疗的带状疱疹相关性三叉神经痛患者的资料。根据PRF治疗过程中所实施的麻醉方式，将患者分为GA组和RA组。比较2组患者的基线资料(人口学特征、合并症的发生情况、疾病特征)。比较2组患者术后1 d，以及术后1个月、3个月和6个月的疼痛视觉模拟评分法(Visual Analogue Scale，VAS)评分，及其与基线值的差异。此外，还比较了2组患者的满意率、住院总时长、直接医疗费用、围手术期并发症(高血压、低血压、心动过缓、心动过速等)发生率。 结果 纳入61例患者，其中GA组29例，RA组32例。2组基线特征比较差异均无统计学意义(均P>0.05)。双因素重复测量方差分析结果显示，时间主效应显著[F(4, 295)=2 181，P<0.001]；组别主效应不显著[F(1, 295)=1.377，P=0.241 5]；交互作用显著[F(4, 295)=4.821，P<0.001]。2组术后1 d、1个月、3个月、6个月的VAS评分均显著低于术前(均P<0.05)；所有时间点2组VAS评分的差异均无统计学意义(均P>0.05)。GA组、RA组的住院费用分别为16 602(14 904，17 988)元、12 719(8 709，13 876)元，2组之间差异有统计学意义(P<0.001)；GA组、RA组的住院时间分别为6(5，7) d、6(5，7) d，2组之间差异无统计学意义(P=0.606)。RA组高血压与心动过速发生率均显著高于GA组(均P<0.05)。面部肿胀、头晕、恶心和呕吐等并发症的发生率2组间比较差异均无统计学意义(均P>0.05)。GA组满意率显著高于RA组(82.76% vs 56.25%，P=0.031)。 结论 GA与RA下行三叉神经节PRF治疗带状疱疹性三叉神经痛的疗效基本相当，但GA下实施PRF可显著提升患者满意度，降低心血管应激，且不增加其他术后并发症的发生风险。GA下行三叉神经节PRF安全可行。

Abstract

Objective Pulsed radiofrequency (PRF) treatment of the trigeminal ganglion via foramen ovale puncture for zoster-associated trigeminal neuralgia typically requires patient feedback during sensory and motor stimulation, and is usually performed under regional anesthesia (RA). However, under RA, patients often experience poor comfort due to pain and anxiety during puncture and PRF, and severe pain occurs when adjusting needle position or increasing output voltage. This often leads to lower-than-optimal treatment voltages, poor patient cooperation, and sometimes interruption or refusal of treatment. The Department of Anesthesiology at Xiangya Hospital, Central South University, has performed CT-guided trigeminal ganglion PRF under general anesthesia (GA) for zoster-associated trigeminal neuralgia. Currently, no studies directly compare the efficacy and safety of GA versus RA for this procedure. This study aims to compare GA and RA in terms of safety and efficacy for trigeminal ganglion PRF treatment of zoster-associated trigeminal neuralgia, providing clinical guidance for optimal anesthesia choice. Methods Data were retrospectively collected for hospitalized and treated with trigeminal ganglion PRF for zoster-associated trigeminal neuralgia at Xiangya Hospital, Central South University, from July 2022 to January 2025. Patients were grouped according to the anesthesia method used during PRF: GA group and RA group. Baseline characteristics (demographics, comorbidities, disease features) were compared between groups. Pain was assessed using the Visual Analogue Scale (VAS) at 1 day, 1 month, 3 months, and 6 months postoperatively, and changes from baseline were analyzed. Patient satisfaction, total hospitalization duration, direct medical costs, and perioperative complications (hypertension, hypotension, bradycardia, tachycardia, etc.) were also compared. Results A total of 61 patients were included (GA group, n=29; RA group, n=32). Baseline characteristics were comparable between groups (all P>0.05). Two-way repeated measures analysis of variance showed a significant main effect of time [F(4, 295)=2 181, P<0.001], no significant main effect of group [F(1, 295)=1.377, P=0.241 5], and a significant interaction effect [F(4, 295)=4.821, P<0.001]. VAS scores at 1 day, 1 month, 3 months, and 6 months postoperatively were significantly lower than preoperative values in both groups (all P<0.05); differences between groups at all time points were not statistically significant (all P>0.05). Median hospitalization costs were 16 602 (14 904, 17 988) CNY for the GA group and 12 719 (8 709, 13 876) CNY for the RA group, with a significant difference (P<0.001). Median hospital stay was 6 (5, 7) days for both groups (P=0.606). Incidences of hypertension and tachycardia were significantly higher in the RA group than the GA group (both P<0.05). Other complications (facial swelling, dizziness, nausea, vomiting) did not differ significantly (all P>0.05). Patient satisfaction was higher in the GA group than the RA group (82.76% vs 56.25%, P=0.031). Conclusion GA and RA provide comparable efficacy for trigeminal ganglion PRF in zoster-associated trigeminal neuralgia. However, GA significantly improves patient satisfaction and reduces cardiovascular stress without increasing other postoperative complications. PRF under GA is safe and feasible.

Graphical abstract

关键词

带状疱疹性三叉神经痛 / 全身麻醉 / 局部麻醉 / 三叉神经节 / 脉冲射频 / 心血管应激

Key words

zoster-associated trigeminal neuralgia / general anesthesia / regional anesthesia / trigeminal ganglion / pulsed radiofrequency / cardiovascular stress

带状疱疹后神经痛(postherpetic neuralgia，PHN)是带状疱疹最常见且严重的慢性并发症，以持续性、烧灼样或刀割样疼痛为特征，严重影响患者的生活质量^[1-2]。当带状疱疹累及三叉神经，尤其是第1支眼支时，患者发生PHN的风险显著增加^[3]。流行病学数据^[4]显示，带状疱疹发病率呈随年龄增长而急剧上升趋势。在中国，≥50岁人群的年发病率为2.9/1 000~5.8/1 000，而≥80岁人群的年发病率更是超过10/1 000。据此估算，中国每年新发带状疱疹病例为150万~300万^[5]。面对如此庞大的患者群体，传统药物治疗常因疗效有限及不良反应明显难以满足临床需求，微创介入技术因而成为重要的补充治疗手段。其中，脉冲射频(pulsed radiofrequency，PRF)凭借其对神经组织损伤小、可有效调节神经功能等优势，在带状疱疹性三叉神经痛治疗中的应用日益广泛^[6-11]。既往针对带状疱疹累及三叉神经的患者，临床多采用借助患者对感觉刺激的实时反馈实现精准定位的方法^[12-13]。然而，该方式术中患者常承受明显疼痛与恐惧，舒适度差、配合度低，难以多次调整射频针位置以精准贴合目标神经，甚至可能导致患者拒绝治疗或治疗中断。为解决上述局限，笔者所在团队在全身麻醉(general anesthesia，GA)下对患者进行三叉神经节PRF治疗，并对靶点选择及射频针尖端进行了优化。目前，关于GA与局部麻醉(regional anesthesia，RA)下三叉神经节PRF疗效的直接对比研究仍较为缺乏，本研究比较2种麻醉方式下的疗效，以期为临床治疗方案的选择提供依据。

1 对象与方法

1.1 伦理声明

本研究方案已获得中南大学湘雅医院(以下简称“我院”)伦理委员会批准(审批号：伦审科简第2025081306)。由于研究的回顾性性质，以及所有患者隐私信息均已进行匿名化处理，伦理委员会豁免了患者知情同意。

1.2 对象

本研究为单中心回顾性队列研究。连续纳入2022年7月至2025年1月期间于我院疼痛科住院治疗，并接受三叉神经节PRF治疗的带状疱疹相关性三叉神经痛患者。

纳入标准：1)诊断为带状疱疹相关性三叉神经痛；2)2022年7月至2025年1月期间在我院接受了三叉神经节PRF治疗。排除标准：1)曾接受电刺激治疗；2)严重的认知障碍；3)严重的心功能障碍；4)严重的肝肾功能损伤；5)基线临床资料缺失；6)未完成预设随访时间或随访资料缺失；7)关键数据缺失。

根据PRF治疗过程中所实施的麻醉方式，将符合纳入标准的患者分为GA组和RA组。麻醉方式由麻醉医师与术者根据患者的具体情况、意愿及治疗安排综合决定。

1.3 PRF方法

患者麻醉后取平卧位，薄枕置于肩下使头后仰。常规对面部皮肤进行消毒，采用专用笔式尖端射频穿刺针，塑形为15°预弯角(图1)。定位穿刺点为患侧口角水平外侧与瞳孔垂线相交处，该点位于口角外侧约2.5 cm处。以20 mL注射器针头破皮后，在CT引导下将射频针刺入皮肤，朝向卵圆孔方向穿入卵圆孔外口内1/3处，进而进入Meckel腔。经CT确认射频针尖端位于三叉神经节及相应分支解剖位置。所有患者采用相同的射频参数：温度42~44 ℃，射频时间1 200 s，脉冲频率2 Hz，脉冲宽度20 ms，射频电压70 V，阻抗维持<500 Ω。

RA组患者常规进行神经电刺激验证：感觉刺激(50 Hz，0.3 V)可复制患者疼痛区域感觉异常；针对第1支及第2支行运动刺激(2 Hz，1.0 V)时，应无下颌肌肉收缩。定位满意后保持针尖方向不变，直至完成PRF治疗。

GA组患者仅在适用情况下行运动刺激验证，确认无关分支无下颌肌肉运动。术中在CT引导下反复调整穿刺针深度及方向，确保针尖位于正确的目标解剖位置，至少进行3个角度的调整(图2)。

射频治疗结束后，拔出射频针，用纱布覆盖穿刺部位并压迫10 min以防止出血。手术结束后，患者返回麻醉恢复室。

1.4 麻醉方案

RA组麻醉方案：常规给予4 L/min纯氧鼻导管吸氧，行心电监护，监测患者心电图(electrocardiogram，ECG)、脉搏血氧饱和度(pulse oxygen saturation，SPO₂)、无创血压(non-invasive blood pressure，NBP)及呼吸频率。消毒后于口角外侧穿刺点行局部浸润(1%利多卡因1 mL)，并在穿刺路径上行不超过卵圆孔位置的局部浸润(1%利多卡因2 mL)。射频针进入卵圆孔后不再给予利多卡因。

GA组麻醉方案：常规面罩吸氧，行心电监护，监测患者ECG、SPO₂、NBP。采用简洁快速诱导麻醉方案，根据患者体重及一般情况，使用瑞马唑仑0.2 mg/kg、依托咪酯0.1 mg/kg或丙泊酚1.5 mg/kg诱导镇静，舒芬太尼10 μg镇痛。置入喉罩，必要时调整喉罩位置直至通气满意，连接呼吸机进行机械通气。麻醉维持采用全凭静脉维持[丙泊酚1.5~4.0 mg/(kg·h)，瑞芬太尼5~10 μg/(kg·h)]。

1.5 基线数据收集

通过电子病历系统及门诊随访记录收集患者资料。基线资料包括：1)年龄、性别等人口学特征；2)主要合并症(如高血压、糖尿病等)；3)三叉神经受累分支分布、病程持续时间；4)基线疼痛水平，采用术前视觉模拟评分法(Visual Analogue Scale，VAS)评估疼痛，0分表示无痛，10分表示疼痛剧烈。

1.6 评价指标及随访管理

主要评价指标为疼痛VAS评分，比较术后1 d，以及术后1个月、3个月和6个月的疼痛VAS评分与基线值的差异。

次要指标包括：1)患者满意率。采用5分制Likert量表(1=非常不满意，5=非常满意)评估患者对治疗的满意度。3分及以上定义为满意，满意率为满意患者人数占该组总人数的百分比。2)卫生经济学指标，包括住院总时长及直接医疗费用。3)安全性指标，即围手术期并发症(高血压、低血压、心动过缓、心动过速等)发生率。高血压定义为高于患者基线水平20%或高于140 mmHg/90 mmHg(1 mmHg=0.133 kPa)，低血压定义为低于基线水平20%或低于90 mmHg/60 mmHg，心动过速定义为心率>100 次/min，心动过缓定义为心率<60 次/min。

术后随访管理采用结构化方案，设置术后6个月为观察终点。通过多模式远程随访完成全程数据采集，所有数据采集均执行标准化操作流程，确保组间可比性及结果可信度。

1.7 统计学处理

采用 GraphPad Prism 9.0软件进行统计学分析。采用Shapiro-Wilk检验进行正态性检验。符合正态分布的连续变量(年龄、病程)以均数±标准差表示。2组间比较采用独立样本t检验；若方差不齐(Levene检验，P<0.05)，则采用Welch’s t检验。分类变量以例(%)表示，组间比较采用Pearson χ²检验。非正态分布的连续变量(住院费用和住院时间)以中位数(第1四分位数，第3四分位数)表示，组间比较采用Mann-Whitney U检验。重复测量数据(VAS评分)采用双因素重复测量方差分析，并进一步用Dunnett检验进行组内不同时间点的比较；采用独立样本t检验及Bonferroni校正进行各时间点2组间的比较。P<0.05为差异有统计学意义。

2 结 果

2.1 临床资料

最终纳入61例患者，其中GA组29例，RA组32例。基线特征均衡性检验结果(表1)显示：人口学特征(年龄、性别构成)、疾病特征(病程、病变神经分支分布)及临床评估指标(合并症情况、基线VAS评分)等在2组间的差异均无统计学意义(均P>0.05，表1、2)。

2.2 VAS评分

双因素重复测量方差分析结果显示，时间主效应显著[F(4, 295)=2 181，P<0.001]，提示2组VAS评分均随时间显著下降；组别主效应不显著[F(1, 295)=1.377，P=0.241 5]，提示2组VAS评分差异无统计学意义；交互作用显著[F(4, 295)=4.821，P<0.001]，提示2组VAS评分随时间变化的趋势不同。

2组术后1 d、1个月、3个月、6个月的VAS评分均显著低于术前(均P<0.05)；所有时间点2组VAS评分的差异均无统计学意义(均P<0.05)。

2.3 住院费用与住院时间比较

GA组、RA组的住院费用分别为16 602(14 904，17 988)元、12 719(8 709，13 876)元，2组之间差异有统计学意义(P<0.001)；GA组、RA组的住院时间分别为6(5，7) d、6(5，7) d，2组之间差异无统计学意义(P=0.606)。

2.4 围手术期并发症发生情况比较

心血管应激反应是RA组常见的并发症，RA组的高血压与心动过速发生率均显著高于GA组(均P<0.05)。2组均未发生需临床干预的严重不良反应，所有并发症均为轻度且具有自限性，共发生面部肿胀5例，头晕9例，恶心、呕吐11例，但均轻微，且2组间比较差异均无统计学意义(均P>0.05，表3)。

2.5 满意率比较

GA组、RA组的满意率分别为82.76%(24/29)、56.25%(18/32)，2组之间差异有统计学意义(P=0.031)。

3 讨 论

带状疱疹由潜伏的水痘-带状疱疹病毒再激活引起^[14-15]，PHN是其最常见且最令人困扰的并发症^[16-17]。对于药物治疗效果不佳或毒副作用显著的患者，PRF因其独特的优势，在PHN治疗中发挥着日益重要的作用^{[6-8, 18-20]}。PRF的确切治疗机制尚未完全阐明，可能通过高频交变电流产生强电场^[21-23]，影响离子通道的通透性^[24]，上调脑源性神经营养因子的表达^[25-26]，下调相关基因的表达^[27]，改善神经炎症^[10]，抑制疼痛介质释放^[28-29]，并抑制小胶质细胞和星形胶质细胞的异常活化^[30]，最终达到镇痛目的。

在三叉神经眼支受累的带状疱疹相关性疼痛的治疗中，传统RA虽可保留患者术中感觉-运动反馈，但存在显著局限性^[31]。眼支解剖位置较深，术中疼痛刺激常引发患者体动和心血管应激反应，导致治疗中断或精度下降。GA可确保患者完全无痛和绝对静止，为此类高精度、高疼痛刺激的操作提供了有利条件，但其应用亦面临独特挑战。GA虽可提供完全镇痛，显著改善穿刺精度与射频场稳定性，但失去患者的实时反馈可能增加误损伤神经的风险。

为提高GA下三叉神经眼支和三叉神经节PRF调控的精准性与安全性^[32-33]，笔者所在课题组针对射频电极进行了创新性的改良。PRF的电场有效半径为2~5 mm^[34]。射频针尖端与目标神经的距离与角度是影响疗效和安全性的关键因素，传统直型射频针存在定位局限：当针尖与目标神经距离>5 mm时，PRF电场强度衰减至阈值以下^[35]，距离过远可能导致治疗无效，过近则增加神经损伤风险^[36]。笔者所在课题组将射频针尖端进行约15°的弯曲，裸露端长度为10 mm，配合三维旋转操作(≥3个方向)，实现对靶点的包裹式接触。弯针通过压力分散机制，降低了神经穿刺损伤及穿透风险^[37-38]。

本研究回顾分析了在GA下实施三叉神经节及眼支PRF调控的疗效，结果显示其疗效与传统RA方案相当，验证了GA下实施高精度神经调控的可行性。关于GA是否增加老年患者并发症的发生风险，目前仍存在争议^[39]。本研究提示GA在老年带状疱疹性三叉神经痛患者PRF操作中具备安全性和操作优势，与在心血管高危患者中获得的证据^[40]形成平行论证。疗效评估结果证实，GA与RA 2种麻醉方式下实施PRF调控均能实现显著的即时镇痛效果，且远期疗效相当。

三叉神经节穿刺路径毗邻脑膜中动脉(距离<2 mm)、颈内动脉(岩骨段间距为3~5 mm)及海绵窦(外侧壁仅隔薄层硬脑膜)^[33]，该区域穿刺最危急的并发症为颅内出血^[41]。本研究采用15°预弯射频针，可使针尖接触压强降低，配合10 mm延长裸露端实现“面接触”调控，显著降低了对血管的剪切应力，并减轻了针尖对血管的直接损伤。本研究未观察到颅内出血等严重并发症，验证了CT三维重建立体定向引导三叉神经节/三叉神经分支PRF调控的安全性^[42]。本研究中RA组高血压与心动过速发生率均显著高于GA组，该现象可通过双重机制解释：一方面，三叉神经受到刺激引起三叉-心血管反射^[43]；另一方面，患者清醒状态下的疼痛及紧张导致应激叠加效应。其他并发症包括面部肿胀、恶心、头晕等，但均短暂且轻微，2组间比较差异均无统计学意义。

本研究存在方法学局限性，在结果解读时需谨慎考量；研究设计为回顾性分析，可能存在偏倚；单中心研究限制了结果的外部效度；样本量较小，可能影响统计分析效能；随访周期仅为术后6个月，未能捕捉长期疗效变化。

综上所述，基于短期随访数据，GA下行三叉神经节或三叉神经分支PRF治疗在效果与安全性方面与RA方案呈现等效性，但患者对GA的主观接受度更高，为重复治疗提供了更好的临床依从性基础。

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基金资助

湖南省自然科学基金(2021JJ31091┫。This work was supported by the Natural Science Foundation of Hunan Province)

湖南省自然科学基金(China ┣2021JJ31091)

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