Abstract
目的
原发性三叉神经痛(primary trigeminal neuralgia，PTN)是神经外科常见的颅神经疾病，严重危害患者的身心健康。经皮穿刺球囊压迫术(percutaneous balloon compression，PBC)通过微创穿刺阻断痛觉传导，已成为治疗PTN的有效术式。然而，PBC术后面部疼痛复发仍是困扰PTN患者的一大问题。术中球囊的形状、压力及压迫时间等因素可影响PBC术后患者的预后。卵圆孔大小对Meckel’s腔内的球囊压力有影响。本研究旨在通过分析卵圆孔大小与PBC术后疼痛复发之间的联系，探讨其对PBC术后疼痛复发的预测价值。
方法
回顾性分析2018年11月至2021年12月于承德医学院附属医院神经外科就诊行PBC治疗的60例PTN患者的临床资料，随访并记录患者术后1、3、6及12个月的巴罗神经学研究所(Barrow Neurological Institute，BNI)疼痛评分，根据术后第12个月时的BNI疼痛评分分级将患者分为治愈组(BNI疼痛评分分级I~Ⅱ级)和复发组(BNI疼痛评分分级Ⅲ~Ⅴ级)，测量2组患者患侧及健侧的卵圆孔长径、横径、面积数据。采用受试者操作特征(receiver operating characteristic，ROC)曲线及曲线下面积(area under the curve，AUC)分析2组患者患侧卵圆孔长径、横径、面积及患/健侧卵圆孔长径比、横径比、面积比与PBC术后疼痛复发之间的关系。
结果
截止术后随访第12个月，50例(83.3%)患者疼痛缓解(治愈组)，10例(16.7%)患者存在不同程度的疼痛复发(复发组)，总有效率83.3%。2组患者术前基线资料的差异均无统计学意义(均P>0.05)。治愈组患侧卵圆孔长径、患/健侧卵圆孔长径比及面积比均明显大于复发组(均P<0.05)；2组间患侧卵圆孔横径、面积及患/健侧卵圆孔横径比的差异均无统计学意义(均P>0.05)。ROC曲线分析结果显示：患侧卵圆孔长径的AUC为0.290(95% CI 0.131~0.449，P=0.073)，患/健侧卵圆孔长径比的AUC为0.792(95% CI 0.628~0.956，P=0.004)，患/健侧卵圆孔面积比的AUC为0.766(95% CI 0.591~0.941，P=0.008)，说明患/健侧卵圆孔长径比及面积比对PBC术后疼痛复发具有良好的预测作用。当患/健侧卵圆孔长径比小于0.886 3或面积比小于0.869 4时，术后易出现疼痛复发。
结论
PBC术前准确评估患者颅底卵圆孔大小，对预测PBC术后疼痛复发具有重要意义。
Keywords: 原发性三叉神经痛, 经皮穿刺球囊压迫术, 卵圆孔, 疼痛复发, 预测
Abstract
Objective
Primary trigeminal neuralgia (PTN) is a common cranial nerve disease in neurosurgery, which seriously endangers the physical and mental health of patients. Percutaneous balloon compression (PBC) has become an effective procedure for the treatment of PTN by blocking pain conduction through minimally invasive puncture. However, the recurrence of facial pain after PBC is still a major problem for PTN patients. Intraoperative balloon shape, pressure and compression time can affect the prognosis of patients with PBC after surgery. The foramen ovale size has an effect on the balloon pressure in Meckel’s lumen. This study aims to analyse the predictive value of foramen ovale size for postoperative pain recurrence of PBC by exploring the relationship between foramen ovale size and postoperative pain recurrence of PBC.
Methods
A retrospectively analysis was conducted on the clinical data of 60 patients with PTN who were treated with PBC in Department of Neurosurgery, Affiliated Hospital of Chengde Medical College from November 2018 to December 2021. We followed-up and recorded the Barrow Neurological Institute (BNI) pain score at 1, 3, 6 and 12 months after operation. According to the BNI pain score at 12 months after surgery, the patients were divided into a cure group (BNI pain score I to Ⅱ) and a recurrence group (BNI pain score Ⅲ to Ⅴ). The long diameter, transverse diameter and area of foramen ovale on the affected side and the healthy side of the 2 groups were measured. Receiver operating characteristic (ROC) curve and area under the curve (AUC) were used for analysis the relationship between the recurrence of pain and the long diameter, transverse diameter, area of foramen ovale on the affected side, and aspect ratio, transverse diameter ratio, area ratio of foramen ovale on the affected side to healthy side in the 2 groups.
Results
At the end of 12 months of follow-up, 50 (83.3%) patients had pain relief (the cured group), 10 (16.7%) patients had different degrees of pain recurrence (the recurrence group), and the total effective rate was 83.3%. There were no significant differences in preoperative baseline data between the 2 groups (all P>0.05). The long diameter of foramen ovale on the affected side, the long diameter ratio and area ratio of foramen ovale on the affected/healthy side in the cured group were significantly higher than those in the recurrence group (all P<0.05), and there were no significant differences in the transverse diameter and area of foramen ovale on the affected side and the transverse diameter ratio of foramen ovale on the affected/healthy side between the 2 groups (all P>0.05). The ROC curve analysis showed that the AUC of the long diameter of foramen ovale on the affected side was 0.290 (95% CI 0.131 to 0.449, P=0.073), and the AUC of aspect ratio of foramen ovale on the affected side to healthy side was 0.792 (95% CI 0.628 to 0.956, P=0.004). The AUC of area ratio of foramen ovale on the affected side to healthy side was 0.766 (95% CI 0.591 to 0.941, P=0.008), indicating that aspect ratio and area ratio of foramen ovale on the affected side to healthy side had a good predictive effect on postoperative pain recurrence of PBC. When aspect ratio of foramen ovale on the affected side to healthy side was less than 0.886 3 or area ratio of foramen ovale on the affected side to healthy side was less than 0.869 4, postoperative pain recurrence was common.
Conclusion
Accurate evaluation of the foramen ovale size of skull base before operation is of great significance in predicting pain recurrence after PBC.
Keywords: primary trigeminal neuralgia, percutaneous balloon compression, foramen ovale, pain recurrence, prediction
随着人们生活压力的增大与生活节奏的不断加快，原发性三叉神经痛(primary trigeminal neuralgia，PTN)的发病率逐渐增高，平均年发病率为(4.5~28.9)/100 000人[1]，最受影响的发病年龄为53(37~67)岁[2-4]。经皮穿刺球囊压迫术(percutaneous balloon compression，PBC)通过微创穿刺阻断痛觉传导，已成为治疗PTN的有效术式，具有简单、安全、快速等特点[5]。然而，PBC术后面部疼痛复发仍是困扰PTN患者的一大问题[6]，其术后2年复发率可达10.7%[7]。许多学者[8-9]认为术中球囊的形状、压力及压迫时间等因素可显著影响PBC预后，当球囊形状达到“梨形”或近似“梨形”时，患者术后疼痛复发减少。但随着PTN患者的增多和PBC的开展，部分患者即便实施标准化PBC，控制术中球囊因素，仍会出现术后疼痛复发的情况。近期有学者[10]对卵圆孔大小与球囊内压力的关系进行研究，发现卵圆孔大小对Meckel’s腔内的球囊压力有着显著影响。然而，目前卵圆孔大小与PBC术后疼痛复发之间的关系尚不明确，本研究旨在通过一项回顾性临床研究，探索卵圆孔大小与PBC术后疼痛复发之间的联系。
1. 对象与方法
1.1. 对象
连续性选取2018年11月至2021年12月于承德医学院附属医院神经外科就诊的60例PTN患者为研究对象。纳入标准：1)根据《三叉神经痛诊疗中国专家共识》[11]诊断为PTN的患者；2)口服药物治疗疼痛控制不佳的患者；3)接受PBC治疗的患者；4)无其他伴随疾病的患者。排除标准：1)失访的患者。纳入的60例患者年龄(63.90±10.76)岁，其中男性17例(28.3%)，女性43例(71.7%)；病程介于2至324个月之间；左侧疼痛28例(46.7%)，右侧疼痛32例(53.3%)。既往行微血管减压术患者4例(6.7%)，甘油注射患者1例(1.7%)，射频热凝患者1例(1.7%)。本研究经承德医学院附属医院伦理委员会批准[审批号(CYFYLL2020247)]。
1.2. 手术操作
该60例PTN患者均由同一位经验丰富的神经外科医师行PBC。患者取仰卧位，全身麻醉，在透视下调整头部摆放位置，使屏幕上患者双侧颧弓与外耳道重合。使用改良Hartel前入路法进行穿刺，其中2处标记点位于患侧沿颧弓外耳道前3 cm处及同侧瞳孔下方2.5 cm处，穿刺针穿刺点位于患侧口角外侧 2.5 cm处(图1)。在C形臂引导下，左手固定患者头部，右手使用14号穿刺针刺破皮肤并进针5~7 cm，穿刺并进入卵圆孔。随即撤出针芯，导入内含导丝的4号Fogarty球囊导管，进入Meckel’s腔内，导管前端超出针尖部分不超过1.7 cm。撤出导丝，在透视下缓慢向球囊内注入0.8 mL非离子碘造影剂，见屏幕上球囊充盈，并根据透视显影情况及时调整导管的位置，直至出现一个理想的“梨形”或近似“梨形”。球囊压迫2 min，然后排空球囊，撤出球囊导管，置入穿刺针芯并拔出穿刺针，压迫穿刺点5 min，无菌敷料固定，手术结束(图2)。
图1.
使用改良Hartel前入路法标记穿刺点
Figure 1 Marking the puncture point using the modified Hartel anterior approach
Marker 1: The affected side was 3 cm anterior to the external auditory canal of the zygomatic arch. Marker 2: 2.5 cm below the ipsilateral pupil. Puncture point: 2.5 cm lateral to the Angle of mouth on the affected side.
图2.
手术操作流程
Figure 2 Surgical procedure A: Adjust the head position so that the bilateral external auditory meatus and zygomatic arch overlap, and the puncture needle is inserted along the puncture point and into the foramen ovale. B: Introduce the balloon catheter into Meckel’s cavity; C-E: Fill the balloon with contrast agent, adjust the balloon position and contrast dose until a “pear shape” or similar “pear shape” appears. F: Remove the balloon catheter and puncture needle.
1.3. 术后疼痛复发情况与分组
对PTN患者采用巴罗神经学研究所(Barrow Neurological Institute，BNI)疼痛评分进行分级(表1)，入组患者术前需满足BNI疼痛评分分级≥Ⅳ。术后24 h内对入组患者进行BNI评分分级。分别于术后1、3、6和12个月进行电话或门诊随访，评价第12个月随访时的疼痛复发情况。按术后第12个月随访疗效，将BNI疼痛评分分级Ⅰ~Ⅱ的患者归为治愈组，BNI疼痛评分分级Ⅲ~Ⅴ的患者归为复发组。
表1.
BNI疼痛评分分级标准
Table 1 Criteria of BNI pain score grading
| BNI疼痛评分分级 | 评分标准 |
|---|---|
| Ⅰ | 无疼痛，不需要服药 |
| Ⅱ | 偶尔疼痛，不需要服药 |
| Ⅲ | 轻微疼痛，服用药物疼痛可控制 |
| Ⅳ | 中等疼痛，服用药物疼痛缓解不明显 |
| Ⅴ | 剧烈疼痛，口服药物疼痛无缓解 |
BNI：巴罗神经学研究所。
1.4. 卵圆孔数据测量
术前采用颅底CT三维重建技术，通过图像浏览软件PACS自带测量工具在轴位上对卵圆孔最大横截面的各项参数进行测量(图3)，记录患者患侧卵圆孔长径、横径、面积大小，计算患/健侧卵圆孔长径比、横径比、面积比。中国人卵圆孔的形状以椭圆形居多[12]，其面积按椭圆面积公式S=(长径×横径)π/4计算。
图3.
卵圆孔数据测量示意图
Figure 3 Schematic diagram of measuring foramen ovale data A: Schematic diagram of three-dimensional reconstruction of skull base, bilateral foramen ovale as shown in the square; B: Measurement of the long diameter and transverse diameter of the foramen ovale.
1.5. 统计学处理
采用SPSS 25.0软件进行数据分析，计量资料以均数±标准差( ±s)表示，组间比较采用t检验分析。计数资料用例(%)表示，组间比较采用χ2检验分析。采用受试者操作特征(receiver operating characteristic，ROC)曲线及曲线下面积(area under the curve，AUC)评价与预后相关指标，通过计算约登指数，选择灵敏度和特异度之和最大的截断点作为界值，确定判断标准。P<0.05为差异有统计学意义。
2. 结 果
2.1. 术后疗效分析
在60例PTN患者中，术后24 h内疼痛缓解59例(98.3%)，未明显缓解1例(1.7%)(此例患者于术后3周左右疼痛自行缓解）。截至术后第12个月随访时，50例(83.3%)疼痛缓解，10例(16.7%)存在不同程度的疼痛复发，总有效率83.3%(表2)。根据术后第12个月随访疗效，将BNI疼痛评分分级Ⅰ~Ⅱ的50例患者归为治愈组，BNI疼痛评分分级Ⅲ~Ⅴ的10例患者归为复发组。2组患者的术前基线资料差异均无统计学意义(均P>0.05，表3)。
表2.
PBC术后随访结果(n=60)
Table 2 Postoperative follow-up results of PBC (n=60)
| BNI疼痛评分分级 | 随访时长/[例(%)] | |||
|---|---|---|---|---|
| 1个月 | 3个月 | 6个月 | 12个月 | |
| Ⅰ~Ⅱ | 59(98.3) | 56(93.3) | 55(91.7) | 50(83.3) |
| Ⅲ~Ⅴ | 1(1.7) | 4(6.7) | 5(8.3) | 10(16.7) |
PBC：经皮穿刺球囊压迫术；BNI：巴罗神经学研究所。
表3.
2组患者患者术前基线资料的比较
Table 3 Comparison of preoperative basic information between the 2 groups
| 组别 | n | 性别/[例(%)] | 年龄分布/[例(%)] | 患侧分布/[例(%)] | 病程/[例(%)] | ||||
|---|---|---|---|---|---|---|---|---|---|
| 男 | 女 | >60岁 | ≤60岁 | 左侧 | 右侧 | >5年 | ≤5年 | ||
| 治愈组 | 50 | 15(88.2) | 35(81.4) | 36(83.7) | 14(82.4) | 22(78.6) | 28(87.5) | 17(85.0) | 33(82.5) |
| 复发组 | 10 | 2(11.8) | 8(18.6) | 7(16.3) | 3(17.6) | 6(21.4) | 4(12.5) | 3(15.0) | 7(17.5) |
| 合计 | 60 | 17(28.3) | 43(71.7) | 43(71.7) | 17(28.3) | 28(46.7) | 32(53.3) | 20(33.3) | 40(66.7) |
| χ² | 0.660 | <0.001 | 0.335 | <0.001 | |||||
| P | 0.798 | 1.000 | 0.563 | 1.000 | |||||
| 组别 | 累及分支*/[例(%)] | 手术史/[例(%)] | ||||||
|---|---|---|---|---|---|---|---|---|
| Ⅱ | Ⅲ | Ⅰ+Ⅱ | Ⅰ+Ⅲ | Ⅱ+Ⅲ | Ⅰ+Ⅱ+Ⅲ | 有 | 无 | |
| 治愈组 | 6(85.7) | 7(70.0) | 8(100.0) | 0(0.0) | 20(87.0) | 9(81.8) | 4(66.7) | 46(85.2) |
| 复发组 | 1(14.3) | 3(30.0) | 0(0.0) | 1(100.0) | 3(13.0) | 2(18.2) | 2(33.3) | 8(14.8) |
| 合计 | 7(11.7) | 10(16.7) | 8(13.3) | 1(1.7) | 23(38.3) | 11(18.3) | 6(10.0) | 54(90.0) |
| χ² | 8.144 | 0.333 | ||||||
| P | 0.148 | 0.564 | ||||||
Ⅰ：三叉神经第一分支，眼神经；II：三叉神经第二分支，上颌神经；III：三叉神经第三分支，下颌神经。*无单独Ⅰ疼痛患者。
2.2. 卵圆孔数据
在纳入的患者中，1例(1.7%)出现最大横截面上患侧卵圆孔内后缘缺损，改用向下一层横截面卵圆孔进行测量，其余患者卵圆孔形态相对规则完整。治愈组患侧卵圆孔长径、患/健侧卵圆孔长径比及面积比均大于复发组，差异均具有统计学意义(均P<0.05)；2组间患侧卵圆孔横径、面积及患/健侧卵圆孔横径比差异均无统计学意义(均P>0.05，表4)。
表4.
2组患者卵圆孔数据比较( ±s)
Table 4 Comparison of foramen ovale data statistics between the 2 groups ( ±s)
| 组别 | n | 患侧 | 患/健侧 | ||||
|---|---|---|---|---|---|---|---|
| 长径/mm | 横径/mm | 面积/mm2 | 长径比 | 横径比 | 面积比 | ||
| 治愈组 | 50 | 7.70±1.18 | 4.44±1.00 | 27.19±8.89 | 1.06±0.17 | 1.02±0.22 | 1.09±0.35 |
| 复发组 | 10 | 6.87±0.84 | 4.25±1.09 | 23.24±7.60 | 0.89±0.13 | 0.91±0.17 | 0.83±0.25 |
| t | 2.095 | 0.540 | 1.311 | 2.870 | 1.446 | 2.280 | |
| P | 0.041 | 0.591 | 0.195 | 0.006 | 0.153 | 0.026 | |
2.3. 卵圆孔数据预测PBC术后疼痛复发的价值
ROC曲线分析结果显示：患侧卵圆孔长径的AUC为0.290(95% CI 0.131~0.449，P=0.073)，患/健侧卵圆孔长径比的AUC为0.792(95% CI 0.628~0.956，P=0.004)，患/健侧卵圆孔面积比的AUC为0.766(95% CI 0.591~0.941，P=0.008；表5)，说明患/健侧卵圆孔长径比与面积比对PBC术后疼痛复发具有良好的预测作用。以患/健侧卵圆孔长径比、面积比为检验变量绘制ROC曲线图，通过计算约登指数，得出患/健侧卵圆孔长径比灵敏度和特异度之和最大的截断点对应的值为0.886 3，灵敏度为88.0%，特异度为70.0%(图4A)；患/健侧卵圆孔面积比灵敏度和特异度之和最大的截断点对应的值为0.869 4，灵敏度为76.0%，特异度为80.0%(图4B)。
表5.
ROC曲线分析结果
Table 5 ROC curve analysis results
| 项目 | AUC | 标准误 | 95% CI | P |
|---|---|---|---|---|
| 患侧长径 | 0.290 | 0.081 | 0.131~0.449 | 0.073 |
| 患/健侧长径比 | 0.792 | 0.084 | 0.628~0.956 | 0.004 |
| 患/健侧面积比 | 0.766 | 0.090 | 0.591~0.941 | 0.008 |
ROC：受试者操作特征；AUC：曲线下面积；CI：置信区间。
图4.
患/健侧卵圆孔长径比(A)和面积比(B)预测PBC术后疼痛复发价值的ROC曲线
Figure 4 ROC curve of the foramen ovale length-diameter ratio (A) and area ratio (B) of the affected side to healthy side to predict the value of pain recurrence after PBC
ROC: Receiver operating characteristic; PBC: Percutaneous balloon compression.
3. 讨 论
PTN是神经外科常见的颅神经疾病[13]，患者常因剧烈疼痛而无法进行洗脸、刷牙及进食等活动，甚至因食物摄入不足而出现营养不良的情况[14]。在PTN发病初期，不少患者会被误诊为“牙痛”，接受非必要的拔牙治疗[15-16]。长期的疼痛还会使患者产生焦虑、抑郁等情绪[17-19]，严重危害患者的身心健康。PTN的病因目前尚未统一，较为公认的理论是“神经血管压迫”学说[20-21]，即由于责任血管对三叉神经的压迫，导致神经纤维发生脱髓鞘改变，细胞膜上电压门控钠通道表达失调，神经元活性升高，从而引发面部疼痛[22]。随着病因学研究的深入，“骨性压迫”所造成的PTN同样不容忽视[23]，卵圆孔附近形成的骨刺以及感染或韧带骨化引起的骨膜增厚，可能导致卵圆孔变窄并挤压三叉神经[24]。该类患者术前影像学资料或开颅手术中未见明确的神经血管压迫征象，但仍有典型的面部疼痛[25]。同时，部分PTN患者可能合并2种及以上的病因，这可能与术后疼痛复发或治疗无效有关。
卵圆孔在PBC实施过程中起到重要作用。术者利用穿刺针将球囊导管通过卵圆孔送入Meckel’s腔内，若卵圆孔存在狭窄、成角或形态不规则等解剖变异，将出现穿刺针进入困难甚至无法进入的情况[26]。卵圆孔长径对于穿刺针到达卵圆孔后能否进一步顺利进入Meckel’s腔有很大影响[27]；卵圆孔小会增加穿刺难度，限制穿刺针穿刺角度，使球囊导管走行于Meckel’s腔外，无法对三叉神经半月节进行有效压迫[28]。一项前瞻性研究[29]认为卵圆孔大小与球囊压力存在关联，卵圆孔小与腔内球囊压力不足相关，后者是导致PBC术后疼痛复发的重要因素之一[30-31]。卵圆孔的大小、形态及常见解剖变异应是术者术前重点关注的内容，对术中穿刺操作具有指导意义[32]。
本研究结果显示：治愈组中患侧卵圆孔长径、患/健侧卵圆孔长径比及面积比均明显大于复发组。从病因学考虑，卵圆孔小的患者PBC术后疼痛暂时缓解，但卵圆孔对三叉神经的卡压并未解除，局部神经元仍处于脱髓鞘状态，持续产生异常的电信号[33-34]。另外，卵圆孔小对穿刺过程的影响，致使球囊位置、形状或压力不理想，神经节压迫不充分，从而导致疼痛复发[35-36]。ROC曲线分析结果显示：患/健侧卵圆孔长径比及面积比对PBC术后疼痛复发具有良好的预测作用，当患者术前经过影像学测量得到患/健侧卵圆孔长径比小于0.886 3或面积比小于0.869 4时，可以认为该患者术后易出现疼痛复发。对于此类患者，术者可通过预先调整穿刺点、优化穿刺路径来降低卵圆孔小造成的穿刺难度。同时，适当增加球囊充盈量或延长神经节压迫时间有助于延长术后无痛生存期，但面部麻木及感觉减退的风险会随之增加[6]。值得注意的是，本研究中无论是患侧卵圆孔长径的数值大小还是患/健侧卵圆孔长径比和面积比的比值大小，其预测趋势均是相同的。但单纯患侧卵圆孔长径的大小对PBC预后的预测效力并不理想，可能与不同个体的骨骼、神经发育情况，三叉神经对卵圆孔骨性压迫的耐受程度不同有关[37]。相反，同一个体双侧卵圆孔的相互对比可在一定程度上消除个体差异所带来的偏倚，因此患/健侧卵圆孔长径比及面积比的预测作用更具代表性。此外，患/健侧卵圆孔长径比较面积比ROC的AUC大，故前者较后者的预测效力更强。
综上所述，PBC是治疗PTN的有效术式，PTN患者颅底卵圆孔的大小、面积等数据容易被测量和计算。针对由于各种原因导致卵圆孔狭窄而出现穿刺困难者，可在术中使用导航或是三维虚拟现实呈像下辅助穿刺[38]。术前通过评估患/健侧卵圆孔长径比、面积比，可有效预测PBC术后疼痛复发情况，使患者对手术疗效有一个更为准确的心理预期，同时为医师临床决策及选择手术方案提供参考。本研究为单中心回顾性临床研究，样本量相对较少，未来可进行大样本、多中心随机对照研究，进一步证实本研究结果。
基金资助
河北省医学科学研究课题计划(20210969)。
This work was supported by the Medical Science Research Project Plan of Hebei Province, China (20210969).
利益冲突声明
作者声称无任何利益冲突。
作者贡献
李传胜 数据核对与分析，文献收集和论文撰写；杨婕 论文审阅与修改；韩凤伟、呼铁民、张继伟、刘兵、闫丽娜、刘文霞 数据采集；王昆鹏 研究设计与指导，论文审阅与修改。所有作者阅读并同意最终的文本。
原文网址
http://xbyxb.csu.edu.cn/xbwk/fileup/PDF/202305682.pdf
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