经计算机断层扫描引导的等离子消融与射频消融治疗原发性三叉神经痛的咀嚼功能障碍：一项随机对照试验。

Masticatory Dysfunction After Computed Tomography-Guided Plasma Ablation vs. Radiofrequency Ablation on Gasserian Ganglion for Idiopathic Trigeminal Neuralgia: A Randomized Controlled Trial.

机构信息

Current affiliation: Department of Pain, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.

Department of Pain Management, Xuanwu Hospital, Capital Medical University, Beijing, China.

出版信息

Pain Med. 2021 Mar 18;22(3):606-615. doi: 10.1093/pm/pnaa389.

DOI:10.1093/pm/pnaa389

PMID:33175164

Abstract

OBJECTIVE

We aimed to evaluate masticatory dysfunction after two different types of ablation on the Gasserian ganglion for the treatment of idiopathic trigeminal neuralgia. We hypothesized that low-temperature plasma radiofrequency ablation (LTP-RFA) was noninferior to radiofrequency thermocoagulation (RFT) with respect to initial efficacy.

METHODS

In the randomized, single-blind, parallel-group, noninferiority trial, 204 participants with idiopathic trigeminal neuralgia were randomly allocated to receive plasma ablation in the LTP-RFA group and radiofrequency ablation in the RFT group in a 1:1 ratio, with random block sizes of four or six. Participants were examined at baseline (T0), on the day of discharge (T1), and at the 6-month follow-up (T2). The primary end point was the clinincal effective rate in the LTP-RFA group compared with that in the RFT group after intervention on the day of discharge. Noninferiority was prespecified at -10%.

RESULTS

The intention-to-treat analysis revealed that the initial efficacy rates were 91.2% in LTP-RFA group and 93.1% in RFT group (rate ratio [RR] = 0.979, 95% confidence interval [CI]: 0.904-1.061, P = 0.795). The difference between the two groups was 1.9% (95% CI: -5.6% to 9.4%), which showed that LTP-RFA demonstrated noninferiority compared with RFT in initial efficacy. Compared with the RFT group, the LTP-RFA group exhibited a significantly greater improvement in the maximum voltage of the masseter muscles with mean differences of 11.40 (95% CI: 10.52 to 12.27, P < 0.001) at T1 and 17.41 (95% CI: 14.68 to 20.13, P < 0.001) at T2, respectively. Similar results were observed for the asymmetry index of occlusion, the maximum voltage of the anterior temporalis, and the activity index of anterior temporalis / masseter muscles. No serious adverse events were observed in either group.

CONCLUSIONS

Compared with the RFT group, noninferior efficacy for pain relief and improvement of masticatory function was revealed in the LTP-RFA group.

摘要

目的

我们旨在评估两种不同的神经节毁损术式（低温等离子射频消融术和射频热凝术）治疗原发性三叉神经痛后患者的咀嚼功能障碍。我们假设，低温等离子射频消融术（LTP-RFA）在初始疗效方面不劣于射频热凝术（RFT）。

方法

在这项随机、单盲、平行分组、非劣效性试验中，204 例原发性三叉神经痛患者按照 1:1 的比例随机分配至 LTP-RFA 组或 RFT 组，采用随机区组设计，区组大小为 4 或 6。在基线（T0）、出院日（T1）和 6 个月随访（T2）时对参与者进行检查。主要终点是干预后出院日时 LTP-RFA 组与 RFT 组的临床有效率。非劣效性预设界值为-10%。

结果

意向治疗分析显示，LTP-RFA 组的初始疗效为 91.2%，RFT 组为 93.1%（率比 [RR] = 0.979，95%置信区间 [CI]：0.904-1.061，P = 0.795）。两组间的差异为 1.9%（95%CI：-5.6%至 9.4%），表明 LTP-RFA 在初始疗效方面不劣于 RFT。与 RFT 组相比，LTP-RFA 组在咀嚼肌最大电压方面的改善更显著，出院时的平均差值为 11.40（95%CI：10.52 至 12.27，P<0.001），在 6 个月随访时为 17.41（95%CI：14.68 至 20.13，P<0.001）。在咬合不对称指数、前颞肌最大电压和前颞肌/咀嚼肌活动指数方面也观察到了类似的结果。两组均未发生严重不良事件。