Kondziolka D, Lemley T, Kestle J R, Lunsford L D, Fromm G H, Jannetta P J
Department of Neurological Surgery, Presbyterian University Hospital, University of Pittsburgh, Pennsylvania.
J Neurosurg. 1994 Jun;80(6):993-7. doi: 10.3171/jns.1994.80.6.0993.
To evaluate the reported benefit of ipsilateral single-application ophthalmic anesthetic eyedrops in patients with typical trigeminal neuralgia, a randomized double-blind placebo-controlled trial was performed. Forty-seven patients were randomly assigned to receive two drops of either proparacaine (25 cases) or saline placebo (22 cases). The experimental and placebo groups were equivalent in regard to patient age, distribution of trigeminal neuralgia pain, duration of pain, current medication regimens, and number of prior procedures performed. Pain response was assessed at 3, 10, and 30 days after instillation using two pain rating scales and a measure of pain frequency. Treatment failure was defined in advance as any of the following: a lack of clinical response, the need for an increase in medication, or the need for surgery. No significant difference in outcomes was found between the two groups either when using a verbal pain rating scale (p = 0.24) or when comparing overall pain status (unchanged, improved throughout the study period, or temporarily improved) (p = 0.98). No difference in the frequency of trigeminal neuralgia attacks between the two treatment groups (scaled within five levels of pain frequency) was detected (p = 0.09). During follow-up monitoring, 11 patients in the test drug group and 14 in the placebo group required surgery because of persistent pain (p = 0.24). The results of this study indicate that single-application topical ophthalmic anesthesia reduces neither the severity nor the frequency of pain in comparison to placebo administration. Although a simple and safe treatment, the single application of topical ophthalmic eyedrops provides no short- or long-term benefit to patients with trigeminal neuralgia.
为评估同侧单次应用眼科麻醉眼药水对典型三叉神经痛患者的疗效，进行了一项随机双盲安慰剂对照试验。47例患者被随机分配接受丙美卡因两滴（25例）或生理盐水安慰剂（22例）。试验组和安慰剂组在患者年龄、三叉神经痛疼痛分布、疼痛持续时间、当前用药方案以及既往手术次数方面相当。在滴入眼药水后3天、10天和30天，使用两种疼痛评分量表和疼痛频率测量方法评估疼痛反应。预先将治疗失败定义为以下任何一种情况：无临床反应、需要增加药物剂量或需要手术。使用言语疼痛评分量表时，两组结果无显著差异（p = 0.24），比较总体疼痛状态（不变、在整个研究期间改善或暂时改善）时也无显著差异（p = 0.98）。未检测到两组治疗组之间三叉神经痛发作频率的差异（按五级疼痛频率分级）（p = 0.09）。在随访监测期间，试验药物组有11例患者，安慰剂组有14例患者因持续疼痛需要手术（p = 0.24）。本研究结果表明，与给予安慰剂相比，单次应用局部眼科麻醉既不能减轻疼痛的严重程度，也不能降低疼痛频率。虽然局部应用眼科眼药水是一种简单且安全的治疗方法，但对三叉神经痛患者没有短期或长期益处。
