Jitpimolmard S, Tiamkao S, Laopaiboon M
Department of Medicine, Faculty of Medicine, Khon Kaen University, Thailand.
J Neurol Neurosurg Psychiatry. 1998 Jun;64(6):751-7. doi: 10.1136/jnnp.64.6.751.
To describe the long term efficacy and side effects of the treatment of hemifacial spasm with Dysport and to evaluate two different sites of injection to hopefully reduce side effects.
This study was designed as a prospective descriptive study. Injections were made subcutaneously around the eye. Peak improvement was subjectively assessed by using a visual analogue scale and reported in percentages (0-100%). Duration of improvement was assessed subjectively and reported in months.
Of 175 cases, 17 were lost to follow up and were excluded. 855 treatments were injected in the remaining 158 patients with a median of 4 treatments. The response rate was 97%. Of 855 treatments, the adjusted mean peak and duration of improvement was 77.2 (95% confidence interval (95%CI) 74.7-79.4)% and 3.4 (95%CI 3.2-3.6) months respectively. In 158 patients (complete group), the long term results from the first to the 12th treatment showed that the mean peak improvement ranged from 72.70 to 80.10% and the duration of improvement was 2.60 to 3.71 months. It remained constant throughout (p=0.40, p=0.87 respectively). The most common side effect was ptosis. Of the 158 patients, 21 completed 12 treatments (subgroup). A separate analysis of this group disclosed a mean peak and duration of improvement from the first to 12th treatments ranging from 70.00 to 78.10% and 2.65 to 4.31 months respectively. Analysis of variance with repeated measures showed no significant variation of peak and duration of improvement over the first to the 12th treatments (p=0.38, p=0.38 respectively). Only 3% of the treatments were unsuccessful but responded to subsequent treatments. The incidence of ptosis was reduced from 27.17% to 9.68% by moving the injection site to the lateral part of orbital orbicularis oculi without any loss of efficacy. The yearly cost of Dysport is considerably less than Botox.
This study is the first to show, in detail, the long term results of treatments of hemifacial spasm with Dysport. The efficacy is constant throughout orbicularis oculi. The efficacy of Dysport is comparable with Botox in long term follow up.
描述使用Dysport治疗面肌痉挛的长期疗效和副作用,并评估两个不同注射部位以有望减少副作用。
本研究设计为前瞻性描述性研究。在眼周皮下进行注射。使用视觉模拟量表主观评估峰值改善情况,并以百分比(0 - 100%)报告。主观评估改善持续时间并以月报告。
175例患者中,17例失访被排除。对其余158例患者进行了855次治疗,中位数为4次治疗。有效率为97%。在855次治疗中,调整后的平均峰值改善和改善持续时间分别为77.2(95%置信区间(95%CI)74.7 - 79.4)%和3.4(95%CI 3.2 - 3.6)个月。在158例患者(完整组)中,从第一次到第12次治疗的长期结果显示,平均峰值改善范围为72.70%至80.10%,改善持续时间为2.60至3.71个月。总体保持恒定(分别为p = 0.40,p = 0.87)。最常见的副作用是上睑下垂。在158例患者中,21例完成了12次治疗(亚组)。对该组单独分析显示,从第一次到第12次治疗的平均峰值改善和改善持续时间分别为70.00%至78.10%和2.65至4.31个月。重复测量方差分析显示,从第一次到第12次治疗,峰值改善和改善持续时间无显著变化(分别为p = 0.38,p = 0.38)。仅3%的治疗无效,但后续治疗有反应。通过将注射部位移至眼轮匝肌外侧部分,上睑下垂的发生率从27.17%降至9.68%,且疗效无任何损失。Dysport的年度成本远低于Botox。
本研究首次详细展示了使用Dysport治疗面肌痉挛的长期结果。在整个眼轮匝肌中疗效恒定。在长期随访中,Dysport的疗效与Botox相当。