Marchetti Albert, Magar Raf, Findley Leslie, Larsen Jan P, Pirtosek Zvezdan, Růzicka Evzen, Jech Robert, Sławek Jaroslaw, Ahmed Fayyaz
Thomson Health Economics Research, Secaucus, New Jersey, USA.
Mov Disord. 2005 Aug;20(8):937-44. doi: 10.1002/mds.20468.
The purpose of this study is to evaluate the real-world dose utilization of Dysport and BOTOX for cervical dystonia and blepharospasm. Six investigational sites (five countries) were identified. Investigators abstracted utilization data for patients who received Dysport before switching to BOTOX or BOTOX before switching to Dysport. Patients were identified during scheduled clinic visits and selected if they met study criteria, which included treatment for at least 2 consecutive years (at least 1 year with Dysport or BOTOX, then switched and maintained on BOTOX or Dysport for at least another year). A total of 114 patients were included in the assessment. Ratios of mean dose for Dysport to BOTOX ranged from a low of 2:1 to a high of 11:1. Thirty-one percent of patients fell into the Dysport-to-BOTOX ratio grouping of 5:1 to less than 6:1; 30% of patients had a mean ratio of Dysport to BOTOX of 4:1 to less than 5:1; and only 21% of all patients evaluated fell into the Dysport-to-BOTOX ratio grouping of 3:1 to less than 4:1. Results are consistent with United Kingdom labeling for botulinum toxins stating that units of different serotype A toxins are not interchangeable and simple dose-conversion factors are not applicable.
本研究的目的是评估肉毒杆菌素（Dysport）和保妥适（BOTOX）在治疗颈部肌张力障碍和眼睑痉挛方面的实际剂量使用情况。确定了6个研究地点（5个国家）。研究人员提取了在改用保妥适之前接受过肉毒杆菌素治疗或在改用肉毒杆菌素之前接受过保妥适治疗的患者的使用数据。在定期门诊就诊时识别患者，并在他们符合研究标准时进行选择，这些标准包括连续治疗至少2年（至少1年使用肉毒杆菌素或保妥适，然后改用并继续使用保妥适或肉毒杆菌素至少1年）。共有114名患者纳入评估。肉毒杆菌素与保妥适的平均剂量比范围从低至2:1到高至11:1。31%的患者的肉毒杆菌素与保妥适剂量比分组为5:1至小于6:1；30%的患者的肉毒杆菌素与保妥适平均剂量比为4:1至小于5:1；在所有接受评估的患者中，只有21%的患者的肉毒杆菌素与保妥适剂量比分组为3:1至小于4:1。结果与英国关于肉毒杆菌毒素的标签一致，该标签表明不同A型血清型毒素的单位不可互换，简单的剂量转换因子不适用。
