Fernandez Hubert H, Pagan Fernando, Danisi Fabio, Greeley David, Jankovic Joseph, Verma Amit, Sethi Kapil, Pappert Eric J
Cleveland Clinic, Cleveland, Ohio, United States of America.
Tremor Other Hyperkinet Mov (N Y). 2013 May 17;3. doi: 10.7916/D8CF9NVD. Print 2013.
We report the interim results from XCiDaBLE, a large, prospective, observational "naturalistic" study evaluating Xeomin® (incobotulinumtoxinA) for Cervical Dystonia or BLEpharospasm in the United States.
Subjects (≥ 18 years old) with cervical dystonia (CD) are followed for two treatment cycles and monitored via Interactive Voice/Web Response. The subject's physician must have chosen to treat with incobotulinumtoxinA prior to and independent of enrollment in this study. Subject-reported scales include the Subject Global Impression-Severity and Improvement and Cervical Dystonia Impact Profile (CDIP-58), and Work Productivity and Quality of Life (QoL) are assessed by means of an employment questionnaire and work history and the SF-12v2 Health Survey (SF-12v2). Subjects are seen by the investigator for three visits, which include a baseline visit (including the first injection), a second injection visit, and a final study visit (12 weeks after the second injection).
This ongoing study includes 145 subjects with a diagnosis of CD. The majority were female (82.3%) and white (91.0%) and had previously been treated with botulinum toxins (77.2%). There were 106 employed at the time of disease onset, but 12.6 years later only 44% were still employed at the time of enrolment into the study, and 20% were either receiving or seeking disability benefits. The mean total dose/treatment of CD was 225.2 units for the first injection. The CDIP-58 total score was significantly improved 4 weeks after the first injection compared to baseline (p≤0.0001). Most subjects noted improvement in their global impression assessment. No new or unexpected adverse events occurred.
The results from these interim analyses confirm previous controlled, single-dose studies of incobotulinumtoxinA in terms of efficacy and safety.
我们报告了XCiDaBLE研究的中期结果，这是一项在美国进行的大型、前瞻性、观察性“自然主义”研究，旨在评估Xeomin®（incobotulinumtoxinA）用于治疗颈部肌张力障碍或眼睑痉挛。
对年龄≥18岁的颈部肌张力障碍（CD）患者进行两个治疗周期的随访，并通过交互式语音/网络应答进行监测。受试者的医生必须在本研究入组之前且独立于本研究选择使用incobotulinumtoxinA进行治疗。受试者报告的量表包括受试者整体印象-严重程度和改善情况以及颈部肌张力障碍影响量表（CDIP-58），工作效率和生活质量（QoL）通过就业问卷、工作经历以及SF-12v2健康调查（SF-12v2）进行评估。研究者对受试者进行三次访视，包括基线访视（包括首次注射）、第二次注射访视以及最终研究访视（第二次注射后12周）。
这项正在进行的研究纳入了145例诊断为CD的受试者。大多数为女性（82.3%）和白人（91.0%），且之前接受过肉毒毒素治疗（77.2%）。发病时1有106人就业，但12.6年后，在入组本研究时只有44%仍在就业，20%正在领取或寻求残疾福利。首次注射时CD的平均总剂量/治疗量为225.2单位。与基线相比，首次注射后4周CDIP-58总分显著改善（p≤0.0001）。大多数受试者在整体印象评估中表示有改善。未发生新的或意外的不良事件。
这些中期分析的结果在疗效和安全性方面证实了之前关于incobotulinumtoxinA的对照单剂量研究。 1 “发病时1”疑为多余表述，原文如此未做修改。
