Brashear A, Watts M W, Marchetti A, Magar R, Lau H, Wang L
Department of Neurology, Indiana University Medical Center, Indianapolis, USA.
Clin Ther. 2000 Dec;22(12):1516-24. doi: 10.1016/s0149-2918(00)83049-0.
Clinical trials have established the efficacy and safety of botulinum toxin type A (BTX-A) in patients with cervical dystonia. To maintain the clinical benefits of BTX-A, injections need to be repeated whenever patients' symptoms begin to recur.
The purpose of this study was to determine, in clinical practice settings, the mean duration of effect of BTX-A in the treatment of adult patients with cervical dystonia.
A retrospective chart review was undertaken at an academic center and a private neurology practice. At each site, > or =50 patients being treated for cervical dystonia were identified and randomized for chart review. Patients had to have received the first assessable injection of BTX-A between January 1, 1998, and March 31, 1998, to coincide with the clinical availability of the most current formulation of the neurotoxin. A chart was eligible for review if the patient was aged > or =18 years, had a documented diagnosis of idiopathic cervical dystonia, was being treated with BTX-A, and had been under the continuous care of investigators from January 1, 1998, to August 31, 1999. Of the 102 patients initially identified, the first 30 from each site who met the study inclusion criteria were assessed for (1) age and sex; (2) severity of dystonia; (3) years of BTX-A use; (4) dates of first, second, third, and fourth BTX-A injections; (5) drug dose; (6) use of electromyography; (7) use of other prescribed therapies; (8) laboratory tests; and (9) adverse events. The mean interval between each visit and mean per-patient duration of effect were calculated and stratified by patient characteristics.
The mean age of the patients was 56.4 years. Two thirds of the patients were women. Forty-one of the 60 patients (68.3%) had either moderate or severe disease, and 48 (80.0%) had experienced cervical dystonia for >5 years. The mean per-patient duration of effect across the 4 visits was 15.5 weeks (range, 12.2-24.3 weeks). The duration of effect did not differ significantly between study sites despite the differences in disease severity, drug dose, and use of adjunctive therapy.
BTX-A the controls symptoms of cervical dystonia for 12 to 24 weeks, with a mean duration of effect per patient of 15.5 weeks.
临床试验已证实A型肉毒毒素（BTX-A）对颈部肌张力障碍患者的有效性和安全性。为维持BTX-A的临床疗效，每当患者症状开始复发时就需要重复注射。
本研究的目的是在临床实践环境中确定BTX-A治疗成年颈部肌张力障碍患者的平均疗效持续时间。
在一个学术中心和一家私立神经病学诊所进行了一项回顾性病历审查。在每个地点，确定≥50名接受颈部肌张力障碍治疗的患者并随机进行病历审查。患者必须在1998年1月1日至1998年3月31日期间接受首次可评估的BTX-A注射，以与最新剂型神经毒素的临床可用性相一致。如果患者年龄≥18岁，有特发性颈部肌张力障碍的记录诊断，正在接受BTX-A治疗，并且在1998年1月1日至1999年8月31日期间一直在研究人员的持续护理下，则该病历符合审查条件。在最初确定的102名患者中，对每个地点符合研究纳入标准的前30名患者进行了以下评估：（1）年龄和性别；（2）肌张力障碍的严重程度；（3）使用BTX-A的年限；（4）首次、第二次、第三次和第四次BTX-A注射的日期；（5）药物剂量；（6）肌电图的使用；（7）其他规定疗法的使用；（8）实验室检查；以及（9）不良事件。计算每次就诊之间的平均间隔时间和每位患者的平均疗效持续时间，并按患者特征进行分层。
患者的平均年龄为56.4岁。三分之二的患者为女性。60名患者中有41名（68.3%）患有中度或重度疾病，48名（80.0%）经历颈部肌张力障碍超过5年。4次就诊期间每位患者的平均疗效持续时间为15.5周（范围为12.2 - 24.3周）。尽管疾病严重程度、药物剂量和辅助治疗的使用存在差异，但研究地点之间的疗效持续时间没有显著差异。
BTX-A可控制颈部肌张力障碍症状12至24周，每位患者的平均疗效持续时间为15.5周。
