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A型肉毒毒素治疗颈部肌张力障碍临床疗效持续时间的系统评价与荟萃分析

Systematic review and meta-analysis of the duration of clinical effect of onabotulinumtoxinA in cervical dystonia.

作者信息

Marsh Wallace A, Monroe Deirdre M, Brin Mitchell F, Gallagher Conor J

机构信息

Allergan, Inc,, Irvine, CA, USA.

出版信息

BMC Neurol. 2014 Apr 27;14:91. doi: 10.1186/1471-2377-14-91.

Abstract

BACKGROUND

Botulinum toxins are considered first-line therapy for treatment of cervical dystonia (CD) and must be injected on a repeat basis. Understanding the duration of clinical benefit of botulinum toxins and its impact on health care utilization are thus important in the contemporary environment. However, there is currently no overall consensus on the duration of effect of onabotulinumtoxinA in the treatment of CD. We performed a systematic review and meta-analysis to identify the duration of effect of onabotulinumtoxinA in CD and investigate factors that may influence it.

METHODS

A systematic literature search identified prospective or retrospective studies reporting duration of effect of onabotulinumtoxinA for the treatment of CD. Inclusion criteria included peer-reviewed, non-review, English-language articles published between January 1980 and January 2013. A formal meta-analysis using Comprehensive Meta-Analysis Version 2 was conducted to identify the duration of effect of onabotulinumtoxinA in the treatment of CD; both fixed and random effects models were performed. Subgroup analyses were performed to identify factors that influenced the duration of effect of onabotulinumtoxinA.

RESULTS

A total of 18 studies (including >1,900 patients) met the inclusion criteria and were used for the meta-analysis. The mean duration of effect of onabotulinumtoxinA in CD was found to be 93.2 days (95% CI 91.8-94.6 days) for the fixed effects model and 95.2 days (95% CI 88.9-101.4 days) for the random effects model. A meta-regression found that dose of onabotulinumtoxinA and country of origin influenced the duration of effect of onabotulinumtoxinA, whereas quality score of the article and study type did not. In particular, doses ≥180 Units were associated with longer durations of effect than doses <180 Units (107-109 days vs. 86-88 days, respectively; p < 0.01). Limitations included pooling studies that used discrete definitions of duration and had different designs and study quality.

CONCLUSIONS

Based on the published literature, the mean duration of effect of onabotulinumtoxinA in CD was 93-95 days (13.2-13.5 weeks). This suggests that, in general, patients with CD treated with onabotulinumtoxinA should require ~4 treatments per year.

摘要

背景

肉毒杆菌毒素被认为是治疗颈部肌张力障碍(CD)的一线疗法,且必须重复注射。因此,了解肉毒杆菌毒素的临床获益持续时间及其对医疗保健利用的影响在当前环境下很重要。然而,目前关于A型肉毒毒素治疗CD的疗效持续时间尚无总体共识。我们进行了一项系统评价和荟萃分析,以确定A型肉毒毒素治疗CD的疗效持续时间,并调查可能影响该持续时间的因素。

方法

通过系统的文献检索,确定报告A型肉毒毒素治疗CD疗效持续时间的前瞻性或回顾性研究。纳入标准包括1980年1月至2013年1月期间发表的经同行评审的、非综述性的英文文章。使用综合荟萃分析2.0版进行正式的荟萃分析,以确定A型肉毒毒素治疗CD的疗效持续时间;同时采用固定效应模型和随机效应模型。进行亚组分析以确定影响A型肉毒毒素疗效持续时间的因素。

结果

共有18项研究(包括1900多名患者)符合纳入标准并用于荟萃分析。固定效应模型中,A型肉毒毒素治疗CD的平均疗效持续时间为93.2天(95%CI 91.8 - 94.6天),随机效应模型中为95.2天(95%CI 88.9 - 101.4天)。荟萃回归发现,A型肉毒毒素的剂量和原产国影响其疗效持续时间,而文章的质量评分和研究类型则无此影响。特别是,剂量≥180单位的疗效持续时间比剂量<180单位的更长(分别为107 - 109天和86 - 88天;p<0.01)。局限性包括汇总的研究使用了不同的疗效持续时间定义,且设计和研究质量各异。

结论

根据已发表的文献,A型肉毒毒素治疗CD的平均疗效持续时间为93 - 95天(13.2 - 13.5周)。这表明,一般而言,接受A型肉毒毒素治疗的CD患者每年应需要约4次治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6008/4013807/525ab337f8e5/1471-2377-14-91-1.jpg

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