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肉毒毒素治疗颈肌张力障碍的不良反应:我们应该归咎于安慰剂多少?

Adverse events with botulinum toxin treatment in cervical dystonia: How much should we blame placebo?

机构信息

Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal; Instituto de Medicina Molecular, Lisbon, Portugal; Center for Evidence-Based Medicine, Faculty of Medicine, University of Lisbon, Lisbon, Portugal.

Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal; Instituto de Medicina Molecular, Lisbon, Portugal; Huntington's Disease Centre, University College London, UK.

出版信息

Parkinsonism Relat Disord. 2018 Nov;56:16-19. doi: 10.1016/j.parkreldis.2018.06.017. Epub 2018 Jun 15.

Abstract

INTRODUCTION

Botulinum toxin (BoNT) is the first line therapy for cervical dystonia (CD), with most patients receiving many treatment sessions, and so come to recognize and expect the benefits and harms of BoNT, making it difficult to separate which adverse events (AEs) are driven by BoNT and which come from patients' expectations.

METHODS

Using the results of three Cochrane systematic reviews of randomized controlled trials (RCTs) we pooled results to calculate the risk of general and specific AEs associated with BoNT, and the proportion of AEs that cannot be pharmacologically attributed to BoNT.

RESULTS

Fifteen RCTs, enrolling 1604 patients, were included. BoNT was associated with an increased risk of AEs, but 79% of this increased risk cannot be pharmacologically attributed to BoNT.

CONCLUSIONS

Patients with CD attach a considerable expectation of harm due to BoNT, reflected in the large proportion of non-pharmacologically-mediated AEs.

摘要

简介

肉毒毒素(BoNT)是治疗颈肌张力障碍(CD)的一线疗法,大多数患者需要接受多次治疗,因此逐渐认识并期待 BoNT 的益处和危害,这使得很难区分哪些不良反应(AEs)是由 BoNT 引起的,哪些是由患者的预期引起的。

方法

利用三项 Cochrane 系统评价随机对照试验(RCT)的结果,我们汇总结果以计算与 BoNT 相关的一般和特定不良反应的风险,以及不能用药理学归因于 BoNT 的不良反应比例。

结果

纳入了 15 项 RCT,共纳入了 1604 名患者。BoNT 与不良反应风险增加相关,但其中 79%的风险增加不能用药理学归因于 BoNT。

结论

CD 患者对 BoNT 产生了相当大的危害预期,这反映在大量非药理学介导的不良反应中。

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