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本文引用的文献

1
Quality of life improvements in patients with cervical dystonia following treatment with a liquid formulation of abobotulinumtoxinA (Dysport ).采用阿替洛尔毒素 A 水剂(Dysport)治疗后,颈肌张力障碍患者生活质量得到改善。
Eur J Neurol. 2019 Jun;26(6):943-e65. doi: 10.1111/ene.13800. Epub 2018 Sep 30.
2
Pharmacological differences and clinical implications of various botulinum toxin preparations: a critical appraisal.各种肉毒杆菌毒素制剂的药理学差异及临床意义:批判性评价
Funct Neurol. 2018 Jan/Mar;33(1):7-18. doi: 10.11138/fneur/2018.33.1.007.
3
Botulinum toxin type A therapy for cervical dystonia.A型肉毒毒素治疗颈部肌张力障碍
Cochrane Database Syst Rev. 2017 Dec 12;12(12):CD003633. doi: 10.1002/14651858.CD003633.pub3.
4
Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making.治疗和/或比较效果的真实世界数据研究的良好实践:ISPOR-ISPE联合特别工作组关于医疗保健决策中真实世界证据的建议。
Pharmacoepidemiol Drug Saf. 2017 Sep;26(9):1033-1039. doi: 10.1002/pds.4297.
5
Clinical Practice: Evidence-Based Recommendations for the Treatment of Cervical Dystonia with Botulinum Toxin.临床实践:肉毒杆菌毒素治疗颈部肌张力障碍的循证推荐
Front Neurol. 2017 Feb 24;8:35. doi: 10.3389/fneur.2017.00035. eCollection 2017.
6
Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial.阿柏西普肉毒素A液体制剂治疗颈部肌张力障碍的疗效与安全性:一项随机对照试验。
Mov Disord. 2016 Nov;31(11):1649-1657. doi: 10.1002/mds.26760. Epub 2016 Sep 21.
7
A Retrospective, Single-Center Comparative Cost Analysis of OnabotulinumtoxinA and AbobotulinumtoxinA for Cervical Dystonia Treatment.一项回顾性、单中心的比较成本分析:肉毒毒素 A 与阿替瑞林治疗颈肌张力障碍的效果。
J Manag Care Spec Pharm. 2015 Oct;21(10):854-60. doi: 10.18553/jmcp.2015.21.10.854.
8
A Comparison of Botox 100 U/mL and Dysport 100 U/mL Using Dose Conversion Ratio 1: 3 and 1: 1.7 in the Treatment of Cervical Dystonia: A Double-Blind, Randomized, Crossover Trial.使用1:3和1:1.7剂量转换比的100 U/mL肉毒杆菌毒素和100 U/mL地宝毒素治疗颈部肌张力障碍的比较:一项双盲、随机、交叉试验。
Clin Neuropharmacol. 2015 Sep-Oct;38(5):170-6. doi: 10.1097/WNF.0000000000000101.
9
Cost-utility analysis of botulinum toxin type A products for the treatment of cervical dystonia.A型肉毒毒素产品治疗颈部肌张力障碍的成本-效用分析。
Am J Health Syst Pharm. 2015 Feb 15;72(4):301-7. doi: 10.2146/ajhp140276.
10
Dysport and Botox at a ratio of 2.5:1 units in cervical dystonia: a double-blind, randomized study.肉毒杆菌素A与保妥适以2.5:1单位比例用于治疗颈部肌张力障碍:一项双盲随机研究
Mov Disord. 2015 Feb;30(2):206-13. doi: 10.1002/mds.26085. Epub 2014 Dec 5.

在颈部肌张力障碍的实际临床管理中,阿柏西普肉毒素A与昂丹司琼肉毒素A的经济学评估

Economic evaluation of AbobotulinumtoxinA vs OnabotulinumtoxinA in real-life clinical management of cervical dystonia.

作者信息

Misra V P, Danchenko N, Maisonobe P, Lundkvist J, Hunger M

机构信息

1Imperial College Healthcare NHS Trust, London, UK.

2Ipsen, Boulogne-Billancourt, France.

出版信息

J Clin Mov Disord. 2020 Feb 11;7:2. doi: 10.1186/s40734-020-0083-0. eCollection 2020.

DOI:10.1186/s40734-020-0083-0
PMID:32071728
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7014631/
Abstract

BACKGROUND

Botulinum neurotoxins type A (BoNT-As) are commonly used treatments for cervical dystonia (CD). Clinical trials have demonstrated the benefits of them in these patients, but data from real-life clinical practice as well as comparative data on the cost and outcome of different BoNT-A formulations are limited. The aim of this study was to compare abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) on their clinical outcomes and drug costs in real-life clinical practice.

METHODS

This analysis included 356 adult patients with idiopathic CD treated with aboBoNT-A ( = 253) or onaBoNT-A ( = 103) from 38 centres across Europe and Australia (NCT00833196). The clinical outcome measures were treatment responses, changes in TWSTRS scores and changes in health utility scores from baseline to study visit 2 and 3. Health utility score was mapped from the TWSTRS total scale, using a previous publication. Costs included drug cost for France.

RESULTS

The aboBoNT-A treated group had 2.06 (95% CI: 1.15 to 3.69) times higher odds of achieving treatment response than the onaBoNT-A treated group. The adjusted mean change in TWSTRS total score from baseline to visit 3 were - 6.42 (95% CI: - 7.52 to - 5.33) for aboBoNT-A and - 3.94 (95% CI: - 5.68 to - 2.2) for onaBoNT-A, with a difference of - 2.48 (95% CI: - 4.57 to - 0.39). The corresponding difference in the adjusted mean change for health utility score was 0.008 (95% CI: 0.001 to 0.014). Mean treatment costs for aboBoNT-A and onaBoNT-A were 314.1 (95% CI: 299.1 to 329.0) and 346.6 (95% CI: 322.9 to 370.4) Euros, respectively.

CONCLUSIONS

This comparative analysis indicated that treatment with aboBoNT-A may be less costly and lead to improved clinical outcomes when compared with onaBoNT-A, from a French healthcare system perspective. Additional comparative clinical data from larger patient cohorts, as well as more information about cost consequences of an improvement in clinical outcome would be of value to further confirm the findings.

摘要

背景

A型肉毒杆菌神经毒素(BoNT-A)是治疗颈部肌张力障碍(CD)的常用方法。临床试验已证明其对这些患者有益,但来自现实临床实践的数据以及不同BoNT-A制剂成本和疗效的比较数据有限。本研究的目的是在现实临床实践中比较阿泊肉毒毒素A(aboBoNT-A)和奥曲肉毒毒素A(onaBoNT-A)的临床疗效和药物成本。

方法

该分析纳入了来自欧洲和澳大利亚38个中心(NCT00833196)的356例接受aboBoNT-A(n = 253)或onaBoNT-A(n = 103)治疗的成年特发性CD患者。临床疗效指标为治疗反应、TWSTRS评分从基线到研究访视2和3的变化以及健康效用评分的变化。健康效用评分根据之前发表的文献从TWSTRS总分换算得出。成本包括法国的药物成本。

结果

aboBoNT-A治疗组实现治疗反应的几率比onaBoNT-A治疗组高2.06倍(95%置信区间:1.15至3.69)。从基线到访视3,aboBoNT-A组TWSTRS总分的调整后平均变化为-6.42(95%置信区间:-7.52至-5.33),onaBoNT-A组为-3.94(95%置信区间:-5.68至-2.2),差异为-2.48(95%置信区间:-4.57至-0.39)。健康效用评分调整后平均变化的相应差异为0.008(95%置信区间:0.001至0.014)。aboBoNT-A和onaBoNT-A的平均治疗成本分别为314.1欧元(95%置信区间:299.1至329.0)和346.6欧元(95%置信区间:322.9至370.4)。

结论

从法国医疗保健系统的角度来看,这项比较分析表明,与onaBoNT-A相比,aboBoNT-A治疗可能成本更低且临床疗效更佳。来自更大患者队列的更多比较临床数据以及关于临床疗效改善的成本后果的更多信息,将有助于进一步证实这些发现。