Abstract：
BACKGROUND: Botulinum toxin (BoNT) is first-line treatment for cervical dystonia (CD). Treatment of CD with BoNT usually requires injections every 3-4 months for as long as symptoms persist, which can be for the lifetime of the individual. Duration of BoNT effect can impact quality of life since it is important that efficacy is maintained throughout an injection cycle to avoid fluctuations of effect after each injection. There is currently no consensus on how to assess duration of BoNT effect in patients with CD.
METHODS: A scoping review was conducted to summarize the available evidence from phase 3 clinical trials of BoNT in CD and on the interpretation of the reported duration of effect. The available evidence was analyzed in the context of clinical experience and real-world treatment practices of CD.
RESULTS: Methods for estimating duration of effect varied across publications; most were based on artificial constructs developed for clinical trials (time until a pre-specified efficacy endpoint was reached) and are not appropriate to apply in clinical practice. Clinical trial outcomes in CD were not objectively evaluated, and did not prioritize patients\' needs or focus on factors that impact patients\' daily living activities and quality of life.
CONCLUSIONS: Better evidence and consistency of reporting for duration of effect for BoNT in CD is needed to help guide clinicians on when reinjection is likely to be required. The goal should be to keep patients as symptom-free as possible with flexible reinjection intervals tailored to individual needs.
METHODS: A scoping review was conducted to summarize the available evidence from phase 3 clinical trials of BoNT in CD and on the interpretation of the reported duration of effect. The available evidence was analyzed in the context of clinical experience and real-world treatment practices of CD.
RESULTS: Methods for estimating duration of effect varied across publications; most were based on artificial constructs developed for clinical trials (time until a pre-specified efficacy endpoint was reached) and are not appropriate to apply in clinical practice. Clinical trial outcomes in CD were not objectively evaluated, and did not prioritize patients\' needs or focus on factors that impact patients\' daily living activities and quality of life.
CONCLUSIONS: Better evidence and consistency of reporting for duration of effect for BoNT in CD is needed to help guide clinicians on when reinjection is likely to be required. The goal should be to keep patients as symptom-free as possible with flexible reinjection intervals tailored to individual needs.
摘要：
背景：肉毒杆菌毒素（BoNT）是宫颈肌张力障碍（CD）的一线治疗方法。使用BoNT治疗CD通常需要每3-4个月注射一次，只要症状持续，这可以是个人的一生。BoNT效应的持续时间可以影响生活质量,因为重要的是在整个注射循环中维持功效以避免每次注射后的效应波动。目前对于如何评估CD患者的BoNT效应持续时间尚无共识。
方法：进行了范围审查，以总结BoNT在CD中的3期临床试验的可用证据以及对报告的作用持续时间的解释。在CD的临床经验和现实世界治疗实践的背景下分析了可用的证据。
结果：估计效果持续时间的方法因出版物而异；大多数是基于为临床试验开发的人工构建体（直到达到预先指定的疗效终点的时间），不适合在临床实践中应用。没有客观评估CD的临床试验结果，并且没有优先考虑患者的需求或关注影响患者日常生活活动和生活质量的因素。
结论：需要更好的证据和一致性来报告BoNT在CD中的作用持续时间，以帮助指导临床医生何时可能需要重新注射。目标应该是通过根据个人需要定制的灵活的再注射间隔，使患者尽可能无症状。
方法：进行了范围审查，以总结BoNT在CD中的3期临床试验的可用证据以及对报告的作用持续时间的解释。在CD的临床经验和现实世界治疗实践的背景下分析了可用的证据。
结果：估计效果持续时间的方法因出版物而异；大多数是基于为临床试验开发的人工构建体（直到达到预先指定的疗效终点的时间），不适合在临床实践中应用。没有客观评估CD的临床试验结果，并且没有优先考虑患者的需求或关注影响患者日常生活活动和生活质量的因素。
结论：需要更好的证据和一致性来报告BoNT在CD中的作用持续时间，以帮助指导临床医生何时可能需要重新注射。目标应该是通过根据个人需要定制的灵活的再注射间隔，使患者尽可能无症状。
