Nuanthaisong Umaphorn, Abraham Nitya, Goldman Howard B
Department of Urology, Center for Female Pelvic Medicine and Reconstructive Surgery, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH; Urology Unit, Department of Surgery, Faculty of Medicine, Vajira Hospital, Navamindradhiraj University, Bangkok, Thailand.
Department of Urology, Center for Female Pelvic Medicine and Reconstructive Surgery, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH.
Urology. 2014 Nov;84(5):1044-8. doi: 10.1016/j.urology.2014.07.046. Epub 2014 Oct 24.
To determine the occurrence of all treatment-related adverse events (AEs), especially life-threatening AEs, after the injection of a cumulative dose of >360 units of onabotulinumtoxinA for multiple indications (neurogenic detrusor overactivity, lower limb spasticity, and so forth) within a 3-month interval.
This is a retrospective cohort study of patients who received >360 units of onabotulinumtoxinA within a 3-month interval, with at least 1 urologic indication for injection, between January 1, 2002 and January 1, 2013. The rate of treatment-related AE up to 8 days after injection and life-threatening AE up to 90 days after injection was compared between the injection sessions below and exceeding the maximum dosage recommendations.
Thirteen patients met the study criteria. Eleven were female patients and had a diagnosis of multiple sclerosis. Sixty-five injection sessions involved >360 units of onabotulinumtoxinA administered within a 90-day interval. Median interval between injections was 54 days (interquartile range [IQR], 30-71 days) and median dose administered was 800 units (IQR, 600-1000 units). Seventy injection sessions involved <360 units of onabotulinumtoxinA administered >90 days after prior injection. Median interval between these injections was 113 days (IQR, 97-158 days) and median dose administered was 200 units (IQR, 100-300 units). The maximum cumulative dosage injected was 1900 units (1500 units for lower extremities and 400 units for bladder). This patient did not experience any AE. There was a total of 6 AEs (general and/or extremity weakness or leg pain) that occurred in 4 patients, of a total of 183 injection sessions. These AEs all eventually resolved. There were no life-threatening AEs in either group.
This is the first report of patients receiving >360 cumulative units of onabotulinumtoxinA within a 3-month interval for multiple indications. There were no life-threatening AEs. This study provides preliminary data on administration of high doses of onabotulinumtoxinA for multiple indications.
确定在3个月内注射累计剂量超过360单位的A型肉毒毒素用于多种适应症（神经源性逼尿肌过度活动、下肢痉挛等）后所有与治疗相关的不良事件（AE）的发生情况，尤其是危及生命的AE。
这是一项回顾性队列研究，研究对象为在2002年1月1日至2013年1月1日期间，在3个月内接受超过360单位A型肉毒毒素且至少有1项泌尿外科注射适应症的患者。比较注射剂量低于和超过最大剂量推荐值的注射疗程在注射后8天内与治疗相关的AE发生率以及注射后90天内危及生命的AE发生率。
13例患者符合研究标准。11例为女性患者，诊断为多发性硬化症。65个注射疗程涉及在90天内注射超过360单位的A型肉毒毒素。注射间隔的中位数为54天（四分位间距[IQR]，30 - 71天），注射的中位剂量为800单位（IQR，600 - 1000单位）。70个注射疗程涉及在前次注射90天后注射低于360单位的A型肉毒毒素。这些注射之间的间隔中位数为113天（IQR，97 - 158天），注射的中位剂量为200单位（IQR，100 - 300单位）。注射的最大累积剂量为1900单位（下肢1500单位，膀胱400单位）。该患者未发生任何AE。在总共183个注射疗程中，4例患者共发生6次AE（全身和/或肢体无力或腿痛）。这些AE最终均得到缓解。两组均未出现危及生命的AE。
这是关于在3个月内为多种适应症接受超过360累积单位A型肉毒毒素的患者的首份报告。未出现危及生命的AE。本研究提供了关于高剂量A型肉毒毒素用于多种适应症给药的初步数据。
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