Lucchese Scott, Daripa Bob, Pulimamidi Shruthi
University of Arkansas for Medical Sciences.
Grant Medical College & Sir J.J. Group of Government Hospitals.
Res Sq. 2023 Mar 14:rs.3.rs-2624326. doi: 10.21203/rs.3.rs-2624326/v1.
Onabotulinum toxin A (OnA) is a well-tolerated and effective treatment for chronic migraine (CM). However, based on research indications that incobotulinum toxin A (InA) would be equally effective, a Veterans' Health Administration Medical Center mandated a 2-year trial of InA as more cost-effective alternative to OnA. Although InA is used for many similar indications as OnA, it is not Food and Drug Administration approved for treating CM, and complications occurred in several patients with CM following this treatment change. We conducted this retrospective analysis to evaluate differences in the efficacy of OnA and InA and identify the reasons for the adverse effects of InA in some of these patients.
We performed a retrospective review of 42 patients who had been effectively treated with OnA and were then switched to InA. The differences between treatment responses to OnA and InA were assessed through the evaluation of pain on injection, number of headache days, and duration of action. Patients received injections at 10- to 13-week intervals. Those who reported excessive pain on injection of InA were switched back to OnA.
Severe burning pain on injection was reported by 16 (38%) patients for InA only and by 1 (2%) patient for both InA and OnA. Neither migraine suppression nor the duration of effect was significantly different between OnA and InA.
Reformulation of InA with a pH-buffered solution may eliminate the difference in pain on injection. InA would then be a good alternative to OnA for treating CM.
A型肉毒杆菌毒素（OnA）是一种耐受性良好且有效的慢性偏头痛（CM）治疗方法。然而，基于研究表明A型肉毒杆菌毒素（InA）可能同样有效，一家退伍军人健康管理局医疗中心开展了一项为期两年的试验，将InA作为比OnA更具成本效益的替代方案。尽管InA与OnA用于许多相似的适应症，但它未获得美国食品药品监督管理局批准用于治疗CM，并且在这种治疗改变后，数名CM患者出现了并发症。我们进行了这项回顾性分析，以评估OnA和InA疗效的差异，并确定部分患者中InA产生不良反应的原因。
我们对42例曾接受OnA有效治疗后转而使用InA的患者进行了回顾性研究。通过评估注射时的疼痛、头痛天数和作用持续时间来评估OnA和InA治疗反应的差异。患者每隔10至13周接受一次注射。那些报告InA注射时疼痛过度的患者重新换回OnA。
仅InA注射时出现严重灼痛的患者有16例（38%），InA和OnA注射时均出现严重灼痛的患者有1例（2%）。OnA和InA在偏头痛抑制和作用持续时间方面均无显著差异。
用pH缓冲溶液重新配制InA可能消除注射时疼痛的差异。那么InA将成为治疗CM的OnA的良好替代方案。
