BACKGROUND OnabotulinumtoxinA is approved as a treatment across multiple indications. For the treatment of spasticity, onabotulinumtoxinA is injected directly into affected muscles. Intramuscular injections may result in local bleeding and related complications, especially in patients receiving anticoagulant therapy. Despite anticoagulants being commonly used, there is limited information in the medical literature regarding the safety of intramuscular medications in patients receiving oral anticoagulants. This retrospective analysis included pooled safety data from Allergan-sponsored studies evaluating onabotulinumtoxinA for the treatment of patients with muscle spasticity. OBJECTIVE The objective of this study was to determine the risk of bleeding complications in patients with post-stroke spasticity receiving antithrombotic therapy and intramuscular onabotulinumtoxinA. METHODS We conducted a retrospective analysis of pooled safety data from 16 randomized, double-blind, placebo-controlled Allergan-sponsored studies of onabotulinumtoxinA for the treatment of post-stroke upper or lower limb muscle spasticity, including adult patients with at least moderate upper or lower limb spasticity and receiving at least one dose of the study drug. Bleeding-related adverse events starting within 4 weeks of study treatment were assessed. The incidence rates of bleeding complications were compared for patients receiving classes of antithrombotic therapy vs those not receiving antithrombotic therapy and for those receiving onabotulinumtoxinA vs placebo (with or without antithrombotic therapy). RESULTS Of 1877 patients, 1182 received antithrombotic therapy. The overall incidence of bleeding complications was < 2%. In those receiving any antithrombotic therapy, the incidence of bleeding was 1.0% vs 1.4% (no antithrombotic therapy); after onabotulinumtoxinA, it was 0.9% for those receiving antithrombotic therapy vs 1.4% (no antithrombotic therapy), and for placebo 1.2% vs 1.4%, respectively. Subgroup results were similar. CONCLUSIONS No apparent increased risk of bleeding complications was observed following administration of onabotulinumtoxinA to patients receiving antithrombotic therapy. Nonetheless, patient education and careful observation of the injection site in patients receiving antithrombotic therapy remains warranted.

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肌痉挛患者同时进行抗栓治疗的安全性：双重双盲研究的回顾性汇总分析。

背景技术肉毒杆菌毒素A被批准为多种适应症的治疗方法。为了治疗痉挛，将肉毒杆菌毒素A直接注射到受影响的肌肉中。肌肉注射可能导致局部出血和相关并发症，特别是在接受抗凝治疗的患者中。尽管通常使用抗凝剂，但是在医学文献中关于口服抗凝剂患者肌内药物安全性的信息有限。这项回顾性分析包括来自Allergan支持的研究的综合安全性数据，这些研究评估了肉毒杆菌毒素A治疗肌肉痉挛的患者。目的本研究的目的是确定接受抗血栓治疗和肌肉内肉毒杆菌毒素A的中风后痉挛患者出血并发症的风险。方法我们回顾性分析了从16项随机，双盲，安慰剂对照的过敏原支持的过敏原onabotulinumtoxinA的研究中收集的安全性数据，这些研究用于治疗中风后上肢或下肢肌肉痉挛，包括年龄至少在中上或中等的成年患者下肢痉挛，并接受至少一剂研究药物。评估了研究治疗4周内开始的与出血有关的不良事件。比较接受抗血栓治疗的患者与未接受抗血栓治疗的患者以及接受肉毒杆菌毒素A与安慰剂（有或没有抗血栓治疗）的出血并发症的发生率。结果在1877例患者中，有1182例接受了抗栓治疗。出血并发症的总发生率＜2％。在接受任何抗栓治疗的患者中，出血发生率分别为1.0％和1.4％（无抗栓治疗）；接受肉毒杆菌毒素A治疗后，接受抗血栓治疗的患者分别为0.9％和1.4％（未接受抗血栓治疗），而安慰剂分别为1.2％和1.4％。亚组的结果相似。结论对接受抗血栓治疗的患者施用了肉毒杆菌毒素A后，未发现出血并发症的风险明显增加。尽管如此，仍然需要对患者进行教育并仔细观察接受抗栓治疗的患者的注射部位。