【 文献重点摘要 】

Objective

To evaluate the long-term safety of repeated administrations of a new botulinum toxin type A (Reloxin; Medicis Pharmaceutical Corp, Scottsdale, Arizona) in the treatment of moderate to severe glabellar lines.

Methods

Open-label assessment of 1200 patients receiving as many as 5 treatments of Reloxin over a 13month period. The product was diluted in 2.5-mL sterile physiologic saline solution, 0.9%, without preservative to a concentration of 50 U of Reloxin per 0.25 mL of solution. Investigators injected 0.05 mL of the solution (10 U each) into each of 5 injection sites in the glabellar area on day 0 of each treatment cycle. There was a minimum 85-day gap between treatments. Postinjection clinical evaluation was performed on days 14 and 30 and monthly thereafter until retreatment, study completion, or early termination. The patients were telephoned on day 7 to check for adverse events (AEs) and concomitant medications, and patient diaries were used to document the onset of treatment effect.

Results

The majority (72%) of treatment-emergent AEs were considered unlikely or not related to study treatment. Probably or possibly related treatment-emergent AEs occurred in 36% of patients. The most frequently occurring related AEs were injection site disorders (18%), nervous system disorders (14% and 12% headache), and eye disorders (9%). Related AEs around the injection site or eyes were usually reported by day 7 and then resolved. Reported ptosis does not differentiate between brow ptosis and eyelid ptosis. A total of 45 patients had a total of 55 instances of ptosis across all cycles, with most episodes lasting less than 3 weeks. The rates of ptosis decreased during successive cycles from 2.4% in cycle 1 to 0.6% in cycle 5. The proportion of patients reporting an onset of response by day 7 ranged from 93% to 95%. By investigator assessment, the response rate (patients reporting none or mild glabellar line severity scale scores on day 30) ranged from 80% to 91% during cycles 1 to 5.

Conclusions

There was no evidence of cumulative AEs or tachyphylaxis with multiple Reloxin treatments over a period of 13 months. The treatments were well tolerated. The rates of ptosis decreased over successive cycles, and the proportion of responders by day 7 ranged from 93% to 95%.

目的

评价一种新型A型肉毒毒素(Reloxin，亚利桑那州斯科茨代尔的Medicis制药公司)重复使用治疗中重度眉间纹的长期安全性。

方法

在13个月的时间里，对1200名接受5种瑞乐辛治疗的患者进行开放标签评估。产品在不含防腐剂的2.5mL无菌生理盐水溶液(0.9%)中稀释至50U/0.25mL溶液。研究人员在每个治疗周期的第0天将0.05mL的溶液(每个10U)注射到眉间区域的5个注射点。两次治疗之间至少有85天的间隔。在注射后第14天和第30天以及此后的每个月进行临床评估，直到再次治疗、研究完成或提前终止。在第7天给患者打电话，检查不良事件(AEs)和伴随药物，并使用患者日记记录治疗效果的开始。

结果

大多数(72%)急诊不良反应被认为不太可能或与研究治疗无关。可能或可能与治疗相关的急诊不良反应发生在36%的患者中。最常见的相关不良反应是注射部位疾病(18%)、神经系统疾病(14%和12%的头痛)和眼部疾病(9%)。注射部位或眼睛周围的相关不良反应通常在第7天前报告，然后消失。据报道，上睑下垂并不区分眉毛下垂和眼睑下垂。共有45名患者在所有周期中总共有55例上睑下垂，大多数发作持续时间不到3周。在连续的周期中，上睑下垂的发生率从周期1的2.4%下降到周期5的0.6%。报告第7天起效的患者比例从93%到95%不等。通过调查者评估，在周期1到5期间，应答率(患者在第30天报告无或轻度眉间纹严重程度量表评分)从80%到91%不等。

结论

在13个月的时间里，没有证据表明多次使用Reloxin治疗会出现累积的不良反应或快速反应。这些治疗耐受性良好。上睑下垂的发生率在连续的周期中下降，到第7天，应答者的比例从93%到95%不等。