Rationale

Most studies evaluating the safety and tolerability of intranasal oxytocin (OT) have not reported consistent adverse events (AEs), but they have largely focused on young men and single-dose administration. Thus, it is unclear whether these findings translate to older individuals and with longer administration periods.

Objective

Extending previous work, this study investigated the safety and tolerability of chronic intranasal OT in generally healthy older men.

Methods

Data were from a randomized, placebo (P)-controlled, double-blind clinical trial evaluating the effects of 4 weeks of self-administered intranasal OT (24 IU twice daily) in older adults with no major physical or cognitive impairments. Heart rate, blood pressure, urine osmolality, and serum metabolic biomarkers were obtained before and at the end of the intervention. AEs were collected during the first 3 weeks and 1 week after cessation of treatment.

Results

Of 103 participants recruited, 95 were randomized and received the intervention (OT = 49, P = 46). OT had no significant impact on cardiovascular, urine, or serum measures. The AEs reported for both treatments were generally mild and few in number, though one participant assigned to OT and two assigned to P dropped out due to AEs. Relative to P, OT did not significantly increase the likelihood of reporting AEs, nor the number or severity of AEs reported.

Conclusion

Chronic intranasal OT appears safe and well-tolerated in generally healthy older men. These findings provide support for continued human research on potential benefits of chronic OT in older adult populations.

中文翻译：

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老年男性慢性鼻内催产素的安全性和耐受性：随机对照试验的结果

基本原理

大多数评估鼻内催产素（OT）安全性和耐受性的研究并未报告一致的不良事件（AE），但它们主要集中在年轻男性和单剂量给药。因此，尚不清楚这些发现是否适用于年龄较大且给药时间较长的个体。

客观的

这项研究扩展了之前的工作，调查了一般健康的老年男性慢性鼻内 OT 的安全性和耐受性。

方法

数据来自一项随机、安慰剂 (P) 对照、双盲临床试验，该试验评估了没有严重身体或认知障碍的老年人自行鼻内 OT（24 IU，每天两次）4 周的效果。在干预之前和结束时获取心率、血压、尿液渗透压和血清代谢生物标志物。AE 在治疗停止后的前 3 周和 1 周内收集。

结果

在招募的 103 名参与者中，95 名被随机分配并接受干预（OT = 49，P = 46）。OT 对心血管、尿液或血清指标没有显着影响。尽管一名分配至 OT 组的参与者和两名分配至 P 组的参与者因 AE 而退出，但两种治疗方法报告的 AE 通常都很轻微且数量很少。相对于 P，OT 并没有显着增加报告 AE 的可能性，也没有显着增加报告 AE 的数量或严重程度。

结论

对于一般健康的老年男性来说，慢性鼻内 OT 似乎是安全且耐受性良好的。这些发现为持续进行人类研究提供了支持，以了解慢性OT对老年人群的潜在益处。