口服喷雾西地那非治疗勃起功能障碍：当前证据与临床展望

文献信息

中文摘要

勃起功能障碍是最常见的男性性功能障碍之一，通常使用5型磷酸二酯酶抑制剂进行管理，其中西地那非仍是处方最广泛的药物。传统片剂已显示出确切的疗效和安全性；然而，治疗依从性常常受到药理学疗效之外因素的影响。近年来，包括口服喷雾系统在内的西地那非替代制剂已被开发出来，以提高治疗可接受性并可能改善整体患者体验。本叙述性综述总结了关于口服喷雾西地那非的当前证据，重点关注其药理学依据、临床疗效、起效时间、安全性、耐受性、患者体验及其在临床实践中的潜在作用。现有证据提示，口服喷雾西地那非可能提供实际优势，尤其是对于吞咽困难或希望获得较少医疗化治疗体验的患者。然而，目前大多数可用数据来自药代动力学研究或与其他替代口服制剂的间接比较，而直接比较性临床研究仍然稀少。因此，目前尚无一致证据表明其与传统片剂相比具有更优的疗效、更快的起效时间或更好的安全性。同样，关于患者报告结局和真实世界有效性的制剂特异性数据仍然有限。因此，口服喷雾西地那非代表一种新兴的替代制剂，可能在特定患者中提高治疗可接受性，但其确切的临床作用尚未确立。有必要开展设计良好的比较性临床试验，以明确其治疗价值并识别最可能从该给药方式中获益的患者人群。

英文摘要

Erectile dysfunction is one of the most prevalent male sexual disorders and is commonly managed with phosphodiesterase type 5 inhibitors, among which sildenafil remains the most widely prescribed agent. Conventional tablet formulations have demonstrated well-established efficacy and safety; however, treatment adherence is frequently influenced by factors beyond pharmacological effectiveness. In recent years, alternative sildenafil formulations, including oral spray systems, have been developed to improve treatment acceptability and potentially enhance the overall patient experience. This narrative review summarizes the current evidence regarding oral spray sildenafil, focusing on its pharmacological rationale, clinical efficacy, onset of action, safety, tolerability, patient experience, and potential role in clinical practice. Available evidence suggests that oral spray sildenafil may offer practical advantages, particularly for patients with swallowing difficulties or those seeking a less medicalized treatment experience. However, most currently available data derive from pharmacokinetic investigations or indirect comparisons with other alternative oral formulations, whereas direct comparative clinical studies remain scarce. Consequently, no consistent evidence currently demonstrates superior efficacy, faster onset of action, or improved safety compared with conventional tablet formulations. Likewise, formulation-specific data regarding patient-reported outcomes and real-world effectiveness remain limited. Oral spray sildenafil therefore represents an emerging alternative formulation that may improve treatment acceptability in selected patients, although its precise clinical role has yet to be established. Well-designed comparative clinical trials are warranted to clarify its therapeutic value and identify patient populations most likely to benefit from this delivery modality.