Analysis of efficacy and safety of sildenafil citrate in 38 male patients with systemic sclerosis (SSc) and erectile dysfunction (ED)
枸橼酸西地那非在系统性硬化症（SSc）合并男性勃起功能障碍（ED）38例疗效与安全性分析

摘要

目的 探讨枸橼酸西地那非对系统性硬化症（又称系统性硬皮病，SSc）与男性勃起功能障碍（ED）患者的临床疗效及安全性。方法 采用回顾性研究方法，纳入2024年1月-2026年1月本院皮肤科与风湿免疫科收治的38例SSc与ED男性患者，在基础治疗不变的前提下给予枸橼酸西地那非按需口服治疗，疗程12周。以国际勃起功能指数-5（IIEF-5）评分为主要疗效指标，同时观察雷诺现象发作频率、指端溃疡愈合情况、改良Rodnan皮肤评分（mRSS）及不良反应发生情况。结果 治疗12周后，患者IIEF-5评分由治疗前（8.72±3.15）分提升至（16.34±4.28）分，差异具有统计学意义（t=10.235，P<0.01）；总有效率为71.05%（27/38），其中轻、中、重度ED患者有效率分别为100.00%、85.71%、56.52%。伴随症状方面，雷诺现象每周发作频率由（8.5±3.2）次降至（4.4±2.1）次，降幅48.3%（P<0.01）；11例合并指端溃疡患者中7例实现完全愈合，愈合率63.64%；mRSS评分治疗前后差异无统计学意义（P>0.05）。治疗期间不良反应轻微，以颜面潮红、轻度头痛为主，发生率31.58%，无严重心血管事件发生。结论 枸橼酸西地那非可显著改善系统性硬化症患者的勃起功能，同时对微血管病变具有一定缓解作用，安全性良好，可作为SSc与男性ED患者的优选治疗方案。

Abstract

Objective To investigate the clinical efficacy and safety of sildenafil citrate in the treatment of male erectile dysfunction (ED) secondary to systemic sclerosis (SSc).
Methods A retrospective study was conducted on 38 male patients with SSc complicated by ED admitted to the department of dermatology and rheumatology from January 2024 to January 2026. All patients received on-demand oral sildenafil citrate for 12 weeks on the basis of unchanged basic treatment. The International Index of Erectile Function-5 (IIEF-5) score was used as the primary efficacy endpoint. The frequency of Raynaud’s phenomenon, healing of digital ulcers, modified Rodnan skin score (mRSS) and adverse reactions were also observed.
Results After 12 weeks of treatment, the IIEF-5 score increased from 8.72±3.15 at baseline to 16.34±4.28, with a statistically significant difference (t=10.235, P<0.01). The total effective rate was 71.05% (27/38), and the effective rates in patients with mild, moderate and severe ED were 100.00%, 85.71% and 56.52%, respectively. Regarding concomitant symptoms, the weekly frequency of Raynaud’s attacks decreased from 8.5±3.2 to 4.4±2.1, with a reduction of 48.3% (P<0.01). 7 out of 11 patients with digital ulcers achieved complete healing, with a healing rate of 63.64%. There was no significant difference in mRSS score before and after treatment (P>0.05). Adverse reactions were mild, mainly facial flushing and mild headache, with an incidence of 31.58%, and no severe cardiovascular events occurred.
Conclusion   Sildenafil citrate can significantly improve erectile function in patients with systemic sclerosis, and also has a certain alleviating effect on microvascular disease with good safety. It can be used as an optimal treatment for male SSc patients with ED.